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Piloting Healthcare Coordination in Hypertension (PRECISION)

16. september 2019 opdateret af: Optima Integrated Health

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?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Carlos, California, Forenede Stater, 94158
        • University of California San Francisco

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical Adoption of a Decision Support Artificial Intelligence
Tidsramme: 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.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Optima Integrated Health

Samarbejdspartnere

University of California, San Francisco

Efterforskere

  • Ledende efterforsker: Gabriela Voskerician, PhD, Optima Integrated Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2015

Primær færdiggørelse (Faktiske)

1. januar 2017

Studieafslutning (Faktiske)

28. februar 2017

Datoer for studieregistrering

Først indsendt

2. december 2016

Først indsendt, der opfyldte QC-kriterier

6. december 2016

Først opslået (Skøn)

9. december 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-16045

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Forhøjet blodtryk

Kliniske forsøg med optima4BP Medication Management

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Betingelser

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Placeringer

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