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Enrolling by Invitation

NCT Number: NCT07053046

PRECIDENTD Engagement Methods for Sites

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.

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Key information

Conditions

Stakeholder Engagement

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Participant Recruitment

    Time frame: 18 months post-baseline

    Total patient participants enrolled in PRECIDENTD across sites

  2. Engagement experience

    Time frame: 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.

  3. Partnership functioning

    Time frame: 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.

  4. Group dynamics

    Time frame: 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.

  5. Equity and Inclusiveness

    Time frame: 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 outcomes

  1. Medication adherence

    Time frame: 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.

  2. Participant retention

    Time frame: Baseline and 18 months

    Proportion of PRECIDENTD study participants completing study visits across sites.

  3. Participant retention

    Time frame: Baseline and 18 months

    Proportion of PRECIDENTD study participants completing study assessments across sites.

  4. Post-engagement capacity and readiness

    Time frame: 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.

  5. Costs and benefits

    Time frame: 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.

  6. Engagement Sustainability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Brigham and Women's Hospital
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)

Acronym: PRECIDENTD-EMS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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