- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01070095
The Electronic Asthma Action Plan System for Implementation in Primary Care (eAAPS)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Brampton, Ontario, Canada, L6X 1N3
- Wise Elephant Family Health Team
-
Hamilton, Ontario, Canada, L8N 3Z6
- McMaster Family Health Team
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Eligible physicians will include all primary care physicians at the 4 sites.
Eligible patients will include:
- patients with asthma, as determined by a validated electronic chart record search algorithm for asthma and on an asthma medication [but not a Chronic Obstructive Pulmonary Disease (COPD) medication] within 1 year;
- patients >/= 16 years of age who understand English
Exclusion Criteria:
- Pregnant patients will be excluded given that conventional AAP recommendations may not be appropriate in this population.
- Any patient deemed to have cognitive limitations or a life expectancy of < 1 year
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Electronic Asthma Action Plan System
Electronic Asthma Action Plan System (eAAPS)
|
The electronic asthma action plan system consists of a tablet device in the physician waiting room which participants use to complete a simple questionnaire, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and finally, a printable asthma action plan that is given to patients, along with the URL for an asthma education website.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
Tidsramme: 24 months
|
Number of eligible patients to whom an AAP was delivered by the physician during the intervention period (52 weeks) compared to the baseline period (52 weeks) Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control
|
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Impact of the eAAPS on Patient-relevant Outcomes Including Hospitalisations, Emergency Room Visits, Unscheduled & Total Visits to the Doctor, Days Off Work/School, Nocturnal/Daytime Asthma Symptoms, Daytime Rescue Bronchodilator Use & Quality of Life.
Tidsramme: Every 2 weeks for 6 months
|
Every 2 weeks for 6 months
|
|
|
Asthma Control Assessment
Tidsramme: 24 months
|
The number of patients with asthma control determined at least once, according to symptom-based criteria (control determination required meeting one or more criteria for uncontrolled asthma or all criteria for controlled asthma). Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control |
24 months
|
|
Medication Escalations
Tidsramme: 24 months
|
The number of patients with escalation of controller therapy Predictor model to include: clinic, appointment provider practitioner type, prior objective diagnosis of asthma, documented physician diagnosis of asthma, presenting complaint type, billing physician (most responsible physician/other), previous emergency department (ED) visits/hospitalizations for asthma, and current asthma control
|
24 months
|
|
Appropriate Medication Changes
Tidsramme: 24 months
|
Number of eligible visits in which patients who had an appropriate medication change made (i.e.
escalation for poor control, and de-escalation for good control, when ascertainable)
|
24 months
|
|
On Treatment Analysis
Tidsramme: During the 12 month intervention period
|
Number of eligible patients to whom an asthma action plan (AAP) was delivered, when decision support was available (52 weeks), counting only intervention period visits in which patients completed the questionnaire before the appointment and the notification prompted clinicians to open the computerized clinical decision support system (CDSS) to take action
|
During the 12 month intervention period
|
|
Number of Practitioners Completing Feedback Questionnaires
Tidsramme: 13 months
|
Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)
|
13 months
|
|
Ratio of Rescue to Controller Medication Prescriptions
Tidsramme: 24 months
|
Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
|
24 months
|
|
Adherence Discussions
Tidsramme: During the 12 month intervention period
|
The number of patients in the intervention period in whom discussions about medication adherence took place
|
During the 12 month intervention period
|
|
System Uptake
Tidsramme: During the 12 month intervention period
|
Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
|
During the 12 month intervention period
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Samir Gupta, MDCM, Unity Health Toronto
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 10-052
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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-
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