Shared Decision-Making Encounter Tool for Adjuvant Treatment of Lung Cancer: Randomized Control Trial
概览
- 阶段
- 不适用
- 干预措施
- Video Recording
- 疾病 / 适应症
- Lung Non-Small Cell Carcinoma
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Degree of involvement of patients by the clinician in the shared decision making
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
This clinical trial compares the use of a shared decision-making communication tool during a clinical encounter to standard care for improving the quality of the shared decision-making process among patients with non-small cell lung cancer. Lung cancer patients are faced with many decisions about their treatment options. Studies have found that patients are most satisfied if they perceive an effort by their physician to share decision making and are afforded sufficient time to make their decision. Shared decision-making tools can help physicians guide the conversation, offer tailored estimates of the potential benefits, harms, and practical inconveniences of the available options, and support deliberations that take into account patient biological and biographical circumstances, goals, and priorities. Incorporating a shared decision-making communication tool into standard clinical encounters may improve the shared-decision making process as well as patient satisfaction with their treatment choice.
详细描述
PRIMARY OBJECTIVES: I. Encounters where standard of care and the non-small cell lung cancer (NSCLC) choice conversation aid were utilized will have an improvement in the quality of the shared decision-making process over encounters with standard of care alone. II. Patients with encounters where the NSCLC choice conversation aid was used along with standard of care will have decreased decisional conflict in regard to treatment choice compared to standard of care alone. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients attend a standard of care visit with their clinician on study. ARM II: Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study. After completion of study intervention, patients are followed up at 2 and 6 weeks.
研究者
入排标准
入选标准
- •CLINICIANS:
- •All clinicians within identified departments participating are eligible (doctor of medicine \[MD\]/doctor of osteopathy \[DO\], fellows/residents, physician assistant \[PA\]/nurse practitioner \[NP\])
- •PATIENTS:
- •Adult patients (\>= 18 years of age)
- •Appointments at Mayo Clinic in Rochester
- •Non-small cell lung cancer (NSCLC) stage \> 1B
- •Eligible by their oncologist for adjuvant treatment
排除标准
- •Exclude patient with major barriers to provide written informed consent or to participate in shared decision-making (i.e., dementia, severe hearing or visual impairment)
研究组 & 干预措施
Arm II (standard of care, conversation aid)
Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
干预措施: Video Recording
Arm II (standard of care, conversation aid)
Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
干预措施: Audio Recording
Arm I (standard of care)
Patients attend a standard of care visit with their clinician on study.
干预措施: Survey Administration
Arm I (standard of care)
Patients attend a standard of care visit with their clinician on study.
干预措施: Video Recording
Arm I (standard of care)
Patients attend a standard of care visit with their clinician on study.
干预措施: Audio Recording
Arm I (standard of care)
Patients attend a standard of care visit with their clinician on study.
干预措施: Best Practice
Arm I (standard of care)
Patients attend a standard of care visit with their clinician on study.
干预措施: Electronic Health Record Review
Arm II (standard of care, conversation aid)
Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
干预措施: Best Practice
Arm II (standard of care, conversation aid)
Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
干预措施: Communication Intervention
Arm II (standard of care, conversation aid)
Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
干预措施: Electronic Health Record Review
Arm II (standard of care, conversation aid)
Patients attend a standard of care visit with the use of the shared decision-making conversation tool by the clinician on study.
干预措施: Survey Administration
结局指标
主要结局
Degree of involvement of patients by the clinician in the shared decision making
时间窗: Baseline (immediately following appointment); 2 weeks post appointment
Evaluated using the 12-item "observing patient involvement" (OPTION12) tool, where reviewers will view and score recorded encounters. The survey tool consists of 12 items scored from 0-4, where 0=no effort and 4=exemplary effort.
Effectiveness of the intervention on implementing shared decision making
时间窗: Baseline (immediately following appointment); 2 weeks post appointment
Effectiveness of the intervention will be assessed using the 9-item Shared Decision Making Questionnaire (SDMQ-9) to evaluate standard of care alone versus using the non-small cell lung cancer (NSCLC) conversation aid plus standard of care. The overall score is the sum of the 9 items, where lower values indicate less perceived shared decision making, and higher scores indicate more perceived shared decision making. Self-reported responses from patients and clinicians will also be collected at multiple timepoints throughout the study.
Provider satisfaction with NSCLC choice conversation aid
时间窗: After each encounter for the duration of the study, until accrual is reached
Provider satisfaction with each encounter will be assessed with two questions. The first will be answered using a 5-point Likert scale where 1=Not at all satisfied and 5=Completely satisfied. The second will be answered using a 7-point scale where 1=No, I would strongly recommend against it and 7=Yes, I would strongly recommend it. Higher overall scores indicate higher satisfaction with the intervention.