AnesthesiaNCT05386082
Anesthesia Core Quality Metrics Consensus Delphi Study
An observational study of Anesthesia and Consensus Development, run by University of British Columbia at 3 sites in Canada.
Trial summary
To develop a ranked list of up to 20 metrics, which can be used to evaluate the quality of anesthesia, perioperative care, and acute pain management for adult inpatient non-cardiac surgical patients for use in quality improvement and quality assurance, research, and continuing medical education in the Canadian care… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Consensus Development
- What is being tested?
- Modified Delphi process
- How many people
- 80 participants
- Where
- 3 sitesCanada
- Study dates
- 26 Sep 2022to 1 Nov 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators aim to recruit 77 participants with the following characteristics: a) 26 anesthesiologists, b) 26 patients and/or their family members/caregivers, c) 9 surgeons, d) 4 nurses, e) 2 physicians each from internal medicine, emergency department, family practice, family practice anesthetists, and 4 health administrators or quality improvement leads
Who may be able to join
- Patient/family participants must have undergone a surgical experience within the past three years, and have the capacity to provide informed consent.
- All other participants must be actively practising in Canada in the disciplines they represent.
Who cannot join
- Participants with self-declared conflicts of interest with this project.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1C 5S7
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Development of a Standardized Set of Core Metrics to Assess the Quality of Anesthesia, Perioperative Care, and Acute Pain Management in Canada: Scoping Review and Multidisciplinary Consensus Delphi Study
To develop a ranked list of up to 20 metrics, which can be used to evaluate the quality of anesthesia, perioperative care, and acute pain management for adult inpatient non-cardiac surgical patients for use in quality improvement and quality assurance, research, and continuing medical education in the Canadian care context.
Read the detailed description
Background: Improving anesthesiology care and perioperative outcomes is a growing field encompassing quality improvement and quality assurance, research, and continuing medical education. Multiple consensus initiatives have standardized perioperative endpoints. However, no standard set of metrics exist to evaluate the quality of Canadian anesthesiology care delivery.
Objective: Develop a ranked list of up to 20 metrics, which can be used to evaluate the quality of anesthesia, perioperative care, and acute pain management for adult inpatient non-cardiac surgical patients for use in quality improvement and quality assurance, research, and continuing medical education in the Canadian care context.
Methods: First, the steering committee will conduct a scoping review of the literature to identify candidate metrics, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) and Joanna Briggs Institute methodology for scoping reviews. Metrics will include patient-reported outcome and patient-reported experience measures, quality and safety indicators, process metrics, and Canadian Anesthesiologists' Society recommended practice standards. The search strategy will include English-language articles published or in use within the past seven years (2015/Jan-2022/March) in 1) MEDLINE, Embase, CINAHL, Web of Science, and Cochrane Database of Systematic Reviews, 2) grey literature, including guidelines, and 3) existing evaluation metrics used by Canadian departments for quality assurance and improvement. Screening and data extraction will be performed by two independent reviewers using Covidence.
Next, following approval from the Research Ethics Board and with written informed consent from participants, a multidisciplinary panel of anesthesiologists, people with lived surgical experience (patients, caregivers), surgeons, nurses, internal medicine and family physicians, hospital administrators, and researchers will iteratively review the list of candidate metrics using a modified Delphi process. Independent voting, using surveys over three rounds, will be used to identify the most important metrics to define the quality of anesthesia, perioperative care, and acute pain management. Additional cycles may be performed if required.
- Conditions
- Anesthesia, Consensus Development
- Being tested
- Modified Delphi process
- Keywords
- Metrics, Perioperative care, Quality of anesthesia, Outcomes, Delphi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Delphi processOther
The study involves a brief demographics survey and Delphi process, i.e. three rounds of information and surveys, in which participants will be asked to score/rank potential metrics.
| Study group | Role | What they receive |
|---|---|---|
| Study participants | Study participants Receives: Other: Modified Delphi process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ranked list of anesthesia, perioperative care, and acute pain management quality metrics
A ranked set of national consensus metrics for evaluating the quality of anesthesia, perioperative care, and acute pain management for adult noncardiac surgical patients that can be used for quality improvement and quality assurance, research, and continuing medical education in the Canadian care context. Metrics where >70% participants voted "definitely priority" will be marked in the publication as the core metric set.
Measured: late 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start26 Sep 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Görges, PhD, University of British Columbia
- Investigators
- Matthias Görges, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386082
- Sponsor's protocol ID
- H22-00519
- Status last verified
- Feb 2024
- First submitted
- 5 May 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Standardized Set of Core Metrics to Assess the Quality of Anesthesia, Perioperative Care, and Acute Pain Management in Canada: Scoping Review and Multidisciplinary Consensus Delphi Study
- ClinicalTrials.gov ID
- NCT05386082
- Acronym / sponsor ID
- H22-00519
- Conditions
- Anesthesia, Consensus Development
- Keywords
- Metrics, Perioperative care, Quality of anesthesia, Outcomes, Delphi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 23 May 2022 (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.
To develop a ranked list of up to 20 metrics, which can be used to evaluate the quality of anesthesia, perioperative care, and acute pain management for adult inpatient non-cardiac surgical patients for use in quality improvement and quality assurance, research, and continuing medical education in the Canadian care context.
Detailed description
Background: Improving anesthesiology care and perioperative outcomes is a growing field encompassing quality improvement and quality assurance, research, and continuing medical education. Multiple consensus initiatives have standardized perioperative endpoints. However, no standard set of metrics exist to evaluate the quality of Canadian anesthesiology care delivery.
Objective: Develop a ranked list of up to 20 metrics, which can be used to evaluate the quality of anesthesia, perioperative care, and acute pain management for adult inpatient non-cardiac surgical patients for use in quality improvement and quality assurance, research, and continuing medical education in the Canadian care context.
Methods: First, the steering committee will conduct a scoping review of the literature to identify candidate metrics, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) and Joanna Briggs Institute methodology for scoping reviews. Metrics will include patient-reported outcome and patient-reported experience measures, quality and safety indicators, process metrics, and Canadian Anesthesiologists' Society recommended practice standards. The search strategy will include English-language articles published or in use within the past seven years (2015/Jan-2022/March) in 1) MEDLINE, Embase, CINAHL, Web of Science, and Cochrane Database of Systematic Reviews, 2) grey literature, including guidelines, and 3) existing evaluation metrics used by Canadian departments for quality assurance and improvement. Screening and data extraction will be performed by two independent reviewers using Covidence.
Next, following approval from the Research Ethics Board and with written informed consent from participants, a multidisciplinary panel of anesthesiologists, people with lived surgical experience (patients, caregivers), surgeons, nurses, internal medicine and family physicians, hospital administrators, and researchers will iteratively review the list of candidate metrics using a modified Delphi process. Independent voting, using surveys over three rounds, will be used to identify the most important metrics to define the quality of anesthesia, perioperative care, and acute pain management. Additional cycles may be performed if required.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | – | Other: Modified Delphi processStudy participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators aim to recruit 77 participants with the following characteristics: a) 26 anesthesiologists, b) 26 patients and/or their family members/caregivers, c) 9 surgeons, d) 4 nurses, e) 2 physicians each from internal medicine, emergency department, family practice, family practice anesthetists, and 4 health administrators or quality improvement leads
Key inclusion criteria (2 listed)
- Patient/family participants must have undergone a surgical experience within the past three years, and have the capacity to provide informed consent.
- All other participants must be actively practising in Canada in the disciplines they represent.
Key exclusion criteria (1 listed)
- Participants with self-declared conflicts of interest with this project.
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 |
|---|---|---|
| Modified Delphi processThe study involves a brief demographics survey and Delphi process, i.e. three rounds of information and surveys, in which participants will be asked to score/rank potential metrics. | Other | Study participants |
Primary outcome
Ranked list of anesthesia, perioperative care, and acute pain management quality metrics
Time frame: late 2022
A ranked set of national consensus metrics for evaluating the quality of anesthesia, perioperative care, and acute pain management for adult noncardiac surgical patients that can be used for quality improvement and quality assurance, research, and continuing medical education in the Canadian care context. Metrics where >70% participants voted "definitely priority" will be marked in the publication as the core metric set.
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 28 Feb 2024.
- Scoping review registrationLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be shared.
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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.
Matthias Görges, PhD principal investigator
The University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Consensus Development, run by University of British Columbia at 3 sites in Canada.
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 2 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Ranked list of anesthesia, perioperative care, and acute pain management quality metrics (time frame: late 2022). 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 28 Feb 2024.