PRECIDENTD Engagement Methods for Sites

Официальное название

PRECIDENTD Engagement Methods for Sites (PRECIDENTD-EMS)

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Participant Recruitment [Срок оценки: 18 months post-baseline]
• Engagement experience [Срок оценки: Baseline and 6, 12, and 18 months post-baseline]
• Partnership functioning [Срок оценки: Baseline and 6, 12, and 18 months post-baseline]
• Group dynamics [Срок оценки: Baseline and 6, 12, and 18 months post-baseline]
• Equity and Inclusiveness [Срок оценки: Baseline and 6, 12, and 18 months post-baseline]

Вторичные конечные точки (6)

• Medication adherence [Срок оценки: Baseline and 18 months]
• Participant retention [Срок оценки: Baseline and 18 months]
• Participant retention [Срок оценки: Baseline and 18 months]
• Post-engagement capacity and readiness [Срок оценки: 12 and 18 months post-baseline]
• Costs and benefits [Срок оценки: Baseline and 6, 12, and 18 months post-baseline]
• Engagement Sustainability [Срок оценки: 12 and 18 months post-baseline]

Критерии участия

Критерии включения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT07053046 · 250764 · SOE-2024C1-37523

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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