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

Sponsor
McMaster University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05813652
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
900,000
1
29.8
30169.3

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Other: Pre-pandemic time period (Jun 22, 2018 to March 12, 2020)
  • Other: Peri-pandemic time period (March 13, 2020 to December 3, 2021)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
900000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Relative Impacts on Preventative Primary Care--a Longitudinal Evaluation of COVID-19 (Phase 1: A Retrospective Cohort Analysis)
Actual Study Start Date :
Oct 5, 2022
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

Other: 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)

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 105 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 McMaster University Department of Family Medicine Hamilton Ontario Canada L8P 1H6

Sponsors and Collaborators

  • McMaster University
  • Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Michelle Howard, PhD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michelle Howard, Michelle Howard, PhD, McMaster University
ClinicalTrials.gov Identifier:
NCT05813652
Other Study ID Numbers:
  • WI1-179885
First Posted:
Apr 14, 2023
Last Update Posted:
Apr 14, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2023