Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 2, 2018
Open Peer Review Period: Aug 3, 2018 - Sep 28, 2018
Date Accepted: Jan 22, 2019
(closed for review but you can still tweet)
A Pragmatic Randomized Controlled Trial of an Interactive Voice Response and Text Message (IVR-T) Intervention to Improve Blood Pressure Control among Individuals with Hypertension Receiving Care at an Urban Indian Health Organization
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.
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 to usual care among individuals with hypertension receiving care at an Urban Indian Health Organization in Albuquerque, New Mexico. The primary endpoint is the change in mean systolic blood pressure between baseline and 12 months. Secondary endpoints include change in diastolic blood pressure, self-reported medication adherence, and the proportion of missed clinic appointments between intervention and control groups.
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 FNCH; 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. This manuscript presents the baseline characteristics of individuals enrolled in the trial, and compares their characteristics to those in the hypertension registry who did not enroll in the trial.
Results:
Over a 9.5-month period, 295 participants were enrolled from a recruitment list of 1,497 individuals. Overall, the differences between those enrolled in the trial and patients with hypertension who were ineligible, could not be reached, or chose not to enroll were minimal. Enrolled individuals had a slightly lower blood pressure (129/77 mmHg vs. 132/79 mmHg, P value .04 for systolic blood pressure, .01 for diastolic blood pressure), were more likely to self-pay for their care (26% vs 10%, P value <.001), and had a more recent primary care visit (164 days vs. 231 days, P value <.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 healthcare at an Urban Indian Health Organization. Trial follow-up will conclude in February 2019. Clinical Trial: Clinicaltrials.gov NCT03135405, http://clinicaltrials.gov/ct2/show/NCT03135405
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.