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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients

Aged ≥65 years old

CLTI

Active symptoms of anxiety or depression (clinician concern)

Disqualifiers

Patients

Palliative - death anticipated within one month

Clinical and research team identify as lacking capacity to participate

Carers

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: 15 patients/carers with CLTI >=65 with symptoms of anxiety and/or depression

Trial outcomes

Primary outcomes

1

Anxiety and/or depression during the SDM process via semi structured interview

Semi structured interviews will be qualitatively analysed via thematic analysis.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

University Hospitals, Leicester

Collaborator

This trial is not recruiting at the moment. You can still explore other options: