A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

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.
    

Detailed description: 
      HTN is associated with the greatest attributable risk for mortality among all modifiable risk
      factors for cardiovascular disease.[1] In 2014, there were approximately 72 million adults
      (29%) with HTN in the US.[2] Several clinical trials have demonstrated that antihypertensive
      medications reduce cardiovascular events.[3] For example, even a 5 mm Hg difference in
      systolic BP (SBP) over 3-5 years can reduce the risk of cardiovascular complications and
      strokes by 25-30%.[4] Yet, approximately 20% of U.S. adults are unaware of their HTN,[5] and
      among patients diagnosed with HTN, 47% are uncontrolled.[2] Thus, there is a critical need to
      effectively treat patients with HTN.

      Clinical inertia has been identified as the primary cause for delays in achieving BP control
      for over 20 years.[6-8] Providers often discount office BP readings that may be falsely
      elevated due to observer or measurement error and/or the clinical surroundings (e.g., white
      coat HTN).[9-11] Patients are often seen only once or twice a year which further delays BP
      control. Furthermore,[8, 12] BP goals are achieved in only 49% of the patients who take
      anti-hypertensive medications.[5] New approaches for acquiring more BP readings are also
      needed to better monitor and titrate treatment because a significant proportion of patients
      on therapy are not adequately controlled despite frequent physician visits.

      Home BP measurements, (i.e., having patients take their BP at home), can facilitate the more
      timely diagnosis of HTN by reducing diagnostic uncertainty. In fact, home measurements are
      better prognostic indicators of stroke and cardiovascular mortality than clinic
      measurements,[13-15] are more closely correlated with end-organ damage from HTN than clinic
      measurements,[16, 17] are cost effective and well-tolerated by patients,[18] and generate BP
      readings that are at least as reproducible as clinic readings.[19] Home BP measurements, if
      available, may help physicians overcome barriers related to clinical inertia.[20] However,
      the data must be followed by action. The researchers have pioneered physician-pharmacist
      collaborative management (PPCM) that has been shown to decrease clinical inertia and improve
      BP control.[21, 22] Pharmacists have been embedded within the medical office to perform BP
      management. The pharmacists are able to assess patients' needs and provide recommendations to
      physicians regarding treatment changes, providing patients with timely therapy
      adjustments.[23] However, many medical office leaders are unable to hire clinical pharmacists
      due to limited resources. Therefore, a "virtual", remote clinical pharmacy service has been
      developed.[24] Pharmacists were able to obtain electronic medical record (EMR) access at all
      intervention offices for private physician offices throughout Iowa. While the physicians
      accepted 95% of the pharmacists' recommendations, the effect on improving BP was modest
      (manuscript under review). Adding the proposed texting platform with home BP monitoring
      should markedly improve the potency of our remote, telepharmacy intervention.

      This trial exhibits clinical equipoise because, although it is known that texting is an
      efficient method for obtaining home BP measurements, and that pharmacist interventions to
      improve BP are cost-effective, it is not known if combining these two interventions will also
      be cost effective. There are four reasons why this study might not be successful. First,
      while meta-analyses have found significantly improved BP with pharmacist interventions some
      studies were not successful.[25] Second, more data does not necessarily mean better data:
      patients could report false values, BP could be abnormally low or high during the measurement
      period, or the data could be ignored. Third, even better data might not lead to better
      outcomes: data could be ignored by pharmacists, physicians or patients; pharmacists'
      recommendations could be ignored by physicians or patients. Fourth, even if the study is
      effective at improving subject outcomes, it might not be cost effective. Texting might not
      save as much time as hypothesized. Thus, further research is needed to address these gaps in
      knowledge.

      There is a critical need for an easy-to-use, cost-effective, mobile health (m-health)
      approach to assist patients and healthcare providers with screening, diagnosis, and
      monitoring of HTN. Small medical offices and those located in poor or rural areas are unable
      to operationalize team-based care with pharmacists. The researchers have overcome this
      barrier with the use of a remote clinical pharmacy services. Coronary heart disease deaths
      could be reduced by 15-20% and stroke deaths by 20-30% if this intervention effectively
      improves BP and is implemented more widely in primary care offices.

      The goal of this proposal is to evaluate whether a scalable, short messaging service (SMS)
      approach combined with a pharmacist-based intervention improves BP management cost
      effectively. To achieve this objective, the following specific aims are proposed:

        1. Determine if mean BP 12 months after the intervention decreases more for the
           intervention group than the control group. The working hypothesis is that those in the
           pharmacist-intervention group will achieve larger BP decreases than those in the control
           group.

        2. Determine if the intervention leads to more intensification of therapy than in the
           control group. The working hypothesis is that subjects in the pharmacist-intervention
           group will have more treatment changes than those in the control group.

        3. Determine the cost effectiveness of the intervention. The working hypothesis is that the
           intervention will be cost effective when compared to the control group.
    

Intervention name(s): Experimental: Pharmacist-Bidirectional Texting Group; Active Comparator: Control Group
Intervention type(s): Other; Other
Intervention description(s): The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.; This group will receive bidirectional texting, but no pharmacist monitoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment