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RecruitingNCT06838689PAQUpdated Nov 19, 2025

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

An interventional study of Comparison of two standard of care regimens in Pediatric Mental Health Services, Cancer Screening and Serious Illness, sponsored by Dartmouth-Hitchcock Medical Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This stratified randomized controlled clinical trial (RCT) is to test Consultative patient, public and clinician involvement (PPCI) in research against Collaborative PPCI in the context of three real-world qualitative research studies. Qualitative research methods can reveal insights into complex health phenomena, such as access to health services, clinician-patient communication, implementation research, and organizational culture and improvement. PPCI has also been acknowledged as indispensable in enhancing the validity, rigor and credibility of research.

The research team developed detailed guides for two approaches to PPCI throughout the lifetime of qualitative research projects, including 1) design, 2) data collection, 3) analysis and 4) dissemination. While there is a strong theoretical rationale that participatory research processes like Consultative PPCI may improve partner engagement more than consultative PPCI, evidence from experimental studies is lacking.

Given this gap, the research question is: How does a Consultative PPCI approach to involvement in research compared to a Collaborative PPCI approach in increasing engagement and partnership trust in research, particularly among historically underrepresented groups?

The study team hypothesizes Collaborative PPCI will result in higher partner-reported engagement, trust and patient-centeredness of research than Consultative PPCI.

Study Aims:

  1. To compare the effectiveness of Consultative PPCI versus Collaborative PPCI on partner engagement in research (primary outcome), partnership trust (secondary outcome).
  2. To use mixed methods to determine whether stakeholder engagement in research and partnership trust vary based on stakeholder characteristics.
  3. To evaluate the extent to which engagement and partnership trust are mediated by engagement experience and group dynamics.

The research team will conduct a randomized controlled trial (RCT) to test the relative effectiveness of these PPCI approaches across three real-world qualitative studies. Participants will be randomly assigned to Consultative or Collaborative PPCI using a stratified approach with three embedded qualitative studies as strata. The core function of Collaborative PPCI is to test a simple, collaborative partner engagement model, while the core function of Consultative PPCI is to test the traditional consultative partner engagement model. The researchers are are operationalizing Consultative PPCI with Community Advisory Boards (CAB) and Collaborative PPCI with a new approach called the Participatory Approach to Qualitative Research (PAQ). The study team selected an RCT with stratified randomization to evaluate the research question in the context of three diverse topic areas, to maintain separate Consultative and Collaborative study groups of reasonable size within each strata (n=10 for each study's CAB or PAQ group, for a total of 60 participants), and to ultimately increase generalizability of results. Following randomization, the researchers will evaluate for balance across groups in participant age, race, ethnicity, rurality and composite socioeconomic status (comprising education and income). The objectives, interventions and outcomes will be measured at the individual participant level. The RCT will be conducted over an 18-month period. The PAQ and CAB arms will have separate professional research staff facilitators, both experienced in CAB and PAQ facilitation; these facilitators will be involved in all three project strata. Prior to study start, the research team will standardize Consultative and Collaborative PPCI training.

02

Conditions studied

  • Pediatric Mental Health Services
  • Cancer Screening
  • Serious Illness

Keywords

  • Pediatric mental health
  • Serious illness in elderly patients
  • cancer screening
03

In context

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria \& Exclusion criteria across three sub-specialties:

Pediatric mental health

Inclusion:

  • 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

Exclusion:

  • 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

Inclusion:

  • Adults aged ≥21 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, health policy experts, and community members
  • Is eligible for population-based cancer screening tests (breast, prostate, cervical, colorectal cancer), or has lived experience or professional expertise relating to generalized cancer screening

Exclusion:

  • 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

Serious illness experience

Inclusion:

  • 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, health policy experts, and community members
  • Has lived experience or professional expertise relating to serious illness (defined as "a health condition that carries a high risk of mortality and either negatively impacts a person's daily functioning or quality of life or excessively strains his or her caregivers."

Exclusion:

  • 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

Note: We will not specifically exclude pregnant women, so they may be included incidentally.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Comparison of two standard of care regimens

  • Experimental
    Collaborative PPCI Model via the Participatory Approach to Qualitative

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

Interventions

  • OtherComparison of two standard of care regimens

    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

06

What researchers measure

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.

    Time frame: 18 months

Secondary outcomes

  1. Research Engagement Survey Tool (REST)

    Partnership Trust, measured using the "build and maintain trust in the partnership" scale of the Research Engagement Survey Tool (REST). Component scores are calculated as means, with four being the best possible score.

    Time frame: 18 months

  2. Patient and Public Involvement in Research Assessment Survey

    Research patient-centeredness, measured using the Patient and Public Involvement in Research Assessment Survey (PAS). Possible scores range from 0-80, with higher scores equating to higher patient-centeredness.

    Time frame: 18 months

  3. Person-Centeredness of Research Scale

    Research patient centeredness, measured using the Person-Centeredness of Research Scale. Possible scores range from -14 to +14, with higher scores representing more patient-centered research.

    Time frame: 18 months

07

Study locations

2 of 2 sites recruiting
  • Geisel School of Medicine at Dartmouth
    Hanover, New Hampshire 03755, United States
    • · Contact · 603-650-5402
    • Christine M Gunn, PhD · Principal investigator
    Recruiting
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
    • · Contact · 603-650-5402
    • JoAnna K Leyenaar, MD, PhD, MPH · Principal investigator
    Recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06838689
Lead sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Patient-Centered Outcomes Research Institute, Dartmouth College
Responsible party
Catherine Hylas Saunders (Assistant Professor of Medicine and of Health Policy and Clinical Practice, Dartmouth-Hitchcock Medical Center) — Principal investigator
First posted
Feb 21, 2025
Start date
Sep 1, 2025
Primary completion
Aug 30, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Nov 19, 2025

Study contacts

Catherine Saunders, Assistant Professor of Medicine, PhD, MPH
Contact
Catherine.Hylas.Saunders@dartmouth.edu
603-650-5402

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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