An Interactive Voice Response and Text Message Intervention to Improve Blood Pressure Control Among Individuals With Hypertension Receiving Care at an Urban Indian Health Organization: Protocol and Baseline Characteristics of a Pragmatic Randomized Controlled Trial

Emily B Schroeder, Kelly Moore, Spero M Manson, Megan A Baldwin, Glenn K Goodrich, Allen S Malone, Lisa E Pieper, Stanley Xu, Meredith M Fort, David Johnson, Linda Son-Stone, John F Steiner, Emily B Schroeder, Kelly Moore, Spero M Manson, Megan A Baldwin, Glenn K Goodrich, Allen S Malone, Lisa E Pieper, Stanley Xu, Meredith M Fort, David Johnson, Linda Son-Stone, John F Steiner

Abstract

Background: Efficient and effective strategies for treating chronic health conditions such as hypertension are particularly needed for under-resourced clinics such as Urban Indian Health Organizations (UIHOs).

Objective: The objective of the Controlling Blood Pressure Trial is to assess the impact of an interactive voice response and text message (IVR-T) intervention compared with usual care among individuals with hypertension receiving care at a UIHO in Albuquerque, New Mexico. This manuscript presents the baseline characteristics of individuals enrolled in the trial and compares their characteristics with those in the hypertension registry who did not enroll in the trial.

Methods: A hypertension registry developed from the clinic's electronic health record was used for recruitment. Potentially eligible participants were contacted by letter and then by phone. Those who expressed interest completed an in-person baseline visit that included a baseline survey and blood pressure measurement using standardized procedures. Individuals randomized to the intervention group could opt to receive either automated text messages or automated phone calls in either English or Spanish. The messages include reminders of upcoming appointments at First Nations Community HealthSource, requests to reschedule recently missed appointments, monthly reminders to refill medications, and weekly motivational messages to encourage self-care, appointment keeping, and medication taking for hypertension. Individuals in the IVR-T arm could opt to nominate a care partner to also receive notices of upcoming and missed appointments. Individuals in the IVR-T arm were also offered a home blood pressure monitor. Follow-up visits will be conducted at 6 months and 12 months.

Results: Over a 9.5-month period from April 2017 to January 2018, 295 participants were enrolled from a recruitment list of 1497 individuals. The enrolled cohort had a mean age of 53 years, was 25.1% (74/295) American Indian or Alaska Native and 51.9% (153/295) Hispanic, and 39.0% (115/295) had a baseline blood pressure greater than or equal to 140/90 mmHg. Overall, the differences between those enrolled in the trial and patients with hypertension who were ineligible, those who could not be reached, or those who chose not to enroll were minimal. Enrolled individuals had a slightly lower blood pressure (129/77 mmHg vs 132/79 mmHg; P=.04 for systolic blood pressure and P=.01 for diastolic blood pressure), were more likely to self-pay for their care (26% vs 10%; P<.001), and had a more recent primary care visit (164 days vs 231 days; P<.001). The enrolled cohort reported a high prevalence of poor health, low socioeconomic status, and high levels of basic material needs.

Conclusions: The Controlling Blood Pressure Trial has successfully enrolled a representative sample of individuals receiving health care at a UIHO. Trial follow-up will conclude in February 2019.

Trial registration: ClinicalTrials.gov NCT03135405; https://ichgcp.net/clinical-trials-registry/NCT03135405 (Archived by WebCite http://www.webcitation.org/76H2B4SO6).

International registered report identifier (irrid): DERR1-10.2196/11794.

Keywords: Indians, North American; hypertension; pragmatic clinical trial; text messages; urban health.

Conflict of interest statement

Conflicts of Interest: None declared.

©Emily B Schroeder, Kelly Moore, Spero M Manson, Megan A Baldwin, Glenn K Goodrich, Allen S Malone, Lisa E Pieper, Stanley Xu, Meredith M Fort, David Johnson, Linda Son-Stone, John F Steiner. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 02.04.2019.

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