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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT03973931

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

5,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

1250

Patients Per Site

20.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Adherence, Medication Medication Adherence Diabetes Mellitus Hypertension Hyperlipidemias Coronary Artery Disease Atrial Fibrillation	Behavioral: Nudge	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5000 participants

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.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

Official Title:

Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Nudge Interventions will include a variety of text messages aimed at improving medication adherence.
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.	Behavioral: Nudge Interventions will include a variety of text messages aimed at improving medication adherence.
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.	Behavioral: Nudge Interventions will include a variety of text messages aimed at improving medication adherence.

Outcome Measures

Primary Outcome Measures

Medication adherence [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.

Secondary Outcome Measures

Blood pressure [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) [Up to 12 months after intervention]
LDL measurements are defined by the last recorded measurement in months 10-12 following study enrollment.
Hemoglobin A1c [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) [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) [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) [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) [Up to 12 months after intervention]
CABG are identified by a procedure in the year following study enrollment.
Cardioversion rates (Cardiovascular clinical events) [Up to 12 months after intervention]
Cardioversion are identified by a procedure in the year following study enrollment.
All-cause hospitalizations (Hospitalizations) [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) [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) [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) [Up to 12 months after intervention]
Healthcare costs and cost offsets associated with the intervention to inform if there were reductions in healthcare utilization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCHealth	Aurora	Colorado	United States	80045
2	University of Colorado Denver	Aurora	Colorado	United States	80045
3	VA Eastern Colorado Health Care System	Aurora	Colorado	United States	80045
4	Denver Health and Hospital Authority	Denver	Colorado	United States	80204