Piloting Healthcare Coordination in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The PRECISION study investigates the possibility of integrating a clinical decision support
      analytic intelligence into the clinical care flow at University of California San Francisco
      Medical Center (UCSF MC). optima-for-blood pressure [optima4BP], our innovation, transforms
      the episodic and reactive nature of uncontrolled HTN pharmacological treatment management
      into a process that is continuous, proactive, and personalized.

      In addition, the clinical adoption of this "technology of the future" will be investigated to
      establish its feasibility in being embedded into the clinical care flow.

      Today's hypertension (HTN) management paradigm often fails to align current patient health
      status with the most effective medication treatment. Without surveillance and rapid-cycles
      analysis of current patient health status and treatment efficacy, HTN management remains a
      struggle. optima4BP addresses pharmacological intervention management by identifying the need
      for a drug treatment change and recommending the most appropriate drug optimization.

      The PRECISION study represent a pilot trial intended to address 2 critical design components
      of optima4BP:

        1. Can optima4BP interoperate with multiple IT platforms to collect and distribute data?

        2. What is the treating physician confidence in using optima4BP?
    

Detailed description: 
      Goal: Conduct a prospective randomized pilot clinical trial embedded within the care delivery
      system at UCSF Medical Center (UCSF). It is intended to evaluate the efficacy of optima4BP in
      improving care coordination for patients with uncontrolled hypertension (HTN). Although
      optima4BP has been evaluated during patient-physician office visits, it has not been
      evaluated for its efficacy to support treatment changes remotely, over time. PRECISION
      investigates this aspect and its impact on stakeholders (physicians and patients). The
      outcomes will set the stage for a scaled-up study of 300 patients at UCSF.

      Study Design: The patients will be randomized to 2 arms (a) optima4BP surveillance and
      treatment recommendation support (O4BP); (b) usual care (UC) - usual care seen appropriate by
      the treating physician). NOTE: The original design prior to study initiation considered a 3
      arms randomization which would also include: enhanced care (EC) representing a "step up" from
      UC by providing the physician with raw remotely collected BP values sent on a monthly cycle.
      However, this arm was abandoned at enrollment because patients in the UC arm were proactively
      reaching out to their physicians with remotely collected BP values from the Qardio® device
      therefore rendering the initially projected Extended Care arm unuseful.

      Every 30 days, the collection of patient information will be followed by an arm-specific
      action. For identified patients in need of a medication change, O4BP physicians will receive
      a treatment change recommendation for review. UC physicians will not receive any information.
      All patients will undergo at least 2 in-office visits, a baseline visit and an exit visit.
      All patients will be asked to provide every 30 days the following information: (a) adherence
      to current HTN treatment; and (b) experienced side-effects and severity. The communication
      will be performed via e-mail between Health-e-Heart (HeH) automated system
      (https://www.health-eheartstudy.org/) and the patient. HeH will automatically obtain BP
      values from the remote monitors provided to each patient.
    

Intervention name(s): optima4BP Medication Management
Intervention type(s): Device
Intervention description(s): A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The medication treatment intervention between arms differs in that the optima4BP arm uses an analytic intelligence algorithm to optimize drug treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: clinical reasoning artificial intelligence; poorly controlled hypertension