- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04107233
Using Electronic Medical Record Data to Improve HIV Primary Care
September 25, 2019 updated by: Unity Health Toronto
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B1W8
- St. Michael's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Family physicians at the St. Michael's Hospital Academic Family Health Team who have at least 20 PLHA.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Audit and feedback directed at family physicians, including reports a one-on-one meeting.
|
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
|
No Intervention: Control
Usual care; may receive the intervention at the end of the study if successful
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Up to date viral load
Time Frame: Within six months
|
Percentage of HIV infected patients who have an up to date HIV viral load
|
Within six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinic visit
Time Frame: Within the last 6 months
|
To assess engagement in care
|
Within the last 6 months
|
Up-to-date cancer screenings
Time Frame: 1-3 years
|
Presence of cancer monitoring for colorectal, breast and cervical cancers
|
1-3 years
|
Vaccinations
Time Frame: Since 2013
|
Up-to-date for both pneumococcal vaccines and seasonal influenza vaccine
|
Since 2013
|
Screening for diabetes
Time Frame: Within 1 year
|
For those 40 or older, the presence of either a fasting blood glucose or HbA1c in the chart
|
Within 1 year
|
Screening for hypercholesterolemia
Time Frame: Within 1 year
|
For those 40 or older.
the presence of an LDL or non-HDL in the chart
|
Within 1 year
|
Screening for osteoporosis
Time Frame: Within 5 years
|
For patients 50 years and older, the presence of a bone mineral density report
|
Within 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew Pinto, MSc MD, Unity Health Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2017
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
May 31, 2019
First Submitted That Met QC Criteria
September 25, 2019
First Posted (Actual)
September 27, 2019
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- SMH-16-381
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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