Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based F… (NCT02579655) | Clinical Trial Compass
CompletedNot Applicable
Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study
Canada4,764 participantsStarted 2015-11
Plain-language summary
The purpose of this study is to determine the effect of two novel interventions; (1) a value-based formulary which eliminates copayment for selected high-value medications (proven to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient education program aimed at lifestyle modification and optimal drug use, combined with relay of information on medication use, on the risk of adverse clinical outcomes (mortality, heart attack, stroke, need for coronary revascularization, and chronic disease related hospitalizations) in low-income seniors with chronic conditions over three years of follow-up or until March 31, 2021 (whichever comes first).
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\>65 years of age (have drug insurance from Alberta Blue Cross with 30% copayment)
Have any one of the following:
* coronary disease
* prior stroke
* chronic kidney disease
* heart failure
OR any two of the following:
* current cigarette smoking (\>1/2 pack per day)
* diabetes mellitus
* hypertension
* hypercholesterolemia
Have total family income \<$50,000
Exclusion Criteria:
* Coverage by another insurance plan where no drug payment is required (i.e. copayment \<30%)
* Inability to participate in education modules (e.g. lack of proficiency in English; cognitive impairment).
* Has every dose of their medication provided to them by a nurse or other professional caregiver?
* Inability to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite rate of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary revascularization, hospitalizations for chronic disease-related ambulatory care sensitive conditions
Timeframe: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)