A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting

• Sponsor: Linnea Polgreen
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Linnea Polgreen, University of Iowa

Study Description

Brief Summary:

Bidirectional texting is an effective way to collect home blood pressure (BP) measurements from subjects, but collecting BP measurements and sending them to physicians does not necessarily lead to decreased BP. Pharmacist interventions have been successful in decreasing subject BP. However, pharmacists are expensive, and in successful interventions, spent a substantial amount of time collecting home BP measurements. In this study, a proven pharmacist intervention will be added to a bidirectional texting program to determine if a combined pharmacist-bidirectional texting intervention is successful at decreasing subject BP and increasing subject BP treatment intensification in a cost-effective manner. This study will be a cluster-randomized, controlled trial of a new intervention.

Condition or disease	Intervention/treatment	Phase
Hypertension	Other: Experimental: Pharmacist-Bidirectional Texting Group; Other: Active Comparator: Control Group	Not Applicable

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Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Masking Description: Research interns conducting baseline and exit data collection will be blinded so that they do not influence responses.
• Primary Purpose: Treatment
• Official Title: A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting
• Estimated Study Start Date: September 2019
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: July 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pharmacist-Bidirectional Texting Group; Patients enrolled in the Pharmacist-Bidirectional Texting Group will return 7 morning and 7 evening blood pressure measurements via text message. The report will be shared with a pharmacist who will monitor them for 12 months. The pharmacist will have access to their entire medical record and will provide support and education via text messaging, email, or phone calls, whichever is preferred by the patient. The pharmacist will develop a care plan and make recommendations to the physician through the electronic medical record to quickly adjust therapy to improve control. They will also recommend laboratory testing if indicated. They will have contact with the patient every 2-3 weeks while blood pressure is uncontrolled, and at least every 2 months when it is controlled. The pharmacist will track all recommendations made to physicians and whether or not they were implemented, modified, or rejected.	Other: Experimental: Pharmacist-Bidirectional Texting Group; The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
Active Comparator: Control Group; Patients randomized to the control group will also return 7 morning and 7 evening blood pressure measurements. The report will be shared with a pharmacist who will call the patient to discuss the measurements and possibly recommend follow up with a physician, but no other pharmacist intervention or monitoring will occur during the 12 months.	Other: Active Comparator: Control Group; This group will receive bidirectional texting, but no pharmacist monitoring.

Outcome Measures

Primary Outcome Measures :

1. Change in Systolic Blood Pressure- 6 Months [ Time Frame: 6 months ]
   Change from baseline in systolic blood pressure in mm Hg at 6 months.
2. Change in Systolic Blood Pressure- 12 Months [ Time Frame: 12 months ]
   Change from baseline in systolic blood pressure in mm Hg at 12 months.

Secondary Outcome Measures :

1. Number of Medication Changes in 12 Months [ Time Frame: 12 months ]
   Total number of medication changes (i.e., dose, discontinuation, initiation, etc.) from baseline as documented in the medical record.
2. Dollars Spent per Patient for 12 Month Bidirectional Texting/Pharmacist Intervention [ Time Frame: 12 months ]
   Total cost of medications, time spent by research staff, and clinics visits per patient from baseline.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Fluent in English or Spanish
• Have a clinic measured blood pressure of > 145 mmHg and/or > 95 mmHg at two previous clinic visits or one previous clinic visit and on the day of enrollment
• Must be a patient at Family Medicine, River Crossings, Scott Blvd, or Muscatine University of Iowa Clinics
• Live in a zip code that is scored as a 4-10 on the Rural-Urban Commuting Area codes

Exclusion Criteria:

• Currently pregnant or planning to become pregnant in the next year
• Prisoner status
• Unable to provide own informed consent

Contacts and Locations

Contacts

Contact: Linnea A Polgreen, PhD; (319) 384-3024; linnea-polgreen@uiowa.edu

Contact: Shelby L Francis, PhD; (319) 678-8037; shelby-francis@uiowa.edu

Sponsors and Collaborators

Linnea Polgreen

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Linnea A Polgreen, PhD; University of Iowa

More Information

• Responsible Party: Linnea Polgreen, Associate Professor, Department of Pharmacy Practice and Science / Division of Health Services Research, University of Iowa
• ClinicalTrials.gov Identifier: NCT03986931 History of Changes
• Other Study ID Numbers: BP Texting and Pharmacist
• First Posted: June 14, 2019
• Last Update Posted: June 14, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases