Cargando…

Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial

BACKGROUND: Limited access to specialized palliative care exposes persons with late-stage Alzheimer’s disease and related dementias (ADRD) to burdensome treatment and unnecessary hospitalization and their caregivers to avoidable strain and financial burden. Addressing this unmet need, the purpose of...

Descripción completa

Detalles Bibliográficos
Autores principales: Toles, M., Kistler, C., Lin, F. C., Lynch, M., Wessell, K., Mitchell, S. L., Hanson, L. C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10518941/
https://www.ncbi.nlm.nih.gov/pubmed/37743478
http://dx.doi.org/10.1186/s13063-023-07614-4
_version_ 1785109621423210496
author Toles, M.
Kistler, C.
Lin, F. C.
Lynch, M.
Wessell, K.
Mitchell, S. L.
Hanson, L. C.
author_facet Toles, M.
Kistler, C.
Lin, F. C.
Lynch, M.
Wessell, K.
Mitchell, S. L.
Hanson, L. C.
author_sort Toles, M.
collection PubMed
description BACKGROUND: Limited access to specialized palliative care exposes persons with late-stage Alzheimer’s disease and related dementias (ADRD) to burdensome treatment and unnecessary hospitalization and their caregivers to avoidable strain and financial burden. Addressing this unmet need, the purpose of this study was to conduct a randomized clinical trial (RCT) of the ADRD-Palliative Care (ADRD-PC) program. METHODS: The study will use a multisite, RCT design and will be set in five geographically diverse US hospitals. Lead investigators and outcome assessors will be masked. The study will use 1:1 randomization of patient-caregiver dyads, and sites will enroll N = 424 dyads of hospitalized patients with late-stage ADRD with their family caregivers. Intervention dyads will receive the ADRD-PC program of (1) dementia-specific palliative care, (2) standardized caregiver education, and (3) transitional care. Control dyads will receive publicly available educational material on dementia caregiving. Outcomes will be measured at 30 days (interim) and 60 days post-discharge. The primary outcome will be 60-day hospital transfers, defined as visits to an emergency department or hospitalization ascertained from health record reviews and caregiver interviews (aim 1). Secondary patient-centered outcomes, ascertained from 30- and 60-day health record reviews and caregiver telephone interviews, will be symptom treatment, symptom control, use of community palliative care or hospice, and new nursing home transitions (aim 2). Secondary caregiver-centered outcomes will be communication about prognosis and goals of care, shared decision-making about hospitalization and other treatments, and caregiver distress (aim 3). Analyses will use intention-to-treat, and pre-specified exploratory analyses will examine the effects of sex as a biologic variable and the GDS stage. DISCUSSION: The study results will determine the efficacy of an intervention that addresses the extraordinary public health impact of late-stage ADRD and suffering due to symptom distress, burdensome treatments, and caregiver strain. While many caregivers prioritize comfort in late-stage ADRD, shared decision-making is rare. Hospitalization creates an opportunity for dementia-specific palliative care, and the study findings will inform care redesign to advance comprehensive dementia-specific palliative care plus transitional care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04948866. Registered on July 2, 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07614-4.
format Online
Article
Text
id pubmed-10518941
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-105189412023-09-26 Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial Toles, M. Kistler, C. Lin, F. C. Lynch, M. Wessell, K. Mitchell, S. L. Hanson, L. C. Trials Study Protocol BACKGROUND: Limited access to specialized palliative care exposes persons with late-stage Alzheimer’s disease and related dementias (ADRD) to burdensome treatment and unnecessary hospitalization and their caregivers to avoidable strain and financial burden. Addressing this unmet need, the purpose of this study was to conduct a randomized clinical trial (RCT) of the ADRD-Palliative Care (ADRD-PC) program. METHODS: The study will use a multisite, RCT design and will be set in five geographically diverse US hospitals. Lead investigators and outcome assessors will be masked. The study will use 1:1 randomization of patient-caregiver dyads, and sites will enroll N = 424 dyads of hospitalized patients with late-stage ADRD with their family caregivers. Intervention dyads will receive the ADRD-PC program of (1) dementia-specific palliative care, (2) standardized caregiver education, and (3) transitional care. Control dyads will receive publicly available educational material on dementia caregiving. Outcomes will be measured at 30 days (interim) and 60 days post-discharge. The primary outcome will be 60-day hospital transfers, defined as visits to an emergency department or hospitalization ascertained from health record reviews and caregiver interviews (aim 1). Secondary patient-centered outcomes, ascertained from 30- and 60-day health record reviews and caregiver telephone interviews, will be symptom treatment, symptom control, use of community palliative care or hospice, and new nursing home transitions (aim 2). Secondary caregiver-centered outcomes will be communication about prognosis and goals of care, shared decision-making about hospitalization and other treatments, and caregiver distress (aim 3). Analyses will use intention-to-treat, and pre-specified exploratory analyses will examine the effects of sex as a biologic variable and the GDS stage. DISCUSSION: The study results will determine the efficacy of an intervention that addresses the extraordinary public health impact of late-stage ADRD and suffering due to symptom distress, burdensome treatments, and caregiver strain. While many caregivers prioritize comfort in late-stage ADRD, shared decision-making is rare. Hospitalization creates an opportunity for dementia-specific palliative care, and the study findings will inform care redesign to advance comprehensive dementia-specific palliative care plus transitional care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04948866. Registered on July 2, 2021. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-023-07614-4. BioMed Central 2023-09-25 /pmc/articles/PMC10518941/ /pubmed/37743478 http://dx.doi.org/10.1186/s13063-023-07614-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Toles, M.
Kistler, C.
Lin, F. C.
Lynch, M.
Wessell, K.
Mitchell, S. L.
Hanson, L. C.
Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial
title Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial
title_full Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial
title_fullStr Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial
title_full_unstemmed Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial
title_short Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial
title_sort palliative care for persons with late-stage alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10518941/
https://www.ncbi.nlm.nih.gov/pubmed/37743478
http://dx.doi.org/10.1186/s13063-023-07614-4
work_keys_str_mv AT tolesm palliativecareforpersonswithlatestagealzheimersandrelateddementiasandtheircaregiversprotocolforarandomizedclinicaltrial
AT kistlerc palliativecareforpersonswithlatestagealzheimersandrelateddementiasandtheircaregiversprotocolforarandomizedclinicaltrial
AT linfc palliativecareforpersonswithlatestagealzheimersandrelateddementiasandtheircaregiversprotocolforarandomizedclinicaltrial
AT lynchm palliativecareforpersonswithlatestagealzheimersandrelateddementiasandtheircaregiversprotocolforarandomizedclinicaltrial
AT wessellk palliativecareforpersonswithlatestagealzheimersandrelateddementiasandtheircaregiversprotocolforarandomizedclinicaltrial
AT mitchellsl palliativecareforpersonswithlatestagealzheimersandrelateddementiasandtheircaregiversprotocolforarandomizedclinicaltrial
AT hansonlc palliativecareforpersonswithlatestagealzheimersandrelateddementiasandtheircaregiversprotocolforarandomizedclinicaltrial