Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices (REMIND)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CVS Caremark
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT02015806
First received: December 13, 2013
Last updated: July 22, 2014
Last verified: July 2014

December 13, 2013
July 22, 2014
March 2014
February 2015   (final data collection date for primary outcome measure)
Optimal medication adherence among patients suboptimally adherent to targeted medications excluding antidepressants [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Optimal adherence to medications is defined as a Medication Possession Ratio (MPR) equal to or greater than 0.80 and assessed using administrative pharmacy claims
Optimal medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Optimal adherence to medications will be defined as a Medication Possession Ratio (MPR) equal to or greater than 0.80 and assessed using administrative pharmacy claims
Complete list of historical versions of study NCT02015806 on ClinicalTrials.gov Archive Site
Average adherence among patients suboptimally adherent to targeted medications including those intended to treat depression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Medication adherence will be calculated using Medication Possession Ratios (MPR) for each of the targeted therapies the patient is on, and assessed using administrative pharmacy claims
Mean Medication Possession Ratio (MPR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
A member level MPR will be calculated over the follow-up period for each targeted condition and then averaged
Average medication adherence for patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Medication adherence will be calculated using Medication Possession Ratios (MPR) for antidepressants, and assessed using administrative pharmacy claims
Not Provided
 
Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
Assessing the Impact of Low-Touch Devices on Medication Adherence

The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a Take-N-Slide, a RxTimerCap, a PillMinder, or none of these devices, with the hypothesis that low-touch devices improve adherence over control and that the increase in adherence is agnostic across devices.

Given that the Take-N-Slide device only has a Yes/No toggle for each day of the week and can therefore only be used once per day, the study population will be stratified into two separate trials based on the frequency with which the study participants' medications are (or could possibly be) taken. Patients who are on a medication that is used more than once daily will be included in Trial 2, which evaluates only the RxTimer Cap and the PillMinder. Within each trial, all patients meeting the inclusion criteria within each trial will be randomized into two blocks, the first of which will consist of all patients suboptimally adherent to all targeted medications excluding antidepressants, and the second of all patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Breast Cancer
  • Cardiovascular Disease
  • Depression
  • Diabetes
  • Mental Health Disorder
  • Behavioral: Rx Timer Cap
    The RxTimer Cap is a pill bottle with a digital timer on the cap that shows the time elapsed since the medication was last taken. Patients randomized to receive the RxTimerCap will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
  • Behavioral: PillMinder
    The pillbox is a plastic organization box with one compartment for every day of the week. Patients randomized to receive a pillbox will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
  • Behavioral: Take-N-Slide
    The Take-N-Slide device is a patented strip with toggles for each day of the week which are meant to be slid after taking a medication. Each Take-N-Slide can be removed and reused for the next prescription bottle. Patients randomized to receive Take-N-Slide will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
  • Experimental: All meds 1x daily use, all but depression, Rx Timer Cap
    Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to receive the Rx Timer Cap
    Intervention: Behavioral: Rx Timer Cap
  • Experimental: All meds 1x daily use, only depression, Rx Timer Cap
    Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to receive the Rx Timer Cap
    Intervention: Behavioral: Rx Timer Cap
  • Experimental: All meds 1x daily use, all but depression, PillMinder
    Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to receive the PillMinder
    Intervention: Behavioral: PillMinder
  • Experimental: All meds 1x daily use, only depression, PillMinder
    Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to receive the PillMinder
    Intervention: Behavioral: PillMinder
  • Experimental: All meds 1x daily use, all but depression, Take-N-Slide
    Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to receive the Take-N-Slide
    Intervention: Behavioral: Take-N-Slide
  • Experimental: All meds 1x daily use, only depression, Take-N-Slide
    Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to receive the Take-N-Slide
    Intervention: Behavioral: Take-N-Slide
  • No Intervention: All meds 1x daily use, all but depression, Control
    Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to proceed with usual care
  • No Intervention: All meds 1x daily use, only depression, Control
    Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to proceed with usual care
  • Experimental: 1 med ≥2x daily use, all but depression, Rx Timer Cap
    Individuals who are suboptimally adherent to targeted therapies except antidepressants, who have at least one medication that is intended for use more than once daily and are randomized to receive the Rx Timer Cap
    Intervention: Behavioral: Rx Timer Cap
  • Experimental: ≥1 med ≥2x daily use, only depression, Rx Timer Cap
    Individuals whose only targeted medications are for depression and who are suboptimally adherent to this therapy, for whom at least one medication is intended for use more than once daily and are randomized to receive the Rx Timer Cap
    Intervention: Behavioral: Rx Timer Cap
  • Experimental: ≥1 med ≥2x daily use, all but depression, PillMinder
    Individuals who are suboptimally adherent to targeted therapies except antidepressants, who have at least one medication that is intended for use more than once daily and are randomized to receive the PillMinder
    Intervention: Behavioral: PillMinder
  • Experimental: ≥1 med ≥2x daily use, only depression, PillMinder
    Individuals whose only targeted medications are for depression and who are suboptimally adherent to this therapy, for whom at least one medication is intended for use more than once daily and are randomized to receive the PillMinder
    Intervention: Behavioral: PillMinder
  • No Intervention: ≥1 med ≥2x daily use, all but depression, Control
    Individuals who are suboptimally adherent to targeted therapies except antidepressants, who have at least one medication that is intended for use more than once daily and are randomized to proceed with usual care
  • No Intervention: ≥1 med ≥2x daily use, only depression, Control
    Individuals whose only targeted medications are for depression and who are suboptimally adherent to this therapy, for whom at least one medication is intended for use more than once daily and are randomized to proceed with usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
53480
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have 1 to 3 oral maintenance medications in pill or capsule form and filled via mail order or at a retail pharmacy within 12 months prior to being identified as being eligible for the study, at least one of which must be intended for either:
  • A chronic condition (defined as breast cancer, cardiovascular disease, diabetes or a major mental health condition); OR
  • Depression.
  • Be suboptimally adherent to all of the targeted drug classes, defined as a Medication Possession Ratio (see Outcomes and Analysis section below for definition) of 30% to less than 80% during the 12 months preceding identification of study eligibility, except where noted below;
  • For patients taking antidepressants in addition to other targeted medications, patients need only be suboptimally adherent to their non-antidepressant medications;.
  • Eligible for pharmacy benefits during the 12 months prior to being identified as being eligible for the study and expected to be eligible for pharmacy benefits through the end of the evaluation period.

Exclusion Criteria:

  • Enrolled in Ready Fill at Mail (a pharmacy benefit program whereby members elect to have medications shipped automatically to them at the time of refill due date or prescription renewal).
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02015806
2013-P-00009085
Not Provided
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
Brigham and Women's Hospital
CVS Caremark
Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
Brigham and Women's Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP