Automated Telephone Monitoring for Symptom Management

用于症状管理的自动电话监控

• 批准号: 6744787
• 负责人: CHARLES W GIVEN
• 金额: $ 86.21万
• 依托单位: MICHIGAN STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-02 至 2007-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6744787
• 关键词: biomedical automation; cancer rehabilitation /care; clinical research; health care service evaluation; human subject; neoplasm /cancer chemotherapy; nursing intervention; oncology nursing; outcomes research; patient care management; patient oriented research; sign /symptom; telemedicine

DESCRIPTION (provided by applicant): To improve the management of symptoms, patients with cancer undergoing chemotherapy are monitored using an automated telephone system to record the severity of seven prevalent symptoms for eight consecutive weeks. When symptom severity reaches two or higher (on a 11 point scale), for one or more symptoms that patient is enrolled into a trial, receives a baseline interview, and is randomized to either an individualized multimodal Patient Assisted Management of Symptoms (PAMS) intervention or to a Telephone Information and Monitoring of Symptoms (TIMS) approach (i.e., enhanced usual care). Both arms of the trial receive a Symptom Management Toolkit (SMT). Patients in the PAMS arm receive 8 weekly calls from a specially trained nurse who will assess all seven symptoms at each contact, and provide individualized interventions using a problem solving approach guided by a computer assisted protocol. Patients in the TIMS arm will receive 8 weekly-automated telephone calls with instructions to refer to specific pages of the SMT and are reminded to call their oncology clinic if symptoms are urgent. At weeks 9 and 15, patients will receive outcome interviews. Following the week 15 interview, patients' medical records will be audited; treatment, cost and charge data collected. Outcomes include: significant reduction in symptom severity and improvement in health states. This research study controls for the method of delivering the intervention (telephone), the intensity (8 weekly contacts), and the use of printed materials in the toolkit (SMT) and seeks to determine the value added by a patient-assisted intervention individualized to meet patients' needs for symptom management (PAMS) plus a SMT when contrasted with symptom monitoring by telephone (TIMS) and referral to a SMT alone. For this study, 350 patients will be accrued. A 30% drop out rate is expected with 122 patients surviving through the 15-week observation in each arm. Special recruitment strategies are presented for accruing and retaining women and minorities. Analysis strategies address reduction among the seven targeted symptoms, the primary outcome, as well as secondary outcomes. Strategies for collection, exploratory analysis, and comparison of utilization and costs between the two arms are presented.

描述（由申请人提供）：为了改善症状的治疗，使用自动电话系统对接受化疗的癌症患者进行监测，以记录连续八周的七种普遍症状的严重程度。当症状严重程度达到两个或更高（以11点尺度上）时，对于患者入学的一个或多个症状，将接受基线访谈，然后随机分配到个性化的多模式患者辅助症状（PAMS）干预措施（PAMS）干预或电话信息和症状信息（TIMS）方法（即）方法（即，可以增强手术）。试验的两个臂都均获得症状管理工具包（SMT）。 PAMS ARM中的患者每周收到8个专门训练的护士的电话，他们将在每次接触时评估所有七个症状，并使用以计算机辅助协议指导的问题解决方法进行个性化干预措施。 TIMS ARM中的患者将接收8个每周自动电话，并指示指示SMT的特定页面，并提醒您在症状紧急的情况下致电其肿瘤诊所。在第9和第15周，患者将接受结果访谈。在第15周访谈之后，将对患者的病历进行审核；收集的处理，成本和费用数据。结果包括：症状严重程度大大降低和健康状况的改善。 This research study controls for the method of delivering the intervention (telephone), the intensity (8 weekly contacts), and the use of printed materials in the toolkit (SMT) and seeks to determine the value added by a patient-assisted intervention individualized to meet patients' needs for symptom management (PAMS) plus a SMT when contrasted with symptom monitoring by telephone (TIMS) and referral to a SMT alone.在这项研究中，将有350名患者获得。预计有30％的辍学率将有122名患者通过每只手臂的15周观察存活。提出了特殊的招聘策略，以应对和保留妇女和少数民族。分析策略解决了七个目标症状，主要结果以及次要结果之间的减少。提出了收集，探索性分析和比较利用率和两个武器之间成本的策略。