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

Official Title:

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

Basic Trial Information

Phase Type Age Sponsor Protocol IDs Status
N/A Interventional 65 Years and older University of Wisconsin, Madison UW 2015-1375
NCT02623335
Enrolling by invitation

Study Design:


Principal Investigator

Associate Professor in Residence
Department of Surgery, Division of General Surgery
Department of Medicine, Division of Geriatrics
Phillip R. Lee Institute for Health Policy Studies
Director, Center for Surgery in Older Adults
Director, Department of Surgery Faculty Mentoring Program

Clinical Research Coordinator

UCSF Medical Center at Mt. Zion
(415) 476-3473 Phone

Trial 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

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 65 and older (though one site, New Jersey Medical School, will enroll patients 60
    and older due to the social vulnerability and age of population)
  • 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)

Detailed Description

To answer the research question, "Could a patient-driven approach that improves decision
making and informs postoperative expectations have more effectiveness than the current
surgeon-directed preoperative conversation?" the investigators will conduct a multi-site
randomized controlled trial of the question prompt list intervention (QPL) for high risk
surgery that will:

Compare the effectiveness of the intervention relative to usual care on the extent of
patient engagement in decision-making for high risk surgery. (Aim 1)
Compare the effectiveness of the intervention relative to usual care on treatment
choice and on psychological well-being and post-treatment regret for patients and
family members. (Aim 2)
Compare the effectiveness of the intervention relative to usual care on interpersonal
and intrapersonal conflict relating to treatment decisions and subsequent treatments
received. (Aim 3)
The overall goals of the study are to help patients and families:

make treatment decisions aligned with their values and goals;
anticipate and make sense of postoperative outcomes; and
experience less postoperative conflict about treatment of serious complications.
Enrolled surgeons will be grouped based on self-report of their clinic practices. "Visit 1
Surgeons" typically have a treatment decision making conversation with patients at their
initial new patient consult. For enrolled patients of these surgeons, we will audio-record
their first consult visit. "Visit 2 Surgeons" typically do not have treatment decision
making discussions at the initial visit- this discussion is generally delayed until a follow
up appointment, after additional testing or review of medical records. The return/second
visit of enrolled patients under the care of Visit 2 Surgeons will be recorded.
When a surgeon is in the usual care arm, patients will receive the current standard for
surgical decision-making. Once an enrolled surgeon has crossed into the intervention arm,
the research team will mail the QPL intervention to all of the surgeon's new consult
patients (for Visit 1 Surgeons) or returning/2nd consult patients (for Visit 2 Surgeons)
about a week prior to their scheduled consultation, regardless of study eligibility. The QPL
intervention includes the QPL intervention brochure, plus a letter from the surgeon
encouraging its use during the upcoming office visit. Eligible patients will be identified
by clinic staff and interested patients will be approached once they arrive in clinic (they
will not receive information about the study prior to their clinic appointment because this
information could interfere with the QPL intervention).
Patients in the usual care arm will receive the current standard for surgical
decision-making. The investigators have observed that usual care includes informed consent
and a surgeon-directed deliberative phase in which surgeons present their own evaluation of
the trade-offs and goals of the proposed intervention. Although this deliberation occurs in
front of patients and families, assumptions about the value of specific outcomes are
surgeon-generated and not specifically linked to patient preferences. For these reasons, the
investigators believe comparing the intervention to usual care is suitable. In addition,
question prompt lists are currently available online and are not distributed by the surgeon.
Patients can obtain and use the lists if they so choose on their own (although most do not).
Additionally, question prompt lists have been shown to be safe and effective in previous
studies in similar but not identical clinical situations.
Surgeons will be randomly assigned within each site to change from usual care to the QPL
intervention at different study wave time points. Prior to study start the investigators
will conduct step-wise randomization using a computer-generated randomization schedule to
determine the crossover wave timing among surgeons. Surgeon cross-over from usual care to
intervention will occur in one direction only and each within-site change will occur once
every four months. Surgical clinics will be contacted one month prior to intervention
implementation to confirm and execute implementation processes and to start mailing the QPL
intervention to patients with office visits scheduled on or after the first day of
intervention transition. A 2-week hiatus in data collection at the start of the cross over
will be instituted in the transition clinics to ensure patients in the intervention group
have had the opportunity to receive the intervention mailing. Surgeons who have crossed over
to the intervention group will be notified when the QPL intervention has been implemented in
their clinic and will be encouraged with bi-weekly email or text reminders to support
patient use of the question list during clinical encounters with patients discussing
surgical treatment options.
For patients in both the usual care and intervention arms: Surgeons who perform high risk
operations and have agreed to participate will help to identify new or returning patients
(depending on their previously reported practice pattern) coming to an outpatient visit to
discuss a major surgical procedure. If a patient consents to the study, study staff will
audio record one conversation (T0) between the attending surgeon and patient and
accompanying family member. Study staff will meet with the patient prior to starting the
audio recording to obtain consent. If there is a family member present at the appointment
and he or she would like to participate in study activities, study staff will obtain consent
from them as well. If a resident/surgical trainee or additional family members and
caretakers are present, study staff will obtain verbal permission to audio record the
resident and all others present. Study staff will wait until the surgeon enters the room and
then turn on the digital audio recorder. Once the audio recorder has been turned on, the
research team member will leave the room and return once the meeting between the patient and
surgeon is complete to terminate and collect the audio recording.
Study staff will conduct follow-up phone calls to administer surveys to the patient and
family member (if they have enrolled) within 12-72 hours of the patient's audio-recorded
treatment decision-making visit (T1). After the visit with the surgeon, the patient's
treatment plan will be determined by chart review and confirmed with the surgeon or clinic
nurse. Administration of the second and third surveys (T2 and T3) will be linked to the
patient's treatment plan. For patients who are scheduled for surgery, surveys will be
administered via telephone to the patient and family member 1-2 (T2) weeks after surgery and
6-8 (T3) weeks after surgery. Based on previous study in this patient population and
clinical setting, the median time between the patient's preoperative visit with the surgeon
and surgery is 31 days. If the patient is unable to participate in study activities,
enrolled family members will still be asked to complete study activities. Patients who did
not have a family member enroll along with them and who are unable to participate in study
activities post-operatively will be considered lost to follow up. For patients who have
non-operative treatment; e.g., medical treatment (chemotherapy, pulmonary rehab) or
observation (active surveillance, no surgical procedure scheduled), study staff will
administer surveys between 6 and 8 weeks (T2) and again between 12 and 14 (T3) weeks after
the patient's audio-recorded treatment decision-making visit with the surgeon. This will
roughly approximate the time frame for study activities for patients who have surgery.
Patients and family members will also be allowed to complete follow up surveys (T2 and T3)
by web survey or mail, if they prefer, though phone surveys will likely be the primary data
collection method, based on prior research.
Some patients of Visit 1 Surgeons will need additional testing (CT scan, PET scan, stress
test) before a treatment decision can be made. These patients and their family members will
complete the initial study activities (audio recording of the initial visit with a surgeon
(T0) and survey at 12-72 hours (T1)). Study staff will not audio record a second (return)
visit with the surgeon or repeat the post visit survey (T1). The second and third surveys
will be linked to the treatment decision after this second interaction with the surgeon: T2:
1-2 weeks postoperatively and T3: 6-8 weeks postoperatively, or T2: 6-8 and T3:12-14 weeks
after the second interaction with the surgeon for those who have non-operative treatment. In
some cases surgeons will telephone the patient after additional testing to develop a
treatment plan. Study staff will not audio record this interaction. Study staff will use
careful chart review and communication with the surgeon and/or his/her clinical staff for
these patients to accurately target the timing of subsequent study activities. After the
final survey is completed study staff will use chart abstraction to identify and record
treatments received and postoperative complications.
Study staff will use chart review immediately after the patient meets with the surgeon (T0)
and again after the final survey (T3) has been completed to record clinical data, treatments
received and outcomes of treatment. Study staff will also screen charts of enrolled patients
weekly in order to confirm treatment plan which may be unclear at the time of their
audio-recorded treatment decision-making visit and is critically important to timing of
subsequent data collection. Data collected will be limited to clinical information
pertaining to surgical care from audio-recorded treatment decision-making visit through to
administration of the final survey (T3).
To investigate Aim 3, the investigators will use a qualitative study design to compare
interpersonal and intrapersonal conflict between study arms as it relates to the phenomenon
of surgical buy in—when the surgeon believes that the patient has agreed to the operative
procedure as well as all possible postoperative care. Conflict between surgeons and patients
and/or family members about additional invasive procedures occurs in the uncommon setting of
serious postoperative complications but may be affected by the QPL intervention, which
includes questions about "What happens if things go wrong?" and specific question prompts
about advance directives. Thus, investigators will use stratified purposeful sampling to
identify a subset of patients who have experienced serious postoperative complications in
each study arm, as determined by chart review. Serious complications include prolonged
hospitalization (more than 8 days postoperatively), prolonged length of stay in intensive
care (greater than 3 days), prolonged mechanical ventilation, myocardial infarction, major
cerebrovascular accident, new onset dialysis or death. Study staff will use chart review at
T3 (12-14 weeks, roughly 6 weeks after surgery) to identify patients who have had serious
complications and ask them and/or their family members to participate in a face-to-face
qualitative interview. The investigators are planning for 3-7 interviews at each study site
and anticipate no more than 10 at each site. Not all patients who consent to Aims 1 and 2 of
the study will participate in Aim 3.
For patients and family members who agree to be interviewed, a trained Qualitative
Interviewer will conduct the interview. The interviewer will meet the patient and family
member at a convenient and private location of their choosing for an in-person interview.
Patients and family members will have the choice to conduct the interview jointly or
separately. Study investigators have employed this technique in previous studies and
successfully interviewed study participants and family members in their homes or at the
medical center in a private room at the time of a follow up medical appointment. Interviews
will generally not be conducted over the telephone as this limits the ability of the
interviewer to respond to non-verbal cues. Interviews will last up to one hour.

Important

Final eligibility is determined by the health professionals conducting the trial and the protocol approved by the Committee on Human Resources (CHR) at the University of California, San Francisco (UCSF). The Patient Consent Form for this trial is available upon request. For more information about this trial, please see the full posting at ClinicalTrials.gov.

Information about this trial was obtained from the NIH Clinical Trials website, http://clinicaltrials.gov on 1/26/2017. UCSF specific information including the PI (Principal Investigator), trial enrollment status, and UCSF Study ID, supplement the ClinicalTrials.gov study posting.
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