PRECIDENTD Engagement Methods for Sites

NCT07053046 | Enrolling By Invitation

• 2 other identifiers: 250764SOE-2024C1-37523
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Stakeholder Engagement

Keywords

Stakeholders; Engagement; Agile Methods; Patient Partners

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Medication adherence

  Baseline and 18 months

• Participant retention

  Baseline and 18 months

• Participant retention

  Baseline and 18 months

• Post-engagement capacity and readiness

  12 and 18 months post-baseline

• Costs and benefits

  Baseline and 6, 12, and 18 months post-baseline

Study Arms (2)

Standard engagement approach

PLACEBO COMPARATOR

Other: Standard engagement approach

Agile methods engagement approach

EXPERIMENTAL

Other: Agile methods engagement approach

Interventions

Standard engagement approach OTHER

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.

Standard engagement approach

Agile methods engagement approach OTHER

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.

Agile methods engagement approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 8, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (1)