Participatory Approaches to Qualitative Research (PAQ): Comparing Two Approaches to Patient, Public and Clinician Involvement in Qualitative Research

NCT06838689 | Recruiting

• 2 other identifiers: PAQ_STUDY02002675_RCTSOE-2023C3-25572
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this trial is to compare two types of patient, public and clinician involvement (PPCI) in research: Consultative PPCI and Collaborative PPCI. The study team will compare these methods of PPCI in a randomized clinical trial (RCT) in which PPCI participants will engage with research teams on one of three real qualitative research interview studies addressing topics: 1) pediatric mental health, 2) cancer screening and 3) serious illness. Qualitative interviews are conversations with people about their experiences and perspectives. In all three qualitative studies, PPCI participants will help us at every stage of the research, from design (making choices about how to set up the study) through dissemination (sharing findings). The researchers do not know about any quantitative (numbers) evidence from RCTs about how well different PPCI approaches work. As far as the study team knows, this is the first RCT of PPCI approaches. Given this gap in knowledge, the research question is: How does a Consultative PPCI approach compare to a Collaborative PPCI approach in increasing engagement and partnership trust in research, particularly among historically underrepresented groups? The researchers' best guess (hypothesis), considering the information available, is that Collaborative PPCI will increase PPCI participant engagement, trust and the patient-centeredness of research more than Consultative PPCI.

Conditions

Pediatric Mental Health Services; Cancer Screening; Serious Illness

Keywords

Pediatric mental health; Serious illness in elderly patients; cancer screening

Outcome Measures

Primary Outcomes (1)

• Patient Engagement in Research scale (PEIRS-22)

  Engagement in research, measured using the Patient Engagement in Research scale (PEIRS-22). Total score is 22-110, with higher scores reflecting greater engagement in research.

  18 months

Secondary Outcomes (3)

• Research Engagement Survey Tool (REST)

  18 months

• Patient and Public Involvement in Research Assessment Survey

  18 months

• Person-Centeredness of Research Scale

  18 months

Study Arms (2)

Consultative PPCI Model via Community Advisory Boards (CAB)

EXPERIMENTAL

Community Advisory Board: a consultative model of engagement where participants attend 4 quarterly meetings with shared leadership between participants and research team.

Other: Comparison of two standard of care regimens

Collaborative PPCI Model via the Participatory Approach to Qualitative

EXPERIMENTAL

Participatory Approach to Qualitative Research: a collaborative model of engagement with 4 idea coproduction sessions and a close partnership with study staff.

Interventions

Comparison of two standard of care regimens OTHER

Participatory Approaches to Qualitative Research (PAQ): Comparing Two Approaches to Patient, Public and Clinician Involvement (PPCI) in Qualitative Research: PAQ and CAB (Community Advisory Boards)

Also known as: Comparison between the CAB and PAQ models of community engagement

Consultative PPCI Model via Community Advisory Boards (CAB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pediatric mental health
• Adults aged ≥18 years
• Can communicate in English
• Able to take part in research activities via a computer or a smartphone
• Patients, care partners, clinicians, other healthcare professionals, teachers and school staff, health policy experts, and community members
• Has lived experience or professional expertise relating to pediatric mental health
• Children \<18 years
• Cannot communicate in English
• Adults unable to provide verbal consent
• Prisoners
• Unable to take part in research activities via a computer or a smartphone
• Generalized cancer screening
• Adults aged ≥21 years
• Can communicate in English
• Able to take part in research activities via a computer or a smartphone

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Dartmouth College: collaborator

Study Sites (2)

Geisel School of Medicine at Dartmouth

Hanover, New Hampshire, 03755, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Related Links

• Related Info

Central Study Contacts

Catherine Saunders, Assistant Professor of Medicine, PhD, MPH

CONTACT

603-650-5402; Catherine.Hylas.Saunders@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers analyzing the data remain blinded to group allocation to minimize bias in data interpretation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and of Health Policy and Clinical Practice

Model Details: Experimental Intervention 1: Consultative PPCI Model via Community Advisory Boards (CAB): Community Advisory Board: a consultative model of engagement where participants attend 4 quarterly meetings with shared leadership between participants and research team. Experimental Intervention 2: Collaborative PPCI Model via the Participatory Approach to Qualitative Research (PAQ) Participatory Approach to Qualitative Research: a collaborative model of engagement with 4 idea coproduction sessions and a close partnership with study staff.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)