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Clinical-Decision Support to Improve Hypertension Care in Primary Care

15. mai 2020 oppdatert av: University of Texas Southwestern Medical Center

Automated Clinical-Decision Support to Improve Hypertension Care Among Overweight Children in Primary Care

Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. If successful, this approach can be used to address other lifestyle-related and complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used nationwide.

The investigators have developed a new, electronic health-record (EHR)-based tool that is designed to help pediatricians:

  1. IDENTIFY AND DOCUMENT

    1. when a child's blood pressure is elevated, and
    2. whether it has been elevated before--including number of prior elevations to document the correct diagnosis (for example, elevated blood pressure, vs. hypertension stage 1, vs. hypertension stage 2), THEN

  2. ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including:

    1. laboratories and studies per 2017 updated guidelines
    2. follow-up interval in primary care
    3. referral to nephrology, when indicated, and
    4. patient education on diet/lifestyle modification.

The investigators are working on improving this system further with addition of orders for:

  1. referral for sleep-apnea testing and treatment, when indicated, and
  2. blood-pressure medications (for example, initiation, titration, or addition of agents depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for pregnancy)

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The investigators' data suggest that (1) addressing obesity-related comorbidities (in combination with high BMI/overweight/obesity) and more frequent follow-up are associated with weight-status improvement in overweight (OW) children, (2) that parents rank checking for weight-related health problems as the #1 most important recommended weight-management clinical practice, but that (3) comorbidities are infrequently addressed. Thus, to improve weight status, interventions are needed to improve comorbidity identification, evaluation, and management in primary care. Because the investigators' data suggest that identification of high blood pressure is particularly poor, and that identifying blood-pressure elevations in young children at three separate encounters is complex, they are using existing underutilized data to automate addressing high blood pressure/hypertension in an electronic health record system (EPIC-based), and, if successful, applying the method to other obesity-related comorbidities in primary care.

OF NOTE: in developing and pilot-testing this decision support tool, providers wanted access to it for patients without overweight/obesity. Thus, although the trial was borne out of work in weight-management research, the initial trial will focus on all children irrespective of weight status.

Studietype

Intervensjonell

Registrering (Faktiske)

2803

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Dallas, Texas, Forente stater, 75390
        • University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria for Providers: Pediatric primary care providers practicing at participating clinics that have agreed to have the decision-support system implemented.

Exclusion Criteria for Providers:

  • Lack of electronic health record

Inclusion Criteria for Children:

  • Measured systolic or diastolic blood pressure >=90th % for age/sex, or
  • >=120 mmHg systolic or >=80 mmHg diastolic (whichever is lower)

Exclusion Criteria for Children:

  • Diagnosis/visit for high blood pressure or hypertension in past 2 years
  • Taking anti-hypertensive medication

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: clinical decision support activated

TWO MED ASSIST ALERTS

  1. Enter height (when missing)
  2. Repeat BP (when high)

ONE PROVIDER ALERT

  1. BP high & prior BP/BP%s
  2. Defines elev. BP, HTN stage 1-2 with button to enter diagnosis
  3. Link to tailored ordersets

TAILORED ORDERSETS

  1. Elevated BP

    1. Button to schedule f-up <6 m
    2. Button for diet/lifestyle counseling/check-out instructions

  2. HTN stage 1

    1. Buttons to order labs/studies pre-checked for stage 1 recs
    2. Button for nephrology referral
    3. Button to schedule f-up in 1-2 wk/<1 m
    4. Button for diet/lifestyle counseling/check-out instructions

  3. HTN stage 2

    1. Buttons to order labs/studies for stage 2
    2. Button for nephrology referral (pre-checked)
    3. Button to f-up 1 wk
    4. Button for diet/lifestyle counseling/check-out instruction
Annen: clinical decision support
Decision support system (see description of hypertension decision support system alerts and order sets for details)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
High blood pressure addressed
Tidsramme: 4-month time series analysis
Proportion of patients with high blood pressure addressed post decision-support implementation (vs. pre-), defined as proportion of patients with elevated blood pressures or higher who have one or more diagnosis or orders placed to diagnose, evaluate, or manage hypertension. We will compare the slope of the post- vs. pre-implementation periods to examine change in monthly rate of HTN eval/management (indicated elements ordered/patients eligible) related to decision support that are in excess of secular trends in clinical practice. In the post-implementation period, the denominator will be determined by tracking patient-level decision-support fires. In the pre-implementation period, the denominator will be determined by applying the decision-support algorithm to retrospective data in monthly increments to identify patients who would have been eligible.
4-month time series analysis

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Texas Southwestern Medical Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. juli 2017

Primær fullføring (Faktiske)

20. november 2017

Studiet fullført (Faktiske)

20. november 2017

Datoer for studieregistrering

Først innsendt

12. januar 2018

Først innsendt som oppfylte QC-kriteriene

13. januar 2018

Først lagt ut (Faktiske)

19. januar 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. mai 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mai 2020

Sist bekreftet

1. mai 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STU 052015-029

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Data are being obtained under a MU agreement/legal contract

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Hypertensjon

Kliniske studier på clinical decision support

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