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成为肿瘤学领域领先的临床医生研究员 行为理论的实施和科学方法，以促进依从性、可及性和公平的癌症护理。 指导研究职业发展奖（PAR-21-299）是他将研究项目发展为以下目标的第一步： 获得美国国立卫生研究院 (NIH) 资助的独立研究员；获得该奖项后，他将遵循结构化计划，接受专家指导，并 在理想的环境中进行研究，口服抗癌（OAC）药物彻底改变了曾经致命的治疗方法。 通过延长生存期和延缓进展来治疗恶性肿瘤；然而，成功通常需要坚持用药 临床试验中药物依从性从 >80-90% 下降（患者接受依从性支持， 主动症状管理，并且免费提供研究药物）在临床实践中约占 40%， 美国国家癌症研究所 (NCI) 建议癌症中心设计和实施。 以健康行为理论、模型和框架为指导的健康计划推广（例如依从性干预措施）。 大多数已发表的依从性干预措施缺乏 NCI 的理论指导方法：它们解决了已知的障碍（例如， 教育和症状管理），但没有解决健康行为的关键调节因素（例如社会支持、自我 此外，许多现有的干预措施都受到影响。 在资源丰富的学术医疗中心进行试点，不适合农村和服务不足的环境。 试点了依从性指导干预措施——包括量身定制的教育和缓解障碍——这增加了 然而，与其他设计的依从性计划类似，慢性白血病患者的这一比例为 48% 至 60%； 圣人说，我们的干预措施在试点阶段后并没有达到最佳效果（依从性<90%）或可持续。 这项拟议研究的目的是提高我们的依从性辅导干预的有效性和可持续性 在城市/学术和农村环境中，通过整合社会认知理论（SCT）——一种经过验证的行为理论， 通过认知、环境和行为影响，通过经过充分测试的规划来概念化健康行为 我们将识别认知、行为和环境决定因素。 在学术/城市和农村环境中遵守 OAC（目标 1）；进行焦点小组讨论以适应我们的要求； 针对当地情况的辅导干预（目标 2）；并在类型依从性辅导干预中测试精细的依从性辅导干预 I 混合有效性-实施研究（目标 3）。 Muluneh 博士将通过以下培训目标。 获得完成研究目标的技能：获得利用健康行为进行干预设计的培训和经验 理论（目标 1）；获得设计有效性实施研究（目标 2）的培训和经验； 并根据拟议的 K08 奖项的调查结果提交 R01 补助金（目标 3）并获得专业知识； 成功的教师职业所需的发展技能（目标 4）。 实施并广泛传播干预措施，以提高肿瘤临床环境中的药物依从性。