Design and implementation of a social cognitive theory-based medication adherence coaching intervention

基于社会认知理论的药物依从性辅导干预的设计与实施

• 批准号: 10644251
• 负责人: Benyam Muluneh
• 金额: $ 19.39万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10644251
• 关键词: Academic Medical Centers; Address; Adherence; Administrator; Adverse effects; Agreement; Antineoplastic Agents; Attitude; Award; Behavior; Behavioral; Cancer Center; Cancer Patient; Cardiology; Caring; Charge; Clinic; Clinical; Clinical Oncology; Clinical Pharmacists; Clinical Trials; Cognition; Cognitive; Communicable Diseases; Complex; Data; Drops; Education; Effectiveness; Effectiveness of Interventions; Environment; Equity; Evaluation; Face; Faculty; Focus Groups; Funding; Future; Goals; Grant; Health Promotion; Health behavior; Healthcare; Home; Hospital Administrators; Hybrids; Institution; Intervention; Interview; K-Series Research Career Programs; Knowledge; Malignant Neoplasms; Mentors; Mentorship; Methods; Modeling; National Cancer Institute; Needs Assessment; Nurses; Oncologist; Oncology; Oncolytic; Oral; Outcome; Patient Education; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Phase; Primary Care; Publishing; Randomized; Recommendation; Research; Research Personnel; Research Project Grants; Resources; Rural; Self Efficacy; Social support; Structure; Surveys; Testing; Training; Translating; United States National Institutes of Health; Urban Community; acceptability and feasibility; adherence rate; anti-cancer; behavior influence; cancer care; cancer therapy; career; chronic leukemia; clinical practice; community center; cost; design; effectiveness evaluation; effectiveness outcome; effectiveness/implementation design; effectiveness/implementation study; expectation; experience; health care service utilization; implementation evaluation; implementation outcomes; implementation science; improved; interest; intervention mapping; intervention refinement; medication compliance; patient oriented; post implementation; programs; rural setting; satisfaction; side effect; skill acquisition; skills; social cognitive theory; socioeconomics; success; symptom management; theories; therapy design; translational potential; urban setting

ABSTRACT Dr. Benyam Muluneh’s long-term career goal is to become a leading clinician-researcher in oncology by leveraging health behavior theories and implementation science methods to promote adherence, access, and equitable cancer care. This K08 Mentored Research Career Development award (PAR-21-299) is an initial step toward developing his research program as an NIH-funded independent investigator; with this award, he will follow a structured plan, receive expert mentorship, and conduct research in an ideal environment. Oral anticancer (OAC) agents revolutionized treatment of once-fatal malignancies by extending survival and delaying progression; however, success often requires a medication adherence rate >90%. Medication adherence drops from >80-90% in clinical trials (where patients receive adherence support, proactive symptom management, and the study drug is provided free of charge) to ~40% in clinical practice, compromising clinical outcomes. The National Cancer Institute (NCI) recommends cancer centers design and implement health promotion programs (e.g. adherence interventions) guided by health behavior theories, models, and frameworks. Most published adherence interventions lack NCI’s theory-guided approach: they address known barriers (eg. patient education and symptom management) without addressing critical moderators of health behavior (eg. social support, self- efficacy), compromising effectiveness and long-term sustainability. Additionally, many of the existing interventions were piloted in well-resourced academic medical centers and were not adapted to rural and underserved settings. Our team piloted an adherence coaching intervention—consisting of tailored education and barrier mitigation—which increased adherence rates from 48% to 60% in chronic leukemia patients; however, similar to other adherence programs designed by clinicians, our intervention was not optimally effective (adherence <90%) or sustainable beyond the pilot phase. The objective of this proposed study is to enhance the effectiveness and sustainability of our adherence coaching intervention in both urban/academic and rural setting, by integrating social cognitive theory (SCT)—a proven behavioral theory that conceptualizes health behavior through cognitive, environmental, and behavioral influences —with a well-tested planning framework called intervention mapping (IM). We will identify cognitive, behavioral, and environmental determinants of adherence to OACs in both academic/urban and rural settings (aim 1); conduct focus group discussions to adapt our adherence coaching intervention for local contexts (aim 2); and test the refined adherence coaching intervention in a Type I Hybrid Effectiveness-Implementation study (aim 3). Through the following training objectives, Dr. Muluneh will acquire the skills to complete the research aims: gain training and experience in intervention design using health behavior theories (objective 1); gain training and experience designing effectiveness-implementation studies (objective 2); prepare and submit an R01 grant based on findings from the proposed K08 award (objective 3); and gain professional development skills necessary for a successful faculty career (objective 4). This foundational knowledge is necessary to implement and widely disseminate interventions to improve medication adherence in oncology clinical settings.

抽象的 Benyam Muluneh博士的长期职业目标是通过利用健康来成为肿瘤学领先的临床研究者 行为理论和实施科学方法，以促进依从性，获取和公平的癌症护理。这个K08 指导研究职业发展奖（PAR-21-299）是朝着开发其研究计划的第一步 NIH资助的独立研究员；有了这个奖项，他将遵循结构化计划，获得专家的精神制，并 在理想环境中进行研究。口服抗癌（OAC）特工彻底改变了曾经致命的治疗 通过扩展生存和延迟进展来恶性；但是，成功通常需要药物依从性 速率> 90％。在临床试验中，药物依从性从> 80-90％下降（患者获得依从性支持， 在临床实践中，主动症状管理和研究药物是免费提供的，至40％， 损害临床结果。国家癌症研究所（NCI）建议癌症中心的设计和实施 健康行为理论，模型和框架指导的健康促进计划（例如依从性干预措施）。 大多数发表的依从性干预措施都缺乏NCI的理论引导方法：它们解决已知障碍（例如患者 教育和症状管理）不解决健康行为的关键主持人（例如，社会支持，自我支持 有效性），妥协有效性和长期可持续性。此外，许多现有干预措施是 在资源丰富的学术医疗中心驾驶，不适合粗糙和服务不足的环境。我们的团队 驾驶依从性教练干预（对量身定制的教育和缓解障碍的措施）提高了 慢性白血病患者的依从率从48％至60％；但是，类似于设计的其他咨询计划 在临床医生的情况下，我们的干预措施在试点阶段之外没有最佳有效（依从性<90％）或可持续性。这 这项拟议的研究的目的是提高我们遵守教练干预的有效性和可持续性 在城市/学术和粗糙环境中，通过整合社会认知理论（SCT），这是一种公认​​的行为理论 通过认知，环境和行为影响概念化健康行为，并进行了经过良好测试的计划 框架称为干预映射（IM）。我们将确定的认知，行为和环境决定者 在学术/城市和粗糙环境中遵守OAC（AIM 1）；进行焦点小组讨论以适应我们的 遵守当地环境的教练干预（AIM 2）；并测试一种类型的精致依从性教练干预 I混合有效性实施研究（AIM 3）。通过以下培训目标，Muluneh博士将 获得完成研究目的的技能：使用健康行为获得干预设计方面的培训和经验 理论（目标1）；获得培训和设计有效实施研究的经验（目标2）；准备 并根据拟议的K08奖项（目标3）的调查结果提交R01赠款；并获得专业 成功的教师职业所需的发展技能（目标4）。这种基本知识对于 实施并广泛传播干预措施，以改善肿瘤学临床环境中的药物依从性。