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临床试验/NCT05876325
NCT05876325已完成不适用

Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families

Jean Edward2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Change in Total Financial Toxicity

研究概览

简要总结

The overall objective of this study was to develop and evaluate FINassist (Financial and Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology financial and legal navigation program. The program leverages Medical Legal Partnerships to enhance cost of care conversations with pediatric oncology patients and caregivers. FINassist optimizes the team-based care model by integrating clinicians, social workers, financial navigators, and legal advocates who work in tandem to enhance cost of care conversations with patients and caregivers, identify and intervene on patient socio-legal needs, and advocate for system-level changes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Caregivers of patients who have any cancer or hematologic disorder diagnosis at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
  • Patients with childhood cancers and/or hematologic disorders at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
  • 18 years and older

排除标准

  • Unable to provide consent

结局指标

主要结局

Change in Total Financial Toxicity

时间窗: Baseline and post intervention, approximately 12 weeks

Measured using the COmprehensive Score for financial Toxicity (COST) tool, a measure that describes the financial distress experienced by cancer patients. Scores range from 0-44 with a higher score representing better financial well-being.

Change in Participant Quality of Life (Depression)

时间窗: Baseline and post intervention, approximately 12 weeks

Measured using the 6-item Patient-Reported Outcomes Measurement Information System PROMIS® Depression Short Form. Scores range from 6 to 30. Higher scores indicate more of the construct being measured.

Number of participants enrolled

时间窗: 12 months

Feasibility was defined as 60% or higher enrolled participant retention and resolution of financial or legal issue (based on existing oncology financial navigation studies)

Change in PROMIS Parent Proxy Pain Interference

时间窗: Baseline and post intervention, approximately 12 weeks

used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.

FINassist Adherence

时间窗: through issue resolution up to 12 months

Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution

Resolution of Socio-legal Issue

时间窗: 12 months

Number of participants that resolved a legal or financial case as a result of FINassist

Change in PROMIS Parent Proxy Global Health

时间窗: Baseline and post intervention, approximately 12 weeks

used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Overall evaluation of physical, mental health, and social health.

FINassist Acceptability assessed by 5-item survey

时间窗: Post intervention at 12 months

Acceptability is measured using a 5 item post-intervention survey of relevance, helpfulness, convenience, recommendation to others, and value. Ratings on a scale from 0 to 10 where a higher score means greater acceptability

Change in Participant Quality of Life (physical and mental)

时间窗: Baseline and post intervention, approximately 12 weeks

Measured using the 10-item PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Global Health scale. A 7-item summary assessment of a child's self-reported health with higher scores representing better quality of life. Values range from 7-35, with higher scores representing better health.

Change in Patient-Provider Trust

时间窗: Baseline and post intervention, approximately 12 weeks

Measured using the the Health Care Relationship (HCR) Trust Scale. The HCR-Trust scale is scored from 0 to 4 with a maximum score of 52. Higher scores represent more trust in healthcare providers

FINassist Retention

时间窗: through study completion up to 12 months

percentage of participants that complete both pre and post-intervention surveys

Change in Participant Quality of Life (Anxiety)

时间窗: Baseline and post intervention, approximately 12 weeks

Measured using the 4-item Patient-Reported Outcomes Measurement Information System PROMIS® Anxiety short form. Scores range from 4 to 20. Higher scores indicate more of the construct being measured.

Change in PROMIS Parent Proxy Fatigue

时间窗: Baseline and post intervention, approximately 12 weeks

used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion.

次要结局

  • Number of Participants Receiving Financial Benefit(12 months)

研究者

发起方
Jean Edward
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean Edward

Associate Professor

University of Kentucky

研究点 (2)

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