Pain ManagementNCT02922101
Evaluation of the Effectiveness of an Audit and Feedback Intervention With Quality Improvement Toolbox in Intensive Care
A study testing Audit and Feedback and Toolbox in people with Pain Management and Critical Care, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This study evaluates the addition of a quality improvement toolbox to an online audit and feedback intervention in Dutch intensive care units. The toolbox comprises for each quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management, Critical Care, Quality Improvement
- What is being tested?
- Audit and Feedback and Toolbox
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to Oct 2018
- 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
- ICUs treating adult (18 years and above) patients
- ICUs willing and able to submit data monthly
- ICUs with a local quality improvement team of at least 1 intensivist and 1 nurse
Who cannot join
- Nil
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
National Intensive Care Evaluation foundation
Amsterdam, North Holland, 1100 EC
About this study
Official title: Increasing the Effectiveness and Understanding of Audit and Feedback Interventions in Intensive Care: Protocol for a Mixed-methods Study
This study evaluates the addition of a quality improvement toolbox to an online audit and feedback intervention in Dutch intensive care units. The toolbox comprises for each quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift). Half of the participating intensive care units will only receive online feedback, while the other half will additionally gain access to the integrated toolbox to facilitate planning and executing actions.
- Conditions
- Pain Management, Critical Care, Quality Improvement
- Being tested
- Audit and Feedback, Toolbox
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and FeedbackBehavioural
Also called A&F, Feedback
An online dashboard that provides insight into clinical performance on pain management quality indicators. It also incorporates an empty action plan, in which participating intensive care units can define potential bottlenecks in the care process and what actions they intend to undertake to improve.
ToolboxBehavioural
Also called Quality Improvement Toolbox
A quality improvement toolbox, incorporated within the action plan, that comprises for each pain management quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift).
| Study group | Role | What they receive |
|---|---|---|
| Audit and Feedback with toolbox | Experimental | Access to an online dashboard that provides insight into clinical performance on quality indicators for pain management; including a quality improvement toolbox to facilitate planning and executing actions. Participating ICUs will receive one educational outreach visit and brief monthly telephone calls. Receives: Behavioral: Audit and Feedback; Behavioral: Toolbox |
| Audit and Feedback without toolbox | Active comparator | Same intervention, but without access to the quality improvement toolbox. Receives: Behavioral: Audit and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from proportion of patient shifts during which pain has been adequately managed
"Adequately managed" is defined: pain measured AND (acceptable pain score OR (unacceptable pain score AND normalized within 1 hour)). The primary outcome measure is a composite score of four quality indicators (= secondary outcome measures).The measure is limited to only patients' first 12 shifts to prevent bias from patients with a long stay. There are 3 shifts in 1 day.
Measured: 9 months
Secondary outcomes (4)
Change from proportion of patient shifts during which pain was measured at least once
Measured: 9 months
Change from proportion of patient shifts during which pain was measured and no unacceptable pain scores were observed
Measured: 9 months
Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured
Measured: 9 months
Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured indicating that the pain score was normalized
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Intensive Care Evaluation Foundation
- Responsible party
- Principal investigator, Prof. dr. Nicolette F. de Keizer, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Nicolette F de Keizer, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922101
- Sponsor's protocol ID
- METC_W16_271
- Status last verified
- Jan 2019
- First submitted
- 26 Sep 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- Individual data sharing
- Yes: The National Intensive Care Evaluation (NICE) foundation has a policy for sharing data among its participating ICUs.
Publications
Gude WT, Roos-Blom MJ, van der Veer SN, Dongelmans DA, de Jonge E, Peek N, de Keizer NF. Facilitating action planning within audit and feedback interventions: a mixed-methods process evaluation of an action implementation toolbox in intensive care. Implement Sci. 2019 Sep 18;14(1):90. doi: 10.1186/s13012-019-0937-8.
PubMed 31533841Roos-Blom MJ, Gude WT, de Jonge E, Spijkstra JJ, van der Veer SN, Peek N, Dongelmans DA, de Keizer NF. Impact of audit and feedback with action implementation toolbox on improving ICU pain management: cluster-randomised controlled trial. BMJ Qual Saf. 2019 Dec;28(12):1007-1015. doi: 10.1136/bmjqs-2019-009588. Epub 2019 Jul 1.
PubMed 31263017Gude WT, Roos-Blom MJ, van der Veer SN, Dongelmans DA, de Jonge E, Francis JJ, Peek N, de Keizer NF. Health professionals' perceptions about their clinical performance and the influence of audit and feedback on their intentions to improve practice: a theory-based study in Dutch intensive care units. Implement Sci. 2018 Feb 17;13(1):33. doi: 10.1186/s13012-018-0727-8.
PubMed 29454393Gude WT, Roos-Blom MJ, van der Veer SN, de Jonge E, Peek N, Dongelmans DA, de Keizer NF. Electronic audit and feedback intervention with action implementation toolbox to improve pain management in intensive care: protocol for a laboratory experiment and cluster randomised trial. Implement Sci. 2017 May 25;12(1):68. doi: 10.1186/s13012-017-0594-8.
PubMed 28545535
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Effectiveness and Understanding of Audit and Feedback Interventions in Intensive Care: Protocol for a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT02922101
- Acronym / sponsor ID
- METC_W16_271
- Conditions
- Pain Management, Critical Care, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- National Intensive Care Evaluation Foundation
- Study start
- Sep 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Oct 2016 (estimated)
- 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.
This study evaluates the addition of a quality improvement toolbox to an online audit and feedback intervention in Dutch intensive care units. The toolbox comprises for each quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift). Half of the participating intensive care units will only receive online feedback, while the other half will additionally gain access to the integrated toolbox to facilitate planning and executing actions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audit and Feedback with toolbox | Experimental | Behavioral: Audit and Feedback, Behavioral: ToolboxAccess to an online dashboard that provides insight into clinical performance on quality indicators for pain management; including a quality improvement toolbox to facilitate planning and executing actions. Participating ICUs will receive one educational outreach visit and brief monthly telephone calls. |
| Audit and Feedback without toolbox | Active comparator | Behavioral: Audit and FeedbackSame intervention, but without access to the quality improvement toolbox. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ICUs treating adult (18 years and above) patients
- ICUs willing and able to submit data monthly
- ICUs with a local quality improvement team of at least 1 intensivist and 1 nurse
Key exclusion criteria (1 listed)
- Nil
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 |
|---|---|---|
| Audit and FeedbackAlso: A&F, FeedbackAn online dashboard that provides insight into clinical performance on pain management quality indicators. It also incorporates an empty action plan, in which participating intensive care units can define potential bottlenecks in the care process and what actions they intend to undertake to improve. | Behavioural | Audit and Feedback with toolbox, Audit and Feedback without toolbox |
| ToolboxAlso: Quality Improvement ToolboxA quality improvement toolbox, incorporated within the action plan, that comprises for each pain management quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift). | Behavioural | Audit and Feedback with toolbox |
Primary outcome
Change from proportion of patient shifts during which pain has been adequately managed
Time frame: 9 months
"Adequately managed" is defined: pain measured AND (acceptable pain score OR (unacceptable pain score AND normalized within 1 hour)). The primary outcome measure is a composite score of four quality indicators (= secondary outcome measures).The measure is limited to only patients' first 12 shifts to prevent bias from patients with a long stay. There are 3 shifts in 1 day.
4 secondary outcomes
Change from proportion of patient shifts during which pain was measured at least once
Time frame: 9 months
Change from proportion of patient shifts during which pain was measured and no unacceptable pain scores were observed
Time frame: 9 months
Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured
Time frame: 9 months
Change from proportion of patient shifts during which an unacceptable pain score was measured, and pain was timely re-measured indicating that the pain score was normalized
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 31533841Gude WT, Roos-Blom MJ, van der Veer SN, Dongelmans DA, de Jonge E, Peek N, de Keizer NF. Facilitating action planning within audit and feedback interventions: a mixed-methods process evaluation of an action implementation toolbox in intensive care. Implement Sci. 2019 Sep 18;14(1):90. doi: 10.1186/s13012-019-0937-8.
- Derived from this study: PubMed 31263017Roos-Blom MJ, Gude WT, de Jonge E, Spijkstra JJ, van der Veer SN, Peek N, Dongelmans DA, de Keizer NF. Impact of audit and feedback with action implementation toolbox on improving ICU pain management: cluster-randomised controlled trial. BMJ Qual Saf. 2019 Dec;28(12):1007-1015. doi: 10.1136/bmjqs-2019-009588. Epub 2019 Jul 1.
- Derived from this study: PubMed 29454393Gude WT, Roos-Blom MJ, van der Veer SN, Dongelmans DA, de Jonge E, Francis JJ, Peek N, de Keizer NF. Health professionals' perceptions about their clinical performance and the influence of audit and feedback on their intentions to improve practice: a theory-based study in Dutch intensive care units. Implement Sci. 2018 Feb 17;13(1):33. doi: 10.1186/s13012-018-0727-8.
- Derived from this study: PubMed 28545535Gude WT, Roos-Blom MJ, van der Veer SN, de Jonge E, Peek N, Dongelmans DA, de Keizer NF. Electronic audit and feedback intervention with action implementation toolbox to improve pain management in intensive care: protocol for a laboratory experiment and cluster randomised trial. Implement Sci. 2017 May 25;12(1):68. doi: 10.1186/s13012-017-0594-8.
- Individual participant dataSharing planned: Yes. The National Intensive Care Evaluation (NICE) foundation has a policy for sharing data among its participating ICUs.
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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.
Nicolette F de Keizer, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audit and Feedback and Toolbox in people with Pain Management and Critical Care, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 10 Jan 2019. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from proportion of patient shifts during which pain has been adequately managed (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02922101, which also lists 4 linked publications.
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 10 Jan 2019.