PCORI-1502-27462 Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment

Summary

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

Interventions

OTHER

QPL (question prompt list) brochure

The QPL intervention includes the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials will be mailed in advance of the patient's appointment with an enrolled surgeon.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• New Jersey Medical School

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Gretchen Schwarze, MD, MPP, FACS · University of Wisconsin, Madison

• Emily Finlayson, MD, MS · University of California, San Francisco

• Zara Cooper, MD, MSc · Brigham and Women's Hospital

• Anne Mosenthal, MD · Rutgers University

• Ana Berlin, MD, MPH · Rutgers University

• Karen Brasel, MD, MPP · Oregon Health and Science University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2018-11-15

Completion

2018-12-14