Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment
Abstract
The investigators will perform a multi-site cluster randomized trial that uses a stepped-wedged design to compare the effectiveness of a Question Prompt List (QPL) intervention to usual care for patients considering high-risk vascular (peripheral, cardiac, neuro) and oncologic operations. This 24-month study will use a time-dependent cluster randomization plan within each of the five study sites: the investigators will randomly assign time points for surgeons who perform high risk operations to cross over from usual care to QPL intervention. Study staff will audiotape the conversation between the patient and surgeon during one preoperative clinic visit; administer surveys to patients and family members at 24 hours, 6 weeks and 12 weeks after that visit; and record surgical decisions, treatments received and associated outcomes. The investigators will use stratified purposeful sampling to identify a subset of patients in each study arm who have experienced serious complications for qualitative interviews.
Conditions: Communication.
Primary outcome: Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised; Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument; Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale; Post-treatment Regret Measured by a Specific Participant Self-report Survey Item.
Enrollment: 446…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 446 participants or records.
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