Clinical trial NCT02579655: Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study
Official title: Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Stroke
Chronic Kidney Disease
Heart Failure
Diabetes Mellitus
Hypertension
Hypercholesterolemia
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
First posted: 2015-10-19
Enrollment: 4764
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

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.

Eligibility 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

Primary outcomes:
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
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Secondary outcomes:
measure: All-cause mortality
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
measure: Non-fatal myocardial infarction
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
measure: Non-fatal stroke
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
measure: Need for coronary revascularization
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
measure: hospitalizations for chronic disease-related ambulatory care sensitive conditions
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
measure: Full adherence to statins
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
measure: Overall quality of life as measured by the Euroqol EQ5D-5L index score
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
measure: Overall health care costs
timeFrame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Braden Manns
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: Kakumanu S, Manns BJ, Tran S, Saunders-Smith T, Hemmelgarn BR, Tonelli M, Tsuyuki R, Ivers N, Southern D, Bakal J, Campbell DJT. Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis. Trials. 2019 Oct 7;20(1):577. doi: 10.1186/s13063-019-3652-5.
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