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

Trial Summary

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 data supports the effectiveness of the treatment Participatory Approaches to Qualitative Research (PAQ)?

Participatory approaches in healthcare research, like PAQ, have shown promise in improving outcomes by involving patients and stakeholders in the research process. Studies indicate that such approaches can enhance the relevance and quality of research, particularly for chronic diseases and complex care needs, by aligning research priorities with patient experiences and fostering collaboration. ^{1 2 3 4 5}

Is Participatory Approaches for Healthcare Research safe for humans?

The research articles do not provide specific safety data for Participatory Approaches for Healthcare Research, but they emphasize the importance of patient involvement in healthcare safety, which suggests a focus on improving safety through collaboration rather than posing direct risks to participants. ^{6 7 8 9 10}

How does the treatment Participatory Approaches to Qualitative Research (PAQ) differ from other treatments?

Participatory Approaches to Qualitative Research (PAQ) is unique because it involves patients and community members actively in the research process, allowing them to contribute their knowledge and perspectives. This approach shifts the power dynamics, making participants co-researchers rather than subjects, which is different from traditional research methods where researchers have more control. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Qualitative Methods in Patient-Centered Outcomes Research. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

What Patients Prioritize for Research to Improve Their Lives and How Their Priorities Get Dismissed again. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Applying a community-based participatory research framework to patient and family engagement in the development of patient-centered outcomes research and practice. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The relevance of participatory research in developing nursing research and practice. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Action research healthcare: Focus on patients, improve quality, drive down costs. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The patient died: What about involvement in the investigation process? [2021]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions designed to promote patient involvement to enhance safety: a systematic review. [2021]

8. Sweden pubmed.ncbi.nlm.nih.gov

[Patient involvement in patient safety]. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Organizing patient safety research to identify risks and hazards. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Naming the "baby" or the "beast"? The importance of concepts and labels in healthcare safety investigation. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

A Guide to Selecting Participatory Research Methods Based on Project and Partnership Goals. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Participatory Quality Development: Engaging Community Members in All Phases of Project Planning and Implementation]. [2016]

13. Germany pubmed.ncbi.nlm.nih.gov

Developing participatory research in radiology: the use of a graffiti wall, cameras and a video box in a Scottish radiology department. [2021]

14. England pubmed.ncbi.nlm.nih.gov

What is participatory research? [2022]

15. Switzerland pubmed.ncbi.nlm.nih.gov

"What Do You Need? What Are You Experiencing?" Relationship Building and Power Dynamics in Participatory Research Projects: Critical Self-Reflections of Researchers. [2022]