Purpose
The study aims to provide a comprehensive evaluation framework for the Value Demonstrating Initiative (VDI) on Chronic Obstructive Pulmonary Disorder (COPD) program that will include an evaluation of project implementation, patient enrollment, patient and provider experiences of care, and program impact on clinical, economic and humanistic outcomes. A mixed-method study design will be utilized.
The VDI on COPD program is a collaborative effort between the Ontario Lung Association (OLA), the Ministry of Health and Long-Term Care (MOHLTC), and Canada’s Research Based Pharmaceutical Companies (Rx&D). This innovative program targets COPD patients in Ontario who are at risk of acute exacerbation and subsequent ED admission or hospitalization. It aims to improve patients’ quality of life and the efficiency of healthcare system via systematic identification of these patients and timely provision of integrated, multidisciplinary community-based care coordinated by a case manager that is tailored to patient needs and severity of the disease.
Research Questions
The primary objective of the project is to evaluate if VDI on COPD program reduces COPD-related hospitalizations/ emergency department (ED) visits at the end of one year of program enrollment, compared to COPD-related hospitalizations/ED visits one year before the enrollment.
The secondary objectives are to evaluate:
The effectiveness (with potential barriers and facilitators) of the patient identification process, patient screening and enrollment.
The feasibility of program implementation (with potential barriers and facilitators) into routine practice and effectiveness of patient care coordination.
Stakeholders’ experiences with VDI on COPD in general and specifically regarding different program components.
Improvements in processes of care as measured by quality indicators (i.e., referral and access to care components).
The impact of the program on patient clinical, economic and humanistic outcomes at 1-year follow-up.
What aspects of the multidisciplinary program (or combinations) most contribute to the outcomes.
The cost-effectiveness of VDI on COPD program.
Inclusion Criteria
Patients:
All patients who meet VDI on COPD program eligibility criteria will be invited to participate in the evaluation study during the study’s accrual period.
VDI on COPD program will enroll patients who have:
• Post-bronchodilator FEV1/FVC ratio of <0.70 at all stages of post-bronchodilator FEV1 severities.
AND
• 1 or more hospitalization(s)/ED visit(s) for COPD exacerbation requiring the use of systemic corticosteroids and/or antibiotics in the past 12 months at all stages of FEV1.
OR
• 1 or more primary care clinic visit(s) for COPD exacerbations requiring the use of systemic corticosteroids and/or antibiotics in the past 12 months AND post-bronchodilator FEV1 < 80% predicted.
Health Care Provider, Administrator and/or Decision Maker:
Any health care provider who referred a patient to the VDI on COPD program
Primary care providers of patients who are enrolled in the study
VDI on COPD case managers involved in the provision of care to patients enrolled in the program
For interviews and surveys, stakeholders must have three months experience with VDI on COPD program
Administrators and/or Decision Makers of the VDI on COPD program as a larger network of care (e.g. Program Managers, key members of the MOHLTC, LHIN, CCAC managers etc.)
Exclusion Criteria
Patient:
• Primary diagnosis of asthma, palliative care COPD patients, uncontrolled psychiatric illness, dementia, and being a resident in a long term care facility with high level of dependency.
Health Care Provider, Technician, Administrator and/or Decision Maker:
• Unable or unwilling to provide verbal informed consent
Design and Methods
Study 1: Implementing VDI on COPD in Ontario (Qualitative study addressing secondary objectives 1-3)
Participants will be recruited in a purposive fashion employing maximum variation sampling. It is planned to interview 25 health care providers and 30 patients across all sites (55 interviews in total), where 20 interviews will happen in Phase 1 (year 1) and remaining 35 later, in Phase 2. The final sample size will be determined by thematic saturation. We will interview stakeholders who had at least three months experience of VDI on COPD program. Open-ended, semi-structured interview guides have been developed for the study. One-on-one interviews will be conducted by trained interviewers with qualitative research expertise. All interviews will be conducted in person, and will be audio-taped, transcribed verbatim and coded by the research team. Data collection and analysis will take place concurrently and will follow an iterative process. Key concepts and an analytic framework will be developed that will interpret and account for the empirical data. Qualitative findings will be used to inform other data analysis (triangulation of data). Relevant documentary sources will also be reviewed to further add to the data collection.
Study 2: Effectiveness and Cost-Effectiveness of VDI on COPD program (Quantitative study addressing primary objective and secondary objectives 4-7)
Study 2 will evaluate processes of care, the effect of VDI on COPD program on clinical, economic (e.g., health care utilization, costs and cost-effectiveness) and humanistic outcomes (e.g., quality of life, adherence).
The study will utilize a quasi-experimental, one-group pre-post study design where the outcomes will be compared at 1 year before and after the VDI on COPD program enrollment. Patient baseline information will be obtained at their first visit, after which patients will participate in one year VDI on COPD program. The primary outcome, the rate of COPD-related hospitalizations and/or ED visits at the end of one year will be first collected using patient self-report and then ascertained from the health administrative databases of Ontario.
Study Timeline
Run-in period: initial 3-month period to operationalize the implementation and pilot data collection
Enrollment: 6 months
Follow-up: 1 year
Total study duration: 3 years
Research Team
Murray Krahn, MD, MSc, FRCPC
Michael Hillmer, PhD
Valeria Rac, MD, PhD
Lusine Abrahamyan, MD, MPH, PhD
Petros Pechlivanoglou, PhD
Nicholas Mitsakakis, MSc, PhD
Dr. Reza Maleki-Yazdi, MD, FRCPC, FCCP
Suzanne Chung, BEd, CCRP
Funding
Ontario Lung Association (OLA)