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NCT04341233 Clinical Trial

Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

— ECAP  

Official title:
Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04341233
Other study ID # IRAS No: 265399
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date February 28, 2023

Study information
Verified date April 2020
Source NHS Lothian
Contact Neil McKay, Dr
Phone 01315371000
Email Neil.McKay@nhslothian.scot.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The 19.5 months project will pilot the introduction of a hospital-based, nurse-led ankylosing spondylitis (AS) and psoriatic arthritis (PsA) service for patients being initiated on biologic therapy in NHS Lothian Edinburgh Western General Hospital.

It is anticipated that this new model of care will improve:

1. The time from referral for biologic therapy to initiation of treatment with a biological therapy due to the dedicated nurse to see patients

2. The management and monitoring of AS and PsA patients post commencement of treatment , in line with The National Institute for Health and Care Excellence (NICE) guidelines

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 170
Est. completion date February 28, 2023
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of AS or PsA

- Referral for initiation of biological therapy by patients regular consultant

- Age 18 years or older

- Willing and able to give informed consent

Exclusion Criteria:

ยท Unable to comply with study procedures

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NHS Lothian

Outcome
Type Measure Description Time frame Safety issue
Primary Setup a nurse-led clinic Appointing a nurse and training in biologic and DMARD counselling, clinical measures and clinic administration. 3 months
Primary Develop and setup a tool, an NHS Lothian Excel database Database enables trust to record data on the time taken to commence treatment with a biologic therapy from the point of initial referral to biologic therapy. 19.5 months
Primary Develop and setup a tool, an NHS Lothian Excel database Database enables trust to audit the results of the existing service for AS and PsA patients within the department (based on a cohort of 60 patients most recently initiated on biologics treatment within the department). 19.5 months
Primary Develop and setup a tool, an NHS Lothian Excel database Database enables trust to audit the results of the implementation of the clinic within the department. 19.5 months
Primary Develop and setup a tool, an NHS Lothian Excel database Database enables trust to assist with demonstrating that the care of patients within the clinic is in accordance with the NICE clinical guidelines and that there has been a reduction in the time to initiate biologic therapy at the end of the project against the baseline assessment. 19.5 months
Primary Develop and setup a tool, an NHS Lothian Excel database Database enables trust to develop a patient referral pathway into a new model of AS and PsA patient care, specifically in the nurse-led clinic. 19.5 months
Primary Develop and setup a tool, an NHS Lothian Excel database Database enables trust to utilise the new nurse-led clinic to improve consistency of care by reviewing and optimising biologic therapy for all new AS and PsA patients within the department according to NICE guideline recommendations. 19.5 months
Primary Develop and setup a tool, an NHS Lothian Excel database Database enables trust to use the evaluated model of care to enable NHS Lothian to build an informed business case to fund the continuation of this service in the future and expand it to all patients in their current service. 19.5 months
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