<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/NCT02212171</url>
  </required_header>
  <id_info>
    <org_study_id>TRIAP</org_study_id>
    <secondary_id>2011111131</secondary_id>
    <nct_id>NCT02212171</nct_id>
  </id_info>
  <brief_title>TRIAP: Is Triage by Healthcare Mini-teams Effective to Improve Efficiency in Primary Health Care?</brief_title>
  <acronym>TRIAP</acronym>
  <official_title>TRIAP: Is Triage by Healthcare Mini-teams Effective to Improve Efficiency in Primary Health Care?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Basque Health Service</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Basque Health Service</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: With new challenges for healthcare, there is a clear consensus among experts on&#xD;
      the need to introduce changes in the organization of care in health centres to address the&#xD;
      problems of over-attendance, bureaucratization and other emerging issues that require growing&#xD;
      amounts of attention. However, there has been insufficient research into possible models and&#xD;
      the impact of their adoption.&#xD;
&#xD;
      The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new&#xD;
      organizational model based on triage and healthcare mini-teams (two general&#xD;
      practitioners/pediatricians, two nurses and one member of the administrative staff) compared&#xD;
      to the current model, aiming to achieve a correct classification of the healthcare needs of&#xD;
      the primary care population and direct them to the most suitable professional.&#xD;
&#xD;
      In addition, the implementation research objective is to identify the facilitators for and&#xD;
      barriers to the implementation of the intervention in the context of primary care.&#xD;
&#xD;
      Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14&#xD;
      healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the&#xD;
      Basque Healthcare Service (Osakidetza) Interior Health Region.&#xD;
&#xD;
      The results will be assessed using the data on morbidity-adjusted attendance of users to&#xD;
      their family doctor, number of referral, addition of new activities to the portfolio of&#xD;
      services, and patient perception and professional satisfaction. All the variables will be&#xD;
      measured at baseline and at the end of the intervention, 24 months later.&#xD;
&#xD;
      Using covariance analysis models, the investigators will estimate the effect attributable to&#xD;
      the intervention by analyzing differences in changes between the two groups, and calculating&#xD;
      the 95% confidence interval, adjusting the comparisons for baseline values. The investigators&#xD;
      will also adjust for potential confounding and effect-modifying variables.&#xD;
&#xD;
      Nominal groups will be held at the end of the intervention with the participation of all the&#xD;
      agents involved in intervention centres to identify the facilitators for and barriers to the&#xD;
      implementation of the intervention.&#xD;
&#xD;
      Discussion: There is a need to develop new forms of organization in primary care services to&#xD;
      respond to new healthcare demands. To pursue this aim, changes have to be introduced in the&#xD;
      organization of healthcare within health centres, redefining the roles of primary care&#xD;
      professionals and refocusing their activity towards population health needs, seeking greater&#xD;
      efficiency in health services.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients attendance</measure>
    <time_frame>Baseline and at 24 months</time_frame>
    <description>Number of visits of the patients to their GP and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.&#xD;
The patients will be classified using the ACG system, on the basis of their age, sex and ICD-9-CM codes of health problems diagnosed over a year in visits to their GP/paediatrician. The ACG case-mix system was designed by researchers at Johns Hopkins University, originally for care on an outpatient basis, and classifies the population into around 100 self-excluding categories.&#xD;
Regardless of the number of contacts with the healthcare services, each person is classified every year into a single ACG depending on their age, sex, and combination of diagnoses they were assigned over the previous 12 months. For this study, we will use the ACG Assignment Software version 7.00.&#xD;
All the tasks performed will be recorded in the Osabide computer system of the Basque Health Service.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients referral: number of patient referrals by GPs and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.</measure>
    <time_frame>Baseline and at 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New activities added to the current portfolio of services</measure>
    <time_frame>Baseline and at 24 months</time_frame>
    <description>Number of programmed activities of health promotion, joint review of medical records by the doctors and nurses to improve the management of certain groups of patients, minor surgery services in PC, activities for achieving a comprehensive approach to managing non-surgical osteomuscular disorders and the use of ultrasound scans.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Baseline and at 24 months</time_frame>
    <description>Measured using the Primary Care Assessment Tool (PCAT) Pasarín MI et al. Evaluation of primary care: The &quot;Primary Care Assessment Tools - Facility version&quot; for the Spanish health system. Gac Sanit. 2013 Jan-Feb;27(1):12-8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction of health professionals</measure>
    <time_frame>Baseline and at 24 months</time_frame>
    <description>In terms of professional quality of life measured using the Professional Quality of Life questionnaire (PQL-35).&#xD;
Cabezas, C. La calidad de vida de los profesionales. FMC. 2000;7 (Supl 7):53-68.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10000</enrollment>
  <condition>Organization of Health Service</condition>
  <arm_group>
    <arm_group_label>TRIAP intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care: Patients in the control group will be treated according to Osakidetza recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TRIAP</intervention_name>
    <description>The primary healthcare professionals organised in healthcare mini-teams, composed of 2 doctors, 2 nurses and 1 member of the administrative staff.&#xD;
Administrative staff:&#xD;
Following a flow chart, they will refer patients with mild self-limiting illnesses as well as consultations regarding chronic disorders in adults to the nurses. They will also perform administrative tasks such as the printing of prescriptions, sick leave reports and medical notes (justifying absence), etc.&#xD;
Nursing staff:&#xD;
They will carry out activities focused on health promotion, self-management and de-medicalisation during visits from patients with mild self-limiting illnesses as well as appointments for chronic diseases in adults.&#xD;
GP:&#xD;
They will develop the new portfolio of services: health promotion, joint review of patient medical records by doctors and nurses to improve the management of certain groups of patients, and organization of minor surgery services, etc.</description>
    <arm_group_label>TRIAP intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study populations are patients of the seven mini-teams established, these&#xD;
             professionals being responsible for the GP lists in the health centres of San Miguel&#xD;
             in Basauri, Miraballes and Ondarroa, and the paediatric list in Etxebarri health&#xD;
             centre. The control units are from the health centres of Basauri-Ariz, Arratia,&#xD;
             Amorebieta and Bermeo, all located in the Interior Health Region.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>
  <location>
    <facility>
      <name>Basque Healthcare Service</name>
      <address>
        <city>Vitoria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 4, 2015</last_update_submitted>
  <last_update_submitted_qc>August 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Basque Health Service</investigator_affiliation>
    <investigator_full_name>Roberto Gonzalez Santisteban</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <!-- 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/NCT02212171
org study id: TRIAP
secondary id: 2011111131
nct id: NCT02212171
lead sponsor: 
has dmc: No
Background: With new challenges for healthcare, there is a clear consensus among experts on
      the need to introduce changes in the organization of care in health centres to address the
      problems of over-attendance, bureaucratization and other emerging issues that require growing
      amounts of attention. However, there has been insufficient research into possible models and
      the impact of their adoption.

      The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new
      organizational model based on triage and healthcare mini-teams (two general
      practitioners/pediatricians, two nurses and one member of the administrative staff) compared
      to the current model, aiming to achieve a correct classification of the healthcare needs of
      the primary care population and direct them to the most suitable professional.

      In addition, the implementation research objective is to identify the facilitators for and
      barriers to the implementation of the intervention in the context of primary care.

      Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14
      healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the
      Basque Healthcare Service (Osakidetza) Interior Health Region.

      The results will be assessed using the data on morbidity-adjusted attendance of users to
      their family doctor, number of referral, addition of new activities to the portfolio of
      services, and patient perception and professional satisfaction. All the variables will be
      measured at baseline and at the end of the intervention, 24 months later.

      Using covariance analysis models, the investigators will estimate the effect attributable to
      the intervention by analyzing differences in changes between the two groups, and calculating
      the 95% confidence interval, adjusting the comparisons for baseline values. The investigators
      will also adjust for potential confounding and effect-modifying variables.

      Nominal groups will be held at the end of the intervention with the participation of all the
      agents involved in intervention centres to identify the facilitators for and barriers to the
      implementation of the intervention.

      Discussion: There is a need to develop new forms of organization in primary care services to
      respond to new healthcare demands. To pursue this aim, changes have to be introduced in the
      organization of healthcare within health centres, redefining the roles of primary care
      professionals and refocusing their activity towards population health needs, seeking greater
      efficiency in health services.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patients attendance
time frame: Baseline and at 24 months
description: Number of visits of the patients to their GP and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.
The patients will be classified using the ACG system, on the basis of their age, sex and ICD-9-CM codes of health problems diagnosed over a year in visits to their GP/paediatrician. The ACG case-mix system was designed by researchers at Johns Hopkins University, originally for care on an outpatient basis, and classifies the population into around 100 self-excluding categories.
Regardless of the number of contacts with the healthcare services, each person is classified every year into a single ACG depending on their age, sex, and combination of diagnoses they were assigned over the previous 12 months. For this study, we will use the ACG Assignment Software version 7.00.
All the tasks performed will be recorded in the Osabide computer system of the Basque Health Service.
measure: Patients referral: number of patient referrals by GPs and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.
time frame: Baseline and at 24 months
measure: New activities added to the current portfolio of services
time frame: Baseline and at 24 months
description: Number of programmed activities of health promotion, joint review of medical records by the doctors and nurses to improve the management of certain groups of patients, minor surgery services in PC, activities for achieving a comprehensive approach to managing non-surgical osteomuscular disorders and the use of ultrasound scans.
measure: Patient satisfaction
time frame: Baseline and at 24 months
description: Measured using the Primary Care Assessment Tool (PCAT) Pasarín MI et al. Evaluation of primary care: The "Primary Care Assessment Tools - Facility version" for the Spanish health system. Gac Sanit. 2013 Jan-Feb;27(1):12-8.
measure: Satisfaction of health professionals
time frame: Baseline and at 24 months
description: In terms of professional quality of life measured using the Professional Quality of Life questionnaire (PQL-35).
Cabezas, C. La calidad de vida de los profesionales. FMC. 2000;7 (Supl 7):53-68.
arm group label: TRIAP intervention
arm group type: Experimental
arm group label: Usual care
arm group type: No Intervention
description: Usual care: Patients in the control group will be treated according to Osakidetza recommendations.
intervention type: Other
intervention name: TRIAP
description: The primary healthcare professionals organised in healthcare mini-teams, composed of 2 doctors, 2 nurses and 1 member of the administrative staff.
Administrative staff:
Following a flow chart, they will refer patients with mild self-limiting illnesses as well as consultations regarding chronic disorders in adults to the nurses. They will also perform administrative tasks such as the printing of prescriptions, sick leave reports and medical notes (justifying absence), etc.
Nursing staff:
They will carry out activities focused on health promotion, self-management and de-medicalisation during visits from patients with mild self-limiting illnesses as well as appointments for chronic diseases in adults.
GP:
They will develop the new portfolio of services: health promotion, joint review of patient medical records by doctors and nurses to improve the management of certain groups of patients, and organization of minor surgery services, etc.
arm group label: TRIAP intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Basque Health Service
investigator full name: Roberto Gonzalez Santisteban
investigator title: Physician