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.
目的: 为评估哮喘治疗干预简短评估的初步有效性,提出了该项由初级治疗人员提供并以动机访谈解决错误哮喘疾病和药物观念的7分钟共同决策提案。 设计: 多中心蒙面双臂分组随机临床试验。 方法: 国家护理研究所资助了(2016年9月)该项为期两年的试点研究。八个提供者被随机分配到两个部门:主动干预(N=4)或剂量匹配的注意力控制(N=4)。护理人员向10名患有不可控哮喘的黑人成年患者(N=80)提供随机分配到的干预。干预后三个月,患者接受随访,测试初步干预对哮喘控制(主要结果)和药物依从性、肺功能以及哮喘相关生活质量(次要结果)的影响。 讨论: 该研究将评估现实世界中一种新型共同决策干预的初步影响,作为一种改善手段,解决黑人成年患者以错误的疾病和药物观念哮喘控制的问题。 这些结果将为未来大规模随机试验提供足以进行干预有效性测试的参考。 影响: 共同决策是一种循证干预措施,实施于劳动和时间密集型研究提案,经证明为有效。服药依从性与贫困和少数成年哮喘患者的明显差异相关。正如所提议的,解决该问题需要一种新的多因素方法。为确保可持续性,共同决策干预必须适应并融入现实环境。试验注册:注册于clincialtrials.gov,为NCT03036267、NCT03300752。.
Keywords: asthma; community-based participatory research; health beliefs; minority; mixed methods; motivational interviewing; nursing; qualitative research; shared decision-making.
© 2018 John Wiley & Sons Ltd.