- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02579655
Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Copayment Elimination and Personalized Education
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
|
Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)
Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle
|
Active Comparator: Copayment Elimination Only
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
|
Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)
|
Active Comparator: Personalized Education Only
In this arm, participants would be randomized to free enrollment in a new personalized education program to help patients manage their chronic conditions
|
Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
Die (y/n)
|
3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
Non-fatal myocardial infarction
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
Nonfatal MI based on administrative data (y/n)
|
3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
Non-fatal stroke
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
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
Time Frame: 3 years or until March 31, 2021 (for patients enrolled after March 31, 2018)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Braden Manns, University of Calgary
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Coronary Disease
- Kidney Diseases
- Renal Insufficiency, Chronic
- Chronic Disease
- Hypercholesterolemia
Other Study ID Numbers
- REB13-1241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
US Department of Veterans AffairsCompleted
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
Clinical Trials on Copayment Elimination
-
The Institute for Functional MedicineFunctional Medicine Coaching AcademyCompleted
-
Baylor College of MedicineNational Institute of Nursing Research (NINR)Completed
-
Vibrant America Clinical LabActive, not recruitingFood SensitivityUnited States
-
NYU Langone HealthCompletedStroke | Post-Stroke HemiparesisUnited States
-
The Canadian College of Naturopathic MedicineCompleted
-
Medical University of BialystokCompletedObesity | Hashimoto DiseasePoland
-
University Hospital MuensterCompletedAngioedema | UrticariaGermany
-
Terry L. WahlsNational Multiple Sclerosis SocietyActive, not recruitingMultiple Sclerosis | Multiple Sclerosis, Relapsing-RemittingUnited States
-
Università degli Studi di BresciaCompleted
-
Dalarna County Council, SwedenGöteborg University; Örebro University, Sweden; Center for Clinical Research...Active, not recruitingInfantile Colic | Constipation - Functional | Bladder Dysfunction | Toilet TrainingSweden