Clinical trial NCT03804905: STUDIIO-Diabetes Pilot: STUdy of Drug Insurance to Improve Outcomes of Diabetes
Official title: A Pilot Pragmatic Randomized Controlled Trial to Evaluate the Impact of Improving Access to Drugs on Type 2 Diabetes Care, Outcomes and Costs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Medication Adherence
Medication Compliance
Medication Nonadherence
Keywords: Type 2 Diabetes Mellitus
Medication Compliance
Medication Insurance
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-01-15
Enrollment: 144
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Canada is the only country with a universal health insurance system that does not provide coverage for prescription drugs to all residents. One-third of working-age Canadians have no insurance. Importantly, many of these uninsured patients already face other barriers to good health: low income, new immigrants, single mothers, etc. For these patients, taking prescription drugs - especially chronic disease treatments that may be required lifelong - can be difficult due to high costs. Patients skip doses, delay renewing prescriptions, or simply do not fill prescriptions recommended by their doctors, because they do not have insurance to cover the costs of prescriptions. Previous research by the study team has suggested that the lack of a universal drug insurance program for working-age Canadians affects the health and well-being of low-income people with diabetes. The goal of this research is to determine the clinical and economic impact of providing drug coverage for uninsured type 2 diabetics.

Detailed description: Previous research has found that lowering patients' out-of-pocket costs has a positive impact on health service utilization, risk factor control and patient-reported health for many chronic diseases, including diabetes, hypertension, HIV and asthma. Among patients with chronic disease, medication adherence was inversely associated with hospitalization rates and total healthcare costs, and these relationships were far stronger for diabetes than for any other chronic disease. A recent meta-analysis of eight observational studies showed that adherence with diabetes medications is associated reduction in cardiovascular events, all-cause mortality and all-cause hospitalization. However, virtually all of this previous research has been observational. Only one rigorous intervention study has examined the impact of reducing patient borne drug costs on clinical outcomes. The outcome of this study showed that free medications led to health outcome improvements and a trend towards lower costs.

The goal of this research project is to determine the impact of providing drug coverage to uninsured individuals with one of the most costly chronic diseases, type 2 diabetes. The ultimate goal is to evaluate if lowering out-of-pocket drug costs for uninsured patients is effective and cost-effective to reduce disease morbidity and mortality. Will policy intervention to reduce patients' drug costs would actually translate into improvements in their health outcomes? What impact a universal program would have on overall drug utilization? What total budget impact such a program might have? What extent the cost savings accrued from improving health outcomes might offset the program's implementation costs. Answering these questions will provide essential evidence to inform decision making for a national publicly-funded pharmacare program.

It will demonstrate how medication utilization changes when access improves, and will identify if barriers to utilization other than affordability exist. Crucially, the economic analyses will help policy makers understand the budget impact and cost-effectiveness of a pharmacare intervention. Thus, this research will provide vital information for policy makers crafting a program to provide free drugs to all uninsured Canadians with chronic disease. Such a program is anticipated to have a positive impact on patient experience: to improve health equity and access for vulnerable patients; to facilitate greater medication adherence; and to enhance shared decision-making between patients and their clinicians for effective self-management care paths. The ultimate impact of this research will be evidence for the cost effectiveness or even cost savings of a drug insurance program aimed at the improving access to medications for disadvantaged patients who are currently uninsured.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of type 2 diabetes record in family physician's electronic medical record
* lack of medication insurance

Exclusion Criteria:

-

Primary outcomes:
measure: Lacking medication insurance
timeFrame: During 2 month run-in period
Secondary outcomes:
measure: Online questionnaire during the run-in period
timeFrame: During 2 month run-in period
measure: Response to the insurance status question
timeFrame: During 2 month run-in period
measure: Recipient of no-cost medications
timeFrame: One year
measure: Time from allocation to use of Trillium Health Partners outpatient pharmacy
timeFrame: One year
Other outcomes:
measure: All-cause mortality or cardiovascular complications
timeFrame: One year
measure: Other chronic diabetes complications
timeFrame: One year
measure: Acute diabetes complications
timeFrame: One year
measure: A1c control
timeFrame: One year
measure: Blood pressure control
timeFrame: One year
measure: LDL-cholesterol control
timeFrame: One year
measure: Medication adherence for study drugs
timeFrame: One year
measure: Medication adherence for non-study drugs
timeFrame: One year
measure: Health care utilization
timeFrame: One year
measure: Health care costs
timeFrame: One year
Locations:
Study officials:
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