Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Victoria Tang, MD, MAS
Headshot of Victoria Tang
Victoria Tang

Description

Summary

The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is:

• What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?

Official Title

Building Resilience for Surgical Recovery: Feasibility and Acceptability Pilot Study

Details

A pilot test of a 9-session psychosocial intervention (Problem Solving Treatment, PST) will be conducted at the University of Texas, Southwestern Medical Center (UTSW). Ninety older surgical patients will be recruited from UTSW's Peri-operative Senior Health (POSH) clinic, with 20 for training, 35 randomized to the intervention arm, and 35 in the control arm. Preliminary data from this study will inform an R01 submission assessing the impact of PST on post-operative functional recovery.

Summary of Objectives:

  1. Examine the feasibility of implementing an evidence-based psychosocial intervention, PST, for older surgical patients with depressive symptoms.
  2. Demonstrate the acceptability of the intervention delivery for older surgical patients with depressive symptoms.
  3. Evaluate the potential improvement in function and reduction in depressive symptoms.

Setting:

Ninety older adults undergoing major surgery will be recruited at the UTSW POSH clinic during the pre-operative period over a 6-month time frame. UTSW POSH sees 15-20 older surgical patients pre-operatively a week.

Recruitment and Enrollment:

Participants will be recruited through two pathways - clinician referral and self-referral. (1) Clinician referral: clinicians will refer via recruitment flyer, by the clinic team at the clinic visit, or via email to the study team. (2) Self-referral: recruitment flyers will be utilized in waiting rooms and clinical offices for interested patients to contact the study team.

Clinician Referral Details:

Clinicians will provide the research team with the patient's name and phone number for recruitment if they believe the patient is experiencing depressive symptoms and has a life expectancy of more than 6 months. The study team will reach out to the patient to recruit them into the study.

Enrollment and Consent:

Enrollment and consent will be conducted over the phone, and consent forms with DocuSign will be sent via email. To reduce discrimination against older adults unfamiliar with the technology, those unable to sign the consent form via DocuSign will be mailed the paper consent form with return postage to sign and send back. Consent will be stored in RedCAP.

Training of Interventionists:

Interventionists will undergo training with a problem-solving therapy master trainer. Participants will be recruited for this training until all interventionists meet criteria for intervention delivery. Refer to the training participant consent form for details.

Keywords

Psychosocial Functioning, Surgery, Older Adults, Physical Function, Postoperative Outcome, Depressive Symptoms, Depression, Problem Solving Therapy (PST)

Eligibility

You can join if…

Open to people ages 65 years and up

  • Scheduled major surgery with an anticipated hospital stay of 3+ days. Major operations include: orthopedic, thoracic or abdominal, cardiac procedures. AND 65+

    AND:

    • Depressive symptoms - PHQ-9 screening with a score of 5+, if the score is 5-9, we need to have at least one of these items included: items #1 and/or #2 on the PHQ-9). OR
    • Positive score (score of 5 or below) in Katz OR
    • Positive score (score 4 or below for men / score of 7 or below for women) in Lawton
  • Scheduled major surgery with an anticipated hospital stay of 3+ days. Major operations include: orthopedic, thoracic or abdominal, cardiac procedures. AND 80+.

You CAN'T join if...

  • Those with severe cognitive impairment (Short Portable Mental Status

    Questionnaire--SPMSQ: screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment);

  • unable to read, speak, and understand English;
  • current alcohol or other substance abuse.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Victoria Tang, MD, MAS
    Dr. Tang is a clinician-researcher who is a national leader in improving the lives of older adults in the surgical setting. Dr. Tang received her MD from University of Texas-Southwestern in 2005. She completed a residency in internal medicine and a fellowship in geriatrics at UT-Southwestern.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06174701
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated