Restraint, PhysicalNCT04476355
Implementation of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients Using the CAN-IMPLEMENT Framework
A study testing Select and Tailor implementation interventions in people with Restraint, Physical and Intensive Care Units, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restraint, Physical, Intensive Care Units, Practice Guideline
- What is being tested?
- Select and Tailor implementation interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient him/herself or the patient's authorized agent signed the informed consent to the study
Who cannot join
- Patients with a history of basic mental illness or cognitive impairment before admission
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: 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.
Read the 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.
- Being tested
- Select and Tailor implementation interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Select and Tailor implementation interventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Select and Tailor implementation interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of utilization of physical restraints
Length of utilization of physical restraints / length of stay in ICU
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Sep 2021
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restraint, PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476355
- Sponsor's protocol ID
- 2019-533
- Status last verified
- Jun 2021
- First submitted
- 28 Jun 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data analyzed in this study is not included in a repository because it contains interview transcripts.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Physical Restraints Clinical Practice Guidelines for Critically Ill Patients and Implementation Study Using the CAN-IMPLEMENT Framework
- ClinicalTrials.gov ID
- NCT04476355
- Acronym / sponsor ID
- 2019-533
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the same ICU, the patients in the study period were the experimental group and the former patients were the control group.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Select and Tailor implementation interventionsIn the same ICU, the patients in the study period were the experimental group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patient him/herself or the patient's authorized agent signed the informed consent to the study
Key exclusion criteria (1 listed)
- Patients with a history of basic mental illness or cognitive impairment before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Select and Tailor implementation interventionsBased 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. | Other | experimental group |
Primary outcome
rate of utilization of physical restraints
Time frame: 2 years
Length of utilization of physical restraints / length of stay in ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No. The data analyzed in this study is not included in a repository because it contains interview transcripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Select and Tailor implementation interventions in people with Restraint, Physical and Intensive Care Units, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of utilization of physical restraints (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.