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| Name | Class |
|---|---|
| Alberta Innovates Health Solutions | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Die (y/n) | 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) |
| Non-fatal myocardial infarction | Nonfatal MI based on administrative data (y/n) |
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Inclusion Criteria:
>65 years of age (have drug insurance from Alberta Blue Cross with 30% copayment)
Have any one of the following:
OR any two of the following:
Have total family income <$50,000
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Braden Manns | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22143232 | Background | 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. | |
| 24850391 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Diabetes-related sub-study protocol and SAP | Jul 7, 2026 |
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| Personalized Education | Behavioral | Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle |
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| 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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. |
| 24744042 | 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. |
| 24667163 | 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. |
| 23576000 | 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. |
| 3936186 | 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. |
| 4046121 | 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. |
| 11242426 | 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. |
| 12759325 | 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. |
| 10030326 | 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. |
| 18268266 | 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. |
| 21978939 | 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. |
| 36871215 | Derived | 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. |
| 36871212 | 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. |
| 33129278 | 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. |
| 31590686 | 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. |
| 27671037 | 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. |
| Jul 7, 2026 |
| Prot_SAP_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Secondary analysis SAP - Medication adherence | Mar 19, 2024 | Mar 19, 2024 | SAP_002.pdf |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D020521 | Stroke |
| D051436 | Renal Insufficiency, Chronic |
| D006333 | Heart Failure |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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