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

NCT04476355 | Unknown

• 1 other identifier: 2019-533
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Restraint, Physical; Intensive Care Units; Practice Guideline; Health Plan Implementation

Outcome Measures

Primary Outcomes (1)

• rate of utilization of physical restraints

  Length of utilization of physical restraints / length of stay in ICU

  2 years

Study Arms (2)

control group

NO INTERVENTION

In the same ICU, the former(2019-12\~2020-12) patients were the control group, data collected through case system.

experimental group

EXPERIMENTAL

In the same ICU, the patients in the study period were the experimental group

Other: Select and Tailor implementation interventions

Interventions

Select and Tailor implementation interventions OTHER

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.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the same ICU, the patients in the study period were the experimental group and the former patients were the control group.

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 20, 2020
• Study Start: September 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)