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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02579655
Other study ID # REB13-1241
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date June 30, 2021

Study information

Verified date March 2024
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 4764
Est. completion date June 30, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Calgary Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: BMJ Open. 2013 Apr 20;3(4):null. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Secondary All-cause mortality Die (y/n) 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Secondary Non-fatal myocardial infarction Nonfatal MI based on administrative data (y/n) 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Secondary Non-fatal stroke Nonfatal stroke based on administrative data (y/n) 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Secondary Need for coronary revascularization 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)
Secondary hospitalizations for chronic disease-related ambulatory care sensitive conditions 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)
Secondary 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) 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Secondary Overall quality of life as measured by the Euroqol EQ5D-5L index score Index score ranges from 0 to 1 (full health) 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
Secondary 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 $. 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
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