An Electronic Shared Decision-Making Application to Improve Asthma Outcomes

NCT ID: NCT04951102

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2022-09-14

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A Patients who receive SDM intervention

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 Type EXPERIMENTAL

Electronic Asthma Shared Decision-Making App

Intervention Type 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 B Patients who receive standard care

Group B patients will receive standard care.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Standard Care for asthma.

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

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 Type EXPERIMENTAL

Shared Decision Making Physician Training Video

Intervention Type 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

Intervention Type 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 B Physicians who provide standard care

Group B physicians will provide standard care.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Standard Care for asthma.

Interventions

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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.

Intervention Type BEHAVIORAL

Shared Decision Making Physician Training Video

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Standard Care

Standard Care for asthma.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Alan Baptist

Assistant Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Baptist, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Michigan Medicine, University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37329951 (View on PubMed)

Other Identifiers

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HUM00193830

Identifier Type: -

Identifier Source: org_study_id

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