Participatory Approaches for Healthcare Research

(PAQ Trial)

Recruiting at 1 trial location

Overseen By Catherine Saunders, Assistant Professor of Medicine, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Children, Non-English speakers, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to involve patients, the public, and healthcare experts in research. It compares two approaches: one where participants provide advice through meetings, and another where they collaborate closely with the research team to shape the study. The trial focuses on pediatric mental health, cancer screening, and serious illness. Individuals with experience in these health issues and who are comfortable using a computer or smartphone for research are ideal candidates. The goal is to determine which approach builds better partnerships and trust, particularly among groups that typically do not participate in research. As an unphased trial, this study offers a unique opportunity to directly influence research methods and improve healthcare outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on participation in research activities rather than medical treatments.

What prior data suggests that these PPCI approaches are safe for participants?

In a previous study, researchers examined the emotional and physical safety of participants in participatory research. They found these methods generally safe, with no reports of harm or serious negative experiences. Participants felt comfortable and secure during the study.

The Participatory Approaches to Qualitative Research (PAQ) used in this trial do not involve traditional medical treatments. Instead, they focus on collaboration and idea-sharing in research, reducing the risk of physical harm since no medical procedures or drugs are involved.

In summary, safety data shows that these participatory approaches are well-tolerated. Participants have not reported any major safety concerns in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative participatory approaches in healthcare research. The Consultative PPCI Model leverages Community Advisory Boards, allowing participants to share leadership with the research team during quarterly meetings, which fosters a strong community connection. On the other hand, the Collaborative PPCI Model emphasizes a close partnership with study staff through idea coproduction sessions, promoting deeper involvement and engagement. These methods stand out because they aim to transform participants from passive subjects into active partners, potentially leading to more relevant and impactful research outcomes.

What evidence suggests that this trial's participatory approaches could be effective for increasing engagement and trust in research?

This trial will compare two main ways to involve participants in research: the Consultative PPCI Model via Community Advisory Boards (CAB) and the Collaborative PPCI Model via the Participatory Approach to Qualitative Research. Although no studies directly compare these methods, the Collaborative approach is thought to foster more engagement and trust. Research has shown that close participant involvement can lead to better results by making research more relevant and patient-focused. The Consultative approach involves participants through advisory boards, while the Collaborative method includes them more deeply in generating ideas and making decisions. This greater involvement is expected to increase participant trust and enhance the quality of research partnerships. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals interested in participating in research related to pediatric mental health, cancer screening, and serious illness. It's designed to involve patients, the public, and clinicians in qualitative research studies. The main requirement is a willingness to engage with research teams.

Inclusion Criteria

Pediatric mental health: Patients, care partners, clinicians, other healthcare professionals, teachers and school staff, health policy experts, and community members

Pediatric mental health: Can communicate in English

Pediatric mental health: Able to take part in research activities via a computer or a smartphone

Exclusion Criteria

My child is under 18 and needs mental health care.

Pediatric mental health: Cannot communicate in English

Pediatric mental health: Adults unable to provide verbal consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Standardization of Consultative and Collaborative PPCI training for research team and participants

4 weeks

Engagement Sessions

Participants engage in either Consultative PPCI via Community Advisory Boards or Collaborative PPCI via Participatory Approach to Qualitative Research

18 months

4 quarterly meetings for CAB, 4 idea coproduction sessions for PAQ

Follow-up

Participants are monitored for engagement and partnership trust using various scales

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Participatory Approaches to Qualitative Research (PAQ)

Trial Overview The study compares two approaches of involving people in research: Consultative PPCI where participants give advice and Collaborative PPCI where they work as partners throughout the study. The impact on engagement, trust, and patient-centeredness will be measured.

How Is the Trial Designed?

Group I: Consultative PPCI Model via Community Advisory Boards (CAB) Experimental Treatment 1 Intervention

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

Group II: Collaborative PPCI Model via the Participatory Approach to Qualitative Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06838689

Participatory Approaches to Qualitative Research (PAQ) ... The research team will conduct a randomized controlled trial (RCT) to test the relative effectiveness of these PPCI approaches across three real-world ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9258244/

A Guide to Selecting Participatory Research Methods ... This article provides an overview for selecting participatory research methods based on project and partnerships goals.

3. jprm.scholasticahq.com jprm.scholasticahq.com/article/13244-participatory-research-methods-choice-points-in-the-research-process

Participatory Research Methods – Choice Points in the ... Participatory research (PR) encompasses research designs, methods, and frameworks that use systematic inquiry in direct collaboration with those affected by an ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06838689

Study Details | NCT06838689 | Participatory Approaches to ... The goal of this trial is to compare two types of patient, public and clinician involvement (PPCI) in research: Consultative PPCI and Collaborative PPCI.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666535222001203

Participatory approaches in primary health care related ... This review aimed to identify the available published implementation research in PHC considering participatory approaches in Low and Middle-Income Countries ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3964461/

The safety of researchers and participants in primary care ... This article discusses the emotional safety of participants and researchers and physical safety considerations for researchers by describing approaches we have ...

7. clinconnect.io clinconnect.io/trials/NCT06838689

Participatory Approaches to Qualitative Research (PAQ) The goal of this trial is to compare two types of patient, public and clinician involvement (PPCI) in research: Consultative PPCI and Collaborative PPCI.

8. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-022-01152-1

Engaging patients in patient safety: a qualitative study ... The present study aimed to qualitatively explore healthcare providers' (HCPs) and managers' perceptions on patient participation in patient safety processes.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023006540

How to engage patients in achieving patient safety Study design. A qualitative study was conducted with the PAR (participatory action research) technique to explore ways to engage patients to achieve safety.

10. pcori.org pcori.org/research-results/2024/developing-and-testing-two-approaches-engagement-research-participatory-approaches-qualitative-research-trial

The Participatory Approaches to Qualitative Research Trial Developing and testing two approaches to engagement in research: The Participatory Approaches to Qualitative Research Trial.