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.

抽象的 同种异体造血细胞移植（HCT）可能是对患者的救生治疗 血液学疾病。鉴于发病率的高风险和 死亡率，需要大量的金钱，时间和努力。旷日持久的住院住宿 最初成功地植入了健康细胞，患者返回家园，必须遵循 需要家庭护理人员帮助降低感染风险和其他的复杂医疗方案 威胁长期治疗成功。遵守患者和家庭护理人员的方案， 但是，是一个重大的临床问题。基于证据的干预措施来帮助患者及其家人 护理人员迫切需要处理后HCT方案的许多挑战，但 很少受到研究的关注。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）干预措施，以帮助HCT患者及其家庭护理人员管理HCT后医疗 作为一个团队的方案。计划的研究将利用定性和定量的结合 在以用户为中心的设计方法中迭代的方法来完善干预措施，并提供证据 可接受性，可行性和功效。在第1阶段，我们将举办焦点小组并纳入患者，家庭 护理人员和医疗保健专业的反馈医疗管理挑战和有用性 干预。在第2阶段，我们将使用少量患者家庭的干预措施相对地完善干预措施 护理人员二元组，导致最终干预。在第3阶段，我们将评估DPST的最终版本 HCT在单点随机对照试验中，以确定可接受性，可行性和功效。我们将 随机化104新移植的同种异体HCT患者 - 家庭护理人员二元组（n = 208）到DPST-HCT 手臂或增强的常规护理比较组和评估研究结果在1、5、12和24周之后 干预完成。我们将（a）确定过程注意事项（可接受性，可行性）； （b）提供一个 初始结果的干预功效的初步测试（基于二元团队的管理：依从性和自我 功效）和次要结果（患者和家庭护理人员的健康，感知健康，与健康有关 生活质量，患者临床事件和患者医疗保健利用。预期的结果将进一步提供 支持基于二元团队的方法来发布HCT医疗方案管理并作为基础 用于多站点RCT测试DPST-HCT。