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Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819].

Haut A, Köpke S, Gerlach A, Mühlhauser I, Haastert B, Meyer G - BMC Geriatr (2009)

Bottom Line: Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects.The primary endpoint is the number of residents with at least one physical restraint at six months.If successful, the intervention should be implemented throughout Germany.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Witten/Herdecke, Faculty for Medicine, Institute of Nursing Science, Stockumer Str. 12, 58453 Witten, Germany. Antonie.Haut@uni-wh.de

ABSTRACT

Background: Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations.

Methods/design: Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures.

Discussion: If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial.

Trial registration: ISRCTN34974819.

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Related in: MedlinePlus

Summary of trial design.
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Figure 1: Summary of trial design.

Mentions: Recruitment of nursing homes takes place in the city of Hamburg, Northern Germany, and in surrounding cities of Witten/Herdecke, West Germany. Each nursing home has to fulfil the inclusion criteria of at least 20% self-reported prevalence of physical restraints. A cluster is defined as a nursing home by itself or an independently working unit of a large nursing home, including all residents. Descriptive data on the cluster, participating residents and prevalence data on physical restraint and psychotropic medication will be collected by a nurse supported by an external investigator. Figure 1 shows the summary of the trial design.


Evaluation of an evidence-based guidance on the reduction of physical restraints in nursing homes: a cluster-randomised controlled trial [ISRCTN34974819].

Haut A, Köpke S, Gerlach A, Mühlhauser I, Haastert B, Meyer G - BMC Geriatr (2009)

Summary of trial design.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2749852&req=5

Figure 1: Summary of trial design.
Mentions: Recruitment of nursing homes takes place in the city of Hamburg, Northern Germany, and in surrounding cities of Witten/Herdecke, West Germany. Each nursing home has to fulfil the inclusion criteria of at least 20% self-reported prevalence of physical restraints. A cluster is defined as a nursing home by itself or an independently working unit of a large nursing home, including all residents. Descriptive data on the cluster, participating residents and prevalence data on physical restraint and psychotropic medication will be collected by a nurse supported by an external investigator. Figure 1 shows the summary of the trial design.

Bottom Line: Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects.The primary endpoint is the number of residents with at least one physical restraint at six months.If successful, the intervention should be implemented throughout Germany.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Witten/Herdecke, Faculty for Medicine, Institute of Nursing Science, Stockumer Str. 12, 58453 Witten, Germany. Antonie.Haut@uni-wh.de

ABSTRACT

Background: Physical restraints are regularly applied in German nursing homes. Their frequency varies substantially between centres. Beneficial effects of physical restraints have not been proven, however, observational studies and case reports suggest various adverse effects. We developed an evidence-based guidance on this topic. The present study evaluates the clinical efficacy and safety of an intervention programme based on this guidance aimed to reduce physical restraints and minimise centre variations.

Methods/design: Cluster-randomised controlled trial with nursing homes randomised either to the intervention group or to the control group with standard information. The intervention comprises a structured information programme for nursing staff, information materials for legal guardians and residents' relatives and a one-day training workshop for nominated nurses. A total of 36 nursing home clusters including approximately 3000 residents will be recruited. Each cluster has to fulfil the inclusion criteria of at least 20% prevalence of physical restraints at baseline. The primary endpoint is the number of residents with at least one physical restraint at six months. Secondary outcome measures are the number of falls and fall-related fractures.

Discussion: If successful, the intervention should be implemented throughout Germany. In case the intervention does not succeed, a three-month pre-post-study with an optimised intervention programme within the control group will follow the randomised trial.

Trial registration: ISRCTN34974819.

Show MeSH
Related in: MedlinePlus