Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.
J Palliat Med. 2019 Sep;22(S1):20-33. doi: 10.1089/jpm.2019.0116.
As health care systems strive to meet the growing needs of seriously ill patients with high symptom burden and functional limitations, they need evidence about how best to deliver home-based palliative care (HBPC). We compare a standard HBPC model that includes routine home visits by nurses and prescribing clinicians with a tech-supported model that aims to promote timely interprofessional team coordination using video consultation with the prescribing clinician while the nurse is in the patient's home. We hypothesize that tech-supported HBPC will be no worse compared with standard HBPC. This study is a pragmatic, cluster randomized noninferiority trial conducted across 14 Kaiser Permanente sites in Southern California and the Pacific Northwest. Registered nurses ( = 102) were randomized to the two models so that approximately half of the participating patient-caregiver dyads will be in each study arm. Adult English or Spanish-speaking patients (estimate 10,000) with any serious illness and a survival prognosis of 1-2 years and their caregivers (estimate 4800) are being recruited to the HomePal study over ∼2.5 years. The primary patient outcomes are symptom improvement at one month and days spent at home. The primary caregiver outcome is perception of preparedness for caregiving. During implementation we had to balance the rigors of conducting a clinical trial with pragmatic realities to ensure responsiveness to culture, structures, workforce, workflows of existing programs across multiple sites, and emerging policy and regulatory changes. We built close partnerships with stakeholders across multiple representative groups to define the comparators, prioritize and refine measures and study conduct, and optimize rigor in our analytical approaches. We have also incorporated extensive fidelity monitoring, mixed-method implementation evaluations, and early planning for dissemination to anticipate and address challenges longitudinally. Trial Registration: ClinicalTrials.gov: NCT#03694431.
随着医疗保健系统努力满足患有严重疾病、症状负担和功能限制的重病患者不断增长的需求，它们需要有关如何最好地提供家庭姑息治疗（HBPC）的证据。我们比较了一种标准的 HBPC 模式，该模式包括护士和处方临床医生的常规家访，以及一种技术支持的模式，该模式旨在通过与处方临床医生的视频咨询来促进护士在患者家中时的及时跨专业团队协调。我们假设技术支持的 HBPC 不会比标准 HBPC 差。 这项研究是一项在加利福尼亚南部和太平洋西北部的 14 个 Kaiser Permanente 站点进行的实用、集群随机非劣效性试验。注册护士（ = 102）被随机分配到两种模式，以便大约一半的参与患者-护理人员对在每个研究臂中。正在招募成年英语或西班牙语患者（估计为 10000 人），他们患有任何严重疾病，预计生存时间为 1-2 年，以及他们的护理人员（估计为 4800 人）参加 HomePal 研究，时间约为 2.5 年。主要的患者结局是一个月时症状改善和在家中度过的天数。主要的护理人员结局是对护理准备情况的感知。 在实施过程中，我们必须平衡进行临床试验的严格性和务实的现实，以确保对多个站点的现有计划的文化、结构、劳动力和工作流程以及新兴的政策和监管变化做出响应。我们与多个代表性群体的利益相关者建立了密切的伙伴关系，以定义比较器、确定和改进措施和研究实施，并优化我们分析方法的严谨性。我们还纳入了广泛的保真度监测、混合方法实施评估以及早期传播计划，以纵向预测和解决挑战。 试验注册：ClinicalTrials.gov：NCT#03694431。
