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Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications

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ClinicalTrials.gov Identifier: NCT03973931
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date November 4, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
Medication adherence [ Time Frame: Up to 12 months after intervention ]
The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Blood pressure [ Time Frame: Up to 12 months after intervention ]
    Blood pressure (systolic and diastolic) measurements are defined by the last recorded measurement in months 10-12 following study enrollment.
  • Low-density lipoproteins (LDL) [ Time Frame: Up to 12 months after intervention ]
    LDL measurements are defined by the last recorded measurement in months 10-12 following study enrollment.
  • Hemoglobin A1c [ Time Frame: Up to 12 months after intervention ]
    Hemoglobin A1c measurements are defined by the last recorded measurement in months 10-12 following study enrollment.
  • Hospitalizations rate (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    Hospitalizations due to hypertension emergency, myocardial infarction (MI), stroke, heart failure, hyperglycemia, and atrial fibrillation, are identified by an inpatient stay in the year following study enrollment.
  • Emergency Department admission rates (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    Emergency Department admissions due to hypertension emergency, myocardial infarction (MI), stroke, heart failure, hyperglycemia, and atrial fibrillation are identified by an event in the year following study enrollment.
  • Percutaneous coronary intervention (PCI) rates, (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    PCI are identified by a procedure in the year following study enrollment.
  • Coronary artery bypass graft (CABG) rates, (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    CABG are identified by a procedure in the year following study enrollment.
  • Cardioversion rates (Cardiovascular clinical events) [ Time Frame: Up to 12 months after intervention ]
    Cardioversion are identified by a procedure in the year following study enrollment.
  • All-cause hospitalizations (Hospitalizations) [ Time Frame: Up to 12 months after intervention ]
    All-cause hospitalizations are identified by an inpatient stay in the year following study enrollment
  • All-cause Emergency Department admissions (Hospitalizations) [ Time Frame: Up to 12 months after intervention ]
    All-cause Emergency Department admissions are identified by an event in the year following study enrollment
  • Implementation costs (Costs) [ Time Frame: Up to 12 months after intervention ]
    The total cost of implementing each intervention to inform the resource use and investment required of each intervention.
  • Healthcare utilization costs (Costs) [ Time Frame: Up to 12 months after intervention ]
    Healthcare costs and cost offsets associated with the intervention to inform if there were reductions in healthcare utilization.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
Official Title  ICMJE Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
Brief Summary The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.
Detailed Description

Background: Up to fifty percent of patients do not take their cardiovascular medications as prescribed resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an intriguing and as of yet untested opportunity to adapt behavioral 'nudges' using ubiquitous cell phone technology to facilitate medication adherence.

Objectives: Aim 1: Conduct a pragmatic patient-level randomized intervention across three health care systems (HCS) to improve adherence to chronic CV medications. The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Secondary outcomes will include intermediate clinical measures (e.g., BP control), CV clinical events (e.g., hospitalizations), healthcare utilization, and costs. Aim 2: Evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. In addition, assess the context and implementation processes to inform local tailoring, adaptations and modifications, and eventual expansion of the intervention within the 3 HCS more broadly and nationally.

Setting: The study will be conducted within three HCS in metro Denver: VA Eastern Colorado Health Care System (VA), Denver Health and Hospital Authority, and UCHealth.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study will be a pragmatic, randomized controlled study with four treatment arms. Once patients are identified through pharmacy refill data to have a 7-day gap in any prescribed CV medication refills, they will be randomized to one of four arms, described in Intervention below. Randomization will be stratified within each of the clinics, and within strata defined by number of other CV medication classes that are prescribed at randomization (1-4), using blocks of 4 patients to ensure balance within clinics over time. Thus, within each clinic and number of other medication stratum, each set of 4 consecutively enrolled subjects will be randomized to the four study arms. Treatments will be initiated immediately upon randomization, in response to the 7-day gap.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Adherence, Medication
  • Medication Adherence
  • Diabetes Mellitus
  • Hypertension
  • Hyperlipidemias
  • Coronary Artery Disease
  • Atrial Fibrillation
Intervention  ICMJE Behavioral: Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.
Study Arms  ICMJE
  • No Intervention: Usual Care
    This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.
  • Experimental: Generic Nudge
    A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
    Intervention: Behavioral: Nudge
  • Experimental: Optimized nudge
    An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent.
    Intervention: Behavioral: Nudge
  • Experimental: Optimized nudge plus AI Chat Bot
    An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10.
    Intervention: Behavioral: Nudge
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
5000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with the following cardiovascular conditions and respective medication classes:
  • Hypertension (Beta-blockers [B-blockers)], Calcium Channel Blocker [CCB], Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blockers [ARB], or Thiazide diuretic)
  • Hyperlipidemia (HMG CoA reductase inhibitor [Statins])
  • Diabetes (Alpha-glucosidase inhibitors, Biguanides, DPP-4 inhibitors, Sodium glucose transport inhibitor, Meglitinides, Sulfonylureas, Thiazolidinediones, or statins Coronary artery disease P2Y12 inhibitor [Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine], B-blockers, ACEi or ARB or statins)
  • Atrial fibrillation (Direct oral anticoagulants, B-blockers, CCB)

Exclusion Criteria:

  • Patients who do not have a mailing address listed in EHR;
  • Patients who do not have a landline or cellphone listed in EHR;
  • Currently pregnant if denoted in the EHR at the time of the data pull;
  • Patients with a mailing address outside of the state of Colorado;
  • Patients that do not speak either English or Spanish.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Lisa Sandy, MA 303-724-5692 lisa.sandy@ucdenver.edu
Contact: Phat Luong, MS 303-724-8096 phat.luong@ucdenver.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03973931
Other Study ID Numbers  ICMJE 18-2779
UH3HL144163 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Data collected as part of this project will be released in accordance with standard data sharing policies and procedures. Data will be made available to the broader scientific community after results are published in peer-reviewed journals.

Prior to making this data available, data will be redacted to strip identifiers and further de-identified by removing indirect identifiers that could lead to "deductive disclosure" of identities.

Due to the small numbers of participants in the qualitative interviews, we do not anticipate sharing raw data from individuals.

The agreement will prohibit the recipient from transferring the data to other users, require that the data's security be protected by standard means and be used for research purposes only. After a requestor completes the data-sharing agreement, we will either mail a CD with a limited dataset to the requestor, or email the data through our secure email system that requires users to create an account to receive sensitive data.

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data will be shared in a timely manner, as requested.
Access Criteria: The study team will share technical and practical knowledge regarding the creation of the chat bot and text messaging intervention, upon request. Further, the study team would readily share all data collection instruments and assessment algorithms used in the project to qualified individuals within the scientific community with the agreement that they will appropriately acknowledge the study team who developed the instruments.
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Michael Ho, MD, PhD University of Colorado, Denver
Principal Investigator: Sheana Bull, PhD, MPH University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date November 2020

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