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Completed

NCT Number: NCT05813652

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

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?

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Key information

Conditions

Diabetes Mellitus Anxiety Disorders Arthritis Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Chronic Disease Chronic Kidney Diseases Chronic Obstructive Pulmonary Disease Congestive Heart Failure Dementia Depression Depression, Anxiety Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Heart Failure Joint Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Mental Disorders Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases Osteoarthritis Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Rheumatic Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster University Department of Family Medicine

Hamilton, Ontario, L8P 1H6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

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)

Primary outcomes

  1. Number and types of encounters (access, comprehensiveness)

    Time frame: Beginning of COVID-19 pandemic, March 13, 2020 through December 3, 2021 as compared to an equal time period prior to pandemic start

    Overall number and types of patient encounters; number and types of chronic condition-related encounters for patients with specific chronic conditions (e.g. diabetes, heart failure, etc.). *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

  2. Diagnoses addressed in encounters (comprehensiveness, appropriateness)

    Time frame: 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.

    Overall number of diagnoses addressed per person, per year; number and proportion of encounters for specific chronic conditions addressed at least once a year; number of patients with specific chronic conditions (e.g. diabetes, heart failure, etc.) with condition-related encounters within 6 months, 12 months. *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age.*

  3. Services provided (comprehensiveness)

    Time frame: 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.

    Number of patients receiving pneumococcal vaccine, influenza vaccine; proportion of patients with specific chronic disease vaccinated for influenza *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

  4. Procedures performed (appropriateness)

    Time frame: 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.

    Proportion of diabetic patients with foot exam in last 12 months *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

  5. Physical exams (appropriateness)

    Time frame: 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.

    Proportion of patients (all patients and those grouped by chronic condition) with blood pressure measured every 6 months, or every 12 months (as appropriate for condition) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

  6. Referrals made to specialists (comprehensiveness)

    Time frame: 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.

    Overall number of referrals made to specialist providers; proportion of patients with specific chronic condition referred to specific specialties as appropriate based on condition (e.g. endocrinology for diabetic patients, cardiology for heart failure patients, etc.) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

  7. Investigations performed (appropriateness)

    Time frame: 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.

    Overall number of investigations and laboratory tests; number and frequency of investigations and laboratory tests performed for patients based on presence of chronic conditions (e.g. number of diabetic patients with HbA1C measured every 6 and 12 months) *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

  8. Monitoring results (appropriateness)

    Time frame: 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.

    Proportion of patients with blood pressure below, at, or above target (as appropriate based on age and presence of chronic conditions); number and proportion of patients with systolic blood pressure in the following ranges: <130, 131-140, 141-150, 151-160, >160 *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

  9. Medications (appropriateness, comprehensiveness)

    Time frame: 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.

    Overall number and frequency of medications specific to chronic conditions (e.g. insulin, oral antidiabetics for diabetic patients, angiotensin receptor blockers and/or angiotensin-converting enzyme inhibitors for heart failure patients, etc.); proportion of patients with specific chronic conditions on indicated medications; number of patients who smoke on nicotine replacement therapy *Note: All outcomes will be measured as applicable to patients' medical conditions and/or age*

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19 (Phase 1: A Retrospective Cohort Analysis)

Acronym: RIPPLE-C

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 14, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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