NCT07529886

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Guy's and St Thomas' NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Critical Limb Threatening Ischaemia
• Depression Disorder
• Anxiety

Timeline

• Start date: 2026-06-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-17

Locations

1 site across 1 country: United Kingdom