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NCT06238089 Clinical Trial

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
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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