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

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ClinicalTrials.gov Identifier: NCT02623335
Recruitment Status : Completed
First Posted : December 7, 2015
Results First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Brigham and Women's Hospital
New Jersey Medical School
Oregon Health and Science University
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Communication Other: QPL (question prompt list) brochure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Navigating High Risk Surgery: Empowering Older Adults to Ask Questions That Inform Decisions About Surgical Treatment
Study Start Date : February 2016
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : December 14, 2018

Arm Intervention/treatment
Experimental: QPL (question prompt list) brochure
Patients were mailed the QPL (question prompt list) prior to their appointment with an enrolled surgeon.
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.

No Intervention: Usual care
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.



Primary Outcome Measures :
  1. Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised [ Time Frame: Within 2 hours of enrollment in the study ]
    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.

  2. Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument [ Time Frame: 24-48 hours after enrollment, 6-8 weeks post-enrollment and 3-4 months post-enrollment ]
    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.

  3. Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale [ Time Frame: 24-48 hours after enrollment ]
    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.

  4. Post-treatment Regret Measured by a Specific Participant Self-report Survey Item [ Time Frame: 3-4 months post-enrollment ]
    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?"


Secondary Outcome Measures :
  1. Participant Autonomy Support Measured by Self-report on the HCCQ Instrument [ Time Frame: 24-48 hours after enrollment ]
    Participant autonomy support was assessed using the self-report measure Health Care Climate Questionnaire (HCCQ). The minimum value for this scale is 1 and the maximum value is 7. Higher scores indicate greater perceived autonomy support.

  2. Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Positive Scale [ Time Frame: 6-8 weeks post-enrollment, 3-4 months post-enrollment post-enrollment ]
    Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact- Positive scale. The minimum value for this scale is 4 and the maximum is 16. Higher values indicate better well-being.

  3. Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Negative Scale [ Time Frame: 6-8 weeks post-enrollment, 3-4 months post-enrollment ]
    Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact- Negative scale. Minimum value for this scale is 4 and maximum is 20. Higher values indicate worse well-being.

  4. Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Anxiety 4a Scale [ Time Frame: 6-8 weeks post-enrollment, 3-4 months post-enrollment ]
    Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a scale. Minimum value for this scale is 4 and maximum is 20. Higher values indicate worse well-being.

  5. Number of Participants Who Had Surgery During the Study Period [ Time Frame: From enrollment to end of data collection 3-4 months later ]
    The total number of participants who had surgery during the study period was tracked through a patient chart review.

  6. Physician Engagement With Patient Measured by Clinic Visit Transcript Coding Using OPTION Coding System [ Time Frame: Within 2 hours of enrollment in the study ]
    Physician engagement with patient was measured by coding the transcript for the patient's clinic visit, using the Observing Patient Involvement in Decision Making instrument (OPTION) scale. Minimum value for this scale is 0 and maximum is 100. Higher scores indicate increased shared decision making.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623335


Sponsors and Collaborators
University of Wisconsin, Madison
Patient-Centered Outcomes Research Institute
University of California, San Francisco
Brigham and Women's Hospital
New Jersey Medical School
Oregon Health and Science University
Investigators
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Principal Investigator: 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 New Jersey Medical School
Principal Investigator: Ana Berlin, MD, MPH Rutgers New Jersey Medical School
Principal Investigator: Karen Brasel, MD, MPP Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02623335    
Other Study ID Numbers: 2015-1375
First Posted: December 7, 2015    Key Record Dates
Results First Posted: October 21, 2019
Last Update Posted: October 21, 2019
Last Verified: September 2019
Keywords provided by University of Wisconsin, Madison:
patient decision making
surgical decision making
question prompt list
shared decision making
decision support techniques