Stroke Clinical Trial
— ACCESSOfficial title:
Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study
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 |
Verified date | March 2024 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Alberta Innovates Health Solutions |
Canada,
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 all — Click here to view all references
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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