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

NCT06238089 | Unknown

• 3 other identifiers: 4548TRUST/VC/AC/SG/6328-9580331470
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Intellectual Disability

Keywords

Intellectual Disability; Learning Disability; Anti-psychotic treatments; Over-prescribing; Psychotropic

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Number (%) of PwID successfully identified who have been prescribed more than 2 anti-psychotic medications yearly over 7.

  Through study completion, an average of 6 months

• Number (%) of PwID with a complete data set.

  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.

  Through study completion, an average of 6 months

Study Arms (7)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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))

You may not qualify if:

• Patients treated with Clozapine
• Under the age of 18 years

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (8)

Cheshire and Wirral Partnership NHS Foundation Trust

Chester, United Kingdom

RECRUITING

Coventry and Warwickshire Partnership NHS Trust

Coventry, United Kingdom

NOT YET RECRUITING

Hertfordshire Partnership University NHS Foundation Trust

Hatfield, United Kingdom

NOT YET RECRUITING

Leicestershire Partnership NHS Trust

Leicester, United Kingdom

RECRUITING

Central and North West London NHS Foundation Trust

London, United Kingdom

RECRUITING

North East London NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

Cornwall Partnership NHS Foundation Trust

Redruth, United Kingdom

NOT YET RECRUITING

Swansea Bay University Health Board

Swansea, United Kingdom

RECRUITING

Related Publications (12)

• 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.

  PMID: 35249557 BACKGROUND

• 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.

  PMID: 35431024 BACKGROUND

• 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.

  PMID: 33118913 BACKGROUND

• 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.

  PMID: 34865678 BACKGROUND

• 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.

  PMID: 27460622 BACKGROUND

• 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.

  PMID: 23845387 BACKGROUND

• 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.

  PMID: 31192534 BACKGROUND

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

  BACKGROUND

• 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).

  BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

• Stanyard E, Neilens H, Allgar V, Bailey M, Musicha C, Purandare K, Perera B, Roy A, Sawhney I, Watkins L, Jaydeokar S, Lennard S, Mitchell S, McGowan P, Laugharne R, Tromans SJ, Shankar R. A novel way to understand and communicate the burden of AntiPsycHotic prescribing for adults across specialist Intellectual Disability services in England and Wales: the APHID feasibility study protocol. Front Health Serv. 2025 May 9;5:1393805. doi: 10.3389/frhs.2025.1393805. eCollection 2025.

  PMID: 40416595 DERIVED

MeSH Terms

Conditions

Intellectual Disability; Learning Disabilities

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders

Study Officials

• Professor Shankar

  University of Plymouth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Shankar

CONTACT

+44 (0) 1752 439831; rohit.shankar@plymouth.ac.uk

Emily Stanyard

CONTACT

+44 (0) 1752 439831; emily.stanyard@plymouth.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Neuropsychiatry

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 2, 2024
• Study Start: December 19, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (8)