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.

NCT Number	NCT07053046
Lead Sponsor	Vanderbilt University Medical Center Collaborators: Patient-Centered Outcomes Research Institute, Brigham and Women's Hospital
Conditions	Stakeholder Engagement
Enrollment	165 participants
Start Date	2025-07-07
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-11