Piloting Healthcare Coordination in Hypertension

NCT02988193 | Completed Results DMC

• 1 other identifier: 15-16045
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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. 1.Can optima4BP interoperate with multiple IT platforms to collect and distribute data?
2. 2.What is the treating physician confidence in using optima4BP?

Conditions

Hypertension

Keywords

clinical reasoning artificial intelligence; poorly controlled hypertension

Outcome Measures

Primary Outcomes (1)

• Clinical Adoption of a Decision Support Artificial Intelligence

  Total number of participants that undergone a treatment change. This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician.

  6 months

Study Arms (2)

optima4BP Medication Management

EXPERIMENTAL

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.

Device: optima4BP Medication Management

Usual Care Medication Management

NO INTERVENTION

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.

Interventions

optima4BP Medication Management 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.

optima4BP Medication Management

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• UCSF General Medicine patient
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Optima Integrated Health: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California San Francisco

San Carlos, California, 94158, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Gabriela Voskerician
• Organization: Optima Integrated Health

gxv4@case.edu

6502233588

Study Officials

• Gabriela Voskerician, PhD

  Optima Integrated Health

  PRINCIPAL INVESTIGATOR

• Liviu Klein, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The medication treatment intervention between arms differs in that the optima4BP arm uses an analytic intelligence algorithm to optimize drug treatment.

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 9, 2016
• Study Start: December 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 28, 2017
• Last Updated: September 18, 2019
• Results First Posted: September 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)