Clinical trial NCT05813652: Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19:Phase 1
Official title: Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19 (Phase 1: A Retrospective Cohort Analysis)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Congestive Heart Failure
Chronic Kidney Diseases
Chronic Obstructive Pulmonary Disease
Depression, Anxiety
Osteoarthritis
Dementia
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-04-14
Enrollment: 900000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all patients who were age 18 years and older in 2018. As only year of birth is available, we will use the mid-point of the year for age calculation. We will include patients who have had at least one encounter or form of contact with their primary care clinic between the dates of March 13, 2018 and March 13, 2020. People with a deceased status during the study period will be included up to the point of death.

Brief summary: The goal of this observational study is to describe the impacts of COVID-19 on primary care chronic condition management in Canada within various patient populations. This will be done by analyzing primary care electronic medial record (EMR) data from the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) database, including data on primary care encounters, as well as various markers for chronic conditions.

The research questions to be investigated are:

1a) What are the changes to the management of chronic conditions in primary care since the onset of the COVID-19 pandemic?

1b) How do these changes differ by age, health status, and socioeconomic status?

Detailed description: This is a retrospective closed cohort study, using a single-arm, pre-post design. The objectives of this study are to describe the impacts of COVID-19 on access, comprehensiveness and appropriateness among adult patients with chronic diseases, and to determine whether changes were associated with socio-demographic characteristics and multi-morbidity. This will be done using using electronic medial record (EMR) data made available by the CPCSSN network. CPCSSN is a research network supported by a primary care EMR database, comprising over 1500 physicians, and nearly 2 million patients from across Canada.

We will be examining prevention and management activities for several exemplar chronic conditions that have a validated CPCSSN case definition and substantial prevalence in primary care (e.g. diabetes, heart failure, etc.). CPCSSN data between 2018-2021 will be analyzed for changes in management of various chronic conditions prior to, and through phases of the pandemic. Changes will also be examined among specific sub-groups of adults, including those with multi-morbidity and socio-economic vulnerabilities.

The primary exposure is the onset of the pandemic: March 13, 2020 to December 3, 2021 versus the equal time frame prior. March 13, 2020 was selected as the date when Canadian provincial governments began enforcing various public health and safety measures in response to the World Health Organization formally declaring the circulating SARS-CoV-2 as a pandemic on March 11, 2020.

We will be examining whether there have been changes in overall access, comprehensiveness, continuity and appropriateness of care (including potential decreases in burdensome or unnecessary care) by applying indicators that incorporate chronic condition monitoring (physical measures, lab tests and investigations), prescriptions, referrals and preventive care, to chronic condition patient populations.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older as of 2018
* Records included in the CPCSSN database
* Patient had at least one encounter with their clinic between March 13, 2018 and March 13, 2020

Exclusion Criteria:

* Patients aged 105 or older as of 2018 will be excluded due to possibility of data entry error

Primary outcomes:
measure: Number and types of encounters (access, comprehensiveness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start
measure: Diagnoses addressed in encounters (comprehensiveness, appropriateness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
measure: Services provided (comprehensiveness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
measure: Procedures performed (appropriateness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
measure: Physical exams (appropriateness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
measure: Referrals made to specialists (comprehensiveness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
measure: Investigations performed (appropriateness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
measure: Monitoring results (appropriateness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
measure: Medications (appropriateness, comprehensiveness)
timeFrame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start. Where possible, monthly rates will be calculated.
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Department of Family Medicine
state: Ontario
Study officials:
affiliation: McMaster University
name: Michelle Howard, PhD
role: PRINCIPAL_INVESTIGATOR
References: