Participatory Approach to Qualitative Research (PAQ): Comparing Two Methods of Engaging Stakeholders in Qualitative Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Patient Engagement in Research scale (PEIRS-22)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researchers analyzing the data remain blinded to group allocation to minimize bias in data interpretation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •across three sub-specialties:
- •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
- •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
- •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
- •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."
- •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.
研究组 & 干预措施
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.
干预措施: Comparison of two standard of care regimens (Other)
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.
结局指标
主要结局
Patient Engagement in Research scale (PEIRS-22)
时间窗: 18 months
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.
次要结局
- Patient and Public Involvement in Research Assessment Survey(18 months)
- Person-Centeredness of Research Scale(18 months)
- Research Engagement Survey Tool (REST)(18 months)
研究者
Catherine Hylas Saunders
Assistant Professor of Medicine and of Health Policy and Clinical Practice
Dartmouth-Hitchcock Medical Center