An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

Asthma Clinical Trial

Official title:

An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951102
• Other study ID #: HUM00193830
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: September 14, 2022

Study information

• Verified date: November 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 14, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Electronic Asthma Shared Decision-Making App
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.
• Shared Decision Making Physician Training Video
Training video to educate physicians on Shared Decision-Making and the use of Shared Decision-Making tools.
• Electronic Asthma Shared Decision-Making App- Patient Data
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.
• Standard Care
Standard Care for asthma.

Locations

Country	Name	City	State
United States	Michigan Medicine, University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit
Secondary	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.	Within 1 week of patient visit
Secondary	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.	Up to 6 months