PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)

PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)

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. The investigators 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. The investigators will examine engagement quality and partner outcomes between the agile and standard engagement arms. The investigators will also explore engagement quality as a potential driver/mediator of the effects of agile methods on partner outcomes.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stakeholder Engagement
• Intervention / Treatment: Other: Standard engagement approach; Other: Agile methods engagement approach

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• PRECIDENTD patient stakeholder advisory council partners
• PRECIDENTD site study staff
• PRECIDENTD site investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Standard engagement approach	Other: Standard engagement approach; Large group meetings led by PRECIDENTD PIs; composed of ~20 sites (with ~25 site investigators and ~40 study staff). PRECIDENTD PIs will share updates and facilitate discussion around any problems. Problem identification and steps toward solution occur sequentially. A problem is identified in the data (e.g., slow recruitment), then brought to the Stakeholder Advisory Council (SAC) for advisement, then back to site investigators and study staff to implement recommended changes, the PIs look at data to see if changes improved the problem. PIs and the Stakeholder Engagement Core broker information and relationships with SAC partners.
Experimental: Agile methods engagement approach	Other: Agile methods engagement approach; Small group meetings led by a coordinator trained in agile methods; composed of ~4 sites each (representing 4-6 investigators and 6-10 study staff), plus 2-3 Stakeholder Advisory Council (SAC) patient partners. Meetings will focus on problem-solving around specific topics and apply agile tools and principles. Sites in each small group will review process data together and each site will identify a specific topic (recruitment, retention, medication adherence) to focus on improving over the next month. Research partners at sites and patient partners will contribute to discussion and reflection on barriers, challenges, successes, and facilitators. Steps toward solutions occur on a rapid timeframe, iteratively using data as a guidepost.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Recruitment	Total patient participants enrolled in PRECIDENTD across sites	18 months post-baseline
Engagement experience	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.	Baseline and 6, 12, and 18 months post-baseline
Partnership functioning	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.	Baseline and 6, 12, and 18 months post-baseline
Group dynamics	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.	Baseline and 6, 12, and 18 months post-baseline
Equity and Inclusiveness	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.	Baseline and 6, 12, and 18 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence	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.	Baseline and 18 months
Participant retention	Proportion of PRECIDENTD study participants completing study visits across sites.	Baseline and 18 months
Participant retention	Proportion of PRECIDENTD study participants completing study assessments across sites.	Baseline and 18 months
Post-engagement capacity and readiness	Item developed by the study team. Items scored on a scale from 0-5, where higher scores indicate better post-engagement capacity and readiness.	12 and 18 months post-baseline
Costs and benefits	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.	Baseline and 6, 12, and 18 months post-baseline
Engagement Sustainability	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.	12 and 18 months post-baseline

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute; Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: June 30, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 8, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Engagement; Stakeholders; Patient Partners; Agile Methods
• Other Study ID Numbers: 250764; SOE-2024C1-37523 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators plan to share IPD data, but have not yet developed a specific plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No