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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03973931
• Other study ID #: 18-2779
• Secondary ID: UH3HL144163
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9501
• Est. completion date: June 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Medication
• Atrial Fibrillation
• Cardiovascular Diseases
• Coronary Artery Disease
• Diabetes Mellitus
• Hyperlipidemias
• Hypertension
• Medication Adherence

Intervention

Behavioral:
• Nudge
Interventions will include a variety of text messages aimed at improving medication adherence.

Locations

Country	Name	City	State
United States	UCHealth	Aurora	Colorado
United States	University of Colorado Denver	Aurora	Colorado
United States	VA Eastern Colorado Health Care System	Aurora	Colorado
United States	Denver Health and Hospital Authority	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (15)

Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011 Apr;86(4):304-14. doi: 10.4065/mcp.2010.0575. Epub 2011 Mar 9. — View Citation

de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2. — View Citation

Gurol-Urganci I, de Jongh T, Vodopivec-Jamsek V, Atun R, Car J. Mobile phone messaging reminders for attendance at healthcare appointments. Cochrane Database Syst Rev. 2013 Dec 5;2013(12):CD007458. doi: 10.1002/14651858.CD007458.pub3. — View Citation

Ho PM, Spertus JA, Masoudi FA, Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006 Sep 25;166(17):1842-7. doi: 10.1001/archinte.166.17.1842. — View Citation

Jackevicius CA, Li P, Tu JV. Prevalence, predictors, and outcomes of primary nonadherence after acute myocardial infarction. Circulation. 2008 Feb 26;117(8):1028-36. doi: 10.1161/CIRCULATIONAHA.107.706820. — View Citation

Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. JAMA. 2006 Dec 6;296(21):2563-71. doi: 10.1001/jama.296.21.joc60162. Epub 2006 Nov 13. — View Citation

Lu CY, Ross-Degnan D, Soumerai SB, Pearson SA. Interventions designed to improve the quality and efficiency of medication use in managed care: a critical review of the literature - 2001-2007. BMC Health Serv Res. 2008 Apr 7;8:75. doi: 10.1186/1472-6963-8-75. — View Citation

Murray MD, Young J, Hoke S, Tu W, Weiner M, Morrow D, Stroupe KT, Wu J, Clark D, Smith F, Gradus-Pizlo I, Weinberger M, Brater DC. Pharmacist intervention to improve medication adherence in heart failure: a randomized trial. Ann Intern Med. 2007 May 15;146(10):714-25. doi: 10.7326/0003-4819-146-10-200705150-00005. — View Citation

Peterson PN, Campagna EJ, Maravi M, Allen LA, Bull S, Steiner JF, Havranek EP, Dickinson LM, Masoudi FA. Acculturation and outcomes among patients with heart failure. Circ Heart Fail. 2012 Mar 1;5(2):160-6. doi: 10.1161/CIRCHEARTFAILURE.111.963561. Epub 2012 Jan 13. — View Citation

Rasmussen JN, Chong A, Alter DA. Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. JAMA. 2007 Jan 10;297(2):177-86. doi: 10.1001/jama.297.2.177. — View Citation

Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, Messenger JC, Khanal S, Peterson ED, Bach RG, Krumholz HM, Cohen DJ. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER registry. Circulation. 2006 Jun 20;113(24):2803-9. doi: 10.1161/CIRCULATIONAHA.106.618066. Epub 2006 Jun 12. — View Citation

Vodopivec-Jamsek V, de Jongh T, Gurol-Urganci I, Atun R, Car J. Mobile phone messaging for preventive health care. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007457. doi: 10.1002/14651858.CD007457.pub2. — View Citation

Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272. — View Citation

Wei L, Flynn R, Murray GD, MacDonald TM. Use and adherence to beta-blockers for secondary prevention of myocardial infarction: who is not getting the treatment? Pharmacoepidemiol Drug Saf. 2004 Nov;13(11):761-6. doi: 10.1002/pds.963. — View Citation

Wei L, Wang J, Thompson P, Wong S, Struthers AD, MacDonald TM. Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study. Heart. 2002 Sep;88(3):229-33. doi: 10.1136/heart.88.3.229. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence	The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data.	Up to 12 months after intervention
Secondary	Blood pressure	Blood pressure (systolic and diastolic) measurements are defined by the last recorded measurement in months 10-12 following study enrollment.	Up to 12 months after intervention
Secondary	Low-density lipoproteins (LDL)	LDL measurements are defined by the last recorded measurement in months 10-12 following study enrollment.	Up to 12 months after intervention
Secondary	Hemoglobin A1c	Hemoglobin A1c measurements are defined by the last recorded measurement in months 10-12 following study enrollment.	Up to 12 months after intervention
Secondary	Hospitalizations rate (Cardiovascular clinical events)	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.	Up to 12 months after intervention
Secondary	Emergency Department admission rates (Cardiovascular clinical events)	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.	Up to 12 months after intervention
Secondary	Percutaneous coronary intervention (PCI) rates, (Cardiovascular clinical events)	PCI are identified by a procedure in the year following study enrollment.	Up to 12 months after intervention
Secondary	Coronary artery bypass graft (CABG) rates, (Cardiovascular clinical events)	CABG are identified by a procedure in the year following study enrollment.	Up to 12 months after intervention
Secondary	Cardioversion rates (Cardiovascular clinical events)	Cardioversion are identified by a procedure in the year following study enrollment.	Up to 12 months after intervention
Secondary	All-cause hospitalizations (Hospitalizations)	All-cause hospitalizations are identified by an inpatient stay in the year following study enrollment	Up to 12 months after intervention
Secondary	All-cause Emergency Department admissions (Hospitalizations)	All-cause Emergency Department admissions are identified by an event in the year following study enrollment	Up to 12 months after intervention
Secondary	Implementation costs (Costs)	The total cost of implementing each intervention to inform the resource use and investment required of each intervention.	Up to 12 months after intervention
Secondary	Healthcare utilization costs (Costs)	Healthcare costs and cost offsets associated with the intervention to inform if there were reductions in healthcare utilization.	Up to 12 months after intervention

External Links

•   NIH Collaboratory Site discussing the Nudge Project