The Electronic Asthma Action Plan System for Implementation in Primary Care (EAAPS)
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 16, 2010 | ||||||||
| Last Updated Date | January 14, 2013 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary outcome will be the percentage 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). [ Time Frame: Every 2 weeks for 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01070095 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
The impact of an eAAP system on patient-relevant outcomes including hospitalisations, ER visits, unscheduled & total visits to the doctor, days off work/school, nocturnal & daytime asthma symptoms, daytime rescue bronchodilator use, & quality of life [ Time Frame: Every 2 weeks for 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Electronic Asthma Action Plan System for Implementation in Primary Care | ||||||||
| Official Title ICMJE | The Electronic Asthma Action Plan System for Implementation in Primary Care | ||||||||
| Brief Summary | 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. The investigators propose to develop a computerized tool that will automatically generate an electronic version of the AAP, based on patient responses to questions about their current asthma control. The investigators hope that this system will eliminate the barriers that physicians face in delivery of an AAP and will increase the frequency with which physicians are able to deliver AAPs to patients with asthma. The objectives of the study are to determine the impact of an electronic asthma action plan system on asthma action plan delivery by primary care physicians, to determine the impact of an electronic asthma action plan system on patient 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | Other: Electronic Asthma Action Plan System
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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| Study Arm (s) | Experimental: Electronic Asthma Action Plan System
Electronic Asthma Action Plan System
Intervention: Other: Electronic Asthma Action Plan System |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | August 2014 | ||||||||
| Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Eligible patients will include:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01070095 | ||||||||
| Other Study ID Numbers ICMJE | 10-0052 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | St. Michael's Hospital, Toronto | ||||||||
| Study Sponsor ICMJE | St. Michael's Hospital, Toronto | ||||||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | St. Michael's Hospital, Toronto | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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