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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03804905
• Other study ID #: 103-2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 64 Years

Eligibility

Inclusion Criteria:

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

• lack of medication insurance

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Medication Adherence
• Medication Compliance
• Medication Nonadherence
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Other chronic diabetes complications	Amputation, retinal photocoagulation, vitrectomy, intravitreal injection, incident microalbuminuria, incident chronic kidney disease	One year
Other	Acute diabetes complications	Emergency department visit or hospitalization for hypo or hyperglycemia	One year
Other	A1c control	A1c level	One year
Other	Blood pressure control	Systolic and diastolic blood pressure levels	One year
Other	LDL-cholesterol control	LDL-cholesterol levels	One year
Other	Medication adherence for study drugs	Medication possession ratio	One year
Other	Medication adherence for non-study drugs	Medication possession ratio	One year
Other	Health care utilization	Ambulatory physician visits, emergency department visits, hospitalizations	One year
Other	Health care costs	Total health care costs across sectors	One year
Primary	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	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
Secondary	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
Secondary	Recipient of no-cost medications	Proportion of patients in the intervention group who receive medications from the Trillium Health Partners outpatient pharmacy	One year
Secondary	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