Recruiting

PPCI Comparison

Sponsor:

Dartmouth-Hitchcock Medical Center

Code:

NCT06838689

Conditions

Pediatric Mental Health Services

Cancer Screening

Serious Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comparison of two standard of care regimens

Study Details

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

Study ID

NCT06838689

Start date

Sep 1, 2025

Status verified date

Nov, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

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

Comparison 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)

Primary outcome measure

  • Patient Engagement in Research scale (PEIRS-22) [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Catherine Saunders, Assistant Professor of Medicine, PhD, MPH

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

Locations

Geisel School of Medicine at Dartmouth

Recruiting

Hanover, New Hampshire, United States, 03755

Contacts

Principal Investigator:

Christine M Gunn, PhD

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

JoAnna K Leyenaar, MD, PhD, MPH

More Information

Sponsor

Dartmouth-Hitchcock Medical Center

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dartmouth-Hitchcock Medical Center on 2025-11-19.