Clinical trial NCT06174701: Building Resilience for Surgical Recovery
Official title: Building Resilience for Surgical Recovery: Feasibility and Acceptability Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosocial Functioning
Surgery
Older Adults
Physical Function
Postoperative Outcome
Depressive Symptoms
Keywords: Psychosocial Functioning
Surgery
Older Adults
Physical Function
Postoperative Outcome
Depressive Symptoms
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of California, San Francisco
First posted: 2023-12-18
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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?

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* ≥ 65 years of age on the day of surgery
* Scheduled major surgery with an anticipated hospital stay of 3+ days. Major operations include: orthopedic, thoracic or abdominal, cardiac procedures
* Depressive symptoms - Patient Health Questionnaire (PHQ-9) screening with a score of 5+, 5-9 being subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, we need to have at least one of these items included: "at least one of the endorsed items needs to be depressed mood or diminished activities" (questions #1 and #2)

Exclusion criteria:

* 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 (scoring 2+ on CAGE questionnaire or answering yes to "Do you currently use any non-prescription drugs or substances?")
* Life expectancy is 6 months or less

Primary outcomes:
measure: Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS)
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Depressive Symptoms as Assessed by Score on the by the Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months and 6 months after baseline
Other outcomes:
measure: Physical pain
timeFrame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
measure: Cognition
timeFrame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
measure: Depressive symptoms
timeFrame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
measure: Self-efficacy
timeFrame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
measure: Anxiety
timeFrame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
measure: Social Support
timeFrame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
measure: Physical Function
timeFrame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Victoria Tang, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.
citation: Oxman TE, Freeman DH Jr, Manheimer ED. Lack of social participation or religious strength and comfort as risk factors for death after cardiac surgery in the elderly. Psychosom Med. 1995 Jan-Feb;57(1):5-15. doi: 10.1097/00006842-199501000-00002.
citation: Etzioni DA, Liu JH, O'Connell JB, Maggard MA, Ko CY. Elderly patients in surgical workloads: a population-based analysis. Am Surg. 2003 Nov;69(11):961-5.
citation: Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc. 2008 Dec;56(12):2171-9. doi: 10.1111/j.1532-5415.2008.02023.x.
citation: Berian JR, Zhou L, Hornor MA, Russell MM, Cohen ME, Finlayson E, Ko CY, Robinson TN, Rosenthal RA. Optimizing Surgical Quality Datasets to Care for Older Adults: Lessons from the American College of Surgeons NSQIP Geriatric Surgery Pilot. J Am Coll Surg. 2017 Dec;225(6):702-712.e1. doi: 10.1016/j.jamcollsurg.2017.08.012. Epub 2017 Oct 17.
citation: Finlayson EV, Birkmeyer JD. Outcomes in vascular surgery: volume versus certification. Surgery. 2001 Nov;130(5):897-8. doi: 10.1067/msy.2001.116926. No abstract available.
citation: Kaplan JA, Finlayson E, Auerbach AD. Impact of Multimodality Pain Regimens on Elective Colorectal Surgery Outcomes. Am Surg. 2017 Apr 1;83(4):414-420.
citation: Oresanya L, Zhao S, Gan S, Fries BE, Goodney PP, Covinsky KE, Conte MS, Finlayson E. Functional outcomes after lower extremity revascularization in nursing home residents: a national cohort study. JAMA Intern Med. 2015 Jun;175(6):951-7. doi: 10.1001/jamainternmed.2015.0486.
citation: Cenzer IS, Tang V, Boscardin WJ, Smith AK, Ritchie C, Wallhagen MI, Espaldon R, Covinsky KE. One-Year Mortality After Hip Fracture: Development and Validation of a Prognostic Index. J Am Geriatr Soc. 2016 Sep;64(9):1863-8. doi: 10.1111/jgs.14237. Epub 2016 Jun 13.
citation: Brembo EA, Kapstad H, Van Dulmen S, Eide H. Role of self-efficacy and social support in short-term recovery after total hip replacement: a prospective cohort study. Health Qual Life Outcomes. 2017 Apr 11;15(1):68. doi: 10.1186/s12955-017-0649-1.
citation: Tang VL, Sudore R, Cenzer IS, Boscardin WJ, Smith A, Ritchie C, Wallhagen M, Finlayson E, Petrillo L, Covinsky K. Rates of Recovery to Pre-Fracture Function in Older Persons with Hip Fracture: an Observational Study. J Gen Intern Med. 2017 Feb;32(2):153-158. doi: 10.1007/s11606-016-3848-2. Epub 2016 Sep 7.
citation: Chereau N, Chandeze MM, Tantardini C, Tresallet C, Lefevre JH, Parc Y, Menegaux F. Antroduodenectomy with Gastroduodenal Anastomosis: Salvage Emergency Surgery for Complicated Peptic Ulcer Disease--Results of a Double Institution Study of 35 Patients. J Gastrointest Surg. 2016 Mar;20(3):539-45. doi: 10.1007/s11605-015-3050-6. Epub 2015 Dec 7.
citation: Ryff CD. In the eye of the beholder: views of psychological well-being among middle-aged and older adults. Psychol Aging. 1989 Jun;4(2):195-201. doi: 10.1037//0882-7974.4.2.195.
citation: Kata A, Sudore R, Finlayson E, Broering JM, Ngo S, Tang VL. Increasing Advance Care Planning Using a Surgical Optimization Program for Older Adults. J Am Geriatr Soc. 2018 Oct;66(10):2017-2021. doi: 10.1111/jgs.15554. Epub 2018 Oct 5.
citation: KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.
citation: Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
citation: Lawrence VA, Hazuda HP, Cornell JE, Pederson T, Bradshaw PT, Mulrow CD, Page CP. Functional independence after major abdominal surgery in the elderly. J Am Coll Surg. 2004 Nov;199(5):762-72. doi: 10.1016/j.jamcollsurg.2004.05.280.
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
citation: Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484.