Symptoms of Anxiety and/or Depression and SDM in Older Patients With CLTI

April 14, 2026 updated by: Guy's and St Thomas' NHS Foundation Trust

Symptoms of Anxiety and/or Depression and the Shared Decision Making (SDM) Process in Older Patients With Critical Limb Threatening Ischaemia (CLTI)

Mental health disorders are common in older people and are often unrecognised. Those living with mental health disorders who are being considered for vascular surgery have worse post operative outcomes, including longer length of hospital stay, higher readmission rates and emergency admissions to hospital. These patients also have more medical conditions contributing to their post surgery complications and poor health outcomes.

Surgery for vascular patients can include life changing operations, such as amputation, which impacts mental health and quality of life.

Shared decision making is the process whereby patients and clinicians work together to make evidence based decisions centred on patient values and preferences and is part of the Comprehensive Geriatric Assessment and optimisation (CGA) model of care. SDM has been shown to improve patient experience through provision of realistic choice, enhanced interaction with clinicians, greater empowerment and increased confidence and trust in healthcare provision. Implementing SDM in vascular patients can be particularly challenging. Evaluating and communicating benefits and risks of available treatments for CLTI in a complex older patient population requires additional consideration beyond the inherent surgical risks. To achieve truly informed SDM, the clinician requires knowledge of the impact of co-existing conditions on postoperative recovery, the natural history of the surgical pathology with and without surgery and an awareness of the benefits and risks of alternative treatments underpinned by skilful communication.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Despite several studies associating mental health with both advancing age and poorer postoperative outcome, few studies have qualitatively explored the lived experience of older people with CLTI. Exploring the patient perspective will allow us to better understand the relationship between CLTI and mental health, and how patients can be better supported through SDM with the potential to reduce decisional regret. This will allow the development of strategies to enhance SDM taking mental health into account.

Study type This is a two-centre qualitative study, using a purposive sample from two NHS tertiary referral centres for vascular surgery (Guy's and St Thomas' NHS Foundation Trust and University Hospitals of Leicester). For this study, semi-structured interviews and a co-production workshop will be undertaken.

Public and patient involvement and engagement This study has been prompted by PPIE work informing the larger POPS-SUp study where patient and carer participants highlighted the need to explore mental health issues in a diverse surgical population with a focus on the impact this may have on SDM and recovery from surgery. The PPIE group told us that people with mental health issues can be especially stigmatised in some minority communities and approaching this topic in a sensitive manner will be key to this study. Following consultation, the investigators recognize the need to collaborate with organisations such as the Centre for Ethnic Health Research and consult a diverse PPI group (established from previous studies) to co-develop recruitment strategies and ensure interview questions are culturally sensitive and appropriate. The investigators have included a budget to translate study documents in two languages (Gujarati and Punjabi) and for a face-to-face interpreter for up to ten interviews to reduce language barriers to participation.

This study will draw on the diverse knowledge and expertise of existing PPIE groups in mental health and vascular surgery and from the existing POPS-SUp study. The investigators have costed for a PPIE representative to work with us specifically on this study who has experience of CLTI and mental health issues. JS will review study documents and be involved in the dissemination and coproduction workshop. The investigators will hold three PPIE meetings with five to six patient representatives, one to provide feedback on the protocol and other study documents, one during the study to discuss findings and dissemination plan (community talks, social media, lay summaries, infographics) and one toward the end of the study for feedback and guidance on next steps.

An appropriate budget has been included in this bid to support all stakeholder and public involvement and engagement activities, including dissemination.

Data collection Purposive sampling of patients/carers will ensure representation from different ethnic and socioeconomic backgrounds and surgical management (type of surgery or conservative management). Patients/carers will be identified and approached in the first instance by the clinical care team.

A purposive sample of 10-15 healthcare professionals (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for older people (aged ≥65 years) on an inpatient vascular surgical ward will be invited to participate by the clinical or research team.

Risks, burdens and benefits The team acknowledge that such a discussion can be upsetting but have developed expertise to signpost patients, carers or family members to appropriate support if distress results from involvement in this study. Whilst acknowledging this potential distress the research team and PPIE partners are clear that the research aims could not be addressed without this component of the study. Some patient partners have also told us that they found the discussion of their decisional regret therapeutic in moving forward.

Staff interviewees may be hesitant to raise criticism or suggest failings of the clinical service. To address this, the participant information sheets will highlight that researchers are independent of those delivering care and that there are no right or wrong answers. The PIS highlights that information will be fully anonymised (including names and places) and will emphasise that the researchers want to learn about things that do not work well so that they can be improved in future.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bridget C Strasser, MBBS (Hons) MPHTM BSc
  • Phone Number: +44 20 7188 7188
  • Email: b.strasser@nhs.net

Study Locations

  • United Kingdom
      • London, United Kingdom, SE19RT
        • Guy's and St Thomas' NHS Foundation Trust
        • Contact:
          • Bridget C Strasser, MBBS (Hons) MPHTM BSc
          • Phone Number: +44 20 7188 7188
          • Email: b.strasser@nhs.net

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with symptoms of anxiety and/or depression living with critical limb threatening ischaemia (CLTI) being considered for surgical intervention

Carers and staff looking after these patients

Description

Inclusion Criteria:

  • Patients

    • Aged ≥65 years old
    • CLTI
    • Active symptoms of anxiety or depression (clinician concern)

  • Carers

    o In a non-paid caring role for a patient aged ≥65 years with CLTI and active symptoms of anxiety or depression

  • Staff o Healthcare professional (vascular surgeons, therapists, clinical nurse specialists, geriatricians, anaesthetists, pharmacists) providing care for people aged ≥65 years with CLTI

Exclusion Criteria:

  • Patients

    • Palliative - death anticipated within one month
    • Clinical and research team identify as lacking capacity to participate

  • Carers

    o Clinical and research team identify as lacking capacity to participate

  • Staff o Not providing care for older people with CLTI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
15 patients/carers with CLTI >=65 with symptoms of anxiety and/or depression
15 staff members caring for patients with CLTI >=65 with symptoms of anxiety and/or depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and/or depression during the SDM process via semi structured interview
Time Frame: 6 months
Semi structured interviews will be qualitatively analysed via thematic analysis.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

University Hospitals, Leicester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 361194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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