<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/NCT03786315</url>
  </required_header>
  <id_info>
    <org_study_id>1819/06</org_study_id>
    <secondary_id>253014</secondary_id>
    <nct_id>NCT03786315</nct_id>
  </id_info>
  <brief_title>Exploring 'VOLITION' in Context - a Study to Inform the Implementation of a New Intervention</brief_title>
  <acronym>VOLITION</acronym>
  <official_title>Exploring 'VOLITION' in Context - a Study to Inform the Implementation of a New Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Exeter</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>
      Trial Design&#xD;
&#xD;
      A mixed-methods sequential explanatory approach in general practices, using quantitative&#xD;
      questionnaire data followed by qualitative interviews.&#xD;
&#xD;
      Trial Participants&#xD;
&#xD;
      Patients aged 65 years and above with more than one long-term health problem&#xD;
      (multimorbidity); and the GPs that these patients consult with.&#xD;
&#xD;
      Planned Sample Size&#xD;
&#xD;
      5 GP practices; 15 GPs; 150 patients&#xD;
&#xD;
      Planned study period:&#xD;
&#xD;
      01/01/21 - 30/12/21; 1 year&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      Primary&#xD;
&#xD;
      To establish the determinants of adoption, implementation and maintenance of the critical,&#xD;
      core components of the VOLITION intervention, designed to be embedded within GP&#xD;
      consultations, and to determine those components of VOLITION that can be tailored to ensure&#xD;
      that the intervention is modifiable in context.&#xD;
&#xD;
      Secondary&#xD;
&#xD;
      To describe the current context of GP consultations for older patients with multimorbidity in&#xD;
      England, including current innovations, in light of recent organisational changes as a result&#xD;
      of the COVID-19 pandemic.&#xD;
&#xD;
      To describe the effect of recent changes to the context of GP consultations (towards remote&#xD;
      consulting) on patients' and GPs' perceptions of shared decision-making To investigate&#xD;
      factors which could potentially influence the successful implementation of interventions such&#xD;
      as VOLITION in the context of remote vs. face-to-face consultations.&#xD;
&#xD;
      The Intervention 'VOLITION':&#xD;
&#xD;
        -  half-day training workshop for GPs in shared decision-making&#xD;
&#xD;
        -  written involvement-facilitating tool for patients (delivered by post and available in&#xD;
           the waiting room).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1 BACKGROUND&#xD;
&#xD;
      The VOLITION intervention was developed to facilitate the involvement of older people with&#xD;
      multimorbidity in clinical decision-making during general practice consultations.The&#xD;
      overarching project follows the Intervention Mapping framework as a means of systematically&#xD;
      applying existing literature and relevant theory to each step of intervention development and&#xD;
      evaluation.&#xD;
&#xD;
      There are two core intervention components:&#xD;
&#xD;
        -  A patient tool, in the form of a leaflet, to facilitate patients to convey their&#xD;
           preferences for involvement to the GP&#xD;
&#xD;
        -  A workshop for GPs, to train them in shared decision-making orientated communication&#xD;
           skills, delivered in the context of the challenges facing GPs when consulting with this&#xD;
           patient group&#xD;
&#xD;
      To enable transparency and sustainability in complex intervention development it is important&#xD;
      to theorise the context in which intervention mechanisms will work. Further research is&#xD;
      required to determine the factors affecting the incorporation of patients' priorities and&#xD;
      preferences during clinical decision-making in the context of remote GP consultations for&#xD;
      older people with multimorbidity. This study will inform the final iteration of 'VOLITION'&#xD;
      ahead of testing the intervention in a randomised controlled pilot study.&#xD;
&#xD;
      3 OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS&#xD;
&#xD;
      The aim of this study is:&#xD;
&#xD;
      To establish the determinants for future adoption, implementation and maintenance of the&#xD;
      VOLITION intervention, and to determine those components of VOLITION that can be tailored to&#xD;
      ensure that the intervention is modifiable in context.&#xD;
&#xD;
      To describe the current modalities of GP consultations for older patients with multimorbidity&#xD;
      in England, including any existing innovations to improve quality and access to GP&#xD;
      consultations for this patient group, in light of recent organisational changes as a result&#xD;
      of the COVID-19 pandemic.&#xD;
&#xD;
      To describe the effect of recent changes to the modality of GP consultations (towards remote&#xD;
      consulting) on patients' and GPs' perceptions of shared decision-making.&#xD;
&#xD;
      To investigate factors which could potentially influence the future implementation and&#xD;
      evaluation of VOLITION in the context of remote vs. face-to-face consultations.&#xD;
&#xD;
      4 STUDY DESIGN&#xD;
&#xD;
      A mixed methods sequential explanatory study undertaken in UK general practices. Quantitative&#xD;
      questionnaire data will be collected first. Qualitative interview data will then be used to&#xD;
      explain, build, and elaborate on the quantitative findings by exploring participants' views&#xD;
      in more depth. Questionnaire data will inform the purposive selection of patient&#xD;
      participants. The quantitative and qualitative phases are therefore connected in the&#xD;
      intermediate stage of the study, prior to the interpretation of the combined findings.&#xD;
&#xD;
      5 STUDY SETTING&#xD;
&#xD;
      Five GP practices will be recruited from Devon, UK. Recruitment of local practices will be&#xD;
      prioritised in order to reduce travel expenses for the research team and with the aim of&#xD;
      shortening the recruitment period. However, to obtain sociodemographic diversity in the&#xD;
      participant sample, practices will be recruited from both rural and urban areas.&#xD;
&#xD;
      A minimum practice size of 3,000 patients will ensure sufficient numbers of eligible&#xD;
      participants. (It is anticipated that there will be approximately 800 older patients with&#xD;
      multimorbidity in an average 8,000 patient practice.&#xD;
&#xD;
      7 STUDY PROCEDURES&#xD;
&#xD;
      7.1 Sampling&#xD;
&#xD;
      An average of three (total = 15 GPs), and at least 2, GPs per practice will be recruited.&#xD;
      Patients aged 65 and above with known multimorbidity, defined as the presence of two or more&#xD;
      long-term conditions, will be approached.&#xD;
&#xD;
      Patient participants will be identified using an automated practice database search strategy&#xD;
      designed by the research team. Recruited GPs will use this 'flag' to identify ten consecutive&#xD;
      potential participants from their working schedule. Random sampling of patients is not&#xD;
      required as the clinical presentations, and therefore the nature of the decision-making&#xD;
      between consecutive consultations, is expected to be random. A total of 150 (minimum 100)&#xD;
      potential patients will be identified across five practices, with the aim of obtaining data&#xD;
      from at least half of these patients.&#xD;
&#xD;
      The sample size is sufficient to allow for the estimation of standard deviations for the&#xD;
      clinical outcome measures being tested and to tentatively report between-group differences in&#xD;
      outcomes by mode of consultation (e.g. face-to-face vs. remote). It is also sufficient to&#xD;
      obtain a purposively selected sub-sample of participants for qualitative interviews.&#xD;
&#xD;
      7.2 Recruitment&#xD;
&#xD;
      Drop-out and loss to follow-up will be taken into account at patient, GP or practice level by&#xD;
      over-recruiting. Practices will receive an email followed by telephone correspondence&#xD;
      inviting their participation. Practice recruitment will be dependent on an expression of&#xD;
      interest from at least two of their GPs. Practices will be incentivised through payment for&#xD;
      local coordination, set-up, and for GPs' time and workload. Payments were determined by&#xD;
      advisors from the South West Clinical Research Network.&#xD;
&#xD;
      For each recruited GP, ten potential patient participants with consecutive GP contacts, for&#xD;
      any mode of consultation (telephone, video, eConsult or face-to-face), will be screened by&#xD;
      GPs using pre-specified eligibility criteria (see eligibility form) at the time of&#xD;
      consultation. Eligibility data will be collected anonymously. If eligible, GPs will label&#xD;
      patient packs to be sent by post following the consultation. Eligible patients will receive a&#xD;
      cover letter, participant information sheet* and a post-consultation questionnaire with a&#xD;
      pre-paid envelope for return to the research team. Using the questionnaire, patients will&#xD;
      indicate their consent to be contacted for a subsequent telephone interview with the&#xD;
      researcher and they will be asked to provide their contact information. Patients who do not&#xD;
      wish to participate will not be expected to return their questionnaire. All recruited GPs&#xD;
      will also be asked to complete a post-consultation questionnaire and to participate in a&#xD;
      telephone interview.&#xD;
&#xD;
      7.3 Consent&#xD;
&#xD;
      Written consent from GPs will be obtained at the time of practice recruitment. Consent to&#xD;
      identify and approach potential patient participants will be obtained from the practice&#xD;
      manager. Consent from patients, to use their questionnaire data, will be confirmed by return&#xD;
      of questionnaires and patients will be advised of this using the Participant Information&#xD;
      Sheet. Written consent will be obtained prior to telephone interviews, informed by an interim&#xD;
      telephone call to clarify procedures and to answer participant's questions, by return of&#xD;
      consent forms in pre-paid envelopes. Verbal consent will also be confirmed before commencing&#xD;
      interviews. If stated, reasons for declining to participate in interviews will be recorded&#xD;
      anonymously. Identifiable data will not be accessed without prior patient consent.&#xD;
&#xD;
      7.4 Baseline data&#xD;
&#xD;
      Practice level data (list size, location and deprivation, practice size, staffing,&#xD;
      rural/urban) and GP participant data (age, gender, ethnicity and time since qualification)&#xD;
      will be collected at the time of recruitment. Information will be requested from practices&#xD;
      regarding whether, and how, they have identified, or addressed, the potential for inequality&#xD;
      in experience of remote consultations for the patient group of interest.&#xD;
&#xD;
      Data will be obtained at practice level regarding the mode (phone, video, eConsult or&#xD;
      face-to-face) and relative frequency of consultations with older patients with&#xD;
      multimorbidity. A template will be provided to GP surgeries in order to collect and compare&#xD;
      data regarding each practice's interpretation and delivery of remote vs. face-to-face&#xD;
      consulting and how GPs' workload is being managed in respect of these. Data will be obtained&#xD;
      from GPs, at the time of recruitment, regarding their preferences for the different&#xD;
      consultation modalities when consulting with older patients with multimorbidity.&#xD;
&#xD;
      Patient demographics (age, gender and ethnicity) and health status data will be collected via&#xD;
      self-report using post-consultation questionnaires. An electronic frailty index score, for&#xD;
      each patient where applicable, will be obtained from GPs on post-consultation questionnaires.&#xD;
&#xD;
      7.5 Study assessments&#xD;
&#xD;
      Quantitative outcome measure data&#xD;
&#xD;
      The General Practice Patient Survey (GPPS) uses five-point Likert scales. A subset of these&#xD;
      are appropriate for evaluation of Patient Reported Outcome Measures (PROMs) on the&#xD;
      post-consultation patient questionnaires. PROMs will be used to collect data on patients'&#xD;
      preferences for involvement in decision-making, the extent to which patients felt engaged in&#xD;
      decision-making, the patient's preferred mode of consultation and whether they obtained this,&#xD;
      their satisfaction with the care received, whether they felt they were given enough time, and&#xD;
      a measure of patient enablement.&#xD;
&#xD;
      A post-consultation questionnaire for GPs will collect data regarding the mode and&#xD;
      approximate duration (using a scale) of consultation and GPs' ratings of the extent to which&#xD;
      they felt they involved the patient in decision-making.&#xD;
&#xD;
      Qualitative interview data&#xD;
&#xD;
      Following receipt and initial analysis of post-consultation participant questionnaires,&#xD;
      twenty patients will be sampled and twice this number will be approached. Patients will be&#xD;
      selected purposively and iteratively, using questionnaire data to ensure heterogeneity by&#xD;
      age, sociodemographic characteristics and health status, and also by mode of consultation&#xD;
      received, preferences for and experiences of shared decision-making. Patients will be&#xD;
      contacted by telephone to arrange an interview. All participating GPs (n = 10-15) will be&#xD;
      invited by email. The sample size will be reviewed when assessing thematic saturation.&#xD;
&#xD;
      Semi-structured telephone interviews will be aided by a topic guide and will be digitally&#xD;
      audio recorded, transcribed and supported by field notes. Following initial open discussion,&#xD;
      the topic guide will encourage participants to discuss the reasoning behind their&#xD;
      questionnaire responses. For example, participants may be prompted to discuss their ratings&#xD;
      of shared decision-making, or their preferences for a particular consultation modality, in&#xD;
      greater depth. The intervention will be described to participants (see topic guide in&#xD;
      Appendix) at a suitable mid-point during telephone interviews, in order to stimulate&#xD;
      discussion regarding factors that could potentially affect the implementation of VOLITION.&#xD;
      Participants will be prompted to discuss these factors in the context of different&#xD;
      consultation modalities and in light of ongoing social distancing measures in the UK.&#xD;
      Intervention materials will not be posted to patients in advance of interviews so as to avoid&#xD;
      the influence of materials on the earlier interview dialogue. Participants will be encouraged&#xD;
      to discuss their own ideas in order to collect fresh data without the influence of the&#xD;
      researcher. Audio recordings of participant interviews will be coded using Nvivo computer&#xD;
      software.&#xD;
&#xD;
      Mixed methods&#xD;
&#xD;
      Data analysis will take a sequential-explanatory approach .The quantitative questionnaire&#xD;
      data and subsequent analysis (see details below) will provide a general understanding of&#xD;
      participants' perspectives on the research problem. The qualitative data and their analysis&#xD;
      will refine and explain the statistical results by exploring purposively selected&#xD;
      participants' views in more depth. Interpretation of interviews will combine both deductive&#xD;
      and inductive methods to investigate whether the theory developed earlier in the project&#xD;
      holds, but also being open to new data and emerging themes. The concept of thematic&#xD;
      saturation will be applied and negative cases will be actively sought. The consistency with&#xD;
      which the coding is applied will be assessed on a fifth of the data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 4, 2021</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Factors potentially influencing the future successful implementation and evaluation of VOLITION</measure>
    <time_frame>2 months</time_frame>
    <description>Questionnaire &amp; interviews with data integration Qualitative data&#xD;
Common themes from the analysis of interview data regarding the perceived impact of the changes towards remote consulting, on patients and on GPs, will be reported. Significant divergent themes will be actively sought.&#xD;
Data integration&#xD;
Interview findings will be presented in line with the purposive sampling (informed by participant questionnaire data). Findings may therefore be interpreted in the context of participant characteristics, or by consultation modality, for example. Where interview themes provide greater depth regarding findings from questionnaire items, the interpretation of these findings will be discussed in the context of existing literature and previously developed theory. Reporting will be designed with a view to informing future policy and interventions to support older people with multimorbidity during remote consultations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The current context of GP consultations for older patients with multimorbidity</measure>
    <time_frame>2 months</time_frame>
    <description>Descriptive &amp; qualitative data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of recent changes to the context of GP consultations on perceptions of shared decision-making</measure>
    <time_frame>2 months</time_frame>
    <description>Questionnaire &amp; interviews with data integration</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Decision Making</condition>
  <condition>Aged</condition>
  <condition>Multimorbidity</condition>
  <condition>General Practice</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <description>Older patients with multimorbidity and the GPs with whom they consult, from across five GP practices in Devon</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Older patients (aged 65 and above) and the GPs that they consult with&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  GP practice located in Devon, UK&#xD;
&#xD;
          -  GP participants must be permanent practice employees&#xD;
&#xD;
          -  Patient participants must be aged 65 and above with multimorbidity&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Previous participation in the focus group study to refine the intervention&#xD;
&#xD;
          -  Locum GPs&#xD;
&#xD;
          -  Trainee GPs and junior doctors working in general practice&#xD;
&#xD;
          -  Temporarily registered patients&#xD;
&#xD;
          -  Vulnerable patients (as screened by usual GP)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jo Butterworth, MRCGP</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Exeter Medical School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jo Butterworth, MRCGP</last_name>
    <phone>01392 726362</phone>
    <phone_ext>6362</phone_ext>
    <email>j.e.butterworth@exeter.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>John Campbell, FRCGP</last_name>
    <phone>01392 722740</phone>
    <phone_ext>2740</phone_ext>
    <email>john.campbell@exeter.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Exeter Medical School</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX1 2LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jo Butterworth</last_name>
      <phone>01392 726362</phone>
      <email>j.e.butterworth@exeter.ac.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
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  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary care</keyword>
  <keyword>Elderly</keyword>
  <keyword>Older age</keyword>
  <keyword>Multimorbidity</keyword>
  <keyword>Shared decision-making</keyword>
  <keyword>Patient involvement</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/NCT03786315
org study id: 1819/06
secondary id: 253014
nct id: NCT03786315
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Trial Design

      A mixed-methods sequential explanatory approach in general practices, using quantitative
      questionnaire data followed by qualitative interviews.

      Trial Participants

      Patients aged 65 years and above with more than one long-term health problem
      (multimorbidity); and the GPs that these patients consult with.

      Planned Sample Size

      5 GP practices; 15 GPs; 150 patients

      Planned study period:

      01/01/21 - 30/12/21; 1 year

      Objectives

      Primary

      To establish the determinants of adoption, implementation and maintenance of the critical,
      core components of the VOLITION intervention, designed to be embedded within GP
      consultations, and to determine those components of VOLITION that can be tailored to ensure
      that the intervention is modifiable in context.

      Secondary

      To describe the current context of GP consultations for older patients with multimorbidity in
      England, including current innovations, in light of recent organisational changes as a result
      of the COVID-19 pandemic.

      To describe the effect of recent changes to the context of GP consultations (towards remote
      consulting) on patients' and GPs' perceptions of shared decision-making To investigate
      factors which could potentially influence the successful implementation of interventions such
      as VOLITION in the context of remote vs. face-to-face consultations.

      The Intervention 'VOLITION':

        -  half-day training workshop for GPs in shared decision-making

        -  written involvement-facilitating tool for patients (delivered by post and available in
           the waiting room).
1 BACKGROUND

      The VOLITION intervention was developed to facilitate the involvement of older people with
      multimorbidity in clinical decision-making during general practice consultations.The
      overarching project follows the Intervention Mapping framework as a means of systematically
      applying existing literature and relevant theory to each step of intervention development and
      evaluation.

      There are two core intervention components:

        -  A patient tool, in the form of a leaflet, to facilitate patients to convey their
           preferences for involvement to the GP

        -  A workshop for GPs, to train them in shared decision-making orientated communication
           skills, delivered in the context of the challenges facing GPs when consulting with this
           patient group

      To enable transparency and sustainability in complex intervention development it is important
      to theorise the context in which intervention mechanisms will work. Further research is
      required to determine the factors affecting the incorporation of patients' priorities and
      preferences during clinical decision-making in the context of remote GP consultations for
      older people with multimorbidity. This study will inform the final iteration of 'VOLITION'
      ahead of testing the intervention in a randomised controlled pilot study.

      3 OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS

      The aim of this study is:

      To establish the determinants for future adoption, implementation and maintenance of the
      VOLITION intervention, and to determine those components of VOLITION that can be tailored to
      ensure that the intervention is modifiable in context.

      To describe the current modalities of GP consultations for older patients with multimorbidity
      in England, including any existing innovations to improve quality and access to GP
      consultations for this patient group, in light of recent organisational changes as a result
      of the COVID-19 pandemic.

      To describe the effect of recent changes to the modality of GP consultations (towards remote
      consulting) on patients' and GPs' perceptions of shared decision-making.

      To investigate factors which could potentially influence the future implementation and
      evaluation of VOLITION in the context of remote vs. face-to-face consultations.

      4 STUDY DESIGN

      A mixed methods sequential explanatory study undertaken in UK general practices. Quantitative
      questionnaire data will be collected first. Qualitative interview data will then be used to
      explain, build, and elaborate on the quantitative findings by exploring participants' views
      in more depth. Questionnaire data will inform the purposive selection of patient
      participants. The quantitative and qualitative phases are therefore connected in the
      intermediate stage of the study, prior to the interpretation of the combined findings.

      5 STUDY SETTING

      Five GP practices will be recruited from Devon, UK. Recruitment of local practices will be
      prioritised in order to reduce travel expenses for the research team and with the aim of
      shortening the recruitment period. However, to obtain sociodemographic diversity in the
      participant sample, practices will be recruited from both rural and urban areas.

      A minimum practice size of 3,000 patients will ensure sufficient numbers of eligible
      participants. (It is anticipated that there will be approximately 800 older patients with
      multimorbidity in an average 8,000 patient practice.

      7 STUDY PROCEDURES

      7.1 Sampling

      An average of three (total = 15 GPs), and at least 2, GPs per practice will be recruited.
      Patients aged 65 and above with known multimorbidity, defined as the presence of two or more
      long-term conditions, will be approached.

      Patient participants will be identified using an automated practice database search strategy
      designed by the research team. Recruited GPs will use this 'flag' to identify ten consecutive
      potential participants from their working schedule. Random sampling of patients is not
      required as the clinical presentations, and therefore the nature of the decision-making
      between consecutive consultations, is expected to be random. A total of 150 (minimum 100)
      potential patients will be identified across five practices, with the aim of obtaining data
      from at least half of these patients.

      The sample size is sufficient to allow for the estimation of standard deviations for the
      clinical outcome measures being tested and to tentatively report between-group differences in
      outcomes by mode of consultation (e.g. face-to-face vs. remote). It is also sufficient to
      obtain a purposively selected sub-sample of participants for qualitative interviews.

      7.2 Recruitment

      Drop-out and loss to follow-up will be taken into account at patient, GP or practice level by
      over-recruiting. Practices will receive an email followed by telephone correspondence
      inviting their participation. Practice recruitment will be dependent on an expression of
      interest from at least two of their GPs. Practices will be incentivised through payment for
      local coordination, set-up, and for GPs' time and workload. Payments were determined by
      advisors from the South West Clinical Research Network.

      For each recruited GP, ten potential patient participants with consecutive GP contacts, for
      any mode of consultation (telephone, video, eConsult or face-to-face), will be screened by
      GPs using pre-specified eligibility criteria (see eligibility form) at the time of
      consultation. Eligibility data will be collected anonymously. If eligible, GPs will label
      patient packs to be sent by post following the consultation. Eligible patients will receive a
      cover letter, participant information sheet* and a post-consultation questionnaire with a
      pre-paid envelope for return to the research team. Using the questionnaire, patients will
      indicate their consent to be contacted for a subsequent telephone interview with the
      researcher and they will be asked to provide their contact information. Patients who do not
      wish to participate will not be expected to return their questionnaire. All recruited GPs
      will also be asked to complete a post-consultation questionnaire and to participate in a
      telephone interview.

      7.3 Consent

      Written consent from GPs will be obtained at the time of practice recruitment. Consent to
      identify and approach potential patient participants will be obtained from the practice
      manager. Consent from patients, to use their questionnaire data, will be confirmed by return
      of questionnaires and patients will be advised of this using the Participant Information
      Sheet. Written consent will be obtained prior to telephone interviews, informed by an interim
      telephone call to clarify procedures and to answer participant's questions, by return of
      consent forms in pre-paid envelopes. Verbal consent will also be confirmed before commencing
      interviews. If stated, reasons for declining to participate in interviews will be recorded
      anonymously. Identifiable data will not be accessed without prior patient consent.

      7.4 Baseline data

      Practice level data (list size, location and deprivation, practice size, staffing,
      rural/urban) and GP participant data (age, gender, ethnicity and time since qualification)
      will be collected at the time of recruitment. Information will be requested from practices
      regarding whether, and how, they have identified, or addressed, the potential for inequality
      in experience of remote consultations for the patient group of interest.

      Data will be obtained at practice level regarding the mode (phone, video, eConsult or
      face-to-face) and relative frequency of consultations with older patients with
      multimorbidity. A template will be provided to GP surgeries in order to collect and compare
      data regarding each practice's interpretation and delivery of remote vs. face-to-face
      consulting and how GPs' workload is being managed in respect of these. Data will be obtained
      from GPs, at the time of recruitment, regarding their preferences for the different
      consultation modalities when consulting with older patients with multimorbidity.

      Patient demographics (age, gender and ethnicity) and health status data will be collected via
      self-report using post-consultation questionnaires. An electronic frailty index score, for
      each patient where applicable, will be obtained from GPs on post-consultation questionnaires.

      7.5 Study assessments

      Quantitative outcome measure data

      The General Practice Patient Survey (GPPS) uses five-point Likert scales. A subset of these
      are appropriate for evaluation of Patient Reported Outcome Measures (PROMs) on the
      post-consultation patient questionnaires. PROMs will be used to collect data on patients'
      preferences for involvement in decision-making, the extent to which patients felt engaged in
      decision-making, the patient's preferred mode of consultation and whether they obtained this,
      their satisfaction with the care received, whether they felt they were given enough time, and
      a measure of patient enablement.

      A post-consultation questionnaire for GPs will collect data regarding the mode and
      approximate duration (using a scale) of consultation and GPs' ratings of the extent to which
      they felt they involved the patient in decision-making.

      Qualitative interview data

      Following receipt and initial analysis of post-consultation participant questionnaires,
      twenty patients will be sampled and twice this number will be approached. Patients will be
      selected purposively and iteratively, using questionnaire data to ensure heterogeneity by
      age, sociodemographic characteristics and health status, and also by mode of consultation
      received, preferences for and experiences of shared decision-making. Patients will be
      contacted by telephone to arrange an interview. All participating GPs (n = 10-15) will be
      invited by email. The sample size will be reviewed when assessing thematic saturation.

      Semi-structured telephone interviews will be aided by a topic guide and will be digitally
      audio recorded, transcribed and supported by field notes. Following initial open discussion,
      the topic guide will encourage participants to discuss the reasoning behind their
      questionnaire responses. For example, participants may be prompted to discuss their ratings
      of shared decision-making, or their preferences for a particular consultation modality, in
      greater depth. The intervention will be described to participants (see topic guide in
      Appendix) at a suitable mid-point during telephone interviews, in order to stimulate
      discussion regarding factors that could potentially affect the implementation of VOLITION.
      Participants will be prompted to discuss these factors in the context of different
      consultation modalities and in light of ongoing social distancing measures in the UK.
      Intervention materials will not be posted to patients in advance of interviews so as to avoid
      the influence of materials on the earlier interview dialogue. Participants will be encouraged
      to discuss their own ideas in order to collect fresh data without the influence of the
      researcher. Audio recordings of participant interviews will be coded using Nvivo computer
      software.

      Mixed methods

      Data analysis will take a sequential-explanatory approach .The quantitative questionnaire
      data and subsequent analysis (see details below) will provide a general understanding of
      participants' perspectives on the research problem. The qualitative data and their analysis
      will refine and explain the statistical results by exploring purposively selected
      participants' views in more depth. Interpretation of interviews will combine both deductive
      and inductive methods to investigate whether the theory developed earlier in the project
      holds, but also being open to new data and emerging themes. The concept of thematic
      saturation will be applied and negative cases will be actively sought. The consistency with
      which the coding is applied will be assessed on a fifth of the data.
observational model: Cohort
time perspective: Cross-Sectional
measure: Factors potentially influencing the future successful implementation and evaluation of VOLITION
time frame: 2 months
description: Questionnaire & interviews with data integration Qualitative data
Common themes from the analysis of interview data regarding the perceived impact of the changes towards remote consulting, on patients and on GPs, will be reported. Significant divergent themes will be actively sought.
Data integration
Interview findings will be presented in line with the purposive sampling (informed by participant questionnaire data). Findings may therefore be interpreted in the context of participant characteristics, or by consultation modality, for example. Where interview themes provide greater depth regarding findings from questionnaire items, the interpretation of these findings will be discussed in the context of existing literature and previously developed theory. Reporting will be designed with a view to informing future policy and interventions to support older people with multimorbidity during remote consultations.
measure: The current context of GP consultations for older patients with multimorbidity
time frame: 2 months
description: Descriptive & qualitative data
measure: The effect of recent changes to the context of GP consultations on perceptions of shared decision-making
time frame: 2 months
description: Questionnaire & interviews with data integration
arm group label: Usual care
description: Older patients with multimorbidity and the GPs with whom they consult, from across five GP practices in Devon
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Jo Butterworth, MRCGP
role: Principal Investigator
affiliation: University of Exeter Medical School
last name: Jo Butterworth, MRCGP
phone: 01392 726362
phone ext: 6362
email: j.e.butterworth@exeter.ac.uk
last name: John Campbell, FRCGP
phone: 01392 722740
phone ext: 2740
email: john.campbell@exeter.ac.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
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responsible party type: Sponsor
sharing ipd: No