<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03837912</url>
  </required_header>
  <id_info>
    <org_study_id>CP17/00017</org_study_id>
    <nct_id>NCT03837912</nct_id>
  </id_info>
  <brief_title>Improving Patient Safety in Spanish Primary Care (PC) Centres</brief_title>
  <acronym>SinergiAPS</acronym>
  <official_title>Intervention Based on the Use of Patient Feedback Collected for Improving Patient Safety in Spanish Primary Care (PC) Centres</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació d'investigació Sanitària de les Illes Balears</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Economía y Competitividad, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació d'investigació Sanitària de les Illes Balears</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Patient safety has been defined as &quot;the avoidance, prevention, and amelioration of adverse&#xD;
      outcomes or injuries stemming from the processes of healthcare&quot;[1]. It has been on the&#xD;
      research agenda for more than two decades, but more prominently since the report 'To Err is&#xD;
      Human'[2]. To date concern about the safety of patients in hospital settings has driven most&#xD;
      research in the field, and the knowledge about patient safety in the primary care (PC)&#xD;
      setting is still sparse.&#xD;
&#xD;
      More emphasis on research on PC patient safety is needed because many safety incidents&#xD;
      identified in hospitals actually originate in PC centres[3], which is where the overwhelming&#xD;
      majority of healthcare is delivered[4]. That is especially in Spain, country with the highest&#xD;
      PC frequentation figures in Europe, (average of 9.5 PC consultations per person per year[5]).&#xD;
&#xD;
      The overall aim of this study is to develop and evaluate an intervention targeted at PC&#xD;
      professionals to improve patient safety in PC centres by providing them with feedback on&#xD;
      patient perceptions, experiences and outcomes of patient safety.&#xD;
&#xD;
      Specific objectives:&#xD;
&#xD;
        1. To translate, cross-culturally adapt and validate the &quot;Patient Reported Experiences and&#xD;
           Outcomes of Safety in Primary Care&quot; (PREOS-PC) instrument into the Spanish context.&#xD;
&#xD;
        2. To develop a feasible, acceptable, low-cost and scalable theory-based intervention&#xD;
           targeted at PC professionals to improve patient safety in PC centres by providing them&#xD;
           with feedback on patient perceptions, experiences, and outcomes of patient safety&#xD;
           collected through the Spanish version of PREOS-PC.&#xD;
&#xD;
        3. To evaluate the acceptability and perceived utility of the intervention, and its&#xD;
           effectiveness in improving safety climate, patient-reported patient safety, and reducing&#xD;
           avoidable hospitalizations, when compared to usual care.&#xD;
&#xD;
      Method/design:&#xD;
&#xD;
      This study will involve 3 stages: Stage 1 (intervention development) will involve: a)&#xD;
      qualitative study with end-users (PC providers) to explore the acceptability and utility of&#xD;
      the proposed intervention, and potential implementation barriers; b) translation,&#xD;
      cross-cultural adaptation and validation of the PREOS-PC survey for use in the Spanish&#xD;
      context; c) development of the intervention components (feedback report and educational&#xD;
      materials), and; d) development of an online tool to electronically administrate the PREOS-PC&#xD;
      and to automatically generate and send feedback reports to PC centres. Stage 2 (piloting the&#xD;
      intervention) will involve a feasibility study in 10 PC centres to inform refinement of the&#xD;
      intervention and trial procedures. Stage 3 (evaluating the intervention) will involve: a) a&#xD;
      cluster Randomized Controlled Trial to evaluate the impact of the intervention on patient&#xD;
      safety culture, patient-reported safety experiences and outcomes, and avoidable hospital&#xD;
      admissions, and; b) a qualitative study with PC providers to evaluate the acceptability and&#xD;
      perceived utility of the intervention&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODS Description of the intervention The intervention will consist in gathering&#xD;
      patient-reported experiences and outcomes of the safety of the healthcare patients received&#xD;
      in their PC centres during the previous 12 months. This information will be processed and fed&#xD;
      back to their PC professionals to help them identify potential problems, and then target&#xD;
      improvements based on problematic areas.&#xD;
&#xD;
      The 3 stages of the intervention are:&#xD;
&#xD;
        1. Measurement: Patients will be approached in the waiting room, the study explained, and&#xD;
           informed consent taken. The PREOS-PC questionnaire will be completed using a&#xD;
           tablet-computer. Patients will be given a choice of whether they would prefer to&#xD;
           self-complete the questionnaire or have it facilitated by the researcher.&#xD;
&#xD;
        2. Feedback: Using a bespoke online tool, the information for each PC centre will be&#xD;
           collated and presented to the centres in the form of an automatically generated&#xD;
           &quot;Feedback Report&quot;, which will offer comparisons with other centres and also include a&#xD;
           set of recommendations about how the problems identified could be addressed.&#xD;
&#xD;
        3. Action planning and change: Participating PC centres will form an Action Planning Team.&#xD;
           Each team will comprise around four people working in the centres. The team will be&#xD;
           responsible for receiving the Feedback Report, considering which area(s) should be&#xD;
           targeted, and developing, implementing and monitoring an action plan for safety&#xD;
           improvement.&#xD;
&#xD;
      This intervention is based on the Feedback Intervention Theory (FIT), which states that&#xD;
      behaviour is regulated through comparison with standards or goals, and that feedback can draw&#xD;
      attention to existing gaps[6]. FIT further postulates that once the gap has been identified,&#xD;
      different methods can be followed in order to decrease it and attain the standard, including&#xD;
      increasing the effort currently done[6], and implementing new strategies to address the&#xD;
      problems identified. This could result in improving proximal outcomes (such as safety&#xD;
      climate), and potentially impact more distal outcomes (e.g. incidence of safety events or&#xD;
      avoidable hospitalizations).&#xD;
&#xD;
      Development and evaluation of the intervention The methods described below are based on the&#xD;
      Medical Research Council guidance for the development and evaluation of complex&#xD;
      interventions[7]. The development and evaluation of the intervention described above will&#xD;
      involve three stages. Stage 1 (intervention development) will involve: a) a qualitative study&#xD;
      with end-users (PC providers) to explore the acceptability and utility of the proposed&#xD;
      intervention, and potential implementation barriers; b) translation, cross-cultural&#xD;
      adaptation and validation of the PREOS-PC survey for use in the Spanish context; c)&#xD;
      development of the intervention components (feedback report and educational materials), and;&#xD;
      d) development of an online tool to administrate the PREOS-PC and to automatically generate&#xD;
      and send feedback reports to PC centres. Stage 2 (piloting the intervention) will involve a&#xD;
      feasibility study in 10 PC centres (260 professionals and 500 patients). Stage 3 (evaluating&#xD;
      the intervention) will involve: a) a cluster randomized controlled trial (48 PC centres, 1248&#xD;
      professionals and 3600 patients) to evaluate the impact of the intervention on patient safety&#xD;
      culture, patient-reported safety experiences and outcomes, and avoidable hospital admissions,&#xD;
      and; b) a qualitative study with PC providers to evaluate the acceptability and perceived&#xD;
      utility of the intervention.&#xD;
&#xD;
      Stage 1: Intervention development&#xD;
&#xD;
      The development of the proposed intervention involves:&#xD;
&#xD;
        1. Qualitative study with PC providers: the investigators will conduct three&#xD;
           semi-structured interviews and four focus groups with PC doctors, nurses, and admin&#xD;
           staff (n=36) to examine the acceptability and perceived utility of the proposed&#xD;
           intervention, and to identify potential barriers towards wider implementation.&#xD;
&#xD;
        2. Translation and cross-cultural adaptation of the PREOS-PC instrument[8] into the Spanish&#xD;
           context. The translation process, based on &quot;state of the art&quot; methods[9], will consist&#xD;
           in forward and back translation by four independent translators, followed by cognitive&#xD;
           interviews with eight to ten participants (diverse in terms of age, sex, and educational&#xD;
           attainment) using the &quot;think aloud&quot; method [10] to ensure the translated version of the&#xD;
           questionnaire is easy to understand and complete. The cross-cultural adaptation will be&#xD;
           carried out using an expert consultation process involving five to seven national&#xD;
           experts in PC patient safety.&#xD;
&#xD;
        3. Development of the intervention elements: the investigators will design the Feedback&#xD;
           Report based on findings from previous studies[11-15] and from the qualitative study&#xD;
           with PC providers above described. The Feedback Report will show the results of the&#xD;
           Spanish PREOS-PC questionnaire specific for each PC centre. It will provide benchmarking&#xD;
           data - i.e., practices will be able to see their individual scores compared to the&#xD;
           average scores of the rest of participating practices. To facilitate the design of&#xD;
           action plans to address the potential safety issues identified in the Feedback Report,&#xD;
           the investigators will also produce a guidance document including a number of&#xD;
           recommendations, good practices and materials to improve patient safety in PC, which&#xD;
           will be identified as a result of a literature review of academic publications and key&#xD;
           resources provided by national and international institutions, including the World&#xD;
           Health Organization[16], the European Union Network for Patient Safety and Quality of&#xD;
           Care (PaSQ Joint Action[17]), the Agency for healthcare research and quality[18], and&#xD;
           the LINNEAUS EuroPC (Primary Care) collaboration[19], among others. The investigators&#xD;
           will also produce a registry form to help PC centres register and monitor progress of&#xD;
           the planned actions to address the safety problems identified. The intervention&#xD;
           materials will also include information to increase PC providers´ awareness of the&#xD;
           usefulness of patient elicited information as a strategy to identify potential safety&#xD;
           problems and design strategies to address them.&#xD;
&#xD;
        4. Development of an online tool: the investigators will develop a bespoke online tool to&#xD;
           allow the electronic administration of the PREOS-PC questionnaire to patients using&#xD;
           tablet-computers. The data collected will be transferred to a database stored in a&#xD;
           virtual server. Once all data has been collected from all participating patients in each&#xD;
           PC centre, the tool will automatically generate and send the Feedback Reports to each of&#xD;
           the participating centres. The tool will also be used to collect data from the&#xD;
           healthcare professionals participating in the trial, which will be stored in a separate&#xD;
           database. PC professionals will have password protected authentication to access to the&#xD;
           provider questionnaire and to access to the Feedback Report.&#xD;
&#xD;
      Stage 2: Piloting the intervention, qualitative study and refining the intervention&#xD;
&#xD;
      Piloting the intervention will involve:&#xD;
&#xD;
        1. Feasibility study: the investigators will pilot the intervention in a three-month,&#xD;
           one-arm (pre-post) feasibility trial. This will allow us to estimate the follow-up rate&#xD;
           for the main trial; test the collection of the planned primary and secondary outcome&#xD;
           data; the willingness of PC centres, providers and patients to participate; and the&#xD;
           trial procedures. It will also allow us to examine the psychometric properties (floor&#xD;
           and ceiling effects, internal consistency (calculating inter-item correlations[20] and&#xD;
           Cronbach´s α[21]), and construct validity (confirmatory factor analysis)) of the Spanish&#xD;
           PREOS-PC, and introduce final changes in the instrument if needed.&#xD;
&#xD;
           Participants will include PC centres, providers and patients.&#xD;
&#xD;
           Sample size: assuming an average of 26 healthcare professionals per centre, recruiting&#xD;
           ten centres will result in approximately 260 professionals taking part in the&#xD;
           feasibility trial. With 260 healthcare professionals, this feasibility study would allow&#xD;
           us to detect 80% follow up rate within 95% confidence intervals of 75.1% to 84.8%. With&#xD;
           500 patients (50 per centre), the study is powered to detect a patient response rate to&#xD;
           the questionnaire of 75% within 95% confidence intervals of 71.2% to 78.8%. 500&#xD;
           participants are sufficient to perform factor analyses and the rest of analyses planned&#xD;
           for the evaluation of the psychometric properties of the Spanish PREOS-PC.&#xD;
&#xD;
           Recruitment: the investigators will recruit 10 PC centres from the Balearic Islands&#xD;
           diverse in terms of list size, deprivation, and rurality. The investigators will recruit&#xD;
           patients, who will be approached in the waiting room by a research assistant and invited&#xD;
           to complete the Spanish PREOS-PC.&#xD;
&#xD;
           Statistical analysis. The investigators will calculate the overall provider follow-up&#xD;
           rate as the proportion of healthcare providers that successfully complete the Spanish&#xD;
           Medical Office Survey on Patient Safety Culture (MOSPSC)[22] at baseline and at three&#xD;
           months post-intervention. The investigators will also calculate the follow-up rate by&#xD;
           type of healthcare provider (nurse, doctor, social worker, administrative, etc.).&#xD;
           Response rate to the patient questionnaire will also be calculated. This will include&#xD;
           total response rate and response rate by centre and patient characteristics (age and&#xD;
           gender).&#xD;
&#xD;
        2. Embedded qualitative study: after the intervention period the investigators will conduct&#xD;
           semi-structured qualitative interviews with 20 healthcare professionals. They will be&#xD;
           purposefully selected to ensure variation in terms of professional roles. Thematic&#xD;
           analysis [23] will be used to explore the acceptability and perceived utility of the&#xD;
           intervention, as well as possible suggestions to improve the intervention delivery or&#xD;
           content.&#xD;
&#xD;
        3. Refining the intervention: Results from the feasibility trial will be used to inform the&#xD;
           potential refinements of the online tool to collect data and generate the Feedback&#xD;
           Reports, also about the intervention as well as the trials procedures. The investigators&#xD;
           will carry out an explicit process to decide the final intervention content, including a&#xD;
           systematic appraisal of the trial processes (both quantitative and qualitative data) and&#xD;
           proposals for solutions to identified problems.&#xD;
&#xD;
      Stage 3: Evaluating the acceptability, perceived utility and effectiveness of the&#xD;
      intervention&#xD;
&#xD;
      The evaluation of the intervention will involve:&#xD;
&#xD;
        1. Cluster randomized controlled trial: the investigators will conduct a multi-centre, 12&#xD;
           month, two-arm, two-level cluster randomized controlled trial (PC professionals within&#xD;
           PC centres; with randomization at the centre level in a 1:1 ratio). A cluster randomised&#xD;
           trial is proposed to avoid the risk of contamination across professionals working in the&#xD;
           same centre. 24 PC centres will be allocated to the control group and 24 to the&#xD;
           intervention group. PC centres in the intervention group will receive the intervention&#xD;
           described above. Centres in the control group will not receive any intervention during&#xD;
           the study period but will receive the Feedback Reports at the end of the study.&#xD;
&#xD;
           Randomization: Randomization will be done using a fully validated randomisation&#xD;
           algorithm. Allocation will be carried out using a non-deterministic minimisation&#xD;
           algorithm to ensure PC centres are balanced for important characteristics (including&#xD;
           region, deprivation, and list size) and baseline measures.&#xD;
&#xD;
           Participants: staff working and patients registered in the included PC centres.&#xD;
&#xD;
           Sample size: The sample size calculation for this trial is based on its main outcome&#xD;
           measure - the Spanish version of the MOSPSC, which ranges from 1-5. Assuming an average&#xD;
           of 26 professionals per centre, approximately 1,248 professionals will take part in the&#xD;
           study (624 in the intervention and 624 in the control group). Assuming a follow-up rate&#xD;
           of 80%, the investigators will have complete data from approximately 998 professionals.&#xD;
           Taking into account the cluster design, and using a conservative estimation of&#xD;
           intra-class correlation of 0.1, this sample size will allow us to detect at least a 0.3&#xD;
           difference in effect size (with 80% power and a significance level of 5%). This would&#xD;
           approximately correspond to a difference of 0.8 points in the index (assuming standard&#xD;
           deviation of 2.3 from a previous study) [24]. The investigators will recruit 75 patients&#xD;
           per centre (3,600 in total) because, according to the psychometric study of the original&#xD;
           version of PREOS-PC[8], that is the number of questionnaires needed to achieve a 0.7&#xD;
           reliability of scale scores at the centre level. A more precise sample size calculation&#xD;
           will be possible after the completion of the feasibility trial above described.&#xD;
&#xD;
           Recruitment and training of PC centres: The investigators will recruit 48 PC centres&#xD;
           from Balearic Islands and other regions in Spain. Centres will be recruited through&#xD;
           scientific societies and key informants. Centres will be purposefully selected in order&#xD;
           to ensure variation in terms of list size, rurality and levels of deprivation. Centres&#xD;
           will be asked to consent as a unit, with all professionals being willing to participate.&#xD;
           Consent will also be taken from patients invited to complete the patient survey.&#xD;
&#xD;
           Data collection: Data will be collected at baseline and 12 months post-intervention&#xD;
           (i.e. 12 months after the Feedback Reports are sent to the centres). The investigators&#xD;
           will monitor the progress of the intervention in all the centres. Data from patients&#xD;
           will include patient reported experiences and outcomes of patient safety in PC (measured&#xD;
           with PREOS-PC) and patient sociodemographic characteristics. Data from healthcare&#xD;
           professionals will be collected through online questionnaires and will include the&#xD;
           perceived safety climate (measured with the Spanish MOSPSC), and sociodemographic and&#xD;
           occupational characteristics. Data from centres will include rate of avoidable&#xD;
           hospitalizations in the previous 12 months (which will be extracted from electronic&#xD;
           medical records), and centre characteristics (rurality, list size, number of healthcare&#xD;
           professionals, and deprivation index).&#xD;
&#xD;
           Statistical analyses: Baseline variables will be presented by randomised group using&#xD;
           frequencies (with percentages) for binary and categorical variables and means (and&#xD;
           standard deviations) or medians (interquartile range) for continuous variables. The&#xD;
           results from the trial will be presented as comparative summary statistics (difference&#xD;
           in proportions or means) with 95% confidence intervals. The primary outcome will be&#xD;
           analysed using a hierarchical model, with individuals (PC professionals) nested within&#xD;
           PC centres in an analysis of covariance adjusted for minimisation factors. All analyses&#xD;
           will be carried out on the basis of intention-to-treat (ITT).&#xD;
&#xD;
        2. Qualitative study with PC providers (within trial qualitative evaluation): An embedded&#xD;
           qualitative study will be carried out to understand the way the intervention is&#xD;
           perceived among PC professionals in terms of acceptability, perceived utility and&#xD;
           implementation barriers (including any unintended consequences). Around 30 PC&#xD;
           professionals in the intervention centres will be invited to take part in an interview&#xD;
           at the end of the trial. The investigators will use purposeful sampling in order to&#xD;
           ensure variation in terms of type of PC professionals (doctors, nurses, administrative&#xD;
           staff, etc.) and of centres (region, rurality, deprivation, list size). Interviews will&#xD;
           take place in the centres or telephonically. Thematic analysis[23] will be used to&#xD;
           identify recurrent themes and subthemes common to interviewees working in centres.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Multi-centre, 12 month, two-arm, two-level cluster randomized controls trial (Primary Care professionals within Primary Care centres, with randomization at the centre level in a 1:1 ratio)</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Patient Safety Climate Synthetic Index</measure>
    <time_frame>At pre-intervention and after 12 months follow-up</time_frame>
    <description>Measured with the Spanish version of the Medical Office Survey on Patient Safety Culture (MOSPSC) at the PC professional level. This scale measures safety culture of the primary health centres.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Centre Activation</measure>
    <time_frame>At pre-intervention and after 12 months follow-up</time_frame>
    <description>Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (the range is from 0 to 100. Higher scores indicate better results)&#xD;
• Centre Activation (11 items; Cronbach's α of the original version=0.89). Average score of the scale.&#xD;
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Patient Activation</measure>
    <time_frame>At pre-intervention and after 12 months follow-up</time_frame>
    <description>Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)&#xD;
• Patient Activation (2 items; α=0.80). Average score of the scale.&#xD;
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Experiences of Safety Problems</measure>
    <time_frame>At pre-intervention and after 12 months follow-up</time_frame>
    <description>Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)&#xD;
• Experiences of Safety Problems (12 items; α= 0.75). Percentage of safety problems.&#xD;
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Harm</measure>
    <time_frame>At pre-intervention and after 12 months follow-up</time_frame>
    <description>Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)&#xD;
• Harm (5 items; α=0.96). Average score of the scale.&#xD;
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Overall rating of patient safety</measure>
    <time_frame>At pre-intervention and after 12 months follow-up</time_frame>
    <description>Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)&#xD;
• Overall rating of patient safety (1 item). Average score of the scale.&#xD;
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of avoidable hospitalizations</measure>
    <time_frame>At pre-intervention and after 12 months follow-up</time_frame>
    <description>Calculated as the number of avoidable hospitalizations per 1,000 patients in the last 12 months. Data on avoidable hospitalizations will be extracted from electronic medical records using available International Classification Diseases (CIE-9) codes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1248</enrollment>
  <condition>Patient Safety</condition>
  <arm_group>
    <arm_group_label>Patient reported safety experiences fed back to PC providers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will consist in gathering patient-reported experiences and outcomes of the safety of the healthcare patients received in their PC centres during the previous 12 months. This information will be processed and fed back to their healthcare professionals to help them identify potential safety problems, and then target improvements based on problematic areas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient reported safety experiences not fed back to providers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Waiting list: the practices allocated to the control group will receive the intervention (feedback report) after the trial finished (i.e., after post-intervention data collection has been completed).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient reported safety experiences fed back to PC providers</intervention_name>
    <description>The intervention will involve three key stages: a) Measurement: Patients will be invited to complete the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire using a tablet-computer. b) Feedback: Using a bespoke online tool, the information will be processed and presented to each centre in the form of a Feedback Report, which will offer comparisons with other centres along with a set of recommendations for addressing the problems identified. c) Action planning and change: centres will form an Action Planning Team, which will be responsible for analyzing the report, considering which area(s) should be improved, and developing, implementing and monitoring an action plan to address the safety problems identified.</description>
    <arm_group_label>Patient reported safety experiences fed back to PC providers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who to have visited their PC centre at least once in the previous 12 months.&#xD;
&#xD;
          -  have to be able to speak Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  overt psychosis/critically ill/altered mental status&#xD;
&#xD;
          -  inability to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ignacio Ricci-Cabello, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut d'Investigació Sanitària de les Illes Balears</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ignacio Ricci-Cabello</name>
      <address>
        <city>Palma De Mallorca</city>
        <state>Balearic Islands</state>
        <zip>07002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://www.wiley.com/en-es/Patient+Safety,+2nd+Edition-p-9781405192217</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.pasq.eu</url>
    <description>The European Union Network for Patient Safety and Quality of Care, PaSQ Joint Action</description>
  </link>
  <link>
    <url>http://www.ahrq.gov.</url>
    <description>Agency for Healthcare Research and Quality</description>
  </link>
  <link>
    <url>https://cordis.europa.eu/project/rcn/90964/reporting/en</url>
    <description>Learning from International Networks about Errors and Understanding Safety in Primary Care</description>
  </link>
  <reference>
    <citation>Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/</citation>
    <PMID>25077248</PMID>
  </reference>
  <reference>
    <citation>Woods DM, Thomas EJ, Holl JL, Weiss KB, Brennan TA. Ambulatory care adverse events and preventable adverse events leading to a hospital admission. Qual Saf Health Care. 2007 Apr;16(2):127-31. doi: 10.1136/qshc.2006.021147.</citation>
    <PMID>17403759</PMID>
  </reference>
  <reference>
    <citation>Green LA, Fryer GE Jr, Yawn BP, Lanier D, Dovey SM. The ecology of medical care revisited. N Engl J Med. 2001 Jun 28;344(26):2021-5. doi: 10.1056/NEJM200106283442611. No abstract available.</citation>
    <PMID>11430334</PMID>
  </reference>
  <reference>
    <citation>Aranaz-Andres JM, Aibar C, Limon R, Mira JJ, Vitaller J, Agra Y, Terol E. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health. 2012 Dec;22(6):921-5. doi: 10.1093/eurpub/ckr168. Epub 2011 Nov 29.</citation>
    <PMID>23180803</PMID>
  </reference>
  <reference>
    <citation>Kluger, A.N. and A. DeNisi, The effects of feedback interventions on performance: a historical review, a meta-analysis, and a preliminary feedback intervention theory. Psychological bulletin, 1996. 119(2): p. 254.</citation>
  </reference>
  <reference>
    <citation>Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.</citation>
    <PMID>23159157</PMID>
  </reference>
  <reference>
    <citation>Ricci-Cabello I, Avery AJ, Reeves D, Kadam UT, Valderas JM. Measuring Patient Safety in Primary Care: The Development and Validation of the &quot;Patient Reported Experiences and Outcomes of Safety in Primary Care&quot; (PREOS-PC). Ann Fam Med. 2016 May;14(3):253-61. doi: 10.1370/afm.1935.</citation>
    <PMID>27184996</PMID>
  </reference>
  <reference>
    <citation>Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.</citation>
    <PMID>15804318</PMID>
  </reference>
  <reference>
    <citation>Someren, Maarten &amp; Barnard, Yvonne &amp; Sandberg, Jacobijn. (1994). The Think Aloud Method - A Practical Guide to Modelling Cognitive Processes.</citation>
  </reference>
  <reference>
    <citation>Boyce MB, Browne JP. Does providing feedback on patient-reported outcomes to healthcare professionals result in better outcomes for patients? A systematic review. Qual Life Res. 2013 Nov;22(9):2265-78. doi: 10.1007/s11136-013-0390-0. Epub 2013 Mar 17.</citation>
    <PMID>23504544</PMID>
  </reference>
  <reference>
    <citation>Kasbauer S, Cooper R, Kelly L, King J. Barriers and facilitators of a near real-time feedback approach for measuring patient experiences of hospital care. Health Policy Technol. 2017 Mar;6(1):51-58. doi: 10.1016/j.hlpt.2016.09.003.</citation>
    <PMID>28367401</PMID>
  </reference>
  <reference>
    <citation>Lawton R, O'Hara JK, Sheard L, Armitage G, Cocks K, Buckley H, Corbacho B, Reynolds C, Marsh C, Moore S, Watt I, Wright J. Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention. BMJ Qual Saf. 2017 Aug;26(8):622-631. doi: 10.1136/bmjqs-2016-005570. Epub 2017 Feb 3.</citation>
    <PMID>28159854</PMID>
  </reference>
  <reference>
    <citation>Porter I, Goncalves-Bradley D, Ricci-Cabello I, Gibbons C, Gangannagaripalli J, Fitzpatrick R, Black N, Greenhalgh J, Valderas JM. Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities. J Comp Eff Res. 2016 Aug;5(5):507-19. doi: 10.2217/cer-2015-0014. Epub 2016 Jul 18.</citation>
    <PMID>27427277</PMID>
  </reference>
  <reference>
    <citation>Greenhalgh J, Dalkin S, Gooding K, Gibbons E, Wright J, Meads D, Black N, Valderas JM, Pawson R. Functionality and feedback: a realist synthesis of the collation, interpretation and utilisation of patient-reported outcome measures data to improve patient care. Southampton (UK): NIHR Journals Library; 2017 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK409450/</citation>
    <PMID>28121094</PMID>
  </reference>
  <reference>
    <citation>Nunnally, J.C. and I.H. Bernstein, Psychometric theory. Vol. 226. 1967: McGraw-Hill New York.</citation>
  </reference>
  <reference>
    <citation>Silvestre-Busto C, Torijano-Casalengua ML, Olivera-Canadas G, Astier-Pena MP, Maderuelo-Fernandez JA, Rubio-Aguado EA. [Adaptation of the Medical Office Survey on Patient Safety Culture (MOSPSC) tool]. Rev Calid Asist. 2015 Jan-Feb;30(1):24-30. doi: 10.1016/j.cali.2014.12.006. Epub 2015 Feb 7. Spanish.</citation>
    <PMID>25659444</PMID>
  </reference>
  <reference>
    <citation>Guest, G., K.M. MacQueen, and E.E. Namey, Applied thematic analysis. 2011: sage.</citation>
  </reference>
  <reference>
    <citation>Ricci-Cabello I, Marsden KS, Avery AJ, Bell BG, Kadam UT, Reeves D, Slight SP, Perryman K, Barnett J, Litchfield I, Thomas S, Campbell SM, Doos L, Esmail A, Valderas JM. Patients' evaluations of patient safety in English general practices: a cross-sectional study. Br J Gen Pract. 2017 Jul;67(660):e474-e482. doi: 10.3399/bjgp17X691085. Epub 2017 Jun 5.</citation>
    <PMID>28583945</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cluster randomized controlled trial</keyword>
  <keyword>primary health care</keyword>
  <keyword>patient safety</keyword>
  <keyword>patient-centred care</keyword>
  <keyword>patient-reported experiences and outcomes measures</keyword>
  <keyword>audit and feedback interventions.</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03837912
org study id: CP17/00017
nct id: NCT03837912
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background:

      Patient safety has been defined as "the avoidance, prevention, and amelioration of adverse
      outcomes or injuries stemming from the processes of healthcare"[1]. It has been on the
      research agenda for more than two decades, but more prominently since the report 'To Err is
      Human'[2]. To date concern about the safety of patients in hospital settings has driven most
      research in the field, and the knowledge about patient safety in the primary care (PC)
      setting is still sparse.

      More emphasis on research on PC patient safety is needed because many safety incidents
      identified in hospitals actually originate in PC centres[3], which is where the overwhelming
      majority of healthcare is delivered[4]. That is especially in Spain, country with the highest
      PC frequentation figures in Europe, (average of 9.5 PC consultations per person per year[5]).

      The overall aim of this study is to develop and evaluate an intervention targeted at PC
      professionals to improve patient safety in PC centres by providing them with feedback on
      patient perceptions, experiences and outcomes of patient safety.

      Specific objectives:

        1. To translate, cross-culturally adapt and validate the "Patient Reported Experiences and
           Outcomes of Safety in Primary Care" (PREOS-PC) instrument into the Spanish context.

        2. To develop a feasible, acceptable, low-cost and scalable theory-based intervention
           targeted at PC professionals to improve patient safety in PC centres by providing them
           with feedback on patient perceptions, experiences, and outcomes of patient safety
           collected through the Spanish version of PREOS-PC.

        3. To evaluate the acceptability and perceived utility of the intervention, and its
           effectiveness in improving safety climate, patient-reported patient safety, and reducing
           avoidable hospitalizations, when compared to usual care.

      Method/design:

      This study will involve 3 stages: Stage 1 (intervention development) will involve: a)
      qualitative study with end-users (PC providers) to explore the acceptability and utility of
      the proposed intervention, and potential implementation barriers; b) translation,
      cross-cultural adaptation and validation of the PREOS-PC survey for use in the Spanish
      context; c) development of the intervention components (feedback report and educational
      materials), and; d) development of an online tool to electronically administrate the PREOS-PC
      and to automatically generate and send feedback reports to PC centres. Stage 2 (piloting the
      intervention) will involve a feasibility study in 10 PC centres to inform refinement of the
      intervention and trial procedures. Stage 3 (evaluating the intervention) will involve: a) a
      cluster Randomized Controlled Trial to evaluate the impact of the intervention on patient
      safety culture, patient-reported safety experiences and outcomes, and avoidable hospital
      admissions, and; b) a qualitative study with PC providers to evaluate the acceptability and
      perceived utility of the intervention
METHODS Description of the intervention The intervention will consist in gathering
      patient-reported experiences and outcomes of the safety of the healthcare patients received
      in their PC centres during the previous 12 months. This information will be processed and fed
      back to their PC professionals to help them identify potential problems, and then target
      improvements based on problematic areas.

      The 3 stages of the intervention are:

        1. Measurement: Patients will be approached in the waiting room, the study explained, and
           informed consent taken. The PREOS-PC questionnaire will be completed using a
           tablet-computer. Patients will be given a choice of whether they would prefer to
           self-complete the questionnaire or have it facilitated by the researcher.

        2. Feedback: Using a bespoke online tool, the information for each PC centre will be
           collated and presented to the centres in the form of an automatically generated
           "Feedback Report", which will offer comparisons with other centres and also include a
           set of recommendations about how the problems identified could be addressed.

        3. Action planning and change: Participating PC centres will form an Action Planning Team.
           Each team will comprise around four people working in the centres. The team will be
           responsible for receiving the Feedback Report, considering which area(s) should be
           targeted, and developing, implementing and monitoring an action plan for safety
           improvement.

      This intervention is based on the Feedback Intervention Theory (FIT), which states that
      behaviour is regulated through comparison with standards or goals, and that feedback can draw
      attention to existing gaps[6]. FIT further postulates that once the gap has been identified,
      different methods can be followed in order to decrease it and attain the standard, including
      increasing the effort currently done[6], and implementing new strategies to address the
      problems identified. This could result in improving proximal outcomes (such as safety
      climate), and potentially impact more distal outcomes (e.g. incidence of safety events or
      avoidable hospitalizations).

      Development and evaluation of the intervention The methods described below are based on the
      Medical Research Council guidance for the development and evaluation of complex
      interventions[7]. The development and evaluation of the intervention described above will
      involve three stages. Stage 1 (intervention development) will involve: a) a qualitative study
      with end-users (PC providers) to explore the acceptability and utility of the proposed
      intervention, and potential implementation barriers; b) translation, cross-cultural
      adaptation and validation of the PREOS-PC survey for use in the Spanish context; c)
      development of the intervention components (feedback report and educational materials), and;
      d) development of an online tool to administrate the PREOS-PC and to automatically generate
      and send feedback reports to PC centres. Stage 2 (piloting the intervention) will involve a
      feasibility study in 10 PC centres (260 professionals and 500 patients). Stage 3 (evaluating
      the intervention) will involve: a) a cluster randomized controlled trial (48 PC centres, 1248
      professionals and 3600 patients) to evaluate the impact of the intervention on patient safety
      culture, patient-reported safety experiences and outcomes, and avoidable hospital admissions,
      and; b) a qualitative study with PC providers to evaluate the acceptability and perceived
      utility of the intervention.

      Stage 1: Intervention development

      The development of the proposed intervention involves:

        1. Qualitative study with PC providers: the investigators will conduct three
           semi-structured interviews and four focus groups with PC doctors, nurses, and admin
           staff (n=36) to examine the acceptability and perceived utility of the proposed
           intervention, and to identify potential barriers towards wider implementation.

        2. Translation and cross-cultural adaptation of the PREOS-PC instrument[8] into the Spanish
           context. The translation process, based on "state of the art" methods[9], will consist
           in forward and back translation by four independent translators, followed by cognitive
           interviews with eight to ten participants (diverse in terms of age, sex, and educational
           attainment) using the "think aloud" method [10] to ensure the translated version of the
           questionnaire is easy to understand and complete. The cross-cultural adaptation will be
           carried out using an expert consultation process involving five to seven national
           experts in PC patient safety.

        3. Development of the intervention elements: the investigators will design the Feedback
           Report based on findings from previous studies[11-15] and from the qualitative study
           with PC providers above described. The Feedback Report will show the results of the
           Spanish PREOS-PC questionnaire specific for each PC centre. It will provide benchmarking
           data - i.e., practices will be able to see their individual scores compared to the
           average scores of the rest of participating practices. To facilitate the design of
           action plans to address the potential safety issues identified in the Feedback Report,
           the investigators will also produce a guidance document including a number of
           recommendations, good practices and materials to improve patient safety in PC, which
           will be identified as a result of a literature review of academic publications and key
           resources provided by national and international institutions, including the World
           Health Organization[16], the European Union Network for Patient Safety and Quality of
           Care (PaSQ Joint Action[17]), the Agency for healthcare research and quality[18], and
           the LINNEAUS EuroPC (Primary Care) collaboration[19], among others. The investigators
           will also produce a registry form to help PC centres register and monitor progress of
           the planned actions to address the safety problems identified. The intervention
           materials will also include information to increase PC providers´ awareness of the
           usefulness of patient elicited information as a strategy to identify potential safety
           problems and design strategies to address them.

        4. Development of an online tool: the investigators will develop a bespoke online tool to
           allow the electronic administration of the PREOS-PC questionnaire to patients using
           tablet-computers. The data collected will be transferred to a database stored in a
           virtual server. Once all data has been collected from all participating patients in each
           PC centre, the tool will automatically generate and send the Feedback Reports to each of
           the participating centres. The tool will also be used to collect data from the
           healthcare professionals participating in the trial, which will be stored in a separate
           database. PC professionals will have password protected authentication to access to the
           provider questionnaire and to access to the Feedback Report.

      Stage 2: Piloting the intervention, qualitative study and refining the intervention

      Piloting the intervention will involve:

        1. Feasibility study: the investigators will pilot the intervention in a three-month,
           one-arm (pre-post) feasibility trial. This will allow us to estimate the follow-up rate
           for the main trial; test the collection of the planned primary and secondary outcome
           data; the willingness of PC centres, providers and patients to participate; and the
           trial procedures. It will also allow us to examine the psychometric properties (floor
           and ceiling effects, internal consistency (calculating inter-item correlations[20] and
           Cronbach´s α[21]), and construct validity (confirmatory factor analysis)) of the Spanish
           PREOS-PC, and introduce final changes in the instrument if needed.

           Participants will include PC centres, providers and patients.

           Sample size: assuming an average of 26 healthcare professionals per centre, recruiting
           ten centres will result in approximately 260 professionals taking part in the
           feasibility trial. With 260 healthcare professionals, this feasibility study would allow
           us to detect 80% follow up rate within 95% confidence intervals of 75.1% to 84.8%. With
           500 patients (50 per centre), the study is powered to detect a patient response rate to
           the questionnaire of 75% within 95% confidence intervals of 71.2% to 78.8%. 500
           participants are sufficient to perform factor analyses and the rest of analyses planned
           for the evaluation of the psychometric properties of the Spanish PREOS-PC.

           Recruitment: the investigators will recruit 10 PC centres from the Balearic Islands
           diverse in terms of list size, deprivation, and rurality. The investigators will recruit
           patients, who will be approached in the waiting room by a research assistant and invited
           to complete the Spanish PREOS-PC.

           Statistical analysis. The investigators will calculate the overall provider follow-up
           rate as the proportion of healthcare providers that successfully complete the Spanish
           Medical Office Survey on Patient Safety Culture (MOSPSC)[22] at baseline and at three
           months post-intervention. The investigators will also calculate the follow-up rate by
           type of healthcare provider (nurse, doctor, social worker, administrative, etc.).
           Response rate to the patient questionnaire will also be calculated. This will include
           total response rate and response rate by centre and patient characteristics (age and
           gender).

        2. Embedded qualitative study: after the intervention period the investigators will conduct
           semi-structured qualitative interviews with 20 healthcare professionals. They will be
           purposefully selected to ensure variation in terms of professional roles. Thematic
           analysis [23] will be used to explore the acceptability and perceived utility of the
           intervention, as well as possible suggestions to improve the intervention delivery or
           content.

        3. Refining the intervention: Results from the feasibility trial will be used to inform the
           potential refinements of the online tool to collect data and generate the Feedback
           Reports, also about the intervention as well as the trials procedures. The investigators
           will carry out an explicit process to decide the final intervention content, including a
           systematic appraisal of the trial processes (both quantitative and qualitative data) and
           proposals for solutions to identified problems.

      Stage 3: Evaluating the acceptability, perceived utility and effectiveness of the
      intervention

      The evaluation of the intervention will involve:

        1. Cluster randomized controlled trial: the investigators will conduct a multi-centre, 12
           month, two-arm, two-level cluster randomized controlled trial (PC professionals within
           PC centres; with randomization at the centre level in a 1:1 ratio). A cluster randomised
           trial is proposed to avoid the risk of contamination across professionals working in the
           same centre. 24 PC centres will be allocated to the control group and 24 to the
           intervention group. PC centres in the intervention group will receive the intervention
           described above. Centres in the control group will not receive any intervention during
           the study period but will receive the Feedback Reports at the end of the study.

           Randomization: Randomization will be done using a fully validated randomisation
           algorithm. Allocation will be carried out using a non-deterministic minimisation
           algorithm to ensure PC centres are balanced for important characteristics (including
           region, deprivation, and list size) and baseline measures.

           Participants: staff working and patients registered in the included PC centres.

           Sample size: The sample size calculation for this trial is based on its main outcome
           measure - the Spanish version of the MOSPSC, which ranges from 1-5. Assuming an average
           of 26 professionals per centre, approximately 1,248 professionals will take part in the
           study (624 in the intervention and 624 in the control group). Assuming a follow-up rate
           of 80%, the investigators will have complete data from approximately 998 professionals.
           Taking into account the cluster design, and using a conservative estimation of
           intra-class correlation of 0.1, this sample size will allow us to detect at least a 0.3
           difference in effect size (with 80% power and a significance level of 5%). This would
           approximately correspond to a difference of 0.8 points in the index (assuming standard
           deviation of 2.3 from a previous study) [24]. The investigators will recruit 75 patients
           per centre (3,600 in total) because, according to the psychometric study of the original
           version of PREOS-PC[8], that is the number of questionnaires needed to achieve a 0.7
           reliability of scale scores at the centre level. A more precise sample size calculation
           will be possible after the completion of the feasibility trial above described.

           Recruitment and training of PC centres: The investigators will recruit 48 PC centres
           from Balearic Islands and other regions in Spain. Centres will be recruited through
           scientific societies and key informants. Centres will be purposefully selected in order
           to ensure variation in terms of list size, rurality and levels of deprivation. Centres
           will be asked to consent as a unit, with all professionals being willing to participate.
           Consent will also be taken from patients invited to complete the patient survey.

           Data collection: Data will be collected at baseline and 12 months post-intervention
           (i.e. 12 months after the Feedback Reports are sent to the centres). The investigators
           will monitor the progress of the intervention in all the centres. Data from patients
           will include patient reported experiences and outcomes of patient safety in PC (measured
           with PREOS-PC) and patient sociodemographic characteristics. Data from healthcare
           professionals will be collected through online questionnaires and will include the
           perceived safety climate (measured with the Spanish MOSPSC), and sociodemographic and
           occupational characteristics. Data from centres will include rate of avoidable
           hospitalizations in the previous 12 months (which will be extracted from electronic
           medical records), and centre characteristics (rurality, list size, number of healthcare
           professionals, and deprivation index).

           Statistical analyses: Baseline variables will be presented by randomised group using
           frequencies (with percentages) for binary and categorical variables and means (and
           standard deviations) or medians (interquartile range) for continuous variables. The
           results from the trial will be presented as comparative summary statistics (difference
           in proportions or means) with 95% confidence intervals. The primary outcome will be
           analysed using a hierarchical model, with individuals (PC professionals) nested within
           PC centres in an analysis of covariance adjusted for minimisation factors. All analyses
           will be carried out on the basis of intention-to-treat (ITT).

        2. Qualitative study with PC providers (within trial qualitative evaluation): An embedded
           qualitative study will be carried out to understand the way the intervention is
           perceived among PC professionals in terms of acceptability, perceived utility and
           implementation barriers (including any unintended consequences). Around 30 PC
           professionals in the intervention centres will be invited to take part in an interview
           at the end of the trial. The investigators will use purposeful sampling in order to
           ensure variation in terms of type of PC professionals (doctors, nurses, administrative
           staff, etc.) and of centres (region, rurality, deprivation, list size). Interviews will
           take place in the centres or telephonically. Thematic analysis[23] will be used to
           identify recurrent themes and subthemes common to interviewees working in centres.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multi-centre, 12 month, two-arm, two-level cluster randomized controls trial (Primary Care professionals within Primary Care centres, with randomization at the centre level in a 1:1 ratio)
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in the Patient Safety Climate Synthetic Index
time frame: At pre-intervention and after 12 months follow-up
description: Measured with the Spanish version of the Medical Office Survey on Patient Safety Culture (MOSPSC) at the PC professional level. This scale measures safety culture of the primary health centres.
measure: Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Centre Activation
time frame: At pre-intervention and after 12 months follow-up
description: Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (the range is from 0 to 100. Higher scores indicate better results)
• Centre Activation (11 items; Cronbach's α of the original version=0.89). Average score of the scale.
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.
measure: Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Patient Activation
time frame: At pre-intervention and after 12 months follow-up
description: Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Patient Activation (2 items; α=0.80). Average score of the scale.
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.
measure: Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Experiences of Safety Problems
time frame: At pre-intervention and after 12 months follow-up
description: Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Experiences of Safety Problems (12 items; α= 0.75). Percentage of safety problems.
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.
measure: Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Harm
time frame: At pre-intervention and after 12 months follow-up
description: Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Harm (5 items; α=0.96). Average score of the scale.
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.
measure: Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC): Overall rating of patient safety
time frame: At pre-intervention and after 12 months follow-up
description: Patient-Reported Patient Safety questionnaire measures the patient safety experiences in Primary Care settings. The following scales from the Spanish PREOS-PC will be used (for each scale the range is from 0 to 100. Higher scores indicate better results)
• Overall rating of patient safety (1 item). Average score of the scale.
For each scale, PC centre level scores will be calculated as the mean score from patients registered in the PC centre. Patient scores will be calculated as the percentage of the maximum score achievable on all items.
measure: Rate of avoidable hospitalizations
time frame: At pre-intervention and after 12 months follow-up
description: Calculated as the number of avoidable hospitalizations per 1,000 patients in the last 12 months. Data on avoidable hospitalizations will be extracted from electronic medical records using available International Classification Diseases (CIE-9) codes
arm group label: Patient reported safety experiences fed back to PC providers
arm group type: Experimental
description: The intervention will consist in gathering patient-reported experiences and outcomes of the safety of the healthcare patients received in their PC centres during the previous 12 months. This information will be processed and fed back to their healthcare professionals to help them identify potential safety problems, and then target improvements based on problematic areas.
arm group label: Patient reported safety experiences not fed back to providers
arm group type: No Intervention
description: Waiting list: the practices allocated to the control group will receive the intervention (feedback report) after the trial finished (i.e., after post-intervention data collection has been completed).
intervention type: Behavioral
intervention name: Patient reported safety experiences fed back to PC providers
description: The intervention will involve three key stages: a) Measurement: Patients will be invited to complete the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire using a tablet-computer. b) Feedback: Using a bespoke online tool, the information will be processed and presented to each centre in the form of a Feedback Report, which will offer comparisons with other centres along with a set of recommendations for addressing the problems identified. c) Action planning and change: centres will form an Action Planning Team, which will be responsible for analyzing the report, considering which area(s) should be improved, and developing, implementing and monitoring an action plan to address the safety problems identified.
arm group label: Patient reported safety experiences fed back to PC providers
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ignacio Ricci-Cabello, PhD
role: Principal Investigator
affiliation: Institut d'Investigació Sanitària de les Illes Balears
facility: 
country: Spain
url: https://www.wiley.com/en-es/Patient+Safety,+2nd+Edition-p-9781405192217
description: Related Info
url: http://www.pasq.eu
description: The European Union Network for Patient Safety and Quality of Care, PaSQ Joint Action
url: http://www.ahrq.gov.
description: Agency for Healthcare Research and Quality
url: https://cordis.europa.eu/project/rcn/90964/reporting/en
description: Learning from International Networks about Errors and Understanding Safety in Primary Care
citation: Institute of Medicine (US) Committee on Quality of Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, editors. To Err is Human: Building a Safer Health System. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225182/
PMID: 25077248
citation: Woods DM, Thomas EJ, Holl JL, Weiss KB, Brennan TA. Ambulatory care adverse events and preventable adverse events leading to a hospital admission. Qual Saf Health Care. 2007 Apr;16(2):127-31. doi: 10.1136/qshc.2006.021147.
PMID: 17403759
citation: Green LA, Fryer GE Jr, Yawn BP, Lanier D, Dovey SM. The ecology of medical care revisited. N Engl J Med. 2001 Jun 28;344(26):2021-5. doi: 10.1056/NEJM200106283442611. No abstract available.
PMID: 11430334
citation: Aranaz-Andres JM, Aibar C, Limon R, Mira JJ, Vitaller J, Agra Y, Terol E. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health. 2012 Dec;22(6):921-5. doi: 10.1093/eurpub/ckr168. Epub 2011 Nov 29.
PMID: 23180803
citation: Kluger, A.N. and A. DeNisi, The effects of feedback interventions on performance: a historical review, a meta-analysis, and a preliminary feedback intervention theory. Psychological bulletin, 1996. 119(2): p. 254.
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
PMID: 23159157
citation: Ricci-Cabello I, Avery AJ, Reeves D, Kadam UT, Valderas JM. Measuring Patient Safety in Primary Care: The Development and Validation of the "Patient Reported Experiences and Outcomes of Safety in Primary Care" (PREOS-PC). Ann Fam Med. 2016 May;14(3):253-61. doi: 10.1370/afm.1935.
PMID: 27184996
citation: Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
PMID: 15804318
citation: Someren, Maarten & Barnard, Yvonne & Sandberg, Jacobijn. (1994). The Think Aloud Method - A Practical Guide to Modelling Cognitive Processes.
citation: Boyce MB, Browne JP. Does providing feedback on patient-reported outcomes to healthcare professionals result in better outcomes for patients? A systematic review. Qual Life Res. 2013 Nov;22(9):2265-78. doi: 10.1007/s11136-013-0390-0. Epub 2013 Mar 17.
PMID: 23504544
citation: Kasbauer S, Cooper R, Kelly L, King J. Barriers and facilitators of a near real-time feedback approach for measuring patient experiences of hospital care. Health Policy Technol. 2017 Mar;6(1):51-58. doi: 10.1016/j.hlpt.2016.09.003.
PMID: 28367401
citation: Lawton R, O'Hara JK, Sheard L, Armitage G, Cocks K, Buckley H, Corbacho B, Reynolds C, Marsh C, Moore S, Watt I, Wright J. Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention. BMJ Qual Saf. 2017 Aug;26(8):622-631. doi: 10.1136/bmjqs-2016-005570. Epub 2017 Feb 3.
PMID: 28159854
citation: Porter I, Goncalves-Bradley D, Ricci-Cabello I, Gibbons C, Gangannagaripalli J, Fitzpatrick R, Black N, Greenhalgh J, Valderas JM. Framework and guidance for implementing patient-reported outcomes in clinical practice: evidence, challenges and opportunities. J Comp Eff Res. 2016 Aug;5(5):507-19. doi: 10.2217/cer-2015-0014. Epub 2016 Jul 18.
PMID: 27427277
citation: Greenhalgh J, Dalkin S, Gooding K, Gibbons E, Wright J, Meads D, Black N, Valderas JM, Pawson R. Functionality and feedback: a realist synthesis of the collation, interpretation and utilisation of patient-reported outcome measures data to improve patient care. Southampton (UK): NIHR Journals Library; 2017 Jan. Available from http://www.ncbi.nlm.nih.gov/books/NBK409450/
PMID: 28121094
citation: Nunnally, J.C. and I.H. Bernstein, Psychometric theory. Vol. 226. 1967: McGraw-Hill New York.
citation: Silvestre-Busto C, Torijano-Casalengua ML, Olivera-Canadas G, Astier-Pena MP, Maderuelo-Fernandez JA, Rubio-Aguado EA. [Adaptation of the Medical Office Survey on Patient Safety Culture (MOSPSC) tool]. Rev Calid Asist. 2015 Jan-Feb;30(1):24-30. doi: 10.1016/j.cali.2014.12.006. Epub 2015 Feb 7. Spanish.
PMID: 25659444
citation: Guest, G., K.M. MacQueen, and E.E. Namey, Applied thematic analysis. 2011: sage.
citation: Ricci-Cabello I, Marsden KS, Avery AJ, Bell BG, Kadam UT, Reeves D, Slight SP, Perryman K, Barnett J, Litchfield I, Thomas S, Campbell SM, Doos L, Esmail A, Valderas JM. Patients' evaluations of patient safety in English general practices: a cross-sectional study. Br J Gen Pract. 2017 Jul;67(660):e474-e482. doi: 10.3399/bjgp17X691085. Epub 2017 Jun 5.
PMID: 28583945
responsible party type: Sponsor
sharing ipd: No