PRECIDENTD Engagement Methods for Sites
- Conditions
- Stakeholder Engagement
- Registration Number
- NCT07053046
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
This trial is evaluating approaches to effective stakeholder engagement as part of an ongoing multi-site trial, called PRECIDENTD (PREvention of Cardiovascular and DiabEtic kidNey disease in Type 2 Diabetes). PRECIDENTD is a PCORI-funded trial comparing two classes of medication for reducing major health events (e.g., heart attack, stroke, kidney disease) in patients with type 2 diabetes. This is a trial within PRECIDENTD examining Engagement Methods for Sites (PRECIDENTD-EMS) in which PRECIDENTD study sites are randomized to agile engagement methods or a standard engagement approach. The application of agile methods will provide opportunities for increased collaboration between patient partners and study sites during the conduct of the study. The hypothesis is that this will result in better research outcomes for the larger PRECIDENTD study, as well as engagement quality and partner outcomes among those engaged with the conduct of the PRECIDENTD study, as compared with a standard engagement approach.
This study is designed to assess if agile methodology - when applied to engagement during the conduct of a study - will affect research outcomes of that study, as well as the quality of engagement.
Aim 1: Evaluate whether agile methods applied to stakeholder engagement impact research outcomes. We will compare research outcomes (recruitment, adherence to assigned medication, and retention in the larger PRECIDENTD study) between study sites in the agile and standard engagement arms.
Aim 2. Evaluate whether agile methods in stakeholder engagement impact partners and identify potential mediators of effects. We will examine engagement quality and partner outcomes between the agile and standard engagement arms. We will also explore engagement quality as a potential driver/mediator of the effects of agile methods on partner outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 165
- PRECIDENTD patient stakeholder advisory council partners
- PRECIDENTD site study staff
- PRECIDENTD site investigators
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Participant Recruitment 18 months post-baseline Total patient participants enrolled in PRECIDENTD across sites
Engagement experience Baseline and 6, 12, and 18 months post-baseline As measured by the Patient Engagement in Research Scale (PEIRS); Procedural requirements and Convenience subscales. Items scored on a scale from 0-5, where higher scores indicate better engagement experiences.
Partnership functioning Baseline and 6, 12, and 18 months post-baseline As measured by the Patient Engagement in Research Scale (PEIRS); Contributions and Support subscales. Items scored on a scale from 0-5, where higher scores indicate better partnership functioning.
Group dynamics Baseline and 6, 12, and 18 months post-baseline As measured by the Patient Engagement in Research Scale (PEIRS); Team environment and interaction subscale. Items scored on a scale from 0-5, where higher scores indicate better group dynamics.
Equity and Inclusiveness Baseline and 6, 12, and 18 months post-baseline Selected \& adapted items from the Research Engagement Survey Tool (REST) - Facilitate collaborative, equitable partnerships subscale. Items scored on a scale from 0-5, where higher scores indicate better equity and inclusiveness.
- Secondary Outcome Measures
Name Time Method Medication adherence Baseline and 18 months Proportion of PRECIDENTD study participants taking assigned study medication across sites. As assessed by participant self-report via communication with study sites and study assessments.
Participant retention Baseline and 18 months Proportion of PRECIDENTD study participants completing study assessments across sites.
Post-engagement capacity and readiness 12 and 18 months post-baseline Item developed by the study team. Items scored on a scale from 0-5, where higher scores indicate better post-engagement capacity and readiness.
Costs and benefits Baseline and 6, 12, and 18 months post-baseline Selected \& adapted items from the Patient Engagement in Research Scale (PEIRS); Benefits subscale. Items scored on a scale from 0-5, where higher scores indicate better benefits.
Engagement Sustainability 12 and 18 months post-baseline Selected \& adapted items from the REST - Partnership sustainability to meet goals and objectives. Items scored on a scale from 0-5, where higher scores indicate better engagement sustainability.