Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study (ACCESS)-study protocol for a 2×2 factorial randomized trial.
BACKGROUND
Chronic diseases result in significant morbidity and costs. Although medications and lifestyle changes are effective for improving outcomes in chronic diseases, many patients do not receive these treatments, in part because of financial barriers, patient and provider-level knowledge gaps, and low patient motivation. The Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study (ACCESS) will determine the impact of two interventions: (1) a value-based formulary which eliminates copayment for high-value preventive medications; and (2) a comprehensive self-management support program aimed at promoting health behavior change and medication adherence, combined with relay of information on medication use to healthcare providers, on cardiovascular events and/or mortality in low-income seniors with elevated cardiovascular risk.


METHODS
The ACCESS study will use a parallel, open label, factorial randomized trial design, with blinded endpoint evaluation in 4714 participants who are over age >65 (and therefore have drug insurance provided by Alberta Blue Cross with 30 % co-payment); are at a high risk for cardiovascular events based on a history of any one of the following: coronary heart disease, prior stroke, chronic kidney disease, heart failure, or any two of the following: current cigarette smoking, diabetes mellitus, hypertension, or hypercholesterolemia; and have a household income <Can$50,000. This 3-year study is powered to detect a minimal clinically important relative risk reduction of 12 % in the composite clinical outcome of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary revascularization, and hospitalizations for chronic disease-related ambulatory care sensitive conditions, each of which will be assessed using healthcare administrative data. Secondary outcomes will include quality of life and healthcare costs.


CONCLUSIONS
Given identified gaps in care in chronic disease, and the frequency of financial and knowledge-related barriers in low-income Albertans, this study will test the impact of providing free high-value preventive medications (i.e., value-based insurance) and a tailored self-management education and facilitated relay strategy on outcomes and costs. By measuring the impact on both health outcomes and costs, as well as the impact on reducing health inequities in this vulnerable population, our study will facilitate informed policy decisions.


BACKGROUND
Clinicaltrials.gov: NCT02579655 . Registered Oct 15, 2015.
Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.
David J T
DJ
Campbell
Departments of Medicine and Community Health Sciences, Libin Institute and Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Marcello
M
Tonelli
Departments of Medicine and Community Health Sciences, Libin Institute and Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Brenda
B
Hemmelgarn
Alberta Health, Edmonton, Canada.
Chad
C
Mitchell
Department of Pharmaceutical Sciences, University of Alberta, Edmonton, Canada.
Ross
R
Tsuyuki
Department of Family Medicine, University of Toronto, Toronto, Canada.
Noah
N
Ivers
Department of Psychology, University of Calgary, Calgary, Canada.
Tavis
T
Campbell
Emergence Creative, New york, USA.
Raj
R
Pannu
Emergence Creative, New york, USA.
Eric
E
Verkerke
Department of Medicine, University of Alberta, Edmonton, Canada.
Scott
S
Klarenbach
Faculty of Nursing, University of Calgary, Calgary, Canada.
Kathryn
K
King-Shier
Alberta Health Services, Edmonton, Canada.
Peter
P
Faris
Departments of Medicine and Community Health Sciences, Libin Institute and Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Canada.
Derek
D
Exner
Department of Medicine, University of British Columbia, Vancouver, Canada.
Vikas
V
Chaubey
Departments of Medicine and Community Health Sciences, Libin Institute and Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Canada. Braden.Manns@albertahealthservices.ca.|Foothills Medical Centre, 1403 29th St. NW, Calgary, Alberta, Canada, T2N 2T9. Braden.Manns@albertahealthservices.ca.
Braden
http://orcid.org/0000-0002-8823-6127
B
Manns
Chronic disease; Cost; Drug insurance; Education; Randomized clinical trial
Clin J Am Soc Nephrol. 2012 Apr;7(4):565-72
22344504
N Engl J Med. 2011 Dec 1;365(22):2088-97
22080794
Med Care. 2002 Aug;40(8):675-85
12187181
Med Care. 2005 Nov;43(11):1130-9
16224307
J Am Board Fam Pract. 2002 Jul-Aug;15(4):334-7
12150470
PLoS One. 2012;7(2):e31115
22328929
Lancet. 2012 Jun 16;379(9833):2252-61
22683130
Med Care Res Rev. 2004 Jun;61(2):225-40
15155053
Lancet. 1999 Feb 20;353(9153):617-22
10030326
JAMA. 2010 Feb 3;303(5):423-9
20124537
Curr Med Res Opin. 2009 Sep;25(9):2303-10
19635045
Hypertension. 2009 Dec;54(6):1423-8
19858407
Open Med. 2012 Dec 11;6(4):e155-65
23687531
JAMA. 2007 Sep 19;298(11):1291-9
17878421
BMC Cardiovasc Disord. 2013 Oct 20;13:88
24138129
Med Care Res Rev. 2006 Dec;63(6):719-41
17099123
Stroke. 2005 Aug;36(8):1776-81
16020772
Am J Manag Care. 2014 Jun;20(6):e229-41
25326932
Health Policy. 2012 Jan;104(1):19-26
21978939
JAMA. 1985 Oct 11;254(14):1926-31
4046121
PLoS One. 2013 Dec 02;8(12):e80633
24312488
J Gen Intern Med. 2007 Apr;22(4):442-7
17372790
Am Heart J. 2002 Aug;144(2):290-6
12177647
CMAJ. 2008 Nov 4;179(10):1007-12
18981441
CMAJ. 2012 Feb 7;184(2):E144-52
22143232
J Am Soc Nephrol. 2014 Mar;25(3):587-94
24231665
J Behav Med. 2008 Dec;31(6):453-62
18784996
Diabetes Care. 2013 May;36(5):1172-80
23238665
BMC Nephrol. 2009 Oct 19;10:30
19840369
JAMA. 2001 Jan 24-31;285(4):421-9
11242426
J Am Coll Cardiol. 2006 Aug 1;48(3):438-45
16875966
Eur Heart J. 2012 Aug;33(16):2088-97
22511654
Lancet. 2012 Sep 1;380(9844):807-14
22717317
JAMA. 2002 Nov 20;288(19):2469-75
12435261
JAMA. 2010 Mar 24;303(12):1151-8
20332400
Med Care. 2005 Feb;43(2):182-8
15655432
Int J Obes (Lond). 2007 Jan;31(1):189-96
16682976
CMAJ Open. 2014 Apr 16;2(2):E51-9
25077130
Prev Med. 2016 Sep;90:155-69
27413005
Am J Manag Care. 2009 Jul;15(7):457-64
19589013
PLoS One. 2014 Mar 11;9(3):e90434
24618721
Arch Intern Med. 2003 Jan 13;163(1):101-6
12523923
Soc Sci Med. 1985;21(10):1063-9
3936186
JAMA. 2003 May 21;289(19):2534-44
12759325
Health Rep. 2014 May;25(5):3-12
24850391
Diabetes Educ. 2015 Feb;41(1):136-46
25486932
Diabet Med. 2016 Jun;33(6):742-51
27105298
Diabet Med. 2011 Apr;28(4):395-413
21392061
JAMA. 2012 Jun 20;307(23):2507-15
22797451
Diabetes Care. 2002 Mar;25(3):512-6
11874939