Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis (ECAP)

April 7, 2020 updated by: NHS Lothian

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

170

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

Study Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of ankylosing spondylitis or psoriatic arthritis requiring initiation of biologic therapy.

Description

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:

· Unable to comply with study procedures

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Setup a nurse-led clinic
Time Frame: 3 months
Appointing a nurse and training in biologic and DMARD counselling, clinical measures and clinic administration.
3 months
Develop and setup a tool, an NHS Lothian Excel database
Time Frame: 19.5 months
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
Develop and setup a tool, an NHS Lothian Excel database
Time Frame: 19.5 months
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
Develop and setup a tool, an NHS Lothian Excel database
Time Frame: 19.5 months
Database enables trust to audit the results of the implementation of the clinic within the department.
19.5 months
Develop and setup a tool, an NHS Lothian Excel database
Time Frame: 19.5 months
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
Develop and setup a tool, an NHS Lothian Excel database
Time Frame: 19.5 months
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
Develop and setup a tool, an NHS Lothian Excel database
Time Frame: 19.5 months
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
Develop and setup a tool, an NHS Lothian Excel database
Time Frame: 19.5 months
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

Collaborators and Investigators

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

Sponsor

NHS Lothian

Investigators

  • Principal Investigator: Neil McKay, Dr, NHS Lothian

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.

Helpful Links

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 (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS No: 265399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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