PRECIDENTD Engagement Methods for Sites

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

Interventions

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.

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.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-07

Primary Completion

2027-02-28

Completion

2027-02-28

Countries

• United States

Study Locations