Proxy Decision-Making for Clinical Research in Nursing Home Residents with Dementia: A Qualitative Analysis

Jonathan M K Bogaerts; Laurie A Warmerdam; Wilco P Achterberg; Jacobijn Gussekloo; Rosalinde K E Poortvliet

doi:10.1016/j.jamda.2023.02.017

Proxy Decision-Making for Clinical Research in Nursing Home Residents with Dementia: A Qualitative Analysis

J Am Med Dir Assoc. 2023 Apr;24(4):541-547.e2. doi: 10.1016/j.jamda.2023.02.017. Epub 2023 Mar 13.

Authors

Jonathan M K Bogaerts¹, Laurie A Warmerdam¹, Wilco P Achterberg², Jacobijn Gussekloo³, Rosalinde K E Poortvliet⁴

Affiliations

¹ Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.
² Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands; University Network for the Care sector South Holland, Leiden University Medical Center, Leiden, the Netherlands.
³ Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands; Department of Internal Medicine, Section Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.
⁴ Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands; University Network for the Care sector South Holland, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: R.K.E.Poortvliet@lumc.nl.

PMID: 36924797
DOI: 10.1016/j.jamda.2023.02.017

Abstract

Objectives: The benefit-risk ratio of many interventions remains unclear in older adults with dementia. Efforts for more representative trial inclusion are made; however, recruiting and particularly gaining informed consent remains complex. For research participation, dementia compels the designation of a legal guardian (LG) to give proxy consent. To advance future trial development, we aimed to provide more insights into the factors that affect the proxy decision-making process in dementia research.

Design: A qualitative analysis of semi-structured interviews about proxy decision-making on participation in dementia research.

Setting and participants: LGs of nursing home residents that gave (n = 19) and refrained from giving (n = 18) proxy consent for a clinical trial (the Danton study) in the Netherlands.

Methods: Verbatim transcripts were thematically analyzed by using a preliminary deductive framework with room for induction of additional emerging themes, being an overall abductive approach. Based on that theme list, related factors of the decision-making process were grouped into overarching levels and merged into a step-by-step process.

Results: When discussing proxy decision-making on the participation of an older adult with dementia in a clinical trial, LGs described interconnected factors on the level of the study and patient. Past experiences and attitudes of the LG influenced the weighing of these study- and patient-related factors, leading to a preliminary decision. Other proxies and treating health care professionals (HCPs) were named as important other stakeholders of the decision-making process.

Conclusions and implications: When giving proxy consent for research participation, LGs weigh study- and patient-related factors, leading to an initial benefit-risk evaluation. This weighing process is influenced by LG-related factors and can be modulated by other proxies or treating HCPs, leading to a definitive decision. Although insights into these underlying mechanisms could facilitate the proxy decision-making process for both LGs and researchers, treating HCPs could act as an independent party.

Keywords: Dementia; nursing home; proxy decision-making; qualitative study; randomized controlled trial; research.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Aged
Decision Making*
Dementia* / therapy
Humans
Informed Consent
Nursing Homes
Proxy
Qualitative Research