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

Stroke Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579655
• Other study ID #: REB13-1241
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Kidney Disease
• Coronary Disease
• Diabetes Mellitus
• Heart Failure
• Hypercholesterolemia
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic
• Stroke

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 all — Click 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)