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临床试验/NCT03057639
NCT03057639终止不适用

Adolescent and Young Adult (AYA) Cancers Clinical Model: An Evaluation of the AYA Clinical Care Model by Assessment of Clinical, Psychosocial, and Health Economic Factors Related to AYA Patient Outcomes

University of Southern California1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2017年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
76
试验地点
1
主要终点
Clinical care model impact on patient's/health care professional's satisfaction with the AYA at USC program as assessed by questionnaires (LAC+USC)

研究概览

简要总结

This research trial studies the Adolescent and Young Adult (AYA) Cancers Clinical Model in evaluating clinical, psychosocial, and health economic factors in adolescent and young adult patients with cancer. Studying the Adolescent and Young Adult Cancers Clinical Model may help doctors learn more about the effect of the AYA services on patient care, including clinical (nurse navigation), psychosocial (social work), and economic (financial) areas.

详细描述

PRIMARY OBJECTIVES:

I. To provide economic understanding of the AYA at University of Southern California (USC) model of care. (Norris)

II. To evaluate the existing AYA at USC program to determine the direct and indirect impact on cost of care. (Norris)

III. To utilize the results of objective (i) to identify cost effectiveness and efficiencies to patient and institution. (Norris)

IV. To identify specific processes within our model of care that can be improved. (Norris)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
15 Years 至 39 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with cancer
  • ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - UNIHEALTH (NORRIS):
  • Patients who were diagnosed at USC Norris Comprehensive Cancer Center and Hospital
  • Patients who are currently receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
  • ADDITIONAL GRANT SPECIFIC INCLUSION CRITERIA - QUEENSCARE (LAC + USC):
  • Patients who are being seen in sarcoma, gynecologic oncology, or genitourinary clinic at LAC + USC (clinics A2C or 4P1)
  • Patients who are currently receiving treatment for a primary or secondary tumor at LAC + USC and who receive oncology care from one of the clinics above
  • Patients who are at or below the poverty level

排除标准

  • Inability to sign informed assent and/or consent
  • Patients who are not receiving chemotherapy and/or radiation therapy for a primary or secondary tumor
  • Primary oncology treatment team believes that participation in AYA at USC would not benefit their patient
  • ADDITIONAL GRANT SPECIFIC EXCLUSION CRITERIA - UNIHEALTH (NORRIS):
  • Patients who are not receiving treatment for a primary or secondary tumor at USC Norris Comprehensive Cancer Center and Hospital
  • ADDITIONAL GRANT SPECIFIC EXCLUSION CRITERIA - QUEENSCARE (LAC+USC):
  • Patients who are not receiving oncology care for a primary or secondary tumor in sarcoma, gynecologic oncology, or genitourinary clinic at LAC + USC (clinics A2C or 4P1)
  • Patients who are above the poverty level

结局指标

主要结局

Clinical care model impact on patient's/health care professional's satisfaction with the AYA at USC program as assessed by questionnaires (LAC+USC)

时间窗: Up to 2 years

Questionnaire scores will be expressed as median values with 95% confidence intervals.

Processes that can be improved (Norris)

时间窗: Up to 2 years

Will utilize the prospective data to estimate key aspects of the AYA at USC service. Any variances in the services over time will be utilized to improve quality and reliability care delivery.

Cost of care (Norris)

时间窗: Up to 2 years

Direct health care costs analyses will be performed from the Total Costs of Care payer perspective. Direct cost will be estimated from paid claims in the extracted electronic medical records, which will include costs for all health care utilization such as outpatient, procedures, laboratory, emergency room visits, hospitalization, and pharmacy. As the healthcare utilization and costs will likely be extremely skewed, healthcare utilization and cost measures will be estimated by using an econometric model (e.g., a negative binomial regression model for utilization count data \[number of services

Incremental cost (Norris)

时间窗: Up to 2 years

The incremental cost between AYA enrolled and non-enrolled will be calculated. In addition to estimation the magnitude of the variability attributed to the different sources of variation, we will also generate an influence diagram (also known as tornado diagram) to display which variables exert the most influence on cost driver.

Clinical care model impact on patient access to AYA specific supportive care as assessed by questionnaires (Norris)

时间窗: Up to 2 years

Questionnaire scores will be expressed as median values with 95% confidence intervals.

次要结局

  • Satisfaction of health care staff as assessed by questionnaires (LAC+USC)(Up to 2 years)
  • Care coordination as assessed by the mean number of supportive care referrals, telephone or email encounters for additional information, educational materials, and or additional interventions provided by the nurse navigator and/or social worker (LAC+USC)(Up to 2 years)
  • Resource allocation as assessed by the mean number of supportive care referrals and per patient follow-up conducted by the nurse navigator and/or social worker (LAC+USC)(Up to 2 years)
  • Patient continuity of care as assessed by the mean number of visits per patient with the assigned clinic lead physician (LAC+USC)(Up to 2 years)
  • Satisfaction of services as assessed by questionnaires (LAC+USC)(Up to 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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