HypertensionPRECISIONNCT02988193
Piloting Healthcare Coordination in Hypertension
A study testing optima4BP Medication Management in people with Hypertension, run by Optima Integrated Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- optima4BP Medication Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Carlos, California, 94158
About this study
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.
Read more
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:
- Can optima4BP interoperate with multiple IT platforms to collect and distribute data?
- What is the treating physician confidence in using optima4BP?
Read the 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
- Being tested
- optima4BP Medication Management
- Keywords
- clinical reasoning artificial intelligence, poorly controlled hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optima4BP Medication ManagementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optima Integrated Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Gabriela Voskerician, PhD, Principal investigator, Optima Integrated HealthLiviu Klein, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988193
- Sponsor's protocol ID
- 15-16045
- Acronym
- PRECISION
- Status last verified
- Mar 2019
- First submitted
- 2 Dec 2016
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Healthcare Coordination in Hypertension
- ClinicalTrials.gov ID
- NCT02988193
- Acronym / sponsor ID
- PRECISION / 15-16045
- Conditions
- Hypertension
- Keywords
- clinical reasoning artificial intelligence, poorly controlled hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Optima Integrated HealthIndustry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 18 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can optima4BP interoperate with multiple IT platforms to collect and distribute data?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The medication treatment intervention between arms differs in that the optima4BP arm uses an analytic intelligence algorithm to optimize drug treatment.
| Arm | Type | Receives |
|---|---|---|
| optima4BP Medication Management | Experimental | Device: optima4BP Medication Managementoptima4BP 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. |
| 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optima4BP Medication ManagementA 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. | Device | optima4BP Medication Management |
Primary outcome
Clinical Adoption of a Decision Support Artificial Intelligence
Time frame: 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Voskerician, PhD principal investigator
Optima Integrated Health
Liviu Klein, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing optima4BP Medication Management in people with Hypertension, run by Optima Integrated Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Adoption of a Decision Support Artificial Intelligence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.