Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT03804905

STUDIIO-Diabetes Pilot: STUdy of Drug Insurance to Improve Outcomes of Diabetes

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

No-cost Medications

Other

Patients will be connected to Trillium Health Partners outpatient pharmacy, and they will be given an information sheet with further details. The patients will get free access to diabetes, blood pressure and cholesterol medications and for glucose test strips. They can attend the pharmacy in person or arrange for home delivery.

Primary outcomes

  1. Lacking medication insurance

    Time frame: During 2 month run-in period

    Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance

Secondary outcomes

  1. Online questionnaire during the run-in period

    Time frame: During 2 month run-in period

    Proportion of type 2 diabetes patients aged 25 to 64 who complete the secure online questionnaire during the run-in period

  2. Response to the insurance status question

    Time frame: During 2 month run-in period

    Proportion of type 2 diabetes patients aged 25 to 64 who responded to the insurance status question on the online questionnaire

  3. Recipient of no-cost medications

    Time frame: One year

    Proportion of patients in the intervention group who receive medications from the Trillium Health Partners outpatient pharmacy

  4. Time from allocation to use of Trillium Health Partners outpatient pharmacy

    Time frame: One year

    Time from allocation to the intervention group to use of the Trillium Health Partners outpatient pharmacy

Other outcomes

  1. All-cause mortality or cardiovascular complications

    Time frame: One year

    All-cause mortality, or hospitalization for myocardial infarction, acute coronary syndrome, coronary revascularization, stroke or heart failure.

  2. Other chronic diabetes complications

    Time frame: One year

    Amputation, retinal photocoagulation, vitrectomy, intravitreal injection, incident microalbuminuria, incident chronic kidney disease

  3. Acute diabetes complications

    Time frame: One year

    Emergency department visit or hospitalization for hypo or hyperglycemia

  4. A1c control

    Time frame: One year

    A1c level

  5. Blood pressure control

    Time frame: One year

    Systolic and diastolic blood pressure levels

  6. LDL-cholesterol control

    Time frame: One year

    LDL-cholesterol levels

  7. Medication adherence for study drugs

    Time frame: One year

    Medication possession ratio

  8. Medication adherence for non-study drugs

    Time frame: One year

    Medication possession ratio

  9. Health care utilization

    Time frame: One year

    Ambulatory physician visits, emergency department visits, hospitalizations

  10. Health care costs

    Time frame: One year

    Total health care costs across sectors

Study contacts

Contact information is provided by the study sponsor or research team.

Baiju Shah, MD PhD FRCPC

CONTACT

[email protected]

416-997-4706

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

A Pilot Pragmatic Randomized Controlled Trial to Evaluate the Impact of Improving Access to Drugs on Type 2 Diabetes Care, Outcomes and Costs

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2019
Registry last updated
Dec 24, 2024

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.

Published trials that share one or more normalized conditions with this study.