Reducing physical restraints in psycho-geriatric nursing home residents

ISRCTN	ISRCTN10117742
DOI	https://doi.org/10.1186/ISRCTN10117742
Protocol serial number	NL592, NTR648
Sponsor	University of Maastricht (UM) (The Netherlands)
Funders	University of Maastricht (UM), Province of Limburg, The Netherlands, Meander Care Group (Zorggroep Meander Oostelijk Zuid-Limburg, the Netherlands)

Submission date: 07/06/2006
Registration date: 07/06/2006
Last edited: 08/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Anna Huizing
Scientific

University Maastricht (UM)
Department of Health Care Studies
Section of Nursing Science
P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone	+31 (0)43 3881545
Email	a.huizing@zw.unimaas.nl

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Reducing physical restraints in psycho-geriatric nursing home residents
Study objectives	It is hypothesized that an educational intervention will lead to a reduction of restraint use in psycho-geriatric nursing home residents.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Physical restraint use
Intervention	The educational intervention consists of an educational programme combined with consultation with a nurse specialist. The educational intervention is designed to comply with the decision-making process concerning restraint use defined in a Dutch guideline for restraint use in care situations and to cause nurses to embrace a philosophy of restraint-free care and be familiar with techniques of individualized care. Nurses in the experimental group attended the educational programme on restraint use. Furthermore, consultation with a nurse specialist was introduced on the experimental wards. There was no educational intervention in the control group and residents received the normal care.
Intervention type	Other
Primary outcome measure(s)	1. Restraint prevalence: the percentage of residents observed restrained at any time during the 24-hour period 2. Restraint intensity: the number of times in four observations that a particular resident is restrained 3. Restraint types: restraint types used in residents 4. Multiple restraint: the number of different restraint types used per resident recorded during the four observations
Key secondary outcome measure(s)	1. Residents' characteristics, like demographic characteristics, cognitive status, self performance in activities of daily living, mobility, fall incidence, fall-related injuries and psycho-active drug use 2. Organisational characteristics, like workload of nurses and staffing level on the wards
Completion date	01/10/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	400
Total final enrolment	432
Key inclusion criteria	Psycho-geriatric nursing home residents
Key exclusion criteria	Nursing home residents suffering from Korsakov’s disease or psychiatric diseases are excluded
Date of first enrolment	01/09/2003
Date of final enrolment	01/10/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Maastricht (UM)

Maastricht
6200 MD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2009	08/01/2021	Yes	No

Editorial Notes

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.