Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study

Conditions
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Stroke, Coronary Disease, Chronic Kidney Disease, Heart Failure, Diabetes Mellitus, Hypertension, Hypercholesterolemia

Intervention / Treatment
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* Behavioral: Copayment Elimination
* Behavioral: Personalized Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Copayment Elimination and Personalized Education<br>In this arm, participants would have copayment elimination (no cost for preventative medications for hypertension, diabetes, and cardiovascular disease) and free enrollment in a new personalized education program to help participants manage their chronic conditions | Behavioral: Copayment Elimination<br>* Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)<br>Behavioral: Personalized Education<br>* Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle<br>|
| Active Comparator: Copayment Elimination Only<br>In this arm, participant's would be randomized to Copayment Elimination (no cost for preventative medications for hypertension, diabetes, and cardiovascular disease) and receive some basic educational information about their chronic disease | Behavioral: Copayment Elimination<br>* Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)<br>|
| Active Comparator: Personalized Education Only<br>In this arm, participants would be randomized to free enrollment in a new personalized education program to help patients manage their chronic conditions | Behavioral: Personalized Education<br>* Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle<br>|
| No Intervention: No intervention<br>In this arm, participants will have access to some basic online educational information about their chronic disease. There is no intervention in this arm. The comparative group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite rate of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary revascularization, hospitalizations for chronic disease-related ambulatory care sensitive conditions | See below for definitions of individual components for this composite outcome. | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Die (y/n) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 
| Non-fatal myocardial infarction | Nonfatal MI based on administrative data (y/n) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 
| Non-fatal stroke | Nonfatal stroke based on administrative data (y/n) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 
| Need for coronary revascularization | Coronary revascularization (angioplasty or bypass surgery) based on administrative data (y/n) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 
| hospitalizations for chronic disease-related ambulatory care sensitive conditions | hospitalizations for chronic disease-related ambulatory care sensitive conditions based on administrative data (y/n) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 
| Full adherence to statins | Full adherence to statins will be measured using the proportion of days covered, which is estimated by the number of days dispensed / number of days between prescription renewals using Alberta Blue Cross data. Patients that have a dispensed supply of statins to cover at least 80% of observed treatment days will be considered adherent (Y/N) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 
| Overall quality of life as measured by the Euroqol EQ5D-5L index score | Index score ranges from 0 to 1 (full health) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) | 
| Overall health care costs | All costs (cost of interventions taken from study data, and costs of all health care encounters taken from Alberta Health administrative data using grouper codes) will be combined into Canadian $. | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) |