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

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

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.

Study Overview

• Status: Completed
• Conditions: Older People; Nursing Homes; Intervention
• Intervention / Treatment: Other: multifactorial interventions

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 354
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Miaoli, Taiwan
    • Nursing homes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: comparison group; The Control Group received no extra care.
Experimental: Intervention Group; Intervention Group, Intervention with follow-up, will have a multifactorial interventions to reduce physical restraint.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
physical restraint use	the percentage of physical restraint use	1 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Multiple restraints	the percentage of multiple restraints	1 minutes
agitated and inappropriate behavior	the percentage of agitated and inappropriate behavior	1 minutes
Extubation rate	the percentage of extubation	1 minutes
falls rate	the percentage of falls	1 minutes
psychotropic medication prescriptions	the percentage of psychotropic medication prescriptions	1 minutes
fall-related fractures	the percentage of fall-related fractures	1 minutes

Collaborators and Investigators

• Sponsor: Su-Hua Liang
• Investigators: Principal Investigator: Su-Hua Liang

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2015
• Primary Completion (Actual): February 29, 2016
• Study Completion (Actual): February 29, 2016

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: restraints; care providers
• Other Study ID Numbers: 104-5256B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No