The HOME Study: Statistical and economic analysis plan for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the time spent in hospital by older acute hospital inpatients.
Aged
Aged, 80 and over
Anxiety
Cognition
Cost-Benefit Analysis
Delivery of Health Care
/ economics
Depression
Female
Geriatric Psychiatry
/ economics
Geriatrics
/ economics
Humans
Inpatients
/ psychology
Length of Stay
Male
Multicenter Studies as Topic
Pragmatic Clinical Trials as Topic
Quality of Life
Quality-Adjusted Life Years
Liaison psychiatry
Multi-morbidity
Psychological medicine
Randomised controlled trial
Statistical analysis plan
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
04 May 2020
04 May 2020
Historique:
received:
28
11
2019
accepted:
14
03
2020
entrez:
6
5
2020
pubmed:
6
5
2020
medline:
30
1
2021
Statut:
epublish
Résumé
Prolonged acute hospital stays are a problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hospital stay. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards which is proactive, focussed, intensive and integrated with medical care. The primary aim of PPM is to reduce the time older people spend in hospital because of unmanaged psychological and social problems. The HOME Study will test the effectiveness and cost-effectiveness of PPM. The study is a two-arm, parallel-group, randomised, controlled superiority trial with linked health economic analysis and an embedded process evaluation. The target population is people aged 65 years and older admitted to acute hospitals. Participants will be randomly allocated to either usual care plus PPM or usual care alone. The primary outcome is the number of days spent as an inpatient in a general hospital in the month following randomisation. Secondary outcomes include quality of life, cognitive function, independent functioning, symptoms of anxiety and depression, and experience of hospital stay. The cost-effectiveness of usual care plus PPM compared with usual care alone will be assessed using quality-adjusted life-years as an outcome as well as costs from the NHS perspective. This update to the published trial protocol gives a detailed plan of the statistical and economic analysis of The HOME Study. ISRCTN registry, ISRCTN86120296. Registered on 3 January 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Prolonged acute hospital stays are a problem for older people and for health services. Failure to effectively manage the psychological and social aspects of illness is an important cause of prolonged hospital stay. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards which is proactive, focussed, intensive and integrated with medical care. The primary aim of PPM is to reduce the time older people spend in hospital because of unmanaged psychological and social problems. The HOME Study will test the effectiveness and cost-effectiveness of PPM.
METHODS/DESIGN
METHODS
The study is a two-arm, parallel-group, randomised, controlled superiority trial with linked health economic analysis and an embedded process evaluation. The target population is people aged 65 years and older admitted to acute hospitals. Participants will be randomly allocated to either usual care plus PPM or usual care alone. The primary outcome is the number of days spent as an inpatient in a general hospital in the month following randomisation. Secondary outcomes include quality of life, cognitive function, independent functioning, symptoms of anxiety and depression, and experience of hospital stay. The cost-effectiveness of usual care plus PPM compared with usual care alone will be assessed using quality-adjusted life-years as an outcome as well as costs from the NHS perspective.
DISCUSSION
CONCLUSIONS
This update to the published trial protocol gives a detailed plan of the statistical and economic analysis of The HOME Study.
TRIAL REGISTRATION
BACKGROUND
ISRCTN registry, ISRCTN86120296. Registered on 3 January 2018.
Identifiants
pubmed: 32366328
doi: 10.1186/s13063-020-04256-8
pii: 10.1186/s13063-020-04256-8
pmc: PMC7197124
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
373Subventions
Organisme : Department of Health
ID : 15/11/16
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12023/21
Pays : United Kingdom
Références
Stat Med. 1999 Aug 15;18(15):1905-42
pubmed: 10532877
Health Econ. 2018 Jan;27(1):7-22
pubmed: 28833869
Psychosomatics. 2009 Nov-Dec;50(6):613-21
pubmed: 19996233
Value Health. 2012 Jul-Aug;15(5):708-15
pubmed: 22867780
Health Econ. 2005 May;14(5):487-96
pubmed: 15497198
Pharmacoeconomics. 2014 Dec;32(12):1157-70
pubmed: 25069632
Health Technol Assess. 2015 Feb;19(14):1-503, v-vi
pubmed: 25692211
Trials. 2019 Aug 7;20(1):483
pubmed: 31391073
Med Decis Making. 2012 Mar-Apr;32(2):350-61
pubmed: 22016450
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Med Care. 1997 Nov;35(11):1095-108
pubmed: 9366889
Health Econ. 1994 Sep-Oct;3(5):309-19
pubmed: 7827647
Clin Trials. 2012 Feb;9(1):48-55
pubmed: 21948059
Lancet. 2005 May 7-13;365(9471):1657-61
pubmed: 15885299
J Am Geriatr Soc. 2005 Apr;53(4):695-9
pubmed: 15817019
Age Ageing. 2004 Mar;33(2):110-5
pubmed: 14960424
Health Econ. 2004 May;13(5):405-15
pubmed: 15127421
Int Disabil Stud. 1988;10(2):64-7
pubmed: 3042746
BMC Med Res Methodol. 2006 Dec 13;6:57
pubmed: 17166270
Int Disabil Stud. 1988;10(2):61-3
pubmed: 3403500
Health Econ. 2001 Dec;10(8):779-87
pubmed: 11747057