A Tool for Improving the Shared Decision-making Process in Patients With Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Best Practice

    Other intervention

    Receive standard of care

  • Communication Intervention

    Other intervention

    Use shared decision-making conversation tool

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Survey Administration

    Other intervention

    Ancillary studies

  • Video Recording

    Other intervention

    Ancillary studies

  • Audio Recording

    Other intervention

    Ancillary studies

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Arm I (standard of care)Active comparator 5 interventions
Group B: Arm II (standard of care, conversation aid)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (immediately following appointment); 2 weeks post appointment
2

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.

Time frame
Baseline (immediately following appointment); 2 weeks post appointment
3

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.

Time frame
After each encounter for the duration of the study, until accrual is reached

Secondary outcomes

Other outcomes

1

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.

Time frame
Baseline (immediately following appointment); 2 weeks post appointment
2

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.

Time frame
Baseline (immediately following appointment); 2 weeks post appointment
3

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.

Time frame
Baseline (immediately following appointment); 2 weeks post appointment

Sponsors and contacts

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