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Group‐randomized trial of tailored brief shared decision‐making to improve asthma control in urban black adults

Abstract

Aims

To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision‐making intervention and evaluate feasibility and acceptability of intervention procedures.

Design

Group‐randomized longitudinal pilot study.

Methods

In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose‐matched attention control intervention (N = 40). BREATHE is a one‐time shared decision‐making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3 months post‐intervention. Data were collected from December 2017 – May 2019 and included surveys, lung function tests, and interviews.

Results

Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1‐month and 3‐month follow‐up, only BREATHE participants had better asthma control at each timepoint (β = 0.77; standard error (SE)[0.17]; ≤ 0.0001; β = 0.71; SE[0.16]; ≤ 0.0001; β = 0.54; SE[0.15]; p = .0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision‐making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow‐up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs.

Conclusion

BREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision‐making in a health disparity population.

Impact

The study addressed the important problem of uncontrolled asthma in a high‐risk vulnerable population. Compared with the dose‐matched attention control condition, participants receiving the novel brief tailored shared decision‐making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision‐making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision‐making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination.

Trail registration

clinicaltrials.gov # NCT03300752.

Shared decision‐making in the BREATHE asthma intervention trial: A research protocol

Aim

To evaluate the preliminary effectiveness of the BRief Evaluation of Asthma TH erapy intervention, a 7‐min primary care provider‐delivered shared decision‐making protocol that uses motivational interviewing to address erroneous asthma disease and medication beliefs.

Design

A multi‐centre masked two‐arm group‐randomized clinical trial.

Methods

This 2‐year pilot study is funded (September 2016) by the National Institute of Nursing Research. Eight providers will be randomized to one of two arms: the active intervention (N = 4) or a dose‐matched attention control (N = 4). Providers will deliver the intervention to which they were randomized to 10 Black adult patients with uncontrolled asthma (N = 80). Patients will be followed three months postintervention to test the preliminary intervention effects on asthma control (primary outcome) and on medication adherence, lung function, and asthma‐related quality of life (secondary outcomes).

Discussion

This study will evaluate the preliminary impact of a novel shared decision‐making intervention delivered in a real world setting to address erroneous disease and medication beliefs as a means of improving asthma control in Black adults. Results will inform a future, large‐scale randomized trial with sufficient power to test the intervention's effectiveness.

Impact

Shared decision‐making is an evidence‐based intervention with proven effectiveness when implemented in the context of labour‐ and time‐intensive research protocols. Medication adherence is linked with the marked disparities evident in poor and minority adults with asthma. Addressing this requires a novel multifactorial approach as we have proposed. To ensure sustainability, shared decision‐making interventions must be adapted to and integrated into real‐world settings.

Trial registration: Registered at clincialtrials.gov as NCT03036267 and NCT03300752.

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