Clinical trial NCT06238089: Anti-psychotic Drug Prescribing Patterns Within Specialist Adult ID Services in England and Wales
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intellectual Disability
Keywords: Intellectual Disability
Learning Disability
Anti-psychotic treatments
Over-prescribing
Psychotropic
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment across the 7-annual timepoints and across the 8 sites.
timeFrame: 2017-2023
measure: 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.
timeFrame: 2017-2023
measure: The differences in chlorpromazine equivalent dose values in PwID prescribed multiple anti-psychotic treatment before, during and after the COVID-19 pandemic.
timeFrame: 2017-2023
measure: 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.
timeFrame: 2017-2023
Secondary outcomes:
Other outcomes:
measure: Number (%) of PwID successfully identified who have been prescribed more than 2 anti-psychotic medications yearly over 7.
timeFrame: Through study completion, an average of 6 months
measure: Number (%) of PwID with a complete data set.
timeFrame: Through study completion, an average of 6 months
measure: 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.
timeFrame: Through study completion, an average of 6 months
Locations:
city: Chester
country: United Kingdom
facility: Cheshire and Wirral Partnership NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: Coventry and Warwickshire Partnership NHS Trust
city: Hatfield
country: United Kingdom
facility: Hertfordshire Partnership University NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: Leicestershire Partnership NHS Trust
city: London
country: United Kingdom
facility: Central and North West London NHS Foundation Trust
city: London
country: United Kingdom
facility: North East London NHS Foundation Trust
city: Redruth
country: United Kingdom
facility: Cornwall Partnership NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: Swansea Bay University Health Board
Study officials:
affiliation: University of Plymouth
name: Professor Shankar
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.
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.
citation: 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.
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.
citation: Mehta H, Glover G. Psychotropic drugs and people with learning disabilities or autism, 2019. Public Health England.
citation: 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).
citation: Taylor DM, Barnes TR and Young AH. The Maudsley prescribing guidelines in psychiatry. 13th ed. West Sussex: Wiley-Blackwell; 2018.
citation: National Health Service. Statistical process control tool. https://www.england.nhs.uk/statisticalprocess-control-tool/ [Accessed 15th December 2023].