Implementation of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients Using the CAN-IMPLEMENT Framework

Development of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients and Implementation Study Using the CAN-IMPLEMENT Framework

Physical restraints (PR) are widely used in ICU around the world. Many institutions have suggested that the use of PR should be reduced. Clinical practice guidelines (CPGs) are a convenient way of packaging evidence and presenting recommendations to healthcare decision makers. There are currently no CPGs on PR in China, while other countries had, so we hope to be able to adapt existing guidelines to apply in Chinese context. We use the CAN-IMPLEMENT approach to adapt and implement the guidelines.

Study Overview

• Status: Active, not recruiting
• Conditions: Intensive Care Units; Restraint, Physical; Practice Guideline; Health Plan Implementation
• Intervention / Treatment: Other: Select and Tailor implementation interventions

Detailed Description

Critically ill patients admitted to intensive care units (ICU) often need more invasive operations (e.g.mechanical ventilation and hemodialysis), due to the needs from their condition, which can also lead to acute pain, discomfort, sleep deprivation, agitation and delirium. Agitation, for example, can propel patients to resist the ventilator, thus increasing the oxygen consumption, causing them to accidentally remove various devices and catheters on them and even posing life-threatening risks. Therefore, the main reason for the use of physical restraints (PR) around ICU is to prevent patients from accidentally removing the catheters or devices needed to protect their safety.

Although PR was used to prevent Unplanned extubation (UE), there were many studies proved that PR is one of the risk factors that account for UE and can not protect patient safety. Indeed, its use has been proven to cause pressure injuries, worsen agitation, delirium and neurovascular complications. But PR is widely used in ICU around the world.

Many institutions have suggested that the use of PR should be reduced, for example, the Government of Ontario released the Patient Restraints Minimization Act in 2001 to "minimize the use of restraints on patients and to encourage hospitals and facilities to use alternative methods, whenever possible, when it is necessary to prevent serious bodily harm by a patient to himself or herself or to others. Registered Nurses Association of Ontario (RNAO) issued clinical practice guidelines on the alternatives to PR in February 2012, aimed to help nurses reduce the use of PR, or use it in a more reasonable and standardized way, and to provide effective alternatives of PR.

Clinical practice guidelines (CPGs) are a convenient way of packaging evidence and presenting recommendations to healthcare decision makers. But the development and updating of high-quality CPGs require substantial time, expertise and resources. Guideline adaptation is the systematic approach to the endorsement and/or modification of a guideline(s) produced in one cultural and organisational setting for application in a different context. Where high quality guidelines are already available, adaptation may be used as an alternative to de novo guideline development to customise the existing guideline to the needs of local users. There are currently no CPGs on PR in China, while other countries had, so we hope to be able to adapt existing guidelines to apply in Chinese context. We use the CAN-IMPLEMENT approach to adapt and implement the guidelines.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The patient him/herself or the patient's authorized agent signed the informed consent to the study

Exclusion Criteria:

• Patients with a history of basic mental illness or cognitive impairment before admission

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control group; In the same ICU, the former(2019-12~2020-12) patients were the control group, data collected through case system.
EXPERIMENTAL: experimental group; In the same ICU, the patients in the study period were the experimental group	Other: Select and Tailor implementation interventions; Based on previously adapted guidelines and the assessment of innovation, adopters and practice environment for barriers and supports, the interventions mainly include patients education, practioners education and system changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of utilization of physical restraints	Length of utilization of physical restraints / length of stay in ICU	2 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2019-533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data analyzed in this study is not included in a repository because it contains interview transcripts.

Drug and device information, study documents

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