The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for older adults with diabetes and multiple chronic conditions: study protocol for a randomized controlled trial.
Community-based settings
Diabetes
Multiple chronic conditions
Older adults
Patient-oriented intervention
Pragmatic effectiveness-implementation trial
Scalability assessment
Self-management
Journal
BMC geriatrics
ISSN: 1471-2318
Titre abrégé: BMC Geriatr
Pays: England
ID NLM: 100968548
Informations de publication
Date de publication:
04 02 2022
04 02 2022
Historique:
received:
30
08
2021
accepted:
23
11
2021
entrez:
5
2
2022
pubmed:
6
2
2022
medline:
19
3
2022
Statut:
epublish
Résumé
Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers. We will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential. An interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP. Clinical Trials.gov Identifier NCT03664583 . Registration date: September 10, 2018.
Sections du résumé
BACKGROUND
Older adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers.
METHODS
We will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential.
DISCUSSION
An interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP.
TRIAL REGISTRATION
Clinical Trials.gov Identifier NCT03664583 . Registration date: September 10, 2018.
Identifiants
pubmed: 35120457
doi: 10.1186/s12877-021-02651-7
pii: 10.1186/s12877-021-02651-7
pmc: PMC8814798
doi:
Banques de données
ClinicalTrials.gov
['NCT03664583']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
99Subventions
Organisme : CIHR
ID : KPG-156883
Pays : Canada
Investigateurs
Jenny Ploeg
(J)
Maureen Markle-Reid
(M)
Ruta Valaitis
(R)
Kathryn Fisher
(K)
Rebecca Ganann
(R)
Johanne Blais
(J)
Andrea Gruneir
(A)
France Légaré
(F)
Janet MacIntyre
(J)
William Montelpare
(W)
Jean-Sébastien Paquette
(JS)
Marie-Eve Poitras
(ME)
Angela Riveroll
(A)
Ali Ben Charif
(AB)
Dean Eurich
(D)
Amiram Gafni
(A)
Gary Lewis
(G)
Lynne Mansell
(L)
Janet Pritchard
(J)
Diana Sherifali
(D)
Lehana Thabane
(L)
Ross Upshur
(R)
Tyler Williamson
(T)
Melissa Northwood
(M)
Cheryl Sadowski
(C)
Frank Tang
(F)
Informations de copyright
© 2022. The Author(s).
Références
BMJ Open. 2018 Sep 8;8(9):e023113
pubmed: 30196269
J Comorb. 2017 Nov 9;7(1):117-123
pubmed: 29354597
J Comorb. 2020 Oct 16;10:2235042X20963390
pubmed: 33117723
Metabolism. 2013 Feb;62(2):303-14
pubmed: 22959500
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
JAMA. 2021 Jul 20;326(3):257-265
pubmed: 34152382
J Am Geriatr Soc. 1975 Oct;23(10):433-41
pubmed: 1159263
Health Econ. 2011 Aug;20(8):897-916
pubmed: 20799344
BMC Public Health. 2017 Aug 1;18(1):68
pubmed: 28764785
J Am Coll Cardiol. 2015 Dec 15;66(23):2648-2662
pubmed: 26670066
J Am Geriatr Soc. 2018 Feb;66(2):263-273
pubmed: 29178317
BMC Health Serv Res. 2014 Feb 26;14:89
pubmed: 24568690
Psychol Health Med. 2016;21(1):92-101
pubmed: 25753761
J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S127-32
pubmed: 12646602
BMC Geriatr. 2017 Jan 31;17(1):40
pubmed: 28143412
Arch Fam Med. 2000 Apr;9(4):333-8
pubmed: 10776361
Eur J Clin Nutr. 2005 Oct;59(10):1149-57
pubmed: 16015256
Diabetes Care. 2000 Jul;23(7):943-50
pubmed: 10895844
Int J Nurs Pract. 2015 May;21 Suppl 2:115-24
pubmed: 26125579
BMC Health Serv Res. 2012 Oct 30;12:373
pubmed: 23110342
Implement Sci. 2015 May 12;10:68
pubmed: 25962598
Health Serv Insights. 2013 Aug 04;6:61-8
pubmed: 25114561
Qual Health Res. 2005 Nov;15(9):1277-88
pubmed: 16204405
Public Health Res Pract. 2016 Jan 28;26(1):e2611604
pubmed: 26863167
Psychosomatics. 1993 Jan-Feb;34(1):61-9
pubmed: 8426892
J Am Geriatr Soc. 2012 Dec;60(12):2342-56
pubmed: 23106132
JAMA. 2016 Sep 20;316(11):1205-1206
pubmed: 27654606
Lancet. 2009 Nov 14;374(9702):1677-86
pubmed: 19878986
QJM. 2011 Aug;104(8):639-51
pubmed: 21558329
J Clin Epidemiol. 1993 Feb;46(2):153-62
pubmed: 8437031
Popul Health Manag. 2016 Dec;19(6):414-420
pubmed: 27008540
J Am Geriatr Soc. 2008 Dec;56(12):2340-8
pubmed: 19093934
Int J Nurs Stud. 2013 May;50(5):587-92
pubmed: 23159157
Health Educ Behav. 2004 Apr;31(2):143-64
pubmed: 15090118
BMJ. 2014 Mar 07;348:g1687
pubmed: 24609605
Implement Sci. 2009 Aug 07;4:50
pubmed: 19664226
CMAJ. 2018 Nov 7;190(Suppl):S40-S41
pubmed: 30404851
BMC Med Res Methodol. 2013 Jul 16;13:92
pubmed: 23855337
Pilot Feasibility Stud. 2016 May 9;2:24
pubmed: 27965843
PLoS One. 2016 Jan 19;11(1):e0147116
pubmed: 26784515
Acad Emerg Med. 2017 Jan;24(1):40-52
pubmed: 27473387
Implement Sci. 2019 Jun 6;14(1):58
pubmed: 31171014
J Am Geriatr Soc. 2013 May;61(5):734-8
pubmed: 23590338
Med Care. 2012 Mar;50(3):217-26
pubmed: 22310560
J Emerg Nurs. 2009 Jun;35(3):191-8; quiz 273
pubmed: 19446122
Transl Behav Med. 2011 Sep;1(3):480-91
pubmed: 24073067
Ann Emerg Med. 2010 Jul;56(1):42-8
pubmed: 20346540
Ann Emerg Med. 2012 Jul;60(1):24-32
pubmed: 22305330
BMJ Open. 2015 Mar 20;5(3):e006620
pubmed: 25795688
Acad Emerg Med. 2013 Nov;20(11):1101-11
pubmed: 24238312
Med Decis Making. 2020 Nov;40(8):946-958
pubmed: 33089748
Med Care Res Rev. 2017 Jun;74(3):311-327
pubmed: 27030234
Public Health Res Pract. 2020 Jun 30;30(2):
pubmed: 32601656
PLoS One. 2013 Nov 11;8(11):e79641
pubmed: 24244534
Cochrane Database Syst Rev. 2016 Mar 14;3:CD006560
pubmed: 26976529
Diabetes Res Clin Pract. 2016 Dec;122:113-123
pubmed: 27833049
BMJ. 2017 Mar 6;356:i6795
pubmed: 28264797
J Clin Oncol. 2012 Dec 1;30(34):4194-201
pubmed: 23071239
J Gerontol. 1981 Jul;36(4):428-34
pubmed: 7252074
Med Care. 2014 Mar;52 Suppl 3:S7-S14
pubmed: 24561762
BMC Health Serv Res. 2017 Apr 14;17(1):273
pubmed: 28410614
Trials. 2017 Feb 6;18(1):55
pubmed: 28166816
Implement Sci. 2017 Nov 22;12(1):139
pubmed: 29166911
JMIR Res Protoc. 2014 Oct 24;3(4):e54
pubmed: 25344620
N Engl J Med. 2007 Nov 22;357(21):2189-94
pubmed: 18032770
Cochrane Database Syst Rev. 2015 Mar 03;(3):CD010523
pubmed: 25733495
Health Aff (Millwood). 2016 Apr;35(4):619-26
pubmed: 27044961
Diabetes Care. 2011 May;34 Suppl 2:S210-4
pubmed: 21525457
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
Ann Fam Med. 2014 May-Jun;12(3):260-9
pubmed: 24821898
BMC Geriatr. 2020 May 13;20(1):174
pubmed: 32404059
Nutr Metab Cardiovasc Dis. 2011 May;21(5):380-9
pubmed: 21470836
BMJ Open. 2019 Aug 15;9(8):e029954
pubmed: 31420394
N Engl J Med. 2002 Feb 7;346(6):393-403
pubmed: 11832527
J Med Internet Res. 2020 Aug 28;22(8):e21609
pubmed: 32716898
Am J Prev Med. 1994 Mar-Apr;10(2):77-84
pubmed: 8037935
CMAJ. 2020 Aug 10;192(32):E901-E906
pubmed: 32778601
BMJ. 2008 Nov 11;337:a2390
pubmed: 19001484
Health Res Policy Syst. 2020 Jan 3;18(1):1
pubmed: 31900230
Ann Intern Med. 2012 Aug 7;157(3):207-10
pubmed: 22868839
Diabet Med. 2015 Nov;32(11):1404-14
pubmed: 25865179
BMJ. 2015 May 08;350:h2147
pubmed: 25956159
BMC Med Res Methodol. 2016 Feb 18;16:20
pubmed: 26891992
BMC Health Serv Res. 2016 Jan 15;16:18
pubmed: 26772769