Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes

Intervention Clinical Trial

Official title:

The Effects of a Multifactorial Intervention to Reduce Physical Restraints for Care Providers in Nursing Homes: A Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193773
• Other study ID #: 104-5256B
• Status: Completed
• Phase: N/A
• Start date: September 7, 2015
• Est. completion date: February 29, 2016

Study information

• Verified date: January 2022
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Scholars from around the world have been strongly advocating restraint-free care in long-term care institutions. Therefore, the aim of this study was to evaluate the effects of a multifactorial intervention to reduce physical restraints for care providers in nursing homes.

Description:

In Taiwanese nursing homes, the use of physical restraints on residents as a protective measure is fairly common. However, physical restraints can be seen as a violation of human rights, and there is no guarantee of the effectiveness or safety of such physical restraints.This study was to evaluate the effects of a multifactorial intervention to reduce physical restraints for care providers in nursing homes. A cluster randomized controlled trial was conducted using pretest-posttest control group design. A purposive sampling of participants was chosen from care providers of 6 nursing home institutions in Taiwan, who were then randomly assigned to the experimental group (3 nursing homes) or the control group (3 nursing homes). The experimental group underwent multifactorial interventions to reduce physical restraint.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: February 29, 2016
• Est. primary completion date: February 29, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A full-time care provider

• Worked in a nursing home for more than three months

• Care providers have imposed physical restraints on elderly residents aged 60 or above Within the last month.

Exclusion Criteria:

• can't speak or read chinese, Vietnamese, Indonesian

Related Conditions & MeSH terms

• Intervention
• Nursing Homes
• Older People

Intervention

Other:
• multifactorial interventions
The experimental group underwent multifactorial interventions to reduce physical restraint, including developing routines for physical restraint, promoting institutional policies to reduce the use of physical restraint, developing alternative methods, education, and consultations.

Locations

Country	Name	City	State
Taiwan	Nursing Homes	Miaoli

Sponsors (1)

Lead Sponsor	Collaborator
Su-Hua Liang

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge	The Knowledge of Restraints use scale . The Knowledge of Restraints use scale was used to assess the knowledge component. The scale consists of 20 items scored as 1 (true) or 0 (false or uncertainty). A higher score indicates more knowledge; total scores range from 0 to 20.	8 minutes
Primary	Attitudes	The Attitudes of Restraints use scale . The Attitudes of Restraints use scale was used to assess participants' attitudes about restraint use. The scale is a 15 items with a 5-point Likert scale ranging from 1 (not at all agree) to 5 (most agree); the range of total scores is from 15 to 75. Higher scores indicate more negative attitudes about physical restraint use.	8 minutes
Primary	Behavior	The Behavior of restraints use scale . The Behavior of restraints use scale was used to assess care providers' behavior about restraint use. The scale consists of 13 items scored as 1 (yes) or 0 (no); the range of total scores is from 0 to 13. The higher the score, the better the behavior.	4 minutes
Primary	physical restraint use	the percentage of physical restraint use	1 minutes
Secondary	Restraint types	The percentage of restraint types use. The restraint types including device (wrist belt, waist belt, ankle belt, vest in wheel chair, belt in wheel chair, wheel chair with a table board, hand mitts, special sheet etc), area (trunk, waist, ankle, wrist), belt in bed, belt in wheel chair, day time, night, whole day.	1 minutes
Secondary	Multiple restraints	the percentage of multiple restraints	1 minutes
Secondary	agitated and inappropriate behavior	the percentage of agitated and inappropriate behavior	1 minutes
Secondary	Extubation rate	the percentage of extubation	1 minutes
Secondary	falls rate	the percentage of falls	1 minutes
Secondary	psychotropic medication prescriptions	the percentage of psychotropic medication prescriptions	1 minutes
Secondary	fall-related fractures	the percentage of fall-related fractures	1 minutes