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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus; Medication Adherence; Medication Compliance; Medication Nonadherence
• Intervention / Treatment: Other: No-cost Medications

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Baiju Shah, MD PhD FRCPC; Phone Number: 416-997-4706; Email: baiju.shah@ices.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Eligible patients of physicians allocated to the usual care arm will continue to access their medications through self-pay or other mechanisms.
Experimental: No-cost Medications; Eligible patients of physicians allocated to the no-cost medications arm will receive free medications through Trillium Health Partners outpatient pharmacy.	Other: No-cost Medications; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lacking medication insurance	Proportion of type 2 diabetes patients aged 25 to 64 who self-report that they lack medication insurance	During 2 month run-in period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Online questionnaire during the run-in period	Proportion of type 2 diabetes patients aged 25 to 64 who complete the secure online questionnaire during the run-in period	During 2 month run-in period
Response to the insurance status question	Proportion of type 2 diabetes patients aged 25 to 64 who responded to the insurance status question on the online questionnaire	During 2 month run-in period
Recipient of no-cost medications	Proportion of patients in the intervention group who receive medications from the Trillium Health Partners outpatient pharmacy	One year
Time from allocation to use of Trillium Health Partners outpatient pharmacy	Time from allocation to the intervention group to use of the Trillium Health Partners outpatient pharmacy	One year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality or cardiovascular complications	All-cause mortality, or hospitalization for myocardial infarction, acute coronary syndrome, coronary revascularization, stroke or heart failure.	One year
Other chronic diabetes complications	Amputation, retinal photocoagulation, vitrectomy, intravitreal injection, incident microalbuminuria, incident chronic kidney disease	One year
Acute diabetes complications	Emergency department visit or hospitalization for hypo or hyperglycemia	One year
A1c control	A1c level	One year
Blood pressure control	Systolic and diastolic blood pressure levels	One year
LDL-cholesterol control	LDL-cholesterol levels	One year
Medication adherence for study drugs	Medication possession ratio	One year
Medication adherence for non-study drugs	Medication possession ratio	One year
Health care utilization	Ambulatory physician visits, emergency department visits, hospitalizations	One year
Health care costs	Total health care costs across sectors	One year

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Institutes of Health Research (CIHR)

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Medication Compliance; Medication Insurance
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 103-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No