TY - JOUR
T1 - Home-delivered meals for people with dementia
T2 - Which model delays nursing home placement? - Protocol for a feasibility pilot
AU - Thomas, Kali S.
AU - Dosa, David M.
AU - Fisher, Alison
AU - Gadbois, Emily
AU - Harrison, Jill
AU - Hilgeman, Michelle
AU - Largent, Emily A.
AU - Lima, Julie
AU - McAuliff, Katie
AU - McCreedy, Ellen
AU - Mills, Whitney
AU - Ornstein, Katherine A.
AU - Shield, Renee R.
AU - Barron, Marycela
AU - Callaghan, Shawna
AU - Clark, Kayla
AU - Culak, Chris
AU - Faris, Vinsen
AU - Frankhauser, Anita E.
AU - Huerta, Sophie
AU - Krause, Katherine
AU - Martinez, Ileana
AU - Mayer, Amanda
AU - Rodriguez, Jacqueline
AU - Theilheimer, Lucy
AU - Truelove, William
AU - Wilson, Inga
AU - Gutman, Roee
N1 - Publisher Copyright:
© 2022
PY - 2022/10
Y1 - 2022/10
N2 - Background: 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. Methods: 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. Conclusion: 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.
AB - Background: 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. Methods: 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. Conclusion: 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.
KW - Dementia
KW - Feasibility pilot
KW - Home-delivered meals
KW - Waiver of consent
UR - http://www.scopus.com/inward/record.url?scp=85137691893&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2022.106897
DO - 10.1016/j.cct.2022.106897
M3 - Article
C2 - 36055581
AN - SCOPUS:85137691893
SN - 1551-7144
VL - 121
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106897
ER -