Person and Caregiver Relevant Outcomes Core (F)

Brown University, Providence RI

Investigators

Linked publications & trials

Abstract

Embedded pragmatic clinical trials (ePCTs) are urgently needed to elucidate evidence-based, scalable interventions to improve dementia care with health care systems (HCS). However, the ultimate success of such ePCTs depends on the outcomes selected to measure the effectiveness of interventions. Two features distinguish outcome selection for ePCTs compared to traditional clinical trials. First, ePCT outcomes must be important to participants and HCS caring for them. Second, outcomes should ideally be efficiently ascertained from real world data sources, such as electronic health records (EHRs). Identifying outcomes meeting both these criteria is challenging, particularly for ePCTs focused on people living with dementia (PLWD) and their care partners (CPs). Meeting this challenge is the over-riding objective of IMPACT’s Patient & Caregiver Relevant Outcomes (PCRO) Core. Before IMPACT began in 2019, there was very little guidance on outcome selection for investigators designing ePCTs in dementia care. Thus, the PCRO Core set out to build the field. As a first step, it created a novel, searchable on-line database, or ‘iLibrary’, of 140 existing outcomes for dementia care and rated each outcome on the suitability for use in an ePCT. The Core led workshops with IMPACT’s Lived Experience Panel to better identify outcomes that are important to PLWD and their CPs which, at the same time, could be obtained pragmatically. The Core also gained an understanding of key challenges of selecting outcomes for ePCTs in dementia care through 155 hours of consultations with investigators applying for IMPACT’s Project grants. Building on this foundation, in the renewal period the PCRO will address persistent gaps needed to advance the field. Related to selecting outcomes for conducting ePCTs among PLWD and the CPs and best practices for ascertaining them pragmatically, the PCRO Core Specific Aims are: Aim 1. Support the design and conduct of ePCTs by providing guidance and consultation to investigators; Aim 2. Enhance investigator capacity by participating in all IMPACT training activities; Aim 3. Develop and disseminate knowledge to advance the field. It will work with the Technical, Data and HCS Core to improve the ascertainment of dementia-relevant outcomes from real world data sources by applying novel methods, such as natural language processing, adding data elements to common EHR platforms (e.g., EPIC), and using multiple sources to define an outcome. The Core will also collaborate with the High Risk Populations and Disparities Core to elucidate better strategies to measure outcomes relevant to high-risk populations. IMPACT: In the past, promising dementia care interventions have been deemed unsuitable for testing in ePCTs because meaningful outcomes measuring their effectiveness could not be ascertained using pragmatic methods. The PCRO Core aims to make it feasible to evaluate such interventions in ePCTs in the future, stemming from advances emanating from its work. The PCRO Core is essential to IMPACT’s vision of transforming the care provided to PLWD and CPs by accelerating the testing and adoption of evidence-based interventions within HCS.