Implementation of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients Using the CAN-IMPLEMENT Framework
Primary Purpose
Restraint, Physical, Intensive Care Units, Practice Guideline
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Select and Tailor implementation interventions
Sponsored by
About this trial
This is an interventional supportive care trial for Restraint, Physical
Eligibility Criteria
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
Sites / Locations
- Second Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
experimental group
Arm Description
In the same ICU, the former(2019-12~2020-12) patients were the control group, data collected through case system.
In the same ICU, the patients in the study period were the experimental group
Outcomes
Primary Outcome Measures
rate of utilization of physical restraints
Length of utilization of physical restraints / length of stay in ICU
Secondary Outcome Measures
Full Information
NCT ID
NCT04476355
First Posted
June 28, 2020
Last Updated
March 28, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04476355
Brief Title
Implementation of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients Using the CAN-IMPLEMENT Framework
Official Title
Development of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients and Implementation Study Using the CAN-IMPLEMENT Framework
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restraint, Physical, Intensive Care Units, Practice Guideline, Health Plan Implementation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
In the same ICU, the patients in the study period were the experimental group and the former patients were the control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
In the same ICU, the former(2019-12~2020-12) patients were the control group, data collected through case system.
Arm Title
experimental group
Arm Type
Experimental
Arm Description
In the same ICU, the patients in the study period were the experimental group
Intervention Type
Other
Intervention Name(s)
Select and Tailor implementation interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
rate of utilization of physical restraints
Description
Length of utilization of physical restraints / length of stay in ICU
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data analyzed in this study is not included in a repository because it contains interview transcripts.
Learn more about this trial
Implementation of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients Using the CAN-IMPLEMENT Framework
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