Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents (IMPRINT)

Dementia Clinical Trial

— IMPRINT  

Official title:

Implementation of a Multicomponent Intervention to Prevent Physical Restraints in Nursing Home Residents: a Cluster-randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341898
• Other study ID #: IMPRINT
• Secondary ID: 01GY1336A01GY133
• Status: Completed
• Phase: N/A
• First received: December 16, 2014
• Last updated: May 2, 2017
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Physical restraints as bedrails and belts are still regularly applied in German nursing homes despite clear evidence showing their lack of effectiveness and safety. In a cluster-randomized controlled trial, the efficacy of a guideline-based multicomponent intervention has been shown with a significant reduction in physical restraints use without adverse events. The present study aims to apply different versions of the original intervention in nursing home residents in four different regions throughout Germany in order to evaluate the effectiveness of the programme.

Methods/Design: Pragmatic cluster-randomized controlled trial comparing two intervention groups ((1) updated original programme and (2) brief version of the updated programme) with a control group (3) receiving printed study materials (optimized usual care). Intervention (1) consists of an information programme for all nurses, additional training and structured support for nominated key nurses, and provision of printed study material and other supportive material. For intervention (2) nurses' training is only optional carried out facultatively by key nurses who have received an additional train-the-trainer module. The control group (3) receives printed study material only. Overall, 120 nursing homes including approximately 10800 residents will be recruited, randomized to one of the three groups and followed up for 12 months. The primary outcome is defined as proportion of residents with at least one physical restraint at 12 months. Physical restraint use will be assessed by direct observation. Secondary outcomes are residents` quality of life as well as safety parameters as i.g. falls and fall-related fractures. Process and cost measures will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10800
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Cluster level

Inclusion Criteria:

• randomly selected nursing homes in each region; no specific inclusion criteria will be applied

Exclusion Criteria:

• no specific exclusion criteria will be applied

Individual level

Inclusion Criteria:

• all residents within the cluster present on the day of data collection

• all residents newly admitted to clusters during follow-up and present on the day of follow-up data collection

Exclusion Criteria:

• no specific exclusion criteria will be applied

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Educational programme for all nurses

• Training and structured support for nominated key nurses

• Facultative train-the-trainer module for key nurses

• Printed study material

• Supportive material (poster, mugs etc.)

Locations

Country	Name	City	State
Germany	Martin-Luther-University Halle-Wittenberg	Halle (Saale)	Sachsen-Anhalt
Germany	University of Hamburg	Hamburg
Germany	University of Lübeck	Lübeck	Schleswig-Holstein
Germany	Witten/Herdecke University	Witten	Nordrhein-Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	Martin-Luther-Universität Halle-Wittenberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process evaluation	Different process parameters will be assessed as e.g. relatives' experiences, staff experiences, leaders' experiences and organizational culture	12 Months
Primary	Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants		12 Months
Secondary	Residents` quality of life (measured by QoL-AD)	Will be measured by QoL-AD for a randomly selected subgroup of 10% of residents	12 Months
Secondary	Falls and fall-related fractures		12 Months
Secondary	Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters)	For economic evaluation cost parameters related to the implementation of the intervention will be collected as well as outcome-related costparameters; explicit trial-associated will not be taken into account	12 Months

External Links

•   project homepage