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

NCT02579655 | Completed

• 1 other identifier: REB13-1241
• Study Type: interventional
• Target: 4,764
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Disease; Stroke; Chronic Kidney Disease; Heart Failure; Diabetes Mellitus; Hypertension; Hypercholesterolemia

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• All-cause mortality

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

• Non-fatal myocardial infarction

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

• Non-fatal stroke

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

• Need for coronary revascularization

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

• hospitalizations for chronic disease-related ambulatory care sensitive conditions

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

Study Arms (4)

Copayment Elimination and Personalized Education

ACTIVE COMPARATOR

In 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

Behavioral: Copayment Elimination; Behavioral: Personalized Education

Copayment Elimination Only

ACTIVE COMPARATOR

In 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

Behavioral: Copayment Elimination

Personalized Education Only

ACTIVE COMPARATOR

In this arm, participants would be randomized to free enrollment in a new personalized education program to help patients manage their chronic conditions

Behavioral: Personalized Education

No intervention

NO INTERVENTION

In 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.

Interventions

Copayment Elimination BEHAVIORAL

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

Copayment Elimination Only; Copayment Elimination and Personalized Education

Personalized Education BEHAVIORAL

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

Copayment Elimination and Personalized Education; Personalized Education Only

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Innovates Health Solutions: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (17)

• 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.

  PMID: 22143232 BACKGROUND

• 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.

  PMID: 24850391 BACKGROUND

• 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.

  PMID: 24744042 BACKGROUND

• 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.

  PMID: 24667163 BACKGROUND

• 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.

  PMID: 23576000 BACKGROUND

• 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.

  PMID: 3936186 BACKGROUND

• 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.

  PMID: 4046121 BACKGROUND

• 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.

  PMID: 11242426 BACKGROUND

• 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.

  PMID: 12759325 BACKGROUND

• 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.

  PMID: 10030326 BACKGROUND

• 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.

  PMID: 18268266 BACKGROUND

• 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.

  PMID: 21978939 BACKGROUND

• 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.

  PMID: 36871215 DERIVED

• 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.

  PMID: 36871212 DERIVED

• 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.

  PMID: 33129278 DERIVED

• 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.

  PMID: 31590686 DERIVED

• Campbell DJ, Tonelli M, Hemmelgarn B, Mitchell C, Tsuyuki R, Ivers N, Campbell T, Pannu R, Verkerke E, Klarenbach S, King-Shier K, Faris P, Exner D, Chaubey V, Manns B; Interdisciplinary Chronic Disease Collaboration. Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study (ACCESS)-study protocol for a 2x2 factorial randomized trial. Implement Sci. 2016 Sep 26;11(1):131. doi: 10.1186/s13012-016-0491-6.

  PMID: 27671037 DERIVED

MeSH Terms

Conditions

Coronary Disease; Stroke; Renal Insufficiency, Chronic; Heart Failure; Diabetes Mellitus; Hypertension; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Braden Manns

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Svare Professor, Health Economics

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: October 19, 2015
• Study Start: November 1, 2015
• Primary Completion: March 31, 2021
• Study Completion: June 30, 2021
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)