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

March 19, 2024 updated by: Braden Manns, University of Calgary
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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

4764

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)
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
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
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.

What is the study measuring?

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
Time Frame: 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.
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Die (y/n)
3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Non-fatal myocardial infarction
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
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
Time Frame: 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)
3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
hospitalizations for chronic disease-related ambulatory care sensitive conditions
Time Frame: 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)
3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Full adherence to statins
Time Frame: 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)
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
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
Time Frame: 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 $.
3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Braden Manns, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimated)

October 19, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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