Quality of Health CareNCT04107233
Using Electronic Medical Record Data to Improve HIV Primary Care
A study testing Audit and Feedback in people with Quality of Health Care and HIV/AIDS, run by Unity Health Toronto at 1 site in Canada.
Trial summary
This cluster randomized control trial examines whether an audit and feedback study improves care of patients living with HIV/AIDS in a family health team setting. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Quality of Health Care, HIV/AIDS, Electronic Health Records
- 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
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2017to 19 Jul 2021
- 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
- Family physicians at the St. Michael's Hospital Academic Family Health Team who have at least 20 PLHA.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Electronic Medical Record Data to Improve HIV Primary Care: an Audit and Feedback Study
This cluster randomized control trial examines whether an audit and feedback study improves care of patients living with HIV/AIDS in a family health team setting.
Read the detailed description
This cluster randomized control trial will use electronic medical record (EMR) data from the St. Michael's Hospital Academic Family Health Team to examine whether the quality of HIV care provided to patients can be improved through an audit and feedback (A\&F) intervention. Our objective is to examine whether A\&F targeting family physicians caring for people living with HIV/AIDS (PHLA) using EMR data can improve laboratory monitoring, engagement in primary care and the uptake of preventive interventions.
- Conditions
- Quality of Health Care, HIV/AIDS, Electronic Health Records
- Being tested
- Audit and Feedback
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audit and FeedbackBehavioural
Charts for enrolled physicians will be audited and they will receive feedback, consisting of tailored reports and one-on-one meeting with colleague to review at baseline, 3 months and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Audit and feedback directed at family physicians, including reports a one-on-one meeting. Receives: Behavioral: Audit and Feedback |
| Control | No intervention | Usual care; may receive the intervention at the end of the study if successful |
What is being measured
The primary outcome is the main question the study is designed to answer.
Up to date viral load
Percentage of HIV infected patients who have an up to date HIV viral load
Measured: Within six months
Secondary outcomes (6)
Clinic visit
To assess engagement in care (number of patients who went to see a physician)
Measured: Within the last 6 months
Up-to-date cancer screenings
Presence of cancer monitoring for colorectal, breast and cervical cancers
Measured: 1-3 years
Vaccinations
Up-to-date for both pneumococcal vaccines and seasonal influenza vaccine (number of patients who received a specific vaccination)
Measured: Since 2013
Screening for diabetes
For those 40 or older, the presence of either a fasting blood glucose or HbA1c in the chart
Measured: Within 1 year
Screening for hypercholesterolemia
For those 40 or older. the presence of an LDL or non-HDL in the chart
Measured: Within 1 year
Screening for osteoporosis
For patients 50 years and older, the presence of a bone mineral density report
Measured: Within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start3 Apr 2017
- Primary completion31 Jan 2019
- Study completion19 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Health CareStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Pinto, MSc MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107233
- Sponsor's protocol ID
- SMH-16-381
- Status last verified
- Dec 2024
- First submitted
- 31 May 2019
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Electronic Medical Record Data to Improve HIV Primary Care: an Audit and Feedback Study
- ClinicalTrials.gov ID
- NCT04107233
- Acronym / sponsor ID
- SMH-16-381
- Conditions
- Quality of Health Care, HIV/AIDS, Electronic Health Records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 27 Sep 2019 (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.
This cluster randomized control trial examines whether an audit and feedback study improves care of patients living with HIV/AIDS in a family health team setting.
Detailed description
This cluster randomized control trial will use electronic medical record (EMR) data from the St. Michael's Hospital Academic Family Health Team to examine whether the quality of HIV care provided to patients can be improved through an audit and feedback (A\&F) intervention. Our objective is to examine whether A\&F targeting family physicians caring for people living with HIV/AIDS (PHLA) using EMR data can improve laboratory monitoring, engagement in primary care and the uptake of preventive interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Audit and FeedbackAudit and feedback directed at family physicians, including reports a one-on-one meeting. |
| Control | No intervention | –Usual care; may receive the intervention at the end of the study if successful |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Family physicians at the St. Michael's Hospital Academic Family Health Team who have at least 20 PLHA.
Key exclusion criteria (1 listed)
- None
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 FeedbackCharts for enrolled physicians will be audited and they will receive feedback, consisting of tailored reports and one-on-one meeting with colleague to review at baseline, 3 months and 6 months | Behavioural | Intervention |
Primary outcome
Up to date viral load
Time frame: Within six months
Percentage of HIV infected patients who have an up to date HIV viral load
6 secondary outcomes
Clinic visit
Time frame: Within the last 6 months
Up-to-date cancer screenings
Time frame: 1-3 years
Vaccinations
Time frame: Since 2013
Screening for diabetes
Time frame: Within 1 year
Screening for hypercholesterolemia
Time frame: Within 1 year
Screening for osteoporosis
Time frame: Within 5 years
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 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Andrew Pinto, MSc MD principal investigator
Unity Health Toronto
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 Quality of Health Care and HIV/AIDS, run by Unity Health Toronto 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 6 Jan 2025. 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?
Up to date viral load (time frame: Within six months). 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 6 Jan 2025.