NCT02341898

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

December 16, 2014

Last Update Submit

May 2, 2017

Conditions

Dementia

Keywords

nursing home carephysical restraintsdementiaimplementation researchcluster-randomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Proportion of residents with at least one physical restraint assessed through direct observation by blinded research assistants

    12 Months

Secondary Outcomes (3)

  • Residents' quality of life (measured by QoL-AD)

    12 Months

  • Falls and fall-related fractures

    12 Months

  • Costs within trial period (cost parameters related to the implementation of the intervention as well as outcome-related cost parameters)

    12 Months

Other Outcomes (1)

  • Process evaluation

    12 Months

Study Arms (3)

Updated original programme

EXPERIMENTAL

Educational programme for all nurses (90 min. single information session); training and structured support for nominated key nurses (one-day training workshop); provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.)

Other: Educational programme for all nursesOther: Training and structured support for nominated key nursesOther: Printed study materialOther: Supportive material (poster, mugs etc.)

Concise updated programme

EXPERIMENTAL

Training and structured support for nominated key nurses (one-day training workshop); nurses' training will be carried out by key nurses as facultative option; key nurses receive an additional train-the-trainer module to apply the educational programme; provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives); supportive material (poster, mugs etc.)

Other: Training and structured support for nominated key nursesOther: Facultative train-the-trainer module for key nursesOther: Printed study materialOther: Supportive material (poster, mugs etc.)

Optimized usual care

ACTIVE COMPARATOR

Provision of printed study material (evidence-based practice guideline; short versions for nurses, legal guardians, and others; information brochures for relatives) only

Other: Printed study material

Interventions

Educational programme for all nursesOTHER
Updated original programme
Training and structured support for nominated key nursesOTHER
Concise updated programmeUpdated original programme
Facultative train-the-trainer module for key nursesOTHER
Concise updated programme
Printed study materialOTHER
Concise updated programmeOptimized usual careUpdated original programme
Supportive material (poster, mugs etc.)OTHER
Concise updated programmeUpdated original programme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Individual level
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Witten/Herdecke University

Witten, North Rhine-Westphalia, 58448, Germany

Location

Martin-Luther-University Halle-Wittenberg

Halle, Saxony-Anhalt, 06112, Germany

Location

University of Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

University of Hamburg

Hamburg, 20146, Germany

Location

Related Publications (2)

  • Abraham J, Kupfer R, Behncke A, Berger-Hoger B, Icks A, Haastert B, Meyer G, Kopke S, Mohler R. Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial. Int J Nurs Stud. 2019 Aug;96:27-34. doi: 10.1016/j.ijnurstu.2019.03.017. Epub 2019 Apr 4.

    PMID: 31014546DERIVED

  • Abraham J, Mohler R, Henkel A, Kupfer R, Icks A, Dintsios CM, Haastert B, Meyer G, Kopke S. Implementation of a Multicomponent intervention to Prevent Physical Restraints In Nursing home residenTs (IMPRINT): study protocol for a cluster-randomised controlled trial. BMC Geriatr. 2015 Jul 21;15:86. doi: 10.1186/s12877-015-0086-0.

    PMID: 26195247DERIVED

Related Links

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sascha Köpke, Prof. Dr.

    University of Lübeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

December 16, 2014

First Posted

January 19, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

DE(4)