Piloting Healthcare Coordination in Hypertension

NCT ID: NCT02988193

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-02-28

Brief 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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

optima4BP Medication Management

optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:

1. curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;

2. medication treatment recommendation;

3. active link to access additional treatment analysis tools.

Group Type: EXPERIMENTAL

optima4BP Medication Management

Intervention Type: DEVICE

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.

Usual Care Medication Management

Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

optima4BP Medication Management

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• UCSF General Medicine patient
• 2 or more values on consecutive office visits within 12 months: systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90
• Therapy with at least 2 anti-hypertensive pharmacological classes at the time of the last office visit

Exclusion Criteria

• Does not own a smartphone
• Does not speak or read English
• Planning to leave UCSF in the next year
• Has a treating physician who refuses to enroll patients
• Treating physician states that:

Patient cannot manage Qardio® arm blood pressure (BP) device (due to cognitive, psychological, physical or other problems), or Patient is already at goal, or Should not participate in the study for any other reason

• Non-compliance with medical follow-up (frequent "no shows")
• Planned coronary revascularization in the next 6 months
• Myocardial infarction, stroke, coronary revascularization, cardiac or aortic surgery in the last 3 months

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Optima Integrated Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriela Voskerician, PhD

Role: PRINCIPAL_INVESTIGATOR

Optima Integrated Health

Liviu Klein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Carlos, California, United States

Countries

United States

Other Identifiers

15-16045

Identifier Type: -

Identifier Source: org_study_id