N/A N=446 Randomized Single-blind Other

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

Communication

Bottom Line

View on ClinicalTrials.gov: NCT02623335 ↗

Enrolled (actual)

446

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised — 68; 55; 95; 89 Participants — p=0.353

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: QPL (question prompt list) brochure (Other)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised	68; 55; 95; 89; 35; 36	0.353
PRIMARY Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument	-1.49; -1.6; -1.88; -1.73	0.84
PRIMARY Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale	21.64; 21.45	0.411
PRIMARY Post-treatment Regret Measured by a Specific Participant Self-report Survey Item	61; 48; 144; 161	0.412
SECONDARY Participant Autonomy Support Measured by Self-report on the HCCQ Instrument	6.39; 6.5	0.009 sig
SECONDARY Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Positive Scale	12.92; 13.52; 12.95; 13.64	0.106
SECONDARY Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Negative Scale	6.92; 6.47; 7.05; 6.25	0.034 sig
SECONDARY Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Anxiety 4a Scale	7.57; 7.18; 7.18; 6.76	0.022 sig
SECONDARY Number of Participants Who Had Surgery During the Study Period	135; 139	—
SECONDARY Physician Engagement With Patient Measured by Clinic Visit Transcript Coding Using OPTION Coding System	34.26; 31.03	0.07

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.

Eligibility Criteria

Surgeons

Inclusion Criteria

Consenting surgeons at participating hospital sites who practice vascular, cardiothoracic, hepatobiliary, colorectal, urologic, gynecologic, head and neck or neurosurgery
Regularly see patients preoperatively in the surgical clinic
Perform high risk operations on older patients with multiple comorbid conditions

Exclusion Criteria

Exclusively perform minimally invasive surgery (laparoscopy), endocrine or breast surgery as these procedures are not typically considered "high risk"
Patient panel is not generally comprised of older adults considering high risk procedures

Patients

Inclusion Criteria

Age 60 and older
One or more chronic conditions from a list comprised of those included in the Charlson Comorbidity Index with 9 additional conditions included due to their saliency to surgical decision making
Have an upcoming outpatient consultation with an enrolled surgeon to discuss treatment for a vascular or oncologic problem that can be treated with a high risk operation
English speaking and Spanish-speaking patients who require an interpreter will be included

Exclusion Criteria

Lack decision-making capacity
Deemed too physically or mentally ill to participate by their surgeon or clinic nurse
Self-report that their vision or literacy skills are too poor to read a newspaper
Cannot speak either English or Spanish with the fluency required to have a valid medical decision-making conversation as the QPL is currently only available in English and Spanish (Spanish speaking patients who require an interpreter to speak with their surgeon will be included)
Participating surgeons may also choose to exclude specific patients for study participation based on their own concerns about the patient participating in the study, for example patients who have urgent surgical needs or don't actually have a surgical problem

Family members

Inclusion Criteria

Family member (patient participant) is enrolled in the study
Present at time of patient enrollment in study

Exclusion Criteria

Lack decision-making capacity
Self-report that their vision or literacy skills are too poor to read a newspaper
Cannot speak either English or Spanish with the fluency required to have a valid medical decision-making conversation as the QPL is currently only available in English and Spanish (Spanish speaking patients who require an interpreter to speak with the surgeon will be included)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02623335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.