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

双元干预改善异基因造血细胞移植后患者家属护理人员团队管理的医疗方案

• 批准号: 10656500
• 负责人: DONNA M POSLUSZNY
• 金额: $ 35.64万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10656500
• 关键词: Address; Adherence; Allogenic; Attention; Cancer Patient; Caregiver well-being; Case Series; Cells; Clinic; Clinical; Clinical Treatment; Comparison arm; Complex; Data; Emotional; Engraftment; Event; Evidence based intervention; Family Caregiver; Feasibility Studies; Feedback; Focus Groups; Health; Health Professional; Healthcare; Hematologic Neoplasms; Hematological Disease; Home; Homologous Transplantation; Hospitals; Inpatients; Intervention; Joints; Life; Literature; Malignant Neoplasms; Medical; Methods; Modification; Morbidity - disease rate; Outcome; Outcome Assessment; Outcome Study; Patients; Perception; Personal Satisfaction; Problem Solving; Procedures; Process; Provider; Qualitative Methods; Randomized; Randomized, Controlled Trials; Regimen; Research; Risk; Role; Self Efficacy; Self Management; Series; Site; Testing; Therapeutic Intervention; Time; Transplant Recipients; Treatment Efficacy; Videoconferencing; Well in self; Work; acceptability and feasibility; arm; cancer therapy; cost; efficacy evaluation; follow-up; graft failure; graft vs host disease; health care service utilization; health management; health related quality of life; hematopoietic cell transplantation; high risk; improved; individual patient; infection risk; innovation; intervention participants; intervention refinement; mortality; novel; post intervention; preference; primary outcome; problem solving therapy; programs; secondary outcome; success; treatment as usual; usability; user centered design

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.

摘要 异基因造血细胞移植(HCT)是一种挽救患者生命的治疗方法 血液病。鉴于发病和死亡的高风险，它也是最能改变生活的疗法之一。 死亡率，并且需要投入大量的金钱、时间和精力。在长期住院后 最初成功植入健康细胞后，患者必须回家，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，以降低感染和其他疾病的风险 对长期治疗成功的威胁。患者和家属照顾者对方案的坚持， 然而，这是一个重大的临床问题。帮助患者及其家属的循证干预 照顾者共同应对HCT后方案的许多挑战是迫切需要的，但已经 几乎没有受到研究的关注。为了满足这一需求，我们开发了一种二元问题解决疗法。 (DPST-HCT)干预以帮助HCT患者及其家庭照顾者管理HCT后的医疗 作为一个团队的养生法。计划中的研究将采用定性和定量相结合的方法 方法在以用户为中心的设计方法中迭代，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，并将患者、家属 护理人员和医疗保健专业人员对医疗管理挑战和 干预行动。在第二阶段，我们将对少数患者家属进行交互干预 照顾者二人组，导致最终的干预。在第三阶段，我们将评估DPST的最终版本- 在一项单部位随机对照试验中，确定可接受性、可行性和有效性。我们会 将104例新移植的同种异体HCT患者-家庭照顾者二元组(N=208)随机分配到DPST-HCT ARM或增强型普通护理比较组，并在1、5、12和24周后评估研究结果 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 干预效果对主要结果的初步检验(二元团队管理：依从性和自我 疗效)和次要结果(患者和家庭照顾者幸福感、感知健康、与健康相关 生活质量、患者临床事件和患者健康护理利用。预期结果将提供进一步的 支持以团队为基础的二元方法来管理HCT后的医疗方案，并将其作为基础 用于多站点RCT以测试DPST-HCT。