Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 4714
Summary
- Conditions
- Chronic Kidney Disease
- Coronary Disease
- Diabetes Mellitus
- Heart Failure
- Hypercholesterolemia
- Hypertension
- Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
Description
Chronic diseases, such as stroke, myocardial infarction, hypertension, diabetes and chronic kidney disease, are the major challenge facing health care systems worldwide. Although medications and lifestyle changes can improve the health of these patients, many do not benefit from these treatments due...
Chronic diseases, such as stroke, myocardial infarction, hypertension, diabetes and chronic kidney disease, are the major challenge facing health care systems worldwide. Although medications and lifestyle changes can improve the health of these patients, many do not benefit from these treatments due to barriers at the level of the patient, provider and/or health system, resulting in a care gap. Multiple barriers may contribute to the observed care gap for patients with these chronic diseases-but prior research has identified that 1) out-of-pocket costs for medications (including co-payments); and 2) lack of patient knowledge about the potential benefits of treatment are particularly important. Although these barriers clearly compromise outcomes among people with chronic diseases, the best way to overcome them and close the care gap is uncertain. In the ACCESS trial, the investigators will study the effect of two novel interventions in 4764 participants with chronic disease. The investigators hypothesize that (1) eliminating copayments for high value cardioprotective medications and (2) a comprehensive patient education program on optimal medication use, combined with relay of information on optimal medication use by the patient to their health care provider, will decrease the risk of adverse clinical outcomes during the follow-up period. Methods and study design: Parallel, open label, factorial randomized controlled trial with blinded endpoint evaluation assessing the impact of two interventions: 1) elimination of patient copayment for selected medications, and 2) patient education with relay of information to the participant's health care provider.
Tracking Information
- NCT #
- NCT02579655
- Collaborators
- Alberta Innovates Health Solutions
- Investigators
- Principal Investigator: Braden Manns University of Calgary