- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01070095
The Electronic Asthma Action Plan System for Implementation in Primary Care (eAAPS)
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
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
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Samir Gupta, MDCM, Unity Health Toronto
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10-052
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