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

Sponsor

University of Calgary (Other)

Overall Status

Completed

CT.gov ID

NCT02579655

Collaborator

Alberta Innovates Health Solutions (Other)

4,764

Enrollment

Location

Arms

67.9

Actual Duration (Months)

70.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Disease Stroke Chronic Kidney Disease Heart Failure Diabetes Mellitus Hypertension Hypercholesterolemia	Behavioral: Copayment Elimination Behavioral: Personalized Education	N/A

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

4764 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Copayment Elimination and Personalized Education 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 Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications) Behavioral: Personalized Education Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle
Active Comparator: Copayment Elimination Only 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 Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)
Active Comparator: Personalized Education Only 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 Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle
No Intervention: No intervention 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.

Outcome Measures

Primary Outcome Measures

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 or until March 31, 2021 (for patients enrolled after March 31, 2018)]
See below for definitions of individual components for this composite outcome.

Secondary Outcome Measures

All-cause mortality [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
Die (y/n)
Non-fatal myocardial infarction [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
Nonfatal MI based on administrative data (y/n)
Non-fatal stroke [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
Nonfatal stroke based on administrative data (y/n)
Need for coronary revascularization [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
Coronary revascularization (angioplasty or bypass surgery) based on administrative data (y/n)
hospitalizations for chronic disease-related ambulatory care sensitive conditions [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
hospitalizations for chronic disease-related ambulatory care sensitive conditions based on administrative data (y/n)
Full adherence to statins [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
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)
Overall quality of life as measured by the Euroqol EQ5D-5L index score [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
Index score ranges from 0 to 1 (full health)
Overall health care costs [3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)]
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 $.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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