Feasibility of the BREATHE Asthma Intervention Trial

NCT ID: NCT03036267

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2017-09-22

Brief Summary

Asthma rates are high and asthma control is greatly reduced in Black, Medicaid-insured adults, due in part to their poor adherence to inhaled corticosteroids (ICS), which in turn may be due to erroneous health beliefs about asthma and negative beliefs regarding ICS. A brief shared decision-making intervention for use by primary care providers in Federally Qualified Health Centers (FQHCs) has the potential to be a novel avenue to greatly improve asthma control in this high-risk patient group.

Detailed Description

Uncontrolled asthma disproportionally impacts Black and poor adults. Adherence to inhaled corticosteroids (ICS), which plays a significant role in asthma control, is relatively low in poor and minority populations. Non-adherence to ICS is associated with erroneous personal health beliefs regarding asthma care and with negative beliefs regarding ICS. Despite this, no intervention concurrently addresses beliefs regarding asthma self-care and ICS. Shared decision-making interventions have not been tested in underserved Black adults, despite this model's success in pediatric populations and in White, privately insured patients with asthma. Federally Qualified Health Centers (FQHCs) have unique challenges to helping patients achieve asthma control but are overlooked in asthma intervention research. Process evaluations are often lacking during intervention development. We will address these treatment and methodological gaps.

Objectives: This pilot study will (1) develop a brief shared decision-making intervention delivered by primary care providers (PCPs) to improve asthma control in Black adults receiving care in FQHCs; (2) evaluate the intervention's feasibility and acceptability; and (3) assess preliminary evidence of intervention effects on asthma control, ICS adherence, forced expiratory volume in one second (FEV1) - an objective lung function measure - and asthma quality of life (QOL) over a 3-month follow-up period.

Hypotheses: (1) The intervention will be feasible and acceptable, and (2) over 3 months, relative to controls, patients whose PCPs are trained in the intervention will have significant improvement on asthma control (primary outcome), ICS adherence, FEV1 and asthma QOL (secondary outcomes).

Methods: Using community-based participatory research and including a Patient Advocate, we will develop the intervention, Brief Evaluation of Asthma Therapy (BREATHE). Intervention development is guided by patient and family/support persons of asthma patients input, as well as PCP feedback. We will then conduct a randomized trial of the intervention with 8 PCPs from 2 FQHCs in Philadelphia, PA; for each PCP we will enroll 10 Black adults (N=80) with uncontrolled asthma, and with erroneous asthma care beliefs and negative ICS beliefs. PCPs will be randomized within FQHC to intervention and control; patients will be followed for 3 months. Process evaluation interviews with patients and PCPs will obtain feedback regarding intervention procedures.

Significance: This study has high public health significance because it (1) targets a highly vulnerable population for poor asthma control - Black poor adults with erroneous asthma care beliefs and with negative ICS beliefs; (2) adapts a model-based intervention to develop a novel intervention delivered by PCPs that simultaneously targets erroneous asthma beliefs and negative ICS beliefs, and which has the potential to amplify intervention effects and increase the likelihood of sustainability; and (3) includes a process evaluation, bridging the gap between science and practice, and aiding in the design of a full-scale randomized controlled trial (RCT).

Conditions

Asthma Chronic; Health Behavior

Keywords

health disparity; motivational interviewing; African American adults; Federally Qualified Health Centers; adherence; health beliefs; self-management; asthma control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

BREATHE

7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach

Group Type: EXPERIMENTAL

BREATHE

Intervention Type: BEHAVIORAL

Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.

Attention Control Condition

7-minute diet and exercise discussion

Group Type: ACTIVE_COMPARATOR

Attention Control Condition

Intervention Type: OTHER

PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.

Interventions

BREATHE

Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.

Intervention Type: BEHAVIORAL

Attention Control Condition

PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.

Intervention Type: OTHER

Other Intervention Names

Shared decision-making using motivational interviewing

Eligibility Criteria

Inclusion Criteria

• Adult patients with persistent asthma or loved ones of adult patients with persistent asthma (prescribed ICS regardless of whether they are using ICS or not) receiving care at the participating FQHCs

Patients must be:

1. Adults (18 years of age or older)

2. PCP-diagnosed persistent asthma

3. Currently prescribed ICS

4. Receiving asthma care at participating FQHCs

5. Who screen positive for uncontrolled asthma

6. Have erroneous personal health and/or negative ICS beliefs

Exclusion Criteria

• Patients with persistent asthma or loved ones of patients with persistent asthma under they age of 18 OR NOT prescribed ICS or NOT receiving care at the participating FQHCs

1. Participation in focus groups during the development phase

2. Non-English speaking

3. Serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or confound analyses

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Maureen George

Associate Professor of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen George, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Spectrum Health Services

Philadelphia, Pennsylvania, United States

Greater Philadelphia Health Action

Philadelphia, Pennsylvania, United States

Countries

United States

References

George M, Arcia A, Chung A, Coleman D, Bruzzese JM. African Americans Want a Focus on Shared Decision-Making in Asthma Adherence Interventions. Patient. 2020 Feb;13(1):71-81. doi: 10.1007/s40271-019-00382-x.

Reference Type: BACKGROUND

PMID: 31414396 (View on PubMed)

George M, Pantalon MV, Sommers MLS, Glanz K, Jia H, Chung A, Norful AA, Poghosyan L, Coleman D, Bruzzese JM. Shared decision-making in the BREATHE asthma intervention trial: A research protocol. J Adv Nurs. 2019 Apr;75(4):876-887. doi: 10.1111/jan.13916. Epub 2019 Jan 24.

Reference Type: DERIVED

PMID: 30479020 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR0605

Identifier Type: -

Identifier Source: org_study_id