Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19:Phase 1

NCT ID: NCT05813652

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

919928 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-05

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus Congestive Heart Failure Chronic Kidney Diseases Chronic Obstructive Pulmonary Disease Depression, Anxiety Osteoarthritis Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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RIPPLE-C cohort

This is a retrospective closed cohort study using a single-arm, pre-post design. Therefore, we will be selecting patients from the CPCSSN database to create our single-arm cohort. Patients included in this cohort will be 18 years of age or older, and will have had at least one contact with their primary care clinic between the dates of March 13, 2018 and March 13, 2020.

Pre-pandemic time period (Jun 22, 2018 to March 12, 2020)

Intervention Type OTHER

The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020)

Peri-pandemic time period (March 13, 2020 to December 3, 2021)

Intervention Type OTHER

The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020)

Interventions

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Pre-pandemic time period (Jun 22, 2018 to March 12, 2020)

The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020)

Intervention Type OTHER

Peri-pandemic time period (March 13, 2020 to December 3, 2021)

The primary exposure is the time period of the pandemic (March 13, 2020 to Dec 3, 2021), compared to pre-pandemic (Jun 22, 2018 to pandemic onset March 12, 2020)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Michelle Howard

Michelle Howard, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Howard, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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McMaster University Department of Family Medicine

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Howard M, Aubrey-Bassler K, Drummond N, Lussier MT, Queenan JA, Vanstone M, Nicholson K, Ramdyal A, Lawson J, Hafid S, Freeman K, Clark R, Mangin D. Effects of the COVID-19 Pandemic on Primary Health Care for Chronic Conditions in Canada: Protocol for a Retrospective Pre-Post Study Using National Practice-Based Research Network Data. JMIR Res Protoc. 2023 Jul 21;12:e49131. doi: 10.2196/49131.

Reference Type DERIVED
PMID: 37477967 (View on PubMed)

Other Identifiers

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WI1-179885

Identifier Type: -

Identifier Source: org_study_id

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