Dyadic Intervention to Improve Patient-Family Caregiver Team-Based Management of the Medical Regimen after Allogenetic Hematopoietic Cell Transplantation

摘要 异基因造血细胞移植（HCT）可以挽救患者的生命， 血液病它也是最改变生活的治疗方法之一，因为发病率高， 死亡率，并需要大量的金钱，时间和努力的承诺。在长期住院后， 并初步成功植入健康细胞后，患者返回家中，在那里他们必须遵循 复杂的医疗方案，需要家庭照顾者的帮助，以减少他们的感染风险和其他 长期治疗成功的威胁。患者和家庭护理者对治疗方案的依从性， 然而，这是一个重要临床问题。循证干预，以帮助患者及其家人 护理人员一起管理HCT后方案的许多挑战是迫切需要的，但 很少受到研究关注。为了满足这种需求，我们开发了一种二元问题解决疗法 （DPST-HCT）干预，以帮助HCT患者及其家庭护理人员管理HCT后医疗 作为一个团队，计划中的研究将采用定性和定量相结合的方法。 在以用户为中心的设计方法中迭代方法，以改进干预并提供证据， 可接受性、可行性和有效性。在第一阶段，我们将进行焦点小组讨论， 护理人员和医疗保健专业人员对医疗管理挑战和 干预。在第二阶段，我们将与少数患者家庭一起完善干预措施 护理人员成对，最终完成干预。在第三阶段，我们将评估DPST的最终版本- 单中心随机对照试验中的HCT，以确定可接受性、可行性和有效性。我们将 将104例新移植的同种异体HCT患者-家庭护理者配对（N=208）随机分配至DPST-HCT组 组或增强型泌尿外科护理比较组，并评估研究后1周、5周、12周和24周的研究结局。 干预完成。我们将（a）确定过程考虑因素（可接受性、可行性）;（B）提供 对主要结果的干预效果的初步测试（基于二元团队的管理：坚持和自我， 疗效）和次要结局（患者和家庭护理者的幸福感、自觉健康、健康相关 生活质量、患者临床事件和患者医疗保健利用。预期结果将进一步提供 支持基于双元团队的方法来进行HCT后医疗方案管理，并作为基础 进行多中心随机对照试验以检测DPST-HCT。

ABSTRACT Allogeneic hematopoietic cell transplantation (HCT) can be a lifesaving treatment for patients with hematologic disease. It is also one of the most life-altering treatments, given the high risks of morbidity and mortality, and requiring extensive commitments of money, time, and effort. Following a protracted inpatient stay and initial successful engraftment of healthy cells, patients return to their homes where they must follow a complex medical regimen that requires the help of a family caregiver to reduce their risk of infection and other threats to long term treatment success. Adherence to the regimen by the patient and family caregiver, however, is a significant clinical problem. Evidence-based interventions to help patients and their family caregivers manage the many challenges of the post-HCT regimen together are urgently needed but have received little research attention. To address this need, we have developed a dyadic problem-solving therapy (DPST-HCT) intervention to help HCT patients and their family caregivers manage the post-HCT medical regimen as a team. The planned research will make use of a combination of qualitative and quantitative methods iteratively within a user-centered design approach to refine the intervention and provide evidence of acceptability, feasibility, and efficacy. In Stage 1, we will conduct focus groups and incorporate patient, family caregiver, and health care professional feedback on medical management challenges and the usefulness of the intervention. In Stage 2, we will interatively refine the intervention with a small number of patient-family caregiver dyads, resulting in a finalized intervention. In Stage 3, we will evaluate the final version of the DPST- HCT in a single-site randomized controlled trial to determine acceptability, feasibility, and efficacy. We will randomize 104 newly transplanted allogeneic HCT patient-family caregiver dyads (N=208) to the DPST-HCT arm or Enhanced Usual Care comparison arm and assess study outcomes at 1-, 5-, 12-, and 24-weeks post- intervention completion. We will (a) determine process considerations (acceptability, feasibility); (b) provide an initial test of intervention efficacy on primary outcomes (dyadic team-based management: adherence and self- efficacy), and secondary outcomes (patient and family caregiver well-being, perceived health, health-related quality of life, patient clinical events, and patient health care utilization. Anticipated results will provide further support for a dyadic team-based approach to post HCT medical regimen management and serve as the basis for a multi-site RCT to test DPST-HCT.