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

Background Since the COVID-19 pandemic began, there have been concerns that interruptions to the health care system may have led to changes in primary care, especially for care of chronic conditions such as diabetes and heart failure. Such changes may have longer term implications for population health. Objective This study aims to describe the impacts of the COVID-19 pandemic on indicators of primary care access, comprehensiveness, and appropriateness among adult patients, as well as on specific indictors of chronic conditions. Additionally, this study aims to determine whether any identified changes were associated with patient sociodemographic characteristics and multimorbidity. Methods This is a retrospective, single-arm, pre-post study using Canadian Primary Care Sentinel Surveillance Network (CPCSSN) data. CPCSSN is a research network supported by a primary care electronic medical record database, comprising over 1500 physicians and nearly 2 million patients. We are examining changes in care (eg, frequency of contacts, laboratory tests and investigations, referrals, medications prescribed, etc) among adults. We will also examine indicators specific to evidence-based recommendations for care in patients with diabetes and those with heart failure. We will compare rates of outcomes during key periods of the pandemic between March 13, 2020, and December 31, 2022, with equal time periods before the pandemic. Differences will be examined among specific subgroups of adults, including by decade of age, number of comorbidities, and socioeconomic status. Regression models appropriate to outcome distributions will be used to estimate changes, adjusting for potential confounders. This analysis is part of a mixed-methods study with a qualitative component investigating how patients with diabetes with or without concurrent heart failure perceived the impact of the pandemic on access to primary care and health care–related decisions. This study was approved by the Hamilton Integrated Research Ethics Board (14782-C). Results The start date of this study was October 5, 2022, and the prospective end date is January 31, 2024. As of May 2023, the study cohort (n=875,934) is defined, data cleaning is complete, and exploratory analyses have begun. Extended analyses using 2022 data are planned once the new data becomes available. We will disseminate results through peer-reviewed publications and academic conference, as well as creating evidence briefs, infographics, and a video for policy maker and patient audiences. Conclusions This study will investigate whether the COVID-19 pandemic has resulted in changes in the provision of primary care in Canada and whether these potential changes have led to gaps in care. This study will also identify patient-level characteristics associated with changes in care patterns across the COVID-19 pandemic. Indicators specific to chronic conditions, namely diabetes and heart failure, will also be explored to determine whether there were changes in care of these conditions. Trial Registration ClinicalTrials.gov NCT05813652; https://clinicaltrials.gov/ct2/show/NCT05813652 International Registered Report Identifier (IRRID) RR1-10.2196/49131

On behalf of the Government of Canada, the Canadian Institutes of Health Research (CIHR) is pleased to inform you that your recent application "Impacts of the COVID-19 pandemic on the primary care of chronic conditions", submitted to the Operating Grant: Addressing the Wider Health Impacts of COVID-19, has been approved for funding.
As a successful nominated principal applicant (NPA), please note that there are additional Conditions of Funding outside of CIHR's standard requirements related to this competition (please refer to the Conditions of Funding section of the funding opportunity and your Authorization for Funding form (AFF) for more details). Furthermore, if you are in receipt or become eligible to receive any funding from another source for any part of this project, you must advise CIHR immediately by following the instructions outlined in the "Funding Overlap Declaration" form (https://cihrirsc.gc.ca/e/797.html). Failure to self-declare overlap could lead to CIHR cancelling all funding related to this grant.
The decisions of this funding opportunity are under embargo. CIHR Communications will be in touch with you in the near future regarding plans for an official public announcement of the decisions. We would ask grant recipients and their institutions to hold off on any public communications (e.g., news releases, external web postings, social media) until the official announcement has taken place.
As outlined in CIHR's equity strategy (https://cihr-irsc.gc.ca/e/50068.html), CIHR is committed to creating an equitable funding system by identifying and eliminating systematic biases towards any individual or group that would hinder access to CIHR funds. CIHR committed to ensuring a minimum proportion of funding was allocated to applications related to Indigenous Health Research (IHR) and that the proportion of grants awarded to applications submitted in French and applications submitted by female nominated principal applicants was not less than the proportion of applications submitted by those groups. However, for this competition, the proportion of applications for all groups was met without the need to apply the equalization process.
As CIHR does not notify co-applicants of the decision, we ask that you inform those individuals involved, along with their research institutions (if different from your own), of the outcome of this application.
Please note that NPIs may be contacted by CIHR to complete a short survey regarding barriers and enablers to their research. CIHR is committed to promoting opportunities for knowledge sharing and collaboration to facilitate and accelerate Canada's research response to the COVID-19 outbreak. As such, the results of the survey may be used to support future activities related to knowledge mobilization in the COVID-19 context. CIHR would like to remind grant recipients that all COVID-19 related publications must be open access, in alignment with the call from the Chief Science Advisors (https://www.ic.gc.ca/eic/site/063.nsf/eng/h_98016.html), and that all data produced as a result of this funding must be shared in line with the Joint statement on sharing research data and findings relevant to the novel coronavirus (nCoV) outbreak (https://wellcome.org/coronavirus-covid-19/open-data). Data related to research by and with First Nations, Métis, or Inuit communities whose traditional and ancestral territories are in Canada must be managed in accordance with data management principles developed and approved by those communities, and on the basis of free, prior and informed consent. This includes, but is not limited to, considerations of Indigenous data sovereignty, as well as data collection, ownership, protection, use, and sharing. The project focuses on the impact of the pandemic on primary care access for patients with chronic diseases. The project is a mixed method design, appropriate to the research questions. The team is well aligned to address the research aims and methodological approach. The team recognizes that the data set does not allow for a robust analysis of demographic data related to marginalized populations and only make inferences with the qualitative data. The team has the expertise to carry out the project and letter of reference provided by the Canadian Primary Care Sentinel Survellaince Network was critical to the success of the quantitative component. Overall the project aligns with the funding opportunity but there should be more specific attention to marginalized populations. The budget is very reasonable given the work the team wants to undertake. People with chronic conditions cannot access their family doctors for routine check-ups due to the COVID-19 pandemic. In avoiding the spread of the virus, most primary care has shifted to virtual care and in-person visits have reduced, which might have a negative impact on the management of chronic conditions. Given the situation, this study aims to evaluate the impacts of COVID-19 on chronic disease care using a large database with electronic medical record data from over 1500 family doctors' practices across Canada. This study will provide evidence on which specific aspects of primary care have been most impacted in the pandemic, and it will identify possible solutions to be recommended for recovering from the pandemic.

Strengths:
• Clear justification for the relevance and importance of the project.
• Research questions and objectives of the proposed study are clear.
• A clear definition of Therapeutic Recreation (TR) was provided.
• Literature review is relevant.
• Potential of the proposed research to achieve timely impacts and maximize health benefits within a rapid response timeframe.
• Data source CPCSSN is well introduced • Sampling and recruitment, data collection, analysis and integration are well-described.
• The team has strong expertise in different areas that are relevant to the study. Weakness: • Additional literature on the impact of the COVID-19 on primary care and the negative impact on the accessibility of health care for different population, and clearly indicate the knowledge and service gaps would be beneficial for the proposed study.
• I would suggest providing a clear definition of conditions management as the research background.
• Whether the different types of data collection have influences on the quality of data and how to address the challenges.
• Gender could be strengthened in this application -in background, recruitment, data analysis, and KT.