Project OASIS: Optimizing Approaches to Select Implementation Strategies

Обзор

Barriers that prevent healthcare methods supported by science from being adopted in the real world have led to low-quality, inequitable medical care. Implementation science aims to bridge the evidence-to-practice gap but still lacks simple and convenient methods to identify implementation barriers, systematically track which strategies work to improve care, and provide accessible data and expert recommendations to guide implementation strategy selection for use in research and practice. Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a hybrid type-III, cluster-randomized trial of a new decision aid tool that matches site variables and barriers to successful implementation strategies.

Подробное описание

Implementation science aims to improve the uptake of evidence-based health care practices (EBPs) by defining barriers that prevent their use, offering strategies to overcome these barriers, and developing methods that help clinicians and researchers choose strategies that best address the barriers they encounter. With strategy selection often being inefficient and idiosyncratic, experts have called for methods to make strategy selection scientific, data-driven, and "precise." This "precision implementation" causes a critical need to identify implementation barriers and facilitators quickly and uniformly, track implementation strategy use and effectiveness, and incorporate data and expert knowledge into the process of matching strategies to barriers. Without these improvements, there is a risk of perpetuating implementation failures and health care disparities.

Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a cluster-randomized, hybrid type III trial to compare a machine learning derived decision aid (DA) for selecting implementation strategies with a current expert opinion-based tool in 20 VA medical centers. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework and assess rates of hepatocellular carcinoma screening (an EBP) for Veterans with cirrhosis at these sites. As this is a facility-level intervention, Veterans with cirrhosis will be cluster randomized to the DA vs. Current Tool arms. The investigators anticipate that Veterans at sites in the DA arm will be significantly more likely to receive screening than Veterans at sites in the Current Tool arm.

Вмешательства

• Поведенческое OASIS DA training
  The OASIS decision aid is a novel implementation strategy selection tool developed by a multidisciplinary team of experts using machine learning algorithms and user-centered design approaches.
• Поведенческое Current DA Tool training
  The CFIR-ERIC Matching Tool is a currently available decision aid tool for selecting implementation strategies that is based on expert opinion.

Первичные конечные точки

• Reach as assessed by hepatocellular carcinoma (HCC) screening rates [Срок оценки: measured quarterly 1 year pre-intervention through 6 months post-intervention]
• Effectiveness as assessed by patient outcomes [Срок оценки: measured quarterly 1 year pre-intervention through 6 months post-intervention]
• Adoption as assessed by % improvement in HCC screening performance [Срок оценки: measured quarterly 1 year pre-intervention through 6 months post-intervention]
• Implementation as assessed by fidelity to HCC screening recommendations [Срок оценки: measured quarterly 1 year pre-intervention through 6 months post-intervention]
• Maintenance as assessed by maintenance of other measures [Срок оценки: 6 months post-intervention]

Вторичные конечные точки (3)

• Acceptability of Intervention Measure (AIM) [Срок оценки: up to 4 weeks, 6 months post-intervention]
• Intervention Appropriateness Measure (IAM) [Срок оценки: up to 4 weeks, 6 months post-intervention]
• Feasibility of Intervention Measure (FIM) [Срок оценки: up to 4 weeks, 6 months post-intervention]

Критерии участия

Критерии включения

Veterans:

• Veterans with two outpatient or one inpatient codes for cirrhosis or its complications who had an encounter in the prior 18 months at a participating VA medical center

VA clinicians:

• Physicians, advance practice providers, nurses, leadership, and staff engaged with selecting and applying implementation strategies to improve care at a participating VA medical center

Критерии исключения

• Veterans post-transplant or with active hepatocellular carcinoma

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

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh

Идентификаторы

NCT: NCT06061328 · IIR 22-033 · 1I01HX003610-01A2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗