The HOME Study: study protocol 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.
Randomised controlled trial
liaison psychiatry
multi-morbidity
protocol
psychological medicine
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
07 Aug 2019
07 Aug 2019
Historique:
received:
22
11
2018
accepted:
05
06
2019
entrez:
9
8
2019
pubmed:
9
8
2019
medline:
14
2
2020
Statut:
epublish
Résumé
Prolonged acute hospital stays are a major 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 stays. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards. PPM is proactive, focussed, intensive and integrated with medical care. A major 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. A two-arm parallel-group randomised controlled superiority trial, with a linked health economic analysis and an embedded process evaluation, will be conducted at three sites. A total of 3588 participants will be recruited and randomised to usual care or usual care plus PPM. The primary outcome is the number of days spent as an inpatient in a general hospital in the month (30 days) post-randomisation. Secondary outcomes for each participant (measured at 1 and 3 months) include quality of life, independent functioning, symptoms of anxiety and depression, cognitive function, and their experience of the hospital stay. The trial has been designed to produce findings that are generalisable to all older medical inpatients (including those with cognitive impairment). It will provide information on the effectiveness and cost-effectiveness of PPM, which we hope will be of value to patients, clinicians, managers and service planners. ISRCTN86120296 . Registered on 3 January 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Prolonged acute hospital stays are a major 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 stays. Proactive Psychological Medicine (PPM) is a new way of providing psychiatry services to medical wards. PPM is proactive, focussed, intensive and integrated with medical care. A major 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
A two-arm parallel-group randomised controlled superiority trial, with a linked health economic analysis and an embedded process evaluation, will be conducted at three sites. A total of 3588 participants will be recruited and randomised to usual care or usual care plus PPM. The primary outcome is the number of days spent as an inpatient in a general hospital in the month (30 days) post-randomisation. Secondary outcomes for each participant (measured at 1 and 3 months) include quality of life, independent functioning, symptoms of anxiety and depression, cognitive function, and their experience of the hospital stay.
DISCUSSION
CONCLUSIONS
The trial has been designed to produce findings that are generalisable to all older medical inpatients (including those with cognitive impairment). It will provide information on the effectiveness and cost-effectiveness of PPM, which we hope will be of value to patients, clinicians, managers and service planners.
TRIAL REGISTRATION
BACKGROUND
ISRCTN86120296 . Registered on 3 January 2018.
Identifiants
pubmed: 31391073
doi: 10.1186/s13063-019-3502-5
pii: 10.1186/s13063-019-3502-5
pmc: PMC6686488
doi:
Types de publication
Clinical Trial Protocol
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
483Subventions
Organisme : Department of Health
ID : HS&DR/15/11/16
Pays : United Kingdom
Organisme : Health Services Research Programme
ID : 15/11/16
Références
Stat Med. 2011 Feb 20;30(4):377-99
pubmed: 21225900
Psychosomatics. 2009 Nov-Dec;50(6):613-21
pubmed: 19996233
J Health Serv Res Policy. 2004 Oct;9(4):197-204
pubmed: 15509405
J Am Geriatr Soc. 2005 Apr;53(4):695-9
pubmed: 15817019
Psychother Psychosom. 2015;84(4):208-16
pubmed: 26022134
Age Ageing. 2004 Mar;33(2):110-5
pubmed: 14960424
Health Technol Assess. 2015 Feb;19(14):1-503, v-vi
pubmed: 25692211
Psychosomatics. 2011 Nov-Dec;52(6):513-20
pubmed: 22054620
Int Disabil Stud. 1988;10(2):64-7
pubmed: 3042746
Health Policy. 1990 Dec;16(3):199-208
pubmed: 10109801
Health Econ. 2001 Dec;10(8):779-87
pubmed: 11747057