Telephone-Based Decision Support for Rural Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Decisional Self-Efficacy (DSE)
研究概览
简要总结
The investigators community based resource center has implemented visit preparation by prompting patients to write down their questions. This is a proven approach to increasing the number of questions and concerns that patients voice during their visits with doctors. The resource center's usual practice is to provide their visit preparation intervention, called Consultation Planning, through in-person counseling sessions. This study asks whether telephone delivery of Consultation Planning would be almost as effective in terms of increasing patient's decision self-efficacy, or confidence in their ability to navigate decisions effectively with their physicians. The study also asks about the cost-effectiveness of telephone delivery compared to in-person delivery. The investigators are answering these questions through a randomized, controlled, non-inferiority trial with two arms: in-person versus telephone delivery of Consultation Planning. The investigators are measuring self-reported psychological outcomes such as decision self-efficacy (primary outcome), preparation for decision making, anxiety, and distress, along with economic outcomes such as health resource utilization and willingness to pay. The investigators hypothesize that Tele-CP can be delivered at a lower patient and resource center cost than in-person CP, and that it will be as effective in terms of impact on a patient's decisional self-efficacy.
详细描述
Breast cancer patients are often advised to write down a list of questions before talking to their surgeons or oncologists about treatment decisions. However, without support, newly diagnosed patients may be too overwhelmed to make a list of their questions. Over the last 30 years, studies have shown that patients benefit from having a researcher or nurse prompt them for questions or any concerns they may have before an upcoming appointment with their primary healthcare provider. In some of these studies, the researcher or nurse then wrote down the patient's questions so that the clinician could be sure to address them.
Today, few facilities provide this type of patient support, known as visit preparation, perhaps because of the cost and/or organizational challenges. Our research team, a partnership between the UCSF Decision Services and the Cancer Resource Centers of Mendocino County (CRCMC) implemented a form of visit preparation known as Consultation Planning (CP). The investigators have made CP work in our communities by training resource center staff to deliver the service in face-to-face interviews with patients.
In a recent completed Pilot Study, the investigators collected and analyzed initial data suggesting that CP is appropriate for diverse, rural patients in Mendocino County (including Native Americans and Latinas), and that CP may be effective when delivered by telephone.
The investigators have now been awarded a grant to examine the effectiveness and cost-effectiveness of delivering CP by telephone (Tele-CP) versus in person.
Primary Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females age 18 or older
- •Diagnosis of Ductal Carcinoma in Situ (DCIS) or local recurrence of DCIS
- •New (stage 1, 2, 3, 4) invasive breast cancer or recurrence
- •Upcoming appointment to see a surgeon or oncologist to discuss treatment options
- •Surgeons or oncologists whom the patient is consulting
- •Able to speak, read, and understand English or Spanish
排除标准
- •Females less than 18 years of age
- •Males with breast cancer
- •Females with breast cancer who are also pregnant (pregnancy changes the breast cancer treatment)
- •Clients who are determined to have "diminished mental capacity" according to the standards of the CRCMC Policy on Mental Competence
结局指标
主要结局
Decisional Self-Efficacy (DSE)
时间窗: 5 min after intervention
次要结局
- CRCMC Client Intake Form(Immediately upon consent)
- STAI Form Y-1 (Anxiety)(-1 hour (1 hour prior to intervention))
- Decisional Conflict Scale (DCS)(1 week avg. (immediately following visit with physician))
- Critical Incident Survey(1 week avg. (immediately following visit with physician))
- Patient Intervention Costs(1 week avg. (immediately following visit with physician))
- Patient Utility Assessments(6 months after intervention)
- Quality of Life Thermometer(6 months after intervention)
- Preparation for Decision Making (PDM) Scale(6 months after intervention)
- Tracking Log of Medical Visits and Treatments(1 week avg. (immediately following appointment with specialist))
- Patient Healthcare Costs(Immediately upon consent; 6 months after intervention)
- STAI Y-1 (Anxiety)(5 minutes after intervention)
研究者
Jeff Belkora
Assistant Professor, Surgery and Health Policy Director, Decision Services
University of California, San Francisco