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OpenTrials
Completed

NCT Number: NCT04951102

An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Medicine, University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Shared Decision Making Physician Training Video

Behavioral

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

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.

Standard Care

Behavioral

Standard Care for asthma.

Primary outcomes

  1. Patient satisfaction

    Time frame: Within 1 week of completing asthma shared decision making app worksheet and their asthma clinic visit

    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 outcomes

  1. Physician satisfaction

    Time frame: Within 1 week of patient visit

    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.

  2. Change in level of asthma control will be determined

    Time frame: Up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2021
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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