Selecting outcomes for pragmatic clinical trials in dementia care: The IMPACT Collaboratory iLibrary

Laura C Hanson; Kathryn Wessell; Natalie Meeks; Antonia V Bennett; Mark Toles; Josh Niznik; Sheryl Zimmerman; Joan Carpenter; Christine S Ritchie; Natalie C Ernecoff; Debra Saliba

doi:10.1111/jgs.18644

Selecting outcomes for pragmatic clinical trials in dementia care: The IMPACT Collaboratory iLibrary

J Am Geriatr Soc. 2024 Feb;72(2):529-535. doi: 10.1111/jgs.18644. Epub 2023 Nov 2.

Authors

Laura C Hanson^{1

2}, Kathryn Wessell², Natalie Meeks², Antonia V Bennett³, Mark Toles⁴, Josh Niznik^{1

5}, Sheryl Zimmerman⁶, Joan Carpenter⁷, Christine S Ritchie⁸, Natalie C Ernecoff⁹, Debra Saliba^{10

11}

Affiliations

¹ Division of Geriatric Medicine & Center for Aging and Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
² Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
³ Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁴ School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁵ Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁶ Schools of Social Work and Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
⁷ School of Nursing, University of Maryland, Baltimore, Maryland, USA.
⁸ Division of Palliative Care and Geriatric Medicine, Massachusetts General Hospital, Harvard Medical School, Mongan Institute Center for Aging and Serious Illness, Boston, Massachusetts, USA.
⁹ RAND Corporation, Pittsburgh, Pennsylvania, USA.
¹⁰ Borun Center, University of California, Los Angeles, California, USA.
¹¹ VA Geriatrics Research, Education and Clinical Center, Los Angeles, California, USA.

PMID: 37916447
PMCID: PMC10922084 (available on 2025-02-01)
DOI: 10.1111/jgs.18644

Abstract

Background: Many interventions improve care and outcomes for people with Alzheimer's Disease and related dementias (ADRD), yet are never disseminated. Pragmatic trials facilitate the adoption and dissemination of best practices, but gaps in pragmatic outcome measurement are a critical obstacle. Our objectives are (1) to describe the development and structure of the IMbedded Pragmatic ADRD Clinical Trials Collaboratory (IMPACT) iLibrary of potential outcome measures for ADRD pragmatic trials, and (2) to assess their pragmatic characteristics.

Methods: We identified potential outcome measures from several sources: a database of administrative and clinical outcome measures from ADRD clinical trials registered in ClinicalTrials.gov, published reviews, and IMPACT pilot pragmatic trial outcome measures. The iLibrary reports (a) number of items, (b) completion time, (c) readability for diverse populations, (d) cost or copyright barriers to use, (e) method of administration, (f) assessor training burden, and (g) feasibility of data capture and interpretation in routine care; a summary of pragmatic characteristics of each outcome measure (high, moderate, low); items or descriptions of items; and links to primary citations regarding development or psychometric properties.

Results: We included 140 outcome measures in the iLibrary: 66 administrative (100% were pragmatic) and 74 clinical (52% were pragmatic). The most commonly addressed outcome domains from administrative assessments included physical function, quality of care or communication concerns, and psychological symptoms or distress behaviors. The most commonly addressed outcome domains from clinical assessments were psychological symptoms or distress behaviors, physical function, cognitive function, and health-related quality of life.

Conclusions: Pragmatic outcome measures are brief, meaningful to diverse populations, easily scored and interpreted by clinicians, and available in electronic format for analysis. The iLibrary can facilitate the selection of measures for a wide range of outcomes relevant to people with ADRD and their care partners.

Keywords: Alzheimer's disease; clinical trials; dementia.

MeSH terms

Alzheimer Disease* / diagnosis
Cognition
Humans
Outcome Assessment, Health Care
Quality of Life*

Abstract

MeSH terms

Grants and funding