Asthma Clinical Trial
Official title:
Feasibility of a Clinician Training Program to Improve Patient-provider Communication in the Presence of Health IT Systems in the Exam Room
| Verified date | September 2017 |
| Source | University of Michigan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The investigators propose to modify and expand the internationally-recognized evidence-based Physician Asthma Care Education (PACE) program to make it a suitable tool for training primary care clinicians on the effective use of EHRs at the point of care. The investigators will first develop the EHR edition of PACE (EHR-PACE) through literature and expert review of best practices for clinicians interacting with patients in the presence of computer systems in the exam room. They will then establish the feasibility and potential impact of EHR-PACE via a randomized design on 125 patients of 20 physicians who receive the intervention on the following outcomes via survey 3 and 6 months post-intervention: patient satisfaction with the physician's performance, asthma control, and asthma-related quality of life. Outcomes will be assessed on patients, but physicians will receive the intervention. Patients will not know which arm their doctor was randomized to. The pilot trial will compare two groups of primary care physicians who see patients with asthma in clinics equipped with certified EHRs. It is hypothesized that patients of physicians who receive EHR-PACE training will achieve better outcomes compared to physicians who do not receive EHR-PACE.
| Status | Completed |
| Enrollment | 126 |
| Est. completion date | August 31, 2017 |
| Est. primary completion date | August 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Physicians: 1. Licensed physician in practice and board certified in primary care or family medicine 2. Treating adults with asthma 3. Full-time in a practice at an Integrated Health Associates clinic that has implemented a certified EHR system for at least one year 4. Consent to participate 5. Will generate a roster of adult asthma patients for inclusion in the study Patients: 1. Treated by the participating physician during the study intake period 2. 18 years of age or older 3. Have a diagnosis of asthma made by a physician using the National Asthma Education and Prevention Program Guidelines 4. Have at least one urgent medical care visit for asthma in the previous year 5. Have access to a telephone 6. Consent to participate Exclusion Criteria: Patients: 1. Have other chronic disorders that have pulmonary complications |
| Country | Name | City | State |
|---|---|---|---|
| United States | Integrated Health Associates ClinSite Research | Ann Arbor | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan | Agency for Healthcare Research and Quality (AHRQ) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline patient report of physician performance at 3 and 6 months | The patient's report of physician performance will be used as the key measure in this study. They will use a validated instrument previously developed by the research group in the PACE trials, focusing on clinical practices of the clinician, especially, use of National Asthma Education and Prevention Program recommended therapies, communication and counseling behaviors specially related to EHR use. | baseline, 3 months, 6 months | |
| Secondary | Change from baseline patient satisfaction at 3 and 6 months | specific facets of satisfaction with care adapted from the widely used Patient Satisfaction Questionnaire, especially as it relates to interactions with clinicians in the presence of EHRs in the exam room | baseline, 3 months, 6 months | |
| Secondary | Change from baseline asthma control at 3 and 6 months | the Asthma Control Test (ACT), a valid measure responsive to changes in asthma control over time | baseline, 3 months, 6 months | |
| Secondary | Change from baseline asthma-related quality of life at 3 and 6 months | Mini Asthma Quality of Life Questionnaire (Mini-AQLQ), a 15-item validated instrument that assesses physical, emotional, and social well-being of adults with asthma through four domains (activity limitations, symptoms, emotional function, and exposure to environmental stimuli). | baseline, 3 months, 6 months |
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