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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed 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 4714 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 three years of follow-up.
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.

Conditions

Interventions

  • Copayment Elimination Behavioral
    Intervention Desc: Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)
    ARM 1: Kind: Experimental
    Label: Copayment Elimination and Personalized Education
    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
    ARM 2: Kind: Experimental
    Label: Copayment Elimination Only
    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
  • Personalized Education Behavioral
    Intervention Desc: Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle
    ARM 1: Kind: Experimental
    Label: Copayment Elimination and Personalized Education
    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
    ARM 2: Kind: Experimental
    Label: Personalized Education Only
    Description: In this arm, participants would be randomized to free enrollment in a new personalized education program to help patients manage their chronic conditions

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite rate of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary revascularization, hospitalizations for chronic disease-related ambulatory care sensitive conditions 3 years No
Secondary All-cause mortality 3 years No
Secondary Non-fatal myocardial infarction 3 years No
Secondary Non-fatal stroke 3 years No
Secondary Need for coronary revascularization 3 years No
Secondary hospitalizations for chronic disease-related ambulatory care sensitive conditions 3 years No
Secondary Full adherence to statins 3 years No
Secondary Overall quality of life as measured by the Euroqol EQ5D-5L index score 3 years No
Secondary Overall health care costs 3 years No

Sponsors