Back to resultsAn Electronic Shared Decision-Making Application to Improve Asthma Outcomes
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Asthma Shared Decision-Making App
Shared Decision Making Physician Training Video
Electronic Asthma Shared Decision-Making App- Patient Data
Standard Care
Sponsored by
About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma, Shared Decision Making, SDM
Eligibility Criteria
Inclusion Criteria:
- English speaking
- Diagnosis of persistent asthma
- Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study
Exclusion Criteria:
- Diagnosis of intermittent asthma
- Any other lung disease
- Smoking greater than 20 pack years or current smoking
- Mental impairment such that participation would not be possible
Sites / Locations
- Michigan Medicine, University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Group A Patients who receive SDM intervention
Group B Patients who receive standard care
Group A Physicians who receive SDM training and electronic Asthma SDM App data
Group B Physicians who provide standard care
Arm Description
Group A patients will complete a pre-visit electronic Asthma SDM App. They may also receive educational information regarding asthma, medication management, smoking cessation, COVID-19 and COVID-19 vaccines.
Group B patients will receive standard care.
Group A physicians will view an SDM Physician Training Video and receive the patients' reported data from the pre-visit asthma SDM App prior to the patients' visits.
Group B physicians will provide standard care.
Outcomes
Primary Outcome Measures
Patient satisfaction
Patient satisfaction as determined by Patient Satisfaction Questionnaire responses. Questions will consist of the SDM-Q-9 (psychometrically validated measures for shared decision-making from the perspectives of patients), questions regarding satisfaction with content covered during the visit, and questions regarding satisfaction with the overall communication between the patient and physician.
Secondary Outcome Measures
Physician satisfaction
Physician satisfaction as determined by Physician Satisfaction Questionnaire responses. Questions will consist of the SDM-Q-DOC (psychometrically validated measures for shared decision-making from the perspectives of health care providers), questions regarding satisfaction with content covered during the visit, and questions regarding satisfaction with the overall communication between the patient and physician. Physicians will receive a small number of satisfaction questionnaires, randomly assigned after patient visits, no more than one a week.
Change in level of asthma control will be determined
Change in level of asthma control as determined by patient follow up asthma control test questionnaire responses regarding interval changes in asthma control, use of systemic steroids, and urgent care and emergency visits for asthma.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04951102
Brief Title
An Electronic Shared Decision-Making Application to Improve Asthma Outcomes
Official Title
An Electronic Shared Decision-Making Application to Improve Asthma Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
September 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will increase knowledge about the feasibility and effect on patient satisfaction and clinical outcomes of using an electronic Shared Decision Making (SDM) application (app) for patients with asthma in the allergy/immunology clinic visit setting. SDM is defined as an approach where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options and make informed choices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Shared Decision Making, SDM
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The subjects will be clustered in 2 groups of patients and physicians based on participating health care provider and clinic location. Group A will be the intervention group and Group B will be the control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A Patients who receive SDM intervention
Arm Type
Experimental
Arm Description
Group A patients will complete a pre-visit electronic Asthma SDM App. They may also receive educational information regarding asthma, medication management, smoking cessation, COVID-19 and COVID-19 vaccines.
Arm Title
Group B Patients who receive standard care
Arm Type
Active Comparator
Arm Description
Group B patients will receive standard care.
Arm Title
Group A Physicians who receive SDM training and electronic Asthma SDM App data
Arm Type
Experimental
Arm Description
Group A physicians will view an SDM Physician Training Video and receive the patients' reported data from the pre-visit asthma SDM App prior to the patients' visits.
Arm Title
Group B Physicians who provide standard care
Arm Type
Active Comparator
Arm Description
Group B physicians will provide standard care.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Asthma Shared Decision-Making App
Intervention Description
The electronic Asthma SDM App will ask questions related to medicine-related, non-medicine-related, and COVID-19-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment. They may also use the Asthma SDM app to find information about asthma, medication management, COVID-19 and COVID-19 vaccines.
Intervention Type
Behavioral
Intervention Name(s)
Shared Decision Making Physician Training Video
Intervention Description
Training video to educate physicians on Shared Decision-Making and the use of Shared Decision-Making tools.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Asthma Shared Decision-Making App- Patient Data
Intervention Description
Data from the pre-visit electronic Asthma SDM app completed by the patients. Data includes medicine-related, non-medicine-related, and COVID-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard Care for asthma.
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Patient satisfaction as determined by Patient Satisfaction Questionnaire responses. Questions will consist of the SDM-Q-9 (psychometrically validated measures for shared decision-making from the perspectives of patients), questions regarding satisfaction with content covered during the visit, and questions regarding satisfaction with the overall communication between the patient and physician.
Time Frame
Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit
Secondary Outcome Measure Information:
Title
Physician satisfaction
Description
Physician satisfaction as determined by Physician Satisfaction Questionnaire responses. Questions will consist of the SDM-Q-DOC (psychometrically validated measures for shared decision-making from the perspectives of health care providers), questions regarding satisfaction with content covered during the visit, and questions regarding satisfaction with the overall communication between the patient and physician. Physicians will receive a small number of satisfaction questionnaires, randomly assigned after patient visits, no more than one a week.
Time Frame
Within 1 week of patient visit
Title
Change in level of asthma control will be determined
Description
Change in level of asthma control as determined by patient follow up asthma control test questionnaire responses regarding interval changes in asthma control, use of systemic steroids, and urgent care and emergency visits for asthma.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English speaking
Diagnosis of persistent asthma
Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study
Exclusion Criteria:
Diagnosis of intermittent asthma
Any other lung disease
Smoking greater than 20 pack years or current smoking
Mental impairment such that participation would not be possible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Baptist, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan Medicine, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Electronic Shared Decision-Making Application to Improve Asthma Outcomes
We'll reach out to this number within 24 hrs