DementiaNCT05385445
Electronic Medical Records to Increase Adherence to the Choosing Wisely Recommendations
A study testing Audit and Feedback in people with Dementia and Viral Infection, run by University of Manitoba at 1 site in Canada.
Trial summary
Audit and Feedback (A\&F), a strategy aimed at promoting modified practice through performance feedback, is a method to change provider behaviour and reduce unnecessary medical services. This study aims to assess the use of A\&F to change: 1. antibiotic prescribing for viral infections 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia, Viral Infection, Vitamin D Deficiency
- What is being tested?
- Audit and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2016to 31 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All primary care providers participating in the Manitoba Primary Care Research Network (MaPCReN), the Manitoba practice-based network of the Canadian Primary Care Sentinel Surveillance Network.
Who cannot join
- Primary care providers not participating in MaPCReN
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba, Department of Family Medicine
Winnipeg, Manitoba, R3W0A8
About this study
Official title: The Use of Electronic Medical Records to Change Clinician Behaviour and Increase Adherence to the Choosing Wisely Recommendations
Audit and Feedback (A\&F), a strategy aimed at promoting modified practice through performance feedback, is a method to change provider behaviour and reduce unnecessary medical services. This study aims to assess the use of A\&F to change:
- antibiotic prescribing for viral infections
- antipsychotic prescribing to patients with dementia
- routine measure of vitamin D in low risk adults
- annual screening blood tests (without direct indication by the risk profile of the patient)
Read the detailed description
The investigators conducted a clustered randomized trial of primary care providers in Manitoba, Canada participating in the Manitoba Primary Care Research Network (MaPCReN) to assess the impact of A\&F interventions to change prescribing and screening rates.
In January 2016, MaPCReN included 239 providers in 46 practices across Manitoba, representing ~20% of Manitoba primary care providers. MaPCReN recruits consenting primary care providers (family physicians, nurse practitioners and community pediatricians) that receive semi-annual feedback reports for practice reflection and quality improvement. Feedback reports provide practice-level details including disease prevalence and clinical characteristics of patients, reported in comparison to other providers at the same practice, health region and provincially
Investigators implemented an A\&F cycle reporting on practice behaviours related to four Choosing Wisely Canada (CWC) recommendations.
- "Don't use antibiotics for upper respiratory infections that are likely viral in origin, such as influenza-like illness, or self-limiting, such as sinus infections of less than seven days of duration." • Bacterial infections of the respiratory tract are rare and usually only secondary complications from initial viral infections. Antibiotics are rarely indicated for upper respiratory illness and patients may suffer adverse effects from antibiotics.
- Don't routinely measure Vitamin D in low risk adults.
- Routine supplementation of vitamin D is recommended for people living in Northern climates regardless of measured laboratory levels. There is no indication for ordering vitamin D unless a patient is suffering severe renal or metabolic disease.
- Don't do annual screening blood tests unless directly indicated by the risk profile of the patient.
- There is minimal value in ordering routine blood tests in asymptomatic patients and in fact some "routine" screening tests such as prostate-specific antigen (PSA) is in fact recommended against due to the likelihood of producing false positive results. This may lead to additional and unnecessary testing.
- Don't prescribe antipsychotics to treat behavioural and psychological symptoms of dementia.
- There are some instances where patients with behavioural symptoms of dementia require antipsychotic medicines although these instances are rare. These medicines should be used judiciously given for this indication because they provide limited benefit and may cause serious side effects including premature death
MaPCReN personnel randomly assigned numbers to clinics for randomization. Number of physicians practicing at each clinic was controlled during randomization.
The intervention "Group 1" received the standard feedback report with a one-page summary of the CWC recommendations of interest. Group 1 did not receive any data specific to their prescribing. Intervention "Group 2" received the standard feedback report, CWC recommendation summary and practice-specific data related to their prescribing rates for the CWC recommendations of interest, compared to rates for other providers at their clinic, in their health region and in the province. The control group received the standard feedback report with no information related to CWC.
The A\&F intervention took place between January 2016 and January 2017. Retrospective Electronic Medical Record (EMR) data from the MaPCReN repository was assessed between January 2014-December 2019 to assess changes in prescribing rates during and immediately following the A\&F intervention (2016/17), as well as assess continued change in practice after the A\&F (2018/19) compared to prescribing rates prior to the A\&F (2014/15). There were seven clinics not included in the 2018/19 analysis due to a change in EMR vendor that may have compromised data quality.
- Conditions
- Dementia, Viral Infection, Vitamin D Deficiency
- Being tested
- Audit and Feedback
- Keywords
- Primary Health Care, Annual Screening
- Medical subject headings
- Dementia, Virus Diseases, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and FeedbackBehavioural
The investigators conducted a clustered randomized trial of primary care providers in Manitoba, Canada participating in the Manitoba Primary Care Research Network (MaPCReN) to assess the impact of Audit \& Feedback interventions to change prescribing and laboratory ordering.
| Study group | Role | What they receive |
|---|---|---|
| Audit and Feedback Group 1 | Experimental | The intervention "Group 1" received the standard feedback report with a one-page summary of the CWC recommendations of interest. Group 1 did not receive any data specific to their prescribing. Receives: Behavioral: Audit and Feedback |
| Audit and Feedback Group 2 | Experimental | Intervention "Group 2" received the standard feedback report, CWC recommendation summary and practice-specific data related to their prescribing rates for the CWC recommendations of interest, compared to rates for other providers at their clinic, in their health region and in the province. Receives: Behavioral: Audit and Feedback |
| Control | No intervention | The control group received the standard feedback report with no information related to CWC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in antibiotic prescribing for upper respiratory infections that are likely viral in origins
Investigators assessed baseline prescribing (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
Measured: 12 months
Change in prescribing of antipsychotics to treat behavioural and psychological symptoms of dementia.
Investigators assessed baseline prescribing (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
Measured: 12 months
Change in Vitamin D laboratory testing
Investigators assessed baseline ordering (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
Measured: 12 months
Change in PSA ordering (annual screening)
Investigators assessed baseline ordering (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
Measured: 12 months
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 start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Model description
- Cluster Randomized Trial. MaPCReN personnel randomly assigned numbers to clinics for randomization. Number of physicians practicing at each clinic was controlled during randomization. The intervention "Group 1" received the standard feedback report with a one-page summary of the CWC recommendations of interest. Group 1 did not receive any data specific to their prescribing. Intervention "Group 2" received the standard feedback report, CWC recommendation summary and practice-specific data related to their prescribing rates for the CWC recommendations of interest, compared to rates for other providers at their clinic, in their health region and in the province. The control group received the standard feedback report with no information related to CWC.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385445
- Sponsor's protocol ID
- HS19281(H2016:022)
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2022
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Singer A, Kosowan L, Katz A, Jolin-Dahel K, Appel K, Lix LM. Prescribing and testing by primary care providers to assess adherence to the Choosing Wisely Canada recommendations: a retrospective cohort study. CMAJ Open. 2018 Dec 10;6(4):E603-E610. doi: 10.9778/cmajo.20180053. Print 2018 Oct-Dec.
PubMed 30530720Singer A, Kosowan L, Abrams EM, Katz A, Lix L, Leong K, Paige A. Implementing an audit and feedback cycle to improve adherence to the Choosing Wisely Canada recommendations: clustered randomized trail. BMC Prim Care. 2022 Nov 26;23(1):302. doi: 10.1186/s12875-022-01912-7.
PubMed 36435746
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Electronic Medical Records to Change Clinician Behaviour and Increase Adherence to the Choosing Wisely Recommendations
- ClinicalTrials.gov ID
- NCT05385445
- Acronym / sponsor ID
- HS19281(H2016:022)
- Conditions
- Dementia, Viral Infection, Vitamin D Deficiency
- Keywords
- Primary Health Care, Annual Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 31 Dec 2019 (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.
Audit and Feedback (A\&F), a strategy aimed at promoting modified practice through performance feedback, is a method to change provider behaviour and reduce unnecessary medical services. This study aims to assess the use of A\&F to change:
- antibiotic prescribing for viral infections
- antipsychotic prescribing to patients with dementia
- routine measure of vitamin D in low risk adults
- annual screening blood tests (without direct indication by the risk profile of the patient)
Detailed description
The investigators conducted a clustered randomized trial of primary care providers in Manitoba, Canada participating in the Manitoba Primary Care Research Network (MaPCReN) to assess the impact of A\&F interventions to change prescribing and screening rates.
In January 2016, MaPCReN included 239 providers in 46 practices across Manitoba, representing ~20% of Manitoba primary care providers. MaPCReN recruits consenting primary care providers (family physicians, nurse practitioners and community pediatricians) that receive semi-annual feedback reports for practice reflection and quality improvement. Feedback reports provide practice-level details including disease prevalence and clinical characteristics of patients, reported in comparison to other providers at the same practice, health region and provincially
Investigators implemented an A\&F cycle reporting on practice behaviours related to four Choosing Wisely Canada (CWC) recommendations.
- "Don't use antibiotics for upper respiratory infections that are likely viral in origin, such as influenza-like illness, or self-limiting, such as sinus infections of less than seven days of duration." • Bacterial infections of the respiratory tract are rare and usually only secondary complications from initial viral infections. Antibiotics are rarely indicated for upper respiratory illness and patients may suffer adverse effects from antibiotics.
- Don't routinely measure Vitamin D in low risk adults.
- Routine supplementation of vitamin D is recommended for people living in Northern climates regardless of measured laboratory levels. There is no indication for ordering vitamin D unless a patient is suffering severe renal or metabolic disease.
- Don't do annual screening blood tests unless directly indicated by the risk profile of the patient.
- There is minimal value in ordering routine blood tests in asymptomatic patients and in fact some "routine" screening tests such as prostate-specific antigen (PSA) is in fact recommended against due to the likelihood of producing false positive results. This may lead to additional and unnecessary testing.
- Don't prescribe antipsychotics to treat behavioural and psychological symptoms of dementia.
- There are some instances where patients with behavioural symptoms of dementia require antipsychotic medicines although these instances are rare. These medicines should be used judiciously given for this indication because they provide limited benefit and may cause serious side effects including premature death
MaPCReN personnel randomly assigned numbers to clinics for randomization. Number of physicians practicing at each clinic was controlled during randomization.
The intervention "Group 1" received the standard feedback report with a one-page summary of the CWC recommendations of interest. Group 1 did not receive any data specific to their prescribing. Intervention "Group 2" received the standard feedback report, CWC recommendation summary and practice-specific data related to their prescribing rates for the CWC recommendations of interest, compared to rates for other providers at their clinic, in their health region and in the province. The control group received the standard feedback report with no information related to CWC.
The A\&F intervention took place between January 2016 and January 2017. Retrospective Electronic Medical Record (EMR) data from the MaPCReN repository was assessed between January 2014-December 2019 to assess changes in prescribing rates during and immediately following the A\&F intervention (2016/17), as well as assess continued change in practice after the A\&F (2018/19) compared to prescribing rates prior to the A\&F (2014/15). There were seven clinics not included in the 2018/19 analysis due to a change in EMR vendor that may have compromised data quality.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Cluster Randomized Trial. MaPCReN personnel randomly assigned numbers to clinics for randomization. Number of physicians practicing at each clinic was controlled during randomization. The intervention "Group 1" received the standard feedback report with a one-page summary of the CWC recommendations of interest. Group 1 did not receive any data specific to their prescribing. Intervention "Group 2" received the standard feedback report, CWC recommendation summary and practice-specific data related to their prescribing rates for the CWC recommendations of interest, compared to rates for other providers at their clinic, in their health region and in the province. The control group received the standard feedback report with no information related to CWC.
| Arm | Type | Receives |
|---|---|---|
| Audit and Feedback Group 1 | Experimental | Behavioral: Audit and FeedbackThe intervention "Group 1" received the standard feedback report with a one-page summary of the CWC recommendations of interest. Group 1 did not receive any data specific to their prescribing. |
| Audit and Feedback Group 2 | Experimental | Behavioral: Audit and FeedbackIntervention "Group 2" received the standard feedback report, CWC recommendation summary and practice-specific data related to their prescribing rates for the CWC recommendations of interest, compared to rates for other providers at their clinic, in their health region and in the province. |
| Control | No intervention | –The control group received the standard feedback report with no information related to CWC. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All primary care providers participating in the Manitoba Primary Care Research Network (MaPCReN), the Manitoba practice-based network of the Canadian Primary Care Sentinel Surveillance Network.
Key exclusion criteria (1 listed)
- Primary care providers not participating in MaPCReN
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 FeedbackThe investigators conducted a clustered randomized trial of primary care providers in Manitoba, Canada participating in the Manitoba Primary Care Research Network (MaPCReN) to assess the impact of Audit \& Feedback interventions to change prescribing and laboratory ordering. | Behavioural | Audit and Feedback Group 1, Audit and Feedback Group 2 |
Primary outcome
Change in antibiotic prescribing for upper respiratory infections that are likely viral in origins
Time frame: 12 months
Investigators assessed baseline prescribing (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
Change in prescribing of antipsychotics to treat behavioural and psychological symptoms of dementia.
Time frame: 12 months
Investigators assessed baseline prescribing (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
Change in Vitamin D laboratory testing
Time frame: 12 months
Investigators assessed baseline ordering (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
Change in PSA ordering (annual screening)
Time frame: 12 months
Investigators assessed baseline ordering (before the intervention, 2014/2015), and compared this to during the intervention (2016/2017) and following the intervention (2018/2019)
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 23 May 2022.
- Background: PubMed 30530720Singer A, Kosowan L, Katz A, Jolin-Dahel K, Appel K, Lix LM. Prescribing and testing by primary care providers to assess adherence to the Choosing Wisely Canada recommendations: a retrospective cohort study. CMAJ Open. 2018 Dec 10;6(4):E603-E610. doi: 10.9778/cmajo.20180053. Print 2018 Oct-Dec.
- Derived from this study: PubMed 36435746Singer A, Kosowan L, Abrams EM, Katz A, Lix L, Leong K, Paige A. Implementing an audit and feedback cycle to improve adherence to the Choosing Wisely Canada recommendations: clustered randomized trail. BMC Prim Care. 2022 Nov 26;23(1):302. doi: 10.1186/s12875-022-01912-7.
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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 Audit and Feedback in people with Dementia and Viral Infection, run by University of Manitoba at 1 site 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 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: finished, as of the sponsor's last update on 23 May 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 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?
Change in antibiotic prescribing for upper respiratory infections that are likely viral in origins (time frame: 12 months). The study lists 4 primary outcomes in all. 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 NCT05385445, which also lists 2 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 23 May 2022.