AzTrials
AzTrials

Coronary DiseaseACCESSNCT02579655

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

A study testing Copayment Elimination and Personalized Education in people with Coronary Disease and Stroke, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Coronary Disease, Stroke, Chronic Kidney Disease
What is being tested?
Copayment Elimination and Personalized Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,764 participants
Where
1 siteCanada
Study dates
Nov 2015to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • >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
Show all 12Show fewer
  • OR any two of the following:
  • current cigarette smoking (>1/2 pack per day)
  • diabetes mellitus
  • hypertension
  • hypercholesterolemia
  • Have total family income <$50,000

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Canada1 site
  • University of Calgary

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

About this study

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).

Read the 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.

Being tested
Copayment Elimination, Personalized Education
Medical subject headings
Coronary Disease, Stroke, Renal Insufficiency, Chronic, Heart Failure, Diabetes Mellitus, Hypertension, Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Copayment EliminationBehavioural

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

  • Personalized EducationBehavioural

    Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle

Study groups in NCT02579655
Study groupRoleWhat they receive
Copayment Elimination and Personalized EducationActive comparatorIn 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
Receives: Behavioral: Copayment Elimination; Behavioral: Personalized Education
Copayment Elimination OnlyActive comparatorIn 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
Receives: Behavioral: Copayment Elimination
Personalized Education OnlyActive comparatorIn this arm, participants would be randomized to free enrollment in a new personalized education program to help patients manage their chronic conditions
Receives: Behavioral: Personalized Education
No interventionNo interventionIn 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    See below for definitions of individual components for this composite outcome.

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

Secondary outcomes (8)
  1. All-cause mortality

    Die (y/n)

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

  2. Non-fatal myocardial infarction

    Nonfatal MI based on administrative data (y/n)

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

  3. Non-fatal stroke

    Nonfatal stroke based on administrative data (y/n)

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

  4. Need for coronary revascularization

    Coronary revascularization (angioplasty or bypass surgery) based on administrative data (y/n)

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

  5. hospitalizations for chronic disease-related ambulatory care sensitive conditions

    hospitalizations for chronic disease-related ambulatory care sensitive conditions based on administrative data (y/n)

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

  6. Full adherence to statins

    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)

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

  7. Overall quality of life as measured by the Euroqol EQ5D-5L index score

    Index score ranges from 0 to 1 (full health)

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

  8. Overall health care costs

    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 $.

    Measured: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion31 Mar 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,764 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02579655
Sponsor's protocol ID
REB13-1241
Acronym
ACCESS
Status last verified
Jul 2026
First submitted
27 Aug 2015
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Manns BJ, Tonelli M, Zhang J, Campbell DJ, Sargious P, Ayyalasomayajula B, Clement F, Johnson JA, Laupacis A, Lewanczuk R, McBrien K, Hemmelgarn BR. Enrolment in primary care networks: impact on outcomes and processes of care for patients with diabetes. CMAJ. 2012 Feb 7;184(2):E144-52. doi: 10.1503/cmaj.110755. Epub 2011 Dec 5.

    PubMed 22143232
  • Campbell DJ, King-Shier K, Hemmelgarn BR, Sanmartin C, Ronksley PE, Weaver RG, Tonelli M, Hennessy D, Manns BJ. Self-reported financial barriers to care among patients with cardiovascular-related chronic conditions. Health Rep. 2014 May;25(5):3-12.

    PubMed 24850391
  • Ronksley PE, Sanmartin C, Campbell DJ, Weaver RG, Allan GM, McBrien KA, Tonelli M, Manns BJ, Hennessy D, Hemmelgarn BR. Perceived barriers to primary care among western Canadians with chronic conditions. Health Rep. 2014 Apr;25(4):3-10.

    PubMed 24744042
  • Mann BS, Barnieh L, Tang K, Campbell DJ, Clement F, Hemmelgarn B, Tonelli M, Lorenzetti D, Manns BJ. Association between drug insurance cost sharing strategies and outcomes in patients with chronic diseases: a systematic review. PLoS One. 2014 Mar 25;9(3):e89168. doi: 10.1371/journal.pone.0089168. eCollection 2014.

    PubMed 24667163
  • Ivers NM, Tricco AC, Taljaard M, Halperin I, Turner L, Moher D, Grimshaw JM. Quality improvement needed in quality improvement randomised trials: systematic review of interventions to improve care in diabetes. BMJ Open. 2013 Apr 9;3(4):e002727. doi: 10.1136/bmjopen-2013-002727. Print 2013.

    PubMed 23576000
  • Leibowitz A, Manning WG, Newhouse JP. The demand for prescription drugs as a function of cost-sharing. Soc Sci Med. 1985;21(10):1063-9. doi: 10.1016/0277-9536(85)90161-3.

    PubMed 3936186
  • Keeler EB, Brook RH, Goldberg GA, Kamberg CJ, Newhouse JP. How free care reduced hypertension in the health insurance experiment. JAMA. 1985 Oct 11;254(14):1926-31.

    PubMed 4046121
  • Tamblyn R, Laprise R, Hanley JA, Abrahamowicz M, Scott S, Mayo N, Hurley J, Grad R, Latimer E, Perreault R, McLeod P, Huang A, Larochelle P, Mallet L. Adverse events associated with prescription drug cost-sharing among poor and elderly persons. JAMA. 2001 Jan 24-31;285(4):421-9. doi: 10.1001/jama.285.4.421.

    PubMed 11242426
  • Psaty BM, Lumley T, Furberg CD, Schellenbaum G, Pahor M, Alderman MH, Weiss NS. Health outcomes associated with various antihypertensive therapies used as first-line agents: a network meta-analysis. JAMA. 2003 May 21;289(19):2534-44. doi: 10.1001/jama.289.19.2534.

    PubMed 12759325
  • Gaede P, Vedel P, Parving HH, Pedersen O. Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet. 1999 Feb 20;353(9153):617-22. doi: 10.1016/S0140-6736(98)07368-1.

    PubMed 10030326
  • Demers V, Melo M, Jackevicius C, Cox J, Kalavrouziotis D, Rinfret S, Humphries KH, Johansen H, Tu JV, Pilote L. Comparison of provincial prescription drug plans and the impact on patients' annual drug expenditures. CMAJ. 2008 Feb 12;178(4):405-9. doi: 10.1503/cmaj.070587.

    PubMed 18268266
  • Daw JR, Morgan SG. Stitching the gaps in the Canadian public drug coverage patchwork?: a review of provincial pharmacare policy changes from 2000 to 2010. Health Policy. 2012 Jan;104(1):19-26. doi: 10.1016/j.healthpol.2011.08.015. Epub 2011 Oct 5.

    PubMed 21978939
  • Campbell DJT, Mitchell C, Hemmelgarn BR, Tonelli M, Faris P, Zhang J, Tsuyuki RT, Fletcher J, Au F, Klarenbach S, Exner DV, Manns BJ; Interdisciplinary Chronic Disease Collaboration. Eliminating Medication Copayments for Low-Income Older Adults at High Cardiovascular Risk: A Randomized Controlled Trial. Circulation. 2023 May 16;147(20):1505-1514. doi: 10.1161/CIRCULATIONAHA.123.064188. Epub 2023 Mar 5.

    PubMed 36871215
  • Campbell DJT, Tonelli M, Hemmelgarn BR, Faris P, Zhang J, Au F, Tsuyuki RT, Mitchell C, Pannu R, Campbell T, Ivers N, Fletcher J, Exner DV, Manns BJ; Interdisciplinary Chronic Disease Collaboration. Self-Management Support Using Advertising Principles for Older Adults With Low Income at High Cardiovascular Risk: A Randomized Controlled Trial. Circulation. 2023 May 16;147(20):1492-1504. doi: 10.1161/CIRCULATIONAHA.123.064189. Epub 2023 Mar 5.

    PubMed 36871212
  • Fletcher JM, Saunders-Smith T, Manns BJ, Tsuyuki R, Hemmelgarn BR, Tonelli M, Campbell DJT. Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis. BMC Med Res Methodol. 2020 Oct 31;20(1):270. doi: 10.1186/s12874-020-01140-6.

    PubMed 33129278

Questions about this trial

What is this clinical trial studying?

A study testing Copayment Elimination and Personalized Education in people with Coronary Disease and Stroke, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02579655, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in