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

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ClinicalTrials.gov Identifier: NCT02579655
Recruitment Status : Active, not recruiting
First Posted : October 19, 2015
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
Braden Manns, University of Calgary

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : November 2015
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) ]
    Die (y/n)

  2. 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. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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 $.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579655


Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Sponsors and Collaborators
University of Calgary
Alberta Innovates Health Solutions
Investigators
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Principal Investigator: Braden Manns University of Calgary

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Braden Manns, Svare Professor, Health Economics, University of Calgary
ClinicalTrials.gov Identifier: NCT02579655     History of Changes
Other Study ID Numbers: REB13-1241
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Coronary Disease
Hypercholesterolemia
Chronic Disease
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Urologic Diseases
Renal Insufficiency
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Myocardial Ischemia
Disease Attributes
Pathologic Processes