A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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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.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm I (standard of care) Patients attend a standard of care visit with their clinician on study. |
Other: Best Practice
Receive standard of care
Other Names:
Other: Electronic Health Record Review
Ancillary studies
Other: Survey Administration
Ancillary studies
Other: Video Recording
Ancillary studies
|
| Experimental: 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. |
Other: Best Practice
Receive standard of care
Other Names:
Other: Communication Intervention
Use shared decision-making conversation tool
Other: Electronic Health Record Review
Ancillary studies
Other: Survey Administration
Ancillary studies
Other: Video Recording
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Effectiveness of the intervention on implementing shared decision making [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.
- Degree of involvement of patients by the clinician in the shared decision making [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.
- Provider satisfaction with NSCLC choice conversation aid [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.
Other Outcome Measures
- Knowledge transfer [Baseline (immediately following appointment); 2 weeks post appointment]
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 [Baseline (immediately following appointment); 2 weeks post appointment]
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) [Baseline (immediately following appointment); 2 weeks post appointment]
The 16 items of DCS are scored on a 0-4 scale where higher scores are reflective of uncertainty about treatment choice.
Eligibility Criteria
Criteria
Inclusion Criteria:
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CLINICIANS:
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All clinicians within identified departments participating are eligible (doctor of medicine [MD]/doctor of osteopathy [DO], fellows/residents, physician assistant [PA]/nurse practitioner [NP])
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PATIENTS:
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Adult patients (>= 18 years of age)
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Appointments at Mayo Clinic in Rochester
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Non-small cell lung cancer (NSCLC) stage > 1B
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Eligible by their oncologist for adjuvant treatment
Exclusion Criteria:
- 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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Rochester | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Konstantinos Leventakos, M.D., Ph.D., Mayo Clinic in Rochester
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-003089
- NCI-2023-07463
- 23-003089