PST in Surgery: Feasibility and Acceptability Pilot

Surgery Clinical Trial

Official title:

Building Psychosocial Resilience in Older Adults Facing Major Surgery: Feasibility and Acceptability Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174701
• Other study ID #: 22-37881
• Secondary ID: 5K76AG059931-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: Erika Higuchi, BS
• Phone: (415) 689-6275?
• Email: erika.higuchi[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 - PHQ-9 screening with a score of 6+, 6-9 being subclinical depression.

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Older Adults
• Physical Function
• Postoperative Outcome
• Psychosocial Functioning
• Surgery

Intervention

Behavioral:
• Problem Solving Therapy (PST)
PST intervention in the form of one-on-one coaching in preparation for surgery and post-operative care. This coaching consists of educating and guiding the patient in developing problem-solving skills. Please refer to the PST Handbook for further detail on the therapy sessions.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical pain	Brief Pain Inventory (BPI) (1 question from the 11 questions) - "Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than these everyday kinds of pain today?" Yes to indicate pain and no to indicate no pain.	day of enrollment, 1 day before surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
Other	Cognition	The Short Portable Mental Status Questionnaire (SPMSQ) (10-items) for assessment of cognitive function in older adults. Scoring scale of 0-8: Screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment.	day of enrollment, 1 day before surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
Other	Depressive symptoms	Measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report questionnaire assesses depression to gauge the severity of depression over the past two weeks. Screening with a score of 5+, 5-9 indicating subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, at least one of these items needs to be included: "at least one of the endorsed items needs to be depressed mood or diminished activities" (questions #1 and #2).	day of enrollment, 1 day before surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
Other	Self-efficacy	As measured by General Perceived Self-efficacy Scale (GSE). A 10-item questionnaire with the total score being the sum of the all items. Scores range from 0-40 with a higher score indicating more self-efficacy.	day of enrollment, 1 day before surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
Other	Anxiety	As measured by General Anxiety Disorder (GAD-7). A 7-item questionnaire with a score of 0-4 indicating minimal anxiety; 5-9 indicating mild anxiety; 10-14 indicating moderate anxiety; 15-21 indicating severe anxiety. Anxiety will also be measured by the Behavioral Activation for Depression Scale Short Form (BADS-SF). A 9-item questionnaire with 6 items focusing on activation and 3 items focusing on avoidance. The range of scores is 0 to 54, with high scores representing higher activation.	day of enrollment, 1 day before surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
Other	Social Support	As measured by Patient-Reported Outcomes Measurement Information System (PROMIS)- Emotional support and instrumental support questions. Scores for each set up questions range from 8-40 where 8 indicates no social support and 40 indicates social support. The initial collection will be used as the baseline measure against which subsequent collections will be compared.	day of enrollment, 1 day before surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
Other	Physical Function	As measured by World Health Organization Disability Assessment Schedule 2.0 (Brief-WHODAS), as this is a community dwelling older adult population and this scales from activity of daily living (ADL) to participation in society. Brief-WHODAS is a 12-item questionnaire where scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. The "summary score" is them converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). Will also be measured by Katz Index of Independence in Activities of Daily Living (ADL) and Lawton Instrumental Activities of Daily Living Scale (IADL).	day of enrollment, 1 day before surgery, 30 days after surgery, 3 months after surgery and 6 months after surgery
Primary	Functional Recovery	6-month functional recovery is measured by a comparison of the pre- and post-operative function using self-report to the World Health Organization Disability Assessment Schedule (Brief-WHODAS). Brief-WHODAS is a 12-item questionnaire where scores assigned to each of the items - "none" (0), "mild" (1), "moderate" (2), "severe" (3), and "extreme" (4) - are summed. The "summary score" is then converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). The rationale for using 6 months for follow-up is that after a major surgery, older adults can take up to 6 months to recover to their new functional baseline and has been used in previous studies.	6 months postoperatively
Secondary	Depressive Symptoms	The secondary outcome is 3 and 6-month depressive symptoms, as measured by the Patient Health Questionnaire (PHQ-9). It is a 9-item questionnaire in which each item can be scored as 0 - Not at all, 1 - Several days, 2 - More than half the days, 3 - Nearly every day. The total score is obtained by summing the scores for each of the nine items, resulting in a range from 0 to 27. 0 indicates no/minimal depression, and 27 indicates severe depression. Baseline, intermediate, outcome measures, and feasibility and acceptability measures will be collected.	3 months and 6 months after surgery