PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)

Vanderbilt University Medical Center

Status: Invitation-only

Conditions: Stakeholder Engagement

Treatments: Other: Standard engagement approach; Other: Agile methods engagement approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07053046

SOE-2024C1-37523 (Other Grant/Funding Number)

250764

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 2 patient groups, including a placebo group

Standard engagement approach

Placebo Comparator group

Treatment:

Other: Standard engagement approach

Agile methods engagement approach

Experimental group

Treatment:

Other: Agile methods engagement approach