Lundstrøm Sanne Lykke, Kamstrup-Larsen Nina, Barrett Barbara Ann, Jørgensen Louise Marie Bidstrup, Hansen Solvej Skriver, Andersen John Sahl, Friderichsen Bolette, Stockmarr Anders, Frølich Anne
Innovation and Research Centre for Multimorbidity, Slagelse Hospital, Region Zealand, Slagelse, Denmark.
Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.
PLoS One. 2024 Dec 4;19(12):e0310697. doi: 10.1371/journal.pone.0310697. eCollection 2024.
Current care is inadequate for patients with complicated multimorbidity, and frequently results in fragmented care. There is no widely agreed-upon optimal organisation of healthcare services for this patient group. By drawing upon existing literature and prior studies, we developed a patient-centred complex intervention for multimorbidity (CIM) and subsequently refined it into CIM version 2 (CIM2). This paper describes the study protocol for a pilot cluster randomised control trail (RCT) evaluating the effectiveness of a general practice-based intervention.
CIM2 aims to support integrated care for patients with complicated multimorbidity. CIM2 comprises five elements: 1) Training healthcare professionals, 2) an extended overview consultation in general practice, 3) a nurse care coordinator in general practice supporting the planning of the patient trajectory, 4) follow-up care services in general practice, and 5) improving the integration of care between general practice, municipality, and hospital. The pilot cluster RCT involve 350 patients with complicated multimorbidity across 14 general practices in Region Zealand and The Capital Region of Denmark. Patients are randomly assigned to either the intervention group or the usual care group. The primary outcome measure is the patients experience of quality of care measured by the Patient Assessment Chronic Illness Care Questionnaire (PACIC). Secondary outcomes include the patient's health-related quality of life, measured by the EuroQol-5 Domain questionnaire (EQ-5D-5L) and the treatment burden measured by the Multimorbidity Treatment Burden Questionnaire (MTBQ). Data on chronic conditions, healthcare utilization, and demographic information such as sex, age, and educational attainment will be collected from national registries. The outcome measures will be recorded before, during, and after implementing the intervention. Qualitative evaluation will include semi-structured interviews with healthcare professionals across various sectors as well as patients. The cost-effectiveness and Incremental Cost Effectiveness Ratio (ICER) of the CIM2 will be assessed using Diagnose Related Group rates.
ClinicalTrials.gov Identifier: NCT05406193. https://clinicaltrials.gov/study/NCT05406193.
目前针对患有复杂多种慢性病的患者的护理并不充分，且常常导致护理碎片化。对于这一患者群体，尚无广泛认可的最佳医疗服务组织方式。通过借鉴现有文献和先前研究，我们开发了一种以患者为中心的复杂慢性病干预措施（CIM），随后将其完善为CIM版本2（CIM2）。本文描述了一项试点整群随机对照试验（RCT）的研究方案，该试验旨在评估基于全科医疗的干预措施的有效性。
CIM2旨在支持对患有复杂多种慢性病的患者进行综合护理。CIM2包含五个要素：1）培训医疗保健专业人员；2）在全科医疗中进行扩展的概述咨询；3）全科医疗中的护士护理协调员，支持患者诊疗轨迹的规划；4）全科医疗中的后续护理服务；5）改善全科医疗、市政当局和医院之间的护理整合。该试点整群随机对照试验涉及丹麦西兰岛地区和首都地区14家全科医疗诊所的350名患有复杂多种慢性病的患者。患者被随机分配到干预组或常规护理组。主要结局指标是通过患者慢性疾病护理评估问卷（PACIC）测量的患者护理质量体验。次要结局包括通过欧洲五维健康量表问卷（EQ-5D-5L）测量的患者健康相关生活质量，以及通过多种慢性病治疗负担问卷（MTBQ）测量的治疗负担。有关慢性病、医疗保健利用情况以及性别、年龄和教育程度等人口统计学信息的数据将从国家登记处收集。结局指标将在实施干预之前、期间和之后进行记录。定性评估将包括对各个部门的医疗保健专业人员以及患者进行半结构化访谈。CIM2的成本效益和增量成本效益比（ICER）将使用诊断相关组费率进行评估。
ClinicalTrials.gov标识符：NCT05406193。https://clinicaltrials.gov/study/NCT05406193。
