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

University of Calgary

Status: Completed

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

Treatments: Behavioral: Copayment Elimination; Behavioral: Personalized Education

Study type: Interventional

Funder types: Other

Identifiers

NCT02579655

REB13-1241

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 4,764 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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4,764 participants in 4 patient groups

Copayment Elimination and Personalized Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Copayment Elimination

Behavioral: Personalized Education

Copayment Elimination Only

Active Comparator group

Description:

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

Treatment:

Behavioral: Copayment Elimination

Personalized Education Only

Active Comparator group

Description:

In this arm, participants would be randomized to free enrollment in a new personalized education program to help patients manage their chronic conditions

Treatment:

Behavioral: Personalized Education

No intervention

No Intervention group

Description:

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.