About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All clinicians within identified departments participating are eligible (doctor of medicine [MD]/doctor of osteopathy [DO], fellows/residents, physician assistant [PA]/nurse practitioner [NP])
Adult patients (>= 18 years of age)
Appointments at Mayo Clinic in Rochester
Non-small cell lung cancer (NSCLC) stage > 1B
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Best Practice
Other interventionReceive standard of care
Communication Intervention
Other interventionUse shared decision-making conversation tool
Electronic Health Record Review
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Video Recording
Other interventionAncillary studies
Audio Recording
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Effectiveness of the intervention on implementing shared decision making
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.
Degree of involvement of patients by the clinician in the shared decision making
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.
Provider satisfaction with NSCLC choice conversation aid
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.
Other outcomes
Knowledge transfer
Knowledge transfer will be assessed using 6 questions about treatment options to prevent recurrence of lung cancer. The 6 questions use a response format of "True / False / Do not know". Correct responses will be summed and divided by the total number of questions asked. If a patient answers at least 1 knowledge question then they will be assessed for this outcome, where all missing responses will be coded as incorrect.
Patient satisfaction
Patient satisfaction with encounter will be assessed with 1 question on a 7-point Likert scale. Patients will be asked whether they would recommend the approach used to others for other discussions.
Decisional conflict scale (DCS)
The 16 items of DCS are scored on a 0-4 scale where higher scores are reflective of uncertainty about treatment choice.
Sponsors and contacts
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