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A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting

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ClinicalTrials.gov Identifier: NCT03986931
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Linnea Polgreen, University of Iowa

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

  Show Detailed Description

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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

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986931


Contacts
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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
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Principal Investigator: Linnea A Polgreen, PhD University of Iowa

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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    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases