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The Electronic Asthma Action Plan System for Implementation in Primary Care (eAAPS)

10 september 2019 uppdaterad av: Unity Health Toronto
Asthma is a common and potentially fatal chronic disease. An asthma action plan (AAP) is a written plan produced by a physician for a patient with asthma, to provide education and guidelines for self-management of worsening asthma symptoms. Studies have shown that AAPs effectively improve asthma control, but physicians fail to provide AAPs due to lack of time and adequate skills. Physicians also often fail to determine if their patients have good asthma control, and to adjust medications in response to patients' control level. The investigators propose to develop and test a computerized tool that will help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire. The investigators hope that this system will eliminate the barriers that physicians face in determining asthma control, adjusting medications, and delivering an AAP, and will increase the frequency with which physicians are able to achieve these goals in patients with asthma. The objectives of the study are to determine the impact of this system on asthma action plan delivery by primary care physicians, the frequency of checking control level, and the frequency and appropriateness of asthma medication changes (in accordance with control). We will also attempt to determine the impact of the system on hospitalisations, emergency room (ER) visits, unscheduled visits to the doctor, total visits to the doctor, days off work or school, nocturnal asthma symptoms, daytime asthma symptoms, daytime rescue puffer use, and quality of life, and to measure physicians' perceptions of and satisfaction with the system.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

This is a 2-year prospective interrupted time series (ITS) study of usual asthma care (baseline period) (year 1) compared to care with the eAAPS in place (intervention period) (year 2). The setting is two academic family health teams (primary health care teams including family physicians, nurses, and allied health members) in Hamilton, Ontario and one community-based family health team in Brampton, Ontario.

Studietyp

Interventionell

Inskrivning (Faktisk)

19

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Ontario
      • Brampton, Ontario, Kanada, L6X 1N3
        • Wise Elephant Family Health Team
      • Hamilton, Ontario, Kanada, L8N 3Z6
        • McMaster Family Health Team
      • Toronto, Ontario, Kanada, M5B 1W8
        • St. Michael's Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

16 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants to Whom an AAP (Asthma Action Plan) Was Delivered by the Clinician
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: Every 2 weeks for 6 months
Every 2 weeks for 6 months
Asthma Control Assessment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 24 months
Ratio of rescue to controller medication prescriptions made during baseline vs intervention periods
24 months
Adherence Discussions
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Samir Gupta, MDCM, Unity Health Toronto

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2012

Primärt slutförande (Faktisk)

1 augusti 2014

Avslutad studie (Faktisk)

1 augusti 2014

Studieregistreringsdatum

Först inskickad

16 februari 2010

Först inskickad som uppfyllde QC-kriterierna

16 februari 2010

Första postat (Uppskatta)

17 februari 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 september 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2019

Senast verifierad

1 september 2019

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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