IMVR - Institute of Medical Sociology, Health Services Research and Rehabilitation Science (IMVR), University of Cologne, Cologne, Germany.
Institute of Health Economics and Clinical Epidemiology, University Hospital Cologne, Cologne, Germany.
BMJ Open. 2020 Mar 9;10(3):e034141. doi: 10.1136/bmjopen-2019-034141.
International standards of care require the complete integration of psycho-oncological care into biomedical cancer treatment. The structured integrated, cross-sectoral psycho-oncological programme 'isPO' is aiming to ensure a provision of care in inpatient and outpatient settings according to a stepped-care approach. Up to now, psycho-oncological care is missing regulated and standardised processes to demonstrate the effectiveness. This study protocol describes the process and outcome evaluation that is conducted, along with the isPO study. The programme evaluation is aiming to proof effectiveness, explain potential discrepancies between expected and observed outcomes. Additionally, provide insight into the implementation process, as well as contextual factors that might promote or inhibit the dissemination and implementation of the stepped care programme will be gained. In addition to these measures, a cost-consequence analysis will provide further evidence aimed at integrating psycho-oncological care into primary healthcare.
The evaluation concept is based on a tripartite strategy consisting of a prospective, formative and summative evaluation. To capture all determinants, a concurrent mixed-method design is applied comprising qualitative (interviews and focus groups) and quantitative (standardised questionnaires) surveys of patients and healthcare providers. In addition, analysis of the psycho-oncological care data (isPO care data) and statutory health insurance claims data will be conducted. Primary and secondary data will complement one another (data linkage) to obtain a more comprehensive picture of the effectiveness and implementation of the complex intervention within the isPO study.
The study has been approved by the ethics committee of the Medical Faculty of the University of Cologne. For all collected data, the relevant national and European data protection regulations will be considered. All personal identifiers (eg, name, date of birth) will be pseudonymised. Dissemination strategies include annual reports as well as quality workshops for the organisations, the presentation of results in publications and on conferences, and public relations.
DRKS00015326; Pre-results.
国际护理标准要求将心理肿瘤学护理完全纳入生物医学癌症治疗中。结构化的综合跨部门心理肿瘤学计划“isPO”旨在根据分级护理方法确保在住院和门诊环境中提供护理。到目前为止，心理肿瘤学护理缺乏经过监管和标准化的流程来证明其有效性。本研究方案描述了正在进行的过程和结果评估，以及 isPO 研究。该方案评估旨在证明有效性，解释预期结果与实际结果之间的潜在差异。此外，还将深入了解实施过程以及可能促进或抑制分级护理计划传播和实施的背景因素。除了这些措施之外，成本效益分析还将提供进一步的证据，旨在将心理肿瘤学护理纳入初级保健。
评估概念基于由前瞻性、形成性和总结性评估组成的三部分策略。为了捕获所有决定因素，应用了同时进行的混合方法设计，包括对患者和医疗保健提供者进行定性（访谈和焦点小组）和定量（标准化问卷）调查。此外，还将对心理肿瘤学护理数据（isPO 护理数据）和法定健康保险索赔数据进行分析。主要和次要数据将相互补充（数据链接），以更全面地了解 isPO 研究中复杂干预的有效性和实施情况。
该研究已获得科隆大学医学院伦理委员会的批准。对于所有收集的数据，将考虑相关的国家和欧洲数据保护法规。所有个人标识符（例如，姓名、出生日期）将被匿名化。传播策略包括年度报告以及为组织提供的质量研讨会、在出版物和会议上展示结果以及公共关系。
DRKS00015326；预结果。
