- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02435394
Web System for Engaging Families & Doctors in Continuous Asthma Quality Improvement (Asthma)
19. april 2016 opdateret af: Total Child Health, Inc.
Asthma, one of the most common pediatric illnesses, is optimally managed according to National Heart Lung and Blood Institute (NHLBI) guidelines yet this is not often done in primary care.
This project is to develop and test the effects of using a module for guideline based care in the Child Health and Development Interactive System (CHADIS) online system by prompting and incorporating patient symptom/control and adherence data from standard questionnaires to inform visits and providing automated patient specific education and Asthma Action Plans in individual Care Portals.
Studieoversigt
Status
Trukket tilbage
Betingelser
Detaljeret beskrivelse
We will complete the formative work collecting professional opinion to create and pilot the initial CHADIS Asthma Intervention module (CHADIS-AI), an innovative decision support system.
CHADIS-AI content will be assembled and vetted by asthma experts and primary care providers (PCPs).
Parent and teen focus groups will vet the content and language of the adherence materials and Care Portal.
A system will also be established for points for patient participation, to give clinicians Maintenance of Certification (MOC) credit, and ongoing run chart reports of their patients' asthma status for continual Quality Improvement (QI) feedback.
The resulting system will be pilot tested and refined by clinician feedback.
Practices will be randomly assigned to intervention vs control.
Control practices will use CHADIS for asthma care without the A-I module.
Intervention practices will be further randomized to have remote coach support for patients or not.
Outcomes will be examined of asthma severity/control, match of severity with guideline based medication management, numbers of Emergency Department (ED) visits, hospitalizations and oral steroid use.
Effect of remote coaching will also be assessed.
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Maryland
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Baltimore, Maryland, Forenede Stater, 21210
- Total Child Health
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-
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
Ikke ældre end 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Asthma diagnosis
Exclusion Criteria:
- Not English or Spanish speaking
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: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Remote Coach plus Asthma Module
The intervention is for practices to have remote coach support for patients with asthma in addition to doctors using CHADIS-Asthma module.
Practices will start sequentially for a time series analysis.
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The intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care.
Andre navne:
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Eksperimentel: Asthma Module- No Coach
The intervention is for practices to use CHADIS-Asthma module to improve patient care without a remote coach assisting patient adherence.
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The intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach.
|
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Aktiv komparator: CHADIS- no Asthma module
Practices using CHADIS but no Asthma module as a control condition.
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The practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
NHLBI recommended controller meds used
Tidsramme: 3-12 months
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match between severity rating and NHLBI recommended med mgt
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3-12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Emergency department visits
Tidsramme: 3-12 months
|
Self reported interval ED visits
|
3-12 months
|
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Asthma trigger mitigation
Tidsramme: 3-12 months
|
self-reported efforts to reduce asthma triggers
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3-12 months
|
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Hospitalizations for asthma
Tidsramme: 3-12 months
|
Self reported hospitalizations
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3-12 months
|
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Steroid bursts
Tidsramme: 3-12 months
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Self reported use of steroid bursts for asthma exacerbations
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3-12 months
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Influenza vaccine receipt
Tidsramme: 3-12 months
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self reported receipt of flu vaccine for this season
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3-12 months
|
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asthma symptom control
Tidsramme: 3-12 months
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severity/control ratings
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3-12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
1. juli 2015
Primær færdiggørelse (Forventet)
1. juni 2016
Studieafslutning (Forventet)
1. juli 2016
Datoer for studieregistrering
Først indsendt
28. april 2015
Først indsendt, der opfyldte QC-kriterier
30. april 2015
Først opslået (Skøn)
6. maj 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R44HL117482 (U.S. NIH-bevilling/kontrakt)
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 .
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