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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intellectual Disability

Detailed 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).

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Professor Shankar; Phone Number: +44 (0) 1752 439831; Email: rohit.shankar@plymouth.ac.uk
• Study Contact Backup: Name: Emily Stanyard; Phone Number: +44 (0) 1752 439831; Email: emily.stanyard@plymouth.ac.uk

Study Locations

• United Kingdom
  • Chester, United Kingdom
    • Recruiting
    • Cheshire and Wirral Partnership NHS Foundation Trust
    • Principal Investigator: Sujeet Jaydeokar
  • Coventry, United Kingdom
    • Not yet recruiting
    • Coventry and Warwickshire Partnership NHS Trust
    • Principal Investigator: Ashok Roy
  • Hatfield, United Kingdom
    • Not yet recruiting
    • Hertfordshire Partnership University NHS Foundation Trust
    • Principal Investigator: Indermeet Sawhney
  • Leicester, United Kingdom
    • Recruiting
    • Leicestershire Partnership NHS Trust
    • Principal Investigator: Samuel Tromans
  • London, United Kingdom
    • Recruiting
    • Central and North West London NHS Foundation Trust
    • Principal Investigator: Kiran Purandare
  • London, United Kingdom
    • Not yet recruiting
    • North East London NHS Foundation Trust
    • Principal Investigator: Bhathika Perera
  • Redruth, United Kingdom
    • Not yet recruiting
    • Cornwall Partnership NHS Foundation Trust
    • Principal Investigator: Richard Laugharne
  • Swansea, United Kingdom
    • Recruiting
    • Swansea Bay University Health Board
    • Principal Investigator: Lance Watkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with Intellectual Disabilities under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
Eligible patients who have had a psychiatric review by specialist adult ID services in 2017.; Adults with an intellectual disability who are under the care of ID services in receipt of >2 oral and/or long-acting intra-muscular (IM) injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2017.
Eligible patients who have had a psychiatric review by specialist adult ID services in 2018.; Adults with an intellectual disability who are under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2018.
Eligible patients who have had a psychiatric review by specialist adult ID services in 2019.; Adults with an intellectual disability who are under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2019.
Eligible patients who have had a psychiatric review by specialist adult ID services in 2020.; Adults with an intellectual disability who are under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2020.
Eligible patients who have had a psychiatric review by specialist adult ID services in 2021.; Adults with an intellectual disability who are under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2021.
Eligible patients who have had a psychiatric review by specialist adult ID services in 2022.; Adults with an intellectual disability who are under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2022.
Eligible patients who have had a psychiatric review by specialist adult ID services in 2023.; Adults with an intellectual disability who are under the care of ID services in receipt of >2 oral and/or long-acting IM injectable anti-psychotic treatments (depots), who have had a psychiatric review by specialist adult ID services in 2023.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Plymouth
• Collaborators: Peninsula Clinical Trials Unit
• Investigators: Principal Investigator: Professor Shankar, University of Plymouth

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Mehta H, Glover G. Psychotropic drugs and people with learning disabilities or autism, 2019. Public Health England.
• 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).
• Taylor DM, Barnes TR and Young AH. The Maudsley prescribing guidelines in psychiatry. 13th ed. West Sussex: Wiley-Blackwell; 2018.
• National Health Service. Statistical process control tool. https://www.england.nhs.uk/statisticalprocess-control-tool/ [Accessed 15th December 2023].

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Psychotropic; Intellectual Disability; Learning Disability; Anti-psychotic treatments; Over-prescribing
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: 4548; TRUST/VC/AC/SG/6328-9580 (Other Grant/Funding Number: The Baily Thomas Charitable Fund); 331470 (Other Identifier: IRAS)

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