Anti-psychotic Drug Prescribing Patterns Within Specialist Adult ID Services in England and Wales

Intellectual Disability Clinical Trial

— APHID  

Official title:

A Novel Way to Understand and Communicate the Burden of Antipsychotic Prescribing for Adults Across Specialist Intellectual Disability Services in England and Wales.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238089
• Other study ID #: 4548
• Secondary ID: TRUST/VC/AC/SG/6
• Status: Recruiting
• Start date: December 19, 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: University of Plymouth
• Contact: Professor Shankar
• Phone: +44 (0) 1752 439831
• Email: rohit.shankar[@]plymouth.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The overall aim of this observational study is to establish the anti-psychotic prescribing patterns across specialist intellectual disability (ID) services in England and Wales by collecting cross-sectional retrospective data at 7 annual time-points (1st July) from 2017 to 2023.

Description:

Feasibility protocol objectives:

1. Is it feasible to identify People with Intellectual Disabilities (PwID) who have been prescribed 2 or more anti-psychotic medications over 7 years retrospectively.

2. It is possible to obtain a complete data set for each patient identified and therefore be able to explore the prescribing patterns across the eight sites.

3. Is it feasible to quantify anti-psychotic treatment (APT) prescribing in PwID as chlorpromazine equivalent dose values across different healthcare Trusts in England and Wales.

Main objectives:

4. To explore yearly and overall prescribing patterns among PwID (with or without mental-health reasons (psychiatric co-morbidities)) in receipt of ≥2 forms of anti-psychotic treatment (multiple) over time?

5. How has multiple anti-psychotic treatment prescribing changed between 2017 and 2023 using chlorpromazine equivalent dose values, in PwID with mental health and no mental health indications?

6. What has been the impact of the COVID-19 pandemic (and corresponding lockdown restrictions in England and Wales) on multiple anti-psychotic treatment prescribing among PwID?

7. Can the NHS England Statistical Process Control tool (SPC) be utilised to track yearly anti-psychotic treatment prescribing among PwID receiving multiple forms of anti-psychotic treatment, and monitor variation between services (sites) and patient groups (e.g. psychiatric co-morbidities; challenging behaviour).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient had psychiatric review by specialist adult ID services in the last year (e.g. for a patient to be included at 1st June 2017, data to be recorded from the most recent psychiatric review within the period between 1st January 2017 - 31st December 2017).

• Patient has a diagnosis of ID

• Patient under the care of specialist adult ID services

• Patient on >2 anti-psychotic treatments (oral and IM injectable (depots))

Exclusion Criteria:

• Patients treated with Clozapine

• Under the age of 18 years

Related Conditions & MeSH terms

• Intellectual Disability

Locations

Country	Name	City	State
United Kingdom	Cheshire and Wirral Partnership NHS Foundation Trust	Chester
United Kingdom	Coventry and Warwickshire Partnership NHS Trust	Coventry
United Kingdom	Hertfordshire Partnership University NHS Foundation Trust	Hatfield
United Kingdom	Leicestershire Partnership NHS Trust	Leicester
United Kingdom	Central and North West London NHS Foundation Trust	London
United Kingdom	North East London NHS Foundation Trust	London
United Kingdom	Cornwall Partnership NHS Foundation Trust	Redruth
United Kingdom	Swansea Bay University Health Board	Swansea

Sponsors (2)

Lead Sponsor	Collaborator
University of Plymouth	Peninsula Clinical Trials Unit

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

Branford D, Shankar R. Antidepressant prescribing for adult people with an intellectual disability living in England. Br J Psychiatry. 2022 Aug;221(2):488-493. doi: 10.1192/bjp.2022.34. — View Citation

Howkins J, Hassiotis A, Bradley E, Levitas A, Sappok T, Sinai A, Thakur A, Shankar R. International clinician perspectives on pandemic-associated stress in supporting people with intellectual and developmental disabilities. BJPsych Open. 2022 Apr 18;8(3):e84. doi: 10.1192/bjo.2022.49. — View Citation

Leucht S, Samara M, Heres S, Davis JM. Dose Equivalents for Antipsychotic Drugs: The DDD Method. Schizophr Bull. 2016 Jul;42 Suppl 1(Suppl 1):S90-4. doi: 10.1093/schbul/sbv167. — View Citation

Mehta H, Glover G. Psychotropic drugs and people with learning disabilities or autism, 2019. Public Health England.

Naqvi D, Perera B, Mitchell S, Sheehan R, Shankar R. COVID-19 pandemic impact on psychotropic prescribing for adults with intellectual disability: an observational study in English specialist community services. BJPsych Open. 2021 Dec 6;8(1):e7. doi: 10.1192/bjo.2021.1064. — View Citation

National Health Service. Statistical process control tool. https://www.england.nhs.uk/statisticalprocess-control-tool/ [Accessed 15th December 2023].

National Health Service. Stopping over medication of people with a learning disability, autism or both (STOMP). NHS England " Stopping over medication of people with a learning disability, autism or both (STOMP) [Accessed 15th December 2023).

Patel MX, Arista IA, Taylor M, Barnes TR. How to compare doses of different antipsychotics: a systematic review of methods. Schizophr Res. 2013 Sep;149(1-3):141-8. doi: 10.1016/j.schres.2013.06.030. Epub 2013 Jul 8. — View Citation

Shankar R, Wilcock M, Deb S, Goodey R, Corson E, Pretorius C, Praed G, Pell A, Vujkovic D, Wilkinson E, Laugharne R, Axby S, Sheehan R, Alexander R. A structured programme to withdraw antipsychotics among adults with intellectual disabilities: The Cornwall experience. J Appl Res Intellect Disabil. 2019 Nov;32(6):1389-1400. doi: 10.1111/jar.12635. Epub 2019 Jun 13. — View Citation

Taylor DM, Barnes TR and Young AH. The Maudsley prescribing guidelines in psychiatry. 13th ed. West Sussex: Wiley-Blackwell; 2018.

Tromans S, Kinney M, Chester V, Alexander R, Roy A, Sander JW, Dudson H, Shankar R. Priority concerns for people with intellectual and developmental disabilities during the COVID-19 pandemic. BJPsych Open. 2020 Oct 29;6(6):e128. doi: 10.1192/bjo.2020.122. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number (%) of PwID successfully identified who have been prescribed more than 2 anti-psychotic medications yearly over 7.	Feasibility objective: Is it feasible to identify PwID who have been prescribed 2 or more anti-psychotic medications over 7 years retrospectively?	Through study completion, an average of 6 months
Other	Number (%) of PwID with a complete data set.	Feasibility objective: Is it possible to obtain a complete data set for each patient identified and therefore be able to explore the prescribing patterns across the eight sites?	Through study completion, an average of 6 months
Other	Number (%) for whom it was feasible to quantify oral and depots anti-psychotic treatment prescribing in PwID as chlorpromazine equivalent dose values across different healthcare trusts in England and Wales.	Feasibility objective: Is it feasible to quantify anti-psychotic treatment (oral and long-acting IM injectables (depots) prescribing in PwID as chlorpromazine equivalent dose values across different healthcare Trusts in England and Wales?	Through study completion, an average of 6 months
Primary	The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment across the 7-annual timepoints and across the 8 sites.	Main objective: To explore yearly and overall prescribing patterns among PwID (with or without mental-health reasons (psychiatric co-morbidities)) in receipt of =2 forms of anti-psychotic treatment (multiple) over time.	2017-2023
Primary	The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment, with mental health indications, compared to those with no mental health indications between 2017 and 2023.	Main objective: How has multiple anti-psychotic treatment prescribing changed between 2017 and 2023 using chlorpromazine equivalent dose values, in PwID with mental health and no mental health indications?	2017-2023
Primary	The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment before, during and after the COVID-19 pandemic.	Main objective: What has been the impact of the COVID-19 pandemic (and corresponding lockdown restrictions in England and Wales) on multiple anti-psychotic treatment prescribing among PwID?	2017-2023
Primary	SPC will be used to compare trends in multiple APT prescribing within/across participating healthcare trusts and utilised to track yearly oral/depots anti-psychotic treatment prescribing and monitor variation between services & patient groups.	Main objective: Can the SPC be utilised to track yearly anti-psychotic treatment prescribing among PwID receiving multiple forms of anti-psychotic treatment, and monitor variation between services (sites) and patient groups (e.g. psychiatric co-morbidities; challenging behaviour)?	2017-2023