Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot

Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Ou...

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Published in:Contemporary clinical trials Vol. 121; p. 106897
Main Authors: Thomas, Kali S, Dosa, David M, Fisher, Alison, Gadbois, Emily, Harrison, Jill, Hilgeman, Michelle, Largent, Emily A, Lima, Julie, McAuliff, Katie, McCreedy, Ellen, Mills, Whitney, Ornstein, Katherine A, Shield, Renee R, Barron, Marycela, Callaghan, Shawna, Clark, Kayla, Culak, Chris, Faris, Vinsen, Frankhauser, Anita E, Huerta, Sophie, Krause, Katherine, Martinez, Ileana, Mayer, Amanda, Rodriguez, Jacqueline, Theilheimer, Lucy, Truelove, William, Wilson, Inga, Gutman, Roee
Format: Journal Article
Language:English
Published: United States 01-10-2022
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Abstract Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Our objective is to present the protocol for a pilot multisite, two-arm, pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among people with dementia. We include justifications for individual randomization with different consent processes and waivers for specific elements of the trial. 236 individuals with dementia on waiting lists at three Meals on Wheels programs' in Florida and Texas will be randomized to receive either: 1) meals delivered multiple times per week by a Meals on Wheels volunteer or paid driver who may socialize with and provide an informal wellness check or 2) frozen meals that are mailed to participants' homes every two weeks. We will evaluate and refine processes for recruitment and randomization; assess adherence to the intervention; identify common themes in participant experience; and test processes for linking participant data with Medicare records and nursing home assessment data. We will conduct exploratory analyses examining time to nursing home placement, the primary outcome for the larger trial. This pilot will inform the follow-on large-scale, definitive pragmatic trial. In addition, the justifications for individual randomization with differing consent procedures for elements of a pragmatic trial provide a model for future trialists looking to develop ethical and feasible pragmatic studies enrolling people with dementia.
AbstractList BACKGROUNDHome-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Our objective is to present the protocol for a pilot multisite, two-arm, pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among people with dementia. We include justifications for individual randomization with different consent processes and waivers for specific elements of the trial. METHODS236 individuals with dementia on waiting lists at three Meals on Wheels programs' in Florida and Texas will be randomized to receive either: 1) meals delivered multiple times per week by a Meals on Wheels volunteer or paid driver who may socialize with and provide an informal wellness check or 2) frozen meals that are mailed to participants' homes every two weeks. We will evaluate and refine processes for recruitment and randomization; assess adherence to the intervention; identify common themes in participant experience; and test processes for linking participant data with Medicare records and nursing home assessment data. We will conduct exploratory analyses examining time to nursing home placement, the primary outcome for the larger trial. CONCLUSIONThis pilot will inform the follow-on large-scale, definitive pragmatic trial. In addition, the justifications for individual randomization with differing consent procedures for elements of a pragmatic trial provide a model for future trialists looking to develop ethical and feasible pragmatic studies enrolling people with dementia.
Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Our objective is to present the protocol for a pilot multisite, two-arm, pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among people with dementia. We include justifications for individual randomization with different consent processes and waivers for specific elements of the trial. 236 individuals with dementia on waiting lists at three Meals on Wheels programs' in Florida and Texas will be randomized to receive either: 1) meals delivered multiple times per week by a Meals on Wheels volunteer or paid driver who may socialize with and provide an informal wellness check or 2) frozen meals that are mailed to participants' homes every two weeks. We will evaluate and refine processes for recruitment and randomization; assess adherence to the intervention; identify common themes in participant experience; and test processes for linking participant data with Medicare records and nursing home assessment data. We will conduct exploratory analyses examining time to nursing home placement, the primary outcome for the larger trial. This pilot will inform the follow-on large-scale, definitive pragmatic trial. In addition, the justifications for individual randomization with differing consent procedures for elements of a pragmatic trial provide a model for future trialists looking to develop ethical and feasible pragmatic studies enrolling people with dementia.
ArticleNumber 106897
Author Mills, Whitney
Mayer, Amanda
Theilheimer, Lucy
Thomas, Kali S
Lima, Julie
Shield, Renee R
Ornstein, Katherine A
Clark, Kayla
Frankhauser, Anita E
Harrison, Jill
Gutman, Roee
Rodriguez, Jacqueline
Huerta, Sophie
Faris, Vinsen
Largent, Emily A
Martinez, Ileana
Wilson, Inga
Krause, Katherine
Dosa, David M
Culak, Chris
Callaghan, Shawna
Truelove, William
Gadbois, Emily
Barron, Marycela
McAuliff, Katie
Hilgeman, Michelle
McCreedy, Ellen
Fisher, Alison
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  organization: Johns Hopkins School of Nursing, Baltimore, MD, USA
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  organization: Neighborly Care Network, Clearwater, FL, USA
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  surname: Gutman
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  organization: Brown University School of Public Health, Providence, RI, USA
BackLink https://www.ncbi.nlm.nih.gov/pubmed/36055581$$D View this record in MEDLINE/PubMed
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crossref_primary_10_1186_s40814_023_01302_5
crossref_primary_10_1001_jamanetworkopen_2023_47195
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Keywords Waiver of consent
Feasibility pilot
Home-delivered meals
Dementia
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Snippet Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant...
BACKGROUNDHome-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two...
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StartPage 106897
SubjectTerms Aged
Dementia
Feasibility Studies
Humans
Meals
Medicare
Nursing Homes
Randomized Controlled Trials as Topic
United States
Title Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot
URI https://www.ncbi.nlm.nih.gov/pubmed/36055581
https://search.proquest.com/docview/2709739886
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