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

NCT02623335 | Completed Results DMC

• 1 other identifier: 2015-1375
• Study Type: interventional
• Target: 446
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

patient decision making; surgical decision making; question prompt list; shared decision making; decision support techniques

Outcome Measures

Primary Outcomes (4)

• Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised

  Patient engagement in decision making was measured by coding the transcript for the patient's clinic visit, using a pre-defined coding scheme that focused on the number and types of questions raised in the audio-recorded treatment decision-making visit. The types of questions that were coded were options questions, expectations questions, risks questions and advance directive questions.

  Within 2 hours of enrollment in the study

• Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument

  Changes in concerns and well-being were measured using the self-report instrument Measure Yourself Concerns and Well-being (MYCaW) instrument. The minimum value for differences in this scale is -6 and maximum value is 6. Higher scores indicate that problems and concerns have diminished.

  24-48 hours after enrollment, 6-8 weeks post-enrollment and 3-4 months post-enrollment

• Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale

  Perceived self-efficacy in patient-physician interactions was measured by participant self-report, using the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) scale. Maximum value for this scale is 25 and minimum is 0. Higher scores indicate greater self-efficacy.

  24-48 hours after enrollment

• Post-treatment Regret Measured by a Specific Participant Self-report Survey Item

  Post-treatment regret was assessed by the following participant self-report survey item: "Looking back, is there anything about your treatment that you would do differently?"

  3-4 months post-enrollment

Secondary Outcomes (6)

• Participant Autonomy Support Measured by Self-report on the HCCQ Instrument

  24-48 hours after enrollment

• Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Positive Scale

  6-8 weeks post-enrollment, 3-4 months post-enrollment post-enrollment

• Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Negative Scale

  6-8 weeks post-enrollment, 3-4 months post-enrollment

• Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Anxiety 4a Scale

  6-8 weeks post-enrollment, 3-4 months post-enrollment

• Number of Participants Who Had Surgery During the Study Period

  From enrollment to end of data collection 3-4 months later

Study Arms (2)

QPL (question prompt list) brochure

EXPERIMENTAL

Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.

Other: QPL (question prompt list) brochure

Usual care

NO INTERVENTION

The investigators observed that usual care included informed consent and a surgeon-directed deliberative phase in which surgeons presented their own evaluation of the trade-offs and goals of the proposed intervention.

Interventions

QPL (question prompt list) brochure OTHER

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.

QPL (question prompt list) brochure

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of California, San Francisco: collaborator
• Brigham and Women's Hospital: collaborator
• New Jersey Medical School: collaborator
• Oregon Health and Science University: collaborator

Related Publications (5)

• Stalter LN, Baggett ND, Hanlon BM, Buffington A, Kalbfell EL, Zelenski AB, Arnold RM, Clapp JT, Schwarze ML. Identifying Patterns in Preoperative Communication about High-Risk Surgical Intervention: A Secondary Analysis of a Randomized Clinical Trial. Med Decis Making. 2023 May;43(4):487-497. doi: 10.1177/0272989X231164142. Epub 2023 Apr 10.

  PMID: 37036062 DERIVED

• Baggett ND, Schulz K, Buffington A, Marka N, Hanlon BM, Zimmermann C, Tucholka J, Fox D, Clapp JT, Arnold RM, Schwarze ML. Surgeon Use of Shared Decision-making for Older Adults Considering Major Surgery: A Secondary Analysis of a Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):406-413. doi: 10.1001/jamasurg.2022.0290.

  PMID: 35319737 DERIVED

• Kalbfell E, Kata A, Buffington AS, Marka N, Brasel KJ, Mosenthal AC, Cooper Z, Finlayson E, Schwarze ML. Frequency of Preoperative Advance Care Planning for Older Adults Undergoing High-risk Surgery: A Secondary Analysis of a Randomized Clinical Trial. JAMA Surg. 2021 Jul 1;156(7):e211521. doi: 10.1001/jamasurg.2021.1521. Epub 2021 Jul 14.

  PMID: 33978693 DERIVED

• Schwarze ML, Buffington A, Tucholka JL, Hanlon B, Rathouz PJ, Marka N, Taylor LJ, Zimmermann CJ, Kata A, Baggett ND, Fox DA, Schmick AE, Berlin A, Glass NE, Mosenthal AC, Finlayson E, Cooper Z, Brasel KJ. Effectiveness of a Question Prompt List Intervention for Older Patients Considering Major Surgery: A Multisite Randomized Clinical Trial. JAMA Surg. 2020 Jan 1;155(1):6-13. doi: 10.1001/jamasurg.2019.3778.

  PMID: 31664452 DERIVED

• Taylor LJ, Rathouz PJ, Berlin A, Brasel KJ, Mosenthal AC, Finlayson E, Cooper Z, Steffens NM, Jacobson N, Buffington A, Tucholka JL, Zhao Q, Schwarze ML. Navigating high-risk surgery: protocol for a multisite, stepped wedge, cluster-randomised trial of a question prompt list intervention to empower older adults to ask questions that inform treatment decisions. BMJ Open. 2017 May 29;7(5):e014002. doi: 10.1136/bmjopen-2016-014002.

  PMID: 28554911 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Gretchen Lee Schwarze, MD, MPP, FACS
• Organization: University of Wisconsin, Madison

schwarze@surgery.wisc.edu

(608) 265-2358

Study Officials

• Gretchen Schwarze, MD, MPP, FACS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Emily Finlayson, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Zara Cooper, MD, MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Anne Mosenthal, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Ana Berlin, MD, MPH

  Rutgers University

  PRINCIPAL INVESTIGATOR

• Karen Brasel, MD, MPP

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 7, 2015
• Study Start: February 1, 2016
• Primary Completion: November 15, 2018
• Study Completion: December 14, 2018
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-09