An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

NCT04951102 | Completed

• 1 other identifier: HUM00193830
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Shared Decision Making; SDM

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Physician satisfaction

  Within 1 week of patient visit

• Change in level of asthma control will be determined

  Up to 6 months

Study Arms (4)

Group A Patients who receive SDM intervention

EXPERIMENTAL

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.

Behavioral: Electronic Asthma Shared Decision-Making App

Group B Patients who receive standard care

ACTIVE COMPARATOR

Group B patients will receive standard care.

Behavioral: Standard Care

Group A Physicians who receive SDM training and electronic Asthma SDM App data

EXPERIMENTAL

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.

Behavioral: Shared Decision Making Physician Training Video; Behavioral: Electronic Asthma Shared Decision-Making App- Patient Data

Group B Physicians who provide standard care

ACTIVE COMPARATOR

Group B physicians will provide standard care.

Behavioral: Standard Care

Interventions

Electronic Asthma Shared Decision-Making App BEHAVIORAL

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.

Group A Patients who receive SDM intervention

Shared Decision Making Physician Training Video BEHAVIORAL

Training video to educate physicians on Shared Decision-Making and the use of Shared Decision-Making tools.

Group A Physicians who receive SDM training and electronic Asthma SDM App data

Electronic Asthma Shared Decision-Making App- Patient Data BEHAVIORAL

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.

Group A Physicians who receive SDM training and electronic Asthma SDM App data

Standard Care BEHAVIORAL

Standard Care for asthma.

Group B Patients who receive standard care; Group B Physicians who provide standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Diagnosis of persistent asthma
• Have an in-person visit or telehealth encounter at the allergy/clinical immunology clinics participating in this study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Lee DL, Hammond JW, Finkel K, Gardner DD, Nelson B, Baptist AP. An Electronic Shared Decision-Making App to Improve Asthma Outcomes: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2023 Oct;11(10):3116-3122.e5. doi: 10.1016/j.jaip.2023.06.016. Epub 2023 Jun 16.

  PMID: 37329951 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alan Baptist, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: July 6, 2021
• Study Start: March 3, 2021
• Primary Completion: March 28, 2022
• Study Completion: September 14, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)