BREATHE: An Efficacy-implementation Trial of a Brief Shared Decision Making Intervention Among Black Adults With Uncontrolled Asthma in Federally Qualified Health Centers (Trial and Post-trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Mean Asthma Control Questionnaire Score
研究概览
简要总结
This study is an efficacy-implementation trial to:
- evaluate systematically the efficacy of BREATHE in 200 Black adults receiving care at urban federally qualified health centers (FQHCs) for uncontrolled asthma; and
- identify multi-level barriers and facilitators to the widespread adoption and implementation of BREATHE in FQHCs.
详细描述
Black adults with asthma are an appropriate target for shared decision-making (SDM) interventions that support disease self-management as Black adults experience a higher asthma burden and worse clinical outcomes than non-Black adults and/or children with asthma of any racial-ethnic background. To date, the application of SDM and community-based interventions targeting Black adults have failed to address these disparities. Therefore, the investigator used patient input to develop BREATHE - BRief intervention to Evaluate Asthma THErapy - a 9-minute SDM intervention focused on reducing the impact of erroneous beliefs on asthma control - and established its efficacy in this health disparity population. This intervention is unique in that it is a one-time brief, tailored intervention integrated into office visits, using the patient's own provider as the interventionist (e.g. scalable). A previously conducted pilot trial demonstrated high fidelity to BREATHE delivery and improved asthma control and reduced symptoms among BREATHE participants compared to a dose-matched attention control condition.
We will conduct post-trial mixed-method interviews with patient participants, their loved ones, and PCPs using evaluation frameworks to determine satisfaction with, and acceptability of, the active and control interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient participants, data collectors, and the statistician will be blinded to assignment. Consent materials will inform patient participants that the focus of the trial is on the communication they have with their clinician about asthma management and control. Immediately after the intervention, patient participants will be asked to guess the condition to which their clinician had been randomized. At the end of participants' final data collection visit, data collectors will be asked to guess whether participants had received the active or control intervention at the visit. These data will provide some measurement of the success of masking.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(participants):
- •Patients participants will
- •be adults (> or = 18 years of age)
- •self-report race as 'Black' race (African American, African, Caribbean, West Indian, multi-racial [Black AND one or more additional races]); identify their ethnicity as Hispanic OR non-Hispanic
- •have clinician-diagnosed persistent asthma (defined as being prescribed inhaled corticosteroids in the last 48 months) or have had an asthma exacerbation (e.g., ER visit, course of Prednisone) regardless of controller medicine use
- •receive asthma care at a partner FQHC and
- •screen positive for uncontrolled asthma as measured by the Asthma Control Questionnaire- 6 items (ACQ-6) and erroneous beliefs as measured by the Conventional and Alternative Management for Asthma (CAM-A) survey.
排除标准
- •(participants):
- •non-English speaking
- •serious mental health conditions that preclude completion of study procedures or confound analyses or
- •participation in a listening session
- •Inclusion Criterion (clinicians):
- •1. those who manage a panel of adult asthma patients
- •Inclusion Criteria (loved ones):
- •must be identified by patient participant as a loved one and
- •loved one must be a family member or friend of the patient participant.
- •Exclusion Criteria (loved ones):
- •non-English speaking or
- •serious mental health conditions that preclude completion of study procedures or confound analyses
研究组 & 干预措施
BREATHE intervention
The patient's primary care provider (PCP) will deliver a brief intervention using motivational interviewing and shared decision making, in a one time 9-minute intervention integrated into an office visit for asthma. PCPs will follow a 4-step script tailored to erroneous asthma and inhaled corticosteroid (ICS) beliefs, as well as ACQ score, measured just prior to the office visit.
干预措施: BREATHE Intervention (Behavioral)
Control Intervention
The patient's primary care provider (PCP) will deliver a 9-minute scripted intervention on credible nutrition and lifestyle information. The control intervention is designed to not be specific enough to change strategies related to asthma control.
干预措施: Control Intervention (Behavioral)
结局指标
主要结局
Mean Asthma Control Questionnaire Score
时间窗: Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention)
Asthma control as measured by improvements in Asthma Control Questionnaire (ACQ) score, a 6-item validated and widely used measure of asthma control. Each question is rated from 0 to 6. A score of 0 indicates well controlled asthma and a score of 6 indicates extremely poorly controlled asthma. The overall ACQ score is the mean score of all 6 items. Lower mean scores indicate greater asthma control, higher mean scores indicate lesser asthma control.
次要结局
- Mean Medication Adherence Report Scale - Asthma Score(Baseline, 1 month, 2 months, 3 months, 6 months, 9 months, 12 Months (post-intervention))
- Mean Asthma Quality of Life Questionnaire Score(Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention))
- Mean Asthma Impairment and Risk Questionnaire Score(Baseline, 1 month, 3 months, 6 months, 12 Months (post-intervention))
- Mean Shared Decision Making-Questionnaire-9 Score(Baseline (immediately post-intervention))
研究者
Maureen George
Professor of Nursing at the Columbia University Irving Medical Center
Columbia University