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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03973931

Recruitment Status : Active, not recruiting

First Posted : June 4, 2019

Last Update Posted : November 4, 2022

View this study on Beta.ClinicalTrials.gov

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, 2022

Actual Study Start Date ^ICMJE

July 1, 2019

Estimated Primary Completion Date

June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

Active, not recruiting

Actual Enrollment ^ICMJE

9501

Original Estimated Enrollment ^ICMJE

5000

Estimated Study Completion Date ^ICMJE

June 30, 2024

Estimated Primary Completion Date

June 30, 2023 (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 information is only displayed when the study is recruiting subjects

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.