Toward Optimization of a Mammography Decision Aid and Clinician Communication Intervention Trial for Rural Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Intervention acceptability
研究概览
简要总结
The overall objective of this COBRE pilot project is to enhance the design of a 3-arm cluster randomized trial that will test the efficacy and mechanism of effect of the MyMammogram DA with or without a provider communication intervention. This will be accomplished through two aims: (1) Refine, with community partner input, a clinical trial protocol to optimize engagement among patients and primary care providers (PCPs) practicing in rural settings. In consultation with patients, PCPs, and informatics experts, the study team will refine site selection, randomization, patient and PCP recruitment, and data collection protocols to meet the needs of the rural health care delivery system and participants. The result of this aim will be a modified protocol and intervention strategy that is acceptable to partners. (2) Adapt and test trial and intervention implementation features to achieve protocol acceptance and adherence. The investigators will pilot the adapted three-arm randomized trial protocol in rural primary care settings that compares the MyMammogram DA with or without a risk summary provided to the PCP pre-visit, relative to usual care. Implementing the trial in two phases (n=15 each) will systematically identify barriers and facilitators to trial participation to refine protocols. Participants will receive acceptability surveys and investigators will conduct qualitative interviews with patients and PCPs to understand experiences with trial implementation from multiple perspectives.
详细描述
This is a three-arm randomized pilot trial that will enroll 30 participants over two study phases. The main objective is to achieve data on trial feasibility (recruitment, retention, randomization, adherence, and acceptability). The primary outcome is Intervention Acceptability.
Procedures: PCPs will be randomized to one of the three arms to prevent contamination across patients (usual care, decision aid, decision aid + clinician communication). Patients will be considered for enrollment if they are aged 40-49, English or Spanish-speaking, have an upcoming primary care visit within 4 weeks, no history of breast cancer, ductal carcinoma in situ, lobular carcinoma in situ, or atypical hyperplasia, and no mammogram within the past 12 months. These patients will be identified via the electronic health record using routine data reports provided to the study team.
Data Collection: Surveys will be conducted at baseline (pre-intervention), post-DA and Post-Visit. Mammography screening information will be collected via medical records, and implementation data will be completed with patients and clinicians who were exposed to the decision aid intervention.
Analysis: All feasibility metrics will be summarized quantitatively, distributions examined for central tendency and spread, and all data assessed for completeness. Data will be presented in a tabular format, with means and standard deviations summarized for the Acceptability of Intervention Measure. Process data will likewise be summarized, reporting proportions of participants meeting each metric (recruitment, retention, randomization, adherence).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 39 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Aged 39-49
- •Upcoming appointment with a participating primary care provider (within 4 weeks)
- •English or Spanish-speaking
排除标准
- •Personal history of breast cancer (including lobular carcinoma in situ and ductal carcinoma in situ or atypical hyperplasia)
- •Mammogram in the prior 9 months
- •Clinician inclusion: Any practicing primary care provider at a participating site.
研究组 & 干预措施
MyMammogram plus provider communication
Patient uses MyMammogram prior to appointment. Provider receives a summary from MyMammogram prior to appointment.
干预措施: MyMammogram (Behavioral)
MyMammogram plus provider communication
Patient uses MyMammogram prior to appointment. Provider receives a summary from MyMammogram prior to appointment.
干预措施: Provider communication (Other)
Usual Care
Usual care.
MyMammogram
Patient uses MyMammogram prior to appointment.
干预措施: MyMammogram (Behavioral)
结局指标
主要结局
Intervention acceptability
时间窗: within one day of completing the intervention
The acceptability e-scale is a 6-item measure for electronically-delivered interventions, where higher scores indicate greater acceptability. Scores range from 6-30.
次要结局
- Recruitment feasibility(4 weeks)
- Retention feasibility(8 weeks)
研究者
Mark A. Creager
Professor of Medicine, Geisel School of Medicine, Dartmouth; Professor of Surgery, Geisel School of Medicine, Dartmouth
Dartmouth-Hitchcock Medical Center