- ICH GCP
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- Klinische Studie NCT01070095
The Electronic Asthma Action Plan System for Implementation in Primary Care (eAAPS)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Ontario
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Brampton, Ontario, Kanada, L6X 1N3
- Wise Elephant Family Health Team
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Hamilton, Ontario, Kanada, L8N 3Z6
- McMaster Family Health Team
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Toronto, Ontario, Kanada, M5B 1W8
- St. Michael's Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Electronic Asthma Action Plan System
Electronic Asthma Action Plan System (eAAPS)
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
Zeitfenster: 24 months
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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
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24 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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.
Zeitfenster: Every 2 weeks for 6 months
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Every 2 weeks for 6 months
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Asthma Control Assessment
Zeitfenster: 24 months
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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
|
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Medication Escalations
Zeitfenster: 24 months
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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
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24 months
|
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Appropriate Medication Changes
Zeitfenster: 24 months
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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)
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24 months
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On Treatment Analysis
Zeitfenster: During the 12 month intervention period
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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
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During the 12 month intervention period
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Number of Practitioners Completing Feedback Questionnaires
Zeitfenster: 13 months
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Number of practitioners completing feedback questionnaires on the system (delivered in the 1 month after end of intervention period)
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13 months
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Ratio of Rescue to Controller Medication Prescriptions
Zeitfenster: 24 months
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Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
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24 months
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Adherence Discussions
Zeitfenster: During the 12 month intervention period
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The number of patients in the intervention period in whom discussions about medication adherence took place
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During the 12 month intervention period
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System Uptake
Zeitfenster: During the 12 month intervention period
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Actual usage of the system: number of patients for whom clinicians accessed the CDSS when actions were required
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During the 12 month intervention period
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Samir Gupta, MDCM, Unity Health Toronto
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 10-052
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Klinische Studien zur Electronic Asthma Action Plan System
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