Maureen George1, Michael V Pantalon2, Marilyn Lynn S Sommers3, Karen Glanz4, Haomiao Jia5, Annie Chung6, Allison A Norful7, Lusine Poghosyan1, Danielle Coleman1, Jean-Marie Bruzzese1. 1. Columbia University School of Nursing, New York, New York. 2. Department of Emergency Medicine, Yale University School of Medicine, New Haven, Connecticut. 3. School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania. 4. Perelman School of Medicine and School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania. 5. School of Nursing and Mailman School of Public Health, Columbia University, New York, New York. 6. Center for Health Behavior Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 7. Columbia University School of Nursing, CUMC Irving Institute for Clinical and Translational Research, New York, New York.
Abstract
AIM: To evaluate the preliminary effectiveness of the BRief Evaluation of Asthma THerapy 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.
RCT Entities:
AIM: To evaluate the preliminary effectiveness of the BRief Evaluation of Asthma THerapy 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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