- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236817
Impact on Patient COmpliance With Medication Using Pre-packaged Blisters for Long-term Medical therapY (I-COMPLY)
Study Overview
Status
Conditions
Detailed Description
For patients in the study group, new prescriptions with three refills were electronically scripted to local compliance packaging pharmacy, ExactCare pharmacy, LLC, Valley View, Ohio, 44125. ExactCare is a local packaging pharmacy that pre-packs medications for patients so that each day's medications come in a separate paper compartment that can be discarded after daily use. They also deliver medications to the patients' homes. At the initiation of the study, ExactCare provided medications in pill packs for all patient medications in a 30-day supply (Figure 2). Pill bottle medications were provided for medications that would run out prior to the initial supply date. Inhalers, nebulizers, injectable medications, as needed medications and medications that required frequent dose changes were not included in the pill packs but were sent separately within the 30-day supply box.
If the patient was started on a new medication by their PCP, the local compliance packaging pharmacy packed this medication in pill packs for the next 30-day box supply and sent pill bottles containing enough pills to last the patient till the next 30-day box. Every pill in the pill pack was coded with an identification number. If the patient's physician discontinued or changed the dose of any medication, the patient was advised to remove the pill from the pack using its identification number and either discard it or make the dose change accordingly.
A study investigator counted the pills left in the control group prior to the study start date. After the study start date, patients in the control group continued to receive their medications the same way they were getting them before being enrolled in this study using either electronic or printed prescriptions. They received instructions about the timing and frequency of medication administration from their physicians and nurses, and picked up their medications from their local pharmacy.
Patients from both groups had a follow-up PCP visit approximately four months from enrollment. Patients received telephone calls prior to their follow-up appointments to remind them to bring their medications from home. During the appointment, the study investigator counted the medications remaining in the pill packs for the study group patients and the pills remaining in pill bottles for the control group patients.
ExactCare provided the initial start date for each patient receiving their pill packs in 30-day supply. Refill dates were accessed from local pharmacies and the EMR for patients in the control group. This information was used to calculate the number of pills expected to remain with each patient at the end of the study and to compare to the actual number of pills remaining. New medications, discontinued medications, and modified-dose medications were not included in the study analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 18 years or older
- Covered by Medicaid insurance
- Seen in clinic at least two times within the past year, follow-up appointment scheduled between January and May 2015
- Prescribed a minimum of four medications daily
Exclusion Criteria:
- Nursing home patients
- Patients with planned hospital stays during the study period
- Patients who were already receiving medications in pre-packed blisters or pill packs prior to study enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-packed blisters for distribution of medications
Patients in the intervention group received prescriptions pre-packaged in individual packets that were delivered by the pharmacy.
|
|
Placebo Comparator: Routine distribution of medications
Patients in the control group continued to receive medications from pharmacies as they did prior to enrollment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of missed pills
Time Frame: 4 month follow-up
|
The primary outcome was the percentage of missed pills in the intervention group versus the control group after four months of enrollment.
|
4 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of missed doses
Time Frame: 4 month follow-up
|
The secondary outcome was the number of daily doses missed.
|
4 month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e259.
- Conn VS, Ruppar TM. Medication adherence outcomes of 771 intervention trials: Systematic review and meta-analysis. Prev Med. 2017 Jun;99:269-276. doi: 10.1016/j.ypmed.2017.03.008. Epub 2017 Mar 16.
- Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Ward BW, Schiller JS, Goodman RA. Multiple chronic conditions among US adults: a 2012 update. Prev Chronic Dis. 2014 Apr 17;11:E62. doi: 10.5888/pcd11.130389.
- Ward BW, Schiller JS. Prevalence of multiple chronic conditions among US adults: estimates from the National Health Interview Survey, 2010. Prev Chronic Dis. 2013 Apr 25;10:E65. doi: 10.5888/pcd10.120203.
- Blazing MA, Giugliano RP, Cannon CP, Musliner TA, Tershakovec AM, White JA, Reist C, McCagg A, Braunwald E, Califf RM. Evaluating cardiovascular event reduction with ezetimibe as an adjunct to simvastatin in 18,144 patients after acute coronary syndromes: final baseline characteristics of the IMPROVE-IT study population. Am Heart J. 2014 Aug;168(2):205-12.e1. doi: 10.1016/j.ahj.2014.05.004. Epub 2014 May 15.
- A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2017 Dec 21;377(25):2506. doi: 10.1056/NEJMx170008. No abstract available.
- Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.
- Pasina L, Brucato AL, Falcone C, Cucchi E, Bresciani A, Sottocorno M, Taddei GC, Casati M, Franchi C, Djade CD, Nobili A. Medication non-adherence among elderly patients newly discharged and receiving polypharmacy. Drugs Aging. 2014 Apr;31(4):283-9. doi: 10.1007/s40266-014-0163-7.
- Marcum ZA, Gellad WF. Medication adherence to multidrug regimens. Clin Geriatr Med. 2012 May;28(2):287-300. doi: 10.1016/j.cger.2012.01.008.
- Conn VS, Ruppar TM, Chan KC, Dunbar-Jacob J, Pepper GA, De Geest S. Packaging interventions to increase medication adherence: systematic review and meta-analysis. Curr Med Res Opin. 2015 Jan;31(1):145-60. doi: 10.1185/03007995.2014.978939. Epub 2014 Nov 4.
- Ritchey M, Chang A, Powers C, Loustalot F, Schieb L, Ketcham M, Durthaler J, Hong Y. Vital Signs: Disparities in Antihypertensive Medication Nonadherence Among Medicare Part D Beneficiaries - United States, 2014. MMWR Morb Mortal Wkly Rep. 2016 Sep 16;65(36):967-76. doi: 10.15585/mmwr.mm6536e1. Erratum In: MMWR Morb Mortal Wkly Rep. 2017 Nov 24;66(46):1281.
- Viswanathan M, Golin CE, Jones CD, Ashok M, Blalock SJ, Wines RC, Coker-Schwimmer EJ, Rosen DL, Sista P, Lohr KN. Interventions to improve adherence to self-administered medications for chronic diseases in the United States: a systematic review. Ann Intern Med. 2012 Dec 4;157(11):785-95. doi: 10.7326/0003-4819-157-11-201212040-00538.
- Stuart B, Davidoff A, Lopert R, Shaffer T, Samantha Shoemaker J, Lloyd J. Does medication adherence lower Medicare spending among beneficiaries with diabetes? Health Serv Res. 2011 Aug;46(4):1180-99. doi: 10.1111/j.1475-6773.2011.01250.x. Epub 2011 Mar 17.
- Stuart BC, Dai M, Xu J, Loh FH, S Dougherty J. Does good medication adherence really save payers money? Med Care. 2015 Jun;53(6):517-23. doi: 10.1097/MLR.0000000000000360.
- Wroe AL. Intentional and unintentional nonadherence: a study of decision making. J Behav Med. 2002 Aug;25(4):355-72. doi: 10.1023/a:1015866415552.
- Gerber BS, Cho YI, Arozullah AM, Lee SY. Racial differences in medication adherence: A cross-sectional study of Medicare enrollees. Am J Geriatr Pharmacother. 2010 Apr;8(2):136-45. doi: 10.1016/j.amjopharm.2010.03.002.
- Lafata JE, Karter AJ, O'Connor PJ, Morris H, Schmittdiel JA, Ratliff S, Newton KM, Raebel MA, Pathak RD, Thomas A, Butler MG, Reynolds K, Waitzfelder B, Steiner JF. Medication Adherence Does Not Explain Black-White Differences in Cardiometabolic Risk Factor Control among Insured Patients with Diabetes. J Gen Intern Med. 2016 Feb;31(2):188-195. doi: 10.1007/s11606-015-3486-0.
- Bahrami H, Kronmal R, Bluemke DA, Olson J, Shea S, Liu K, Burke GL, Lima JA. Differences in the incidence of congestive heart failure by ethnicity: the multi-ethnic study of atherosclerosis. Arch Intern Med. 2008 Oct 27;168(19):2138-45. doi: 10.1001/archinte.168.19.2138.
- Pi-Sunyer FX. Obesity and diabetes in blacks. Diabetes Care. 1990 Nov;13(11):1144-9. doi: 10.2337/diacare.13.11.1144.
- Braverman J, Dedier J. Predictors of medication adherence for African American patients diagnosed with hypertension. Ethn Dis. 2009 Autumn;19(4):396-400.
- Siegel D, Lopez J, Meier J. Antihypertensive medication adherence in the Department of Veterans Affairs. Am J Med. 2007 Jan;120(1):26-32. doi: 10.1016/j.amjmed.2006.06.028.
- Williams A, Manias E, Walker R. Interventions to improve medication adherence in people with multiple chronic conditions: a systematic review. J Adv Nurs. 2008 Jul;63(2):132-43. doi: 10.1111/j.1365-2648.2008.04656.x.
- Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. Cochrane Database Syst Rev. 2002;(2):CD000011. doi: 10.1002/14651858.CD000011.
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 (Actual)
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
Other Study ID Numbers
- 14-1554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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