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      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


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          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).


          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.


          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.


          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.


          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; http://clinicaltrials.gov/ct2/show/NCT03135405 (Archived by WebCite http://www.webcitation.org/76H2B4SO6)

          International Registered Report Identifier (IRRID)


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          Most cited references35

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          The PRECIS-2 tool: designing trials that are fit for purpose.

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            A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results

            Randomized controlled trials (RCTs) are conducted under idealized and rigorously controlled conditions that may compromise their external validity. A literature review was conducted of published English language articles that reported the findings of studies assessing external validity by a comparison of the patient sample included in RCTs reporting on pharmaceutical interventions with patients from everyday clinical practice. The review focused on publications in the fields of cardiology, mental health, and oncology. A range of databases were interrogated (MEDLINE; EMBASE; Science Citation Index; Cochrane Methodology Register). Double-abstract review and data extraction were performed as per protocol specifications. Out of 5,456 de-duplicated abstracts, 52 studies met the inclusion criteria (cardiology, n = 20; mental health, n = 17; oncology, n = 15). Studies either performed an analysis of the baseline characteristics (demographic, socioeconomic, and clinical parameters) of RCT-enrolled patients compared with a real-world population, or assessed the proportion of real-world patients who would have been eligible for RCT inclusion following the application of RCT inclusion/exclusion criteria. Many of the included studies concluded that RCT samples are highly selected and have a lower risk profile than real-world populations, with the frequent exclusion of elderly patients and patients with co-morbidities. Calculation of ineligibility rates in individual studies showed that a high proportion of the general disease population was often excluded from trials. The majority of studies (n = 37 [71.2 %]) explicitly concluded that RCT samples were not broadly representative of real-world patients and that this may limit the external validity of the RCT. Authors made a number of recommendations to improve external validity. Findings from this review indicate that there is a need to improve the external validity of RCTs such that physicians treating patients in real-world settings have the appropriate evidence on which to base their clinical decisions. This goal could be achieved by trial design modification to include a more representative patient sample and by supplementing RCT evidence with data generated from observational studies. In general, a thoughtful approach to clinical evidence generation is required in which the trade-offs between internal and external validity are considered in a holistic and balanced manner. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-1023-4) contains supplementary material, which is available to authorized users.
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              The assessment of refill compliance using pharmacy records: methods, validity, and applications.

              The refill records of computerized pharmacy systems are used increasingly as a source of compliance information. We reviewed the English-language literature to develop a typology of methods for assessing refill compliance (RC), to describe the epidemiology of compliance in obtaining medications, to identify studies that attempted to validate RC measures, to describe clinical features that predicted RC, and to describe the uses of RC measures in epidemiologic and health services research. In most of the 41 studies reviewed, patients obtained less medication than prescribed; gaps in treatment were common. Of the studies that assessed the validity of RC measures, most found significant associations between RC and other compliance measures, as well as measures of drug presence (e.g., serum drug levels) or physiologic drug effects. Refill compliance was generally not correlated with demographic characteristics of study populations, was higher among drugs with fewer daily doses, and was inconsistently associated with the total number of drugs prescribed. We conclude that, though some methodologic problems require further study, RC measures can be a useful source of compliance information in population-based studies when direct measurement of medication consumption is not feasible.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                April 2019
                02 April 2019
                : 8
                : 4
                : e11794
                [1 ] Kaiser Permanente Colorado Institute for Health Research Aurora, CO United States
                [2 ] Department of Medicine University of Colorado Anschutz Medical Campus Aurora, CO United States
                [3 ] Centers for American Indian and Alaska Native Health University of Colorado Anschutz Medical Campus Aurora, CO United States
                [4 ] First Nations Community HealthSource Albuquerque, NM United States
                Author notes
                Corresponding Author: Emily B Schroeder emily.b.schroeder@ 123456kp.org
                Author information
                ©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.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                : 2 August 2018
                : 7 January 2019
                : 15 January 2019
                : 22 January 2019

                indians, north american,hypertension,urban health,pragmatic clinical trial,text messages


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