PRECIDENTD Engagement Methods for Sites
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard engagement approach, Agile methods engagement approach.
- Who it may be relevant to
- Registry conditions: Stakeholder Engagement. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)
Overview
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.
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 a - 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
Primary outcome measures
- Participant Recruitment [Time frame: 18 months post-baseline]
- Engagement experience [Time frame: Baseline and 6, 12, and 18 months post-baseline]
- Partnership functioning [Time frame: Baseline and 6, 12, and 18 months post-baseline]
- Group dynamics [Time frame: Baseline and 6, 12, and 18 months post-baseline]
- Equity and Inclusiveness [Time frame: Baseline and 6, 12, and 18 months post-baseline]
Secondary outcome measures (6)
- Medication adherence [Time frame: Baseline and 18 months]
- Participant retention [Time frame: Baseline and 18 months]
- Participant retention [Time frame: Baseline and 18 months]
- Post-engagement capacity and readiness [Time frame: 12 and 18 months post-baseline]
- Costs and benefits [Time frame: Baseline and 6, 12, and 18 months post-baseline]
- Engagement Sustainability [Time frame: 12 and 18 months post-baseline]
Eligibility criteria
Inclusion criteria
- PRECIDENTD patient stakeholder advisory council partners
- PRECIDENTD site study staff
- PRECIDENTD site investigators
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT07053046 · 250764 · SOE-2024C1-37523