Abstract
Background
Overmedication of people with intellectual disabilities, particularly the off-licence use of psychotropic medicines for behaviours that challenge (BtC), is a significant public health concern. To address this issue, NHS England in the UK launched an initiative called ‘STopping Over-Medication of People with learning disabilities, autism or both (STOMP)’. However, limited resources are available to implement STOMP. Staff who support adults with intellectual disabilities play a pivotal role in the prescribing process. Thus, properly training staff should reduce the number of staff requests for medicines for BtC. Previous field tests on SPECTROM (N=60) showed a positive impact, but none of these were RCTs. Thus, there is a need for a feasibility RCT before a large-scale RCT.
Aims
The primary aim of the study was to evaluate the feasibility of conducting an appropriately powered cluster randomised controlled trial (RCT) involving SPECTROM.
Methods
Clusters (community homes and supported living accommodations) were randomised to SPECTROM or the control arm in a 2:1 ratio. Only participants in the SPECTROM arm received the SPECTROM training. Both groups received the standard training from their organisations. SPECTROM is a hybrid/blended learning program comprising 14 modules and includes internal and external resources. Two of these 14 modules were used for face-to-face training, through which the other modules and resources were introduced. These two core modules are Medicine/STOMP and Alternatives to medication (ATM). Anonymised psychotropic medicine prescriptions were collected pre and post-training at six months to detect any signal of SPECTROM’s effect. Changes in staff attitude toward BtC and psychotropic knowledge were assessed by analysing pre- and post-training data at 4 weeks and 6 months using the Management of Aggression and Violence Attitudes Scale-Revised-Intellectual Disabilities (MAVAS-R-ID) and the Psychotropic Knowledge Questionnaire-Revised (PKQ-R). A mixed-methods process evaluation involving a questionnaire and two focus groups, one with service managers (n = 7) and one with support staff (n = 7), was conducted to assess the barriers and facilitators of SPECTROM training.
Results
26 homes were randomised to the SPECTROM and 13 in the control arm. SPECTROM training was delivered to 140 staff. The training sessions were delivered online via MS Teams by the research team, each lasting 4 hours. There was a greater total antipsychotic and antidepressant dose reduction at the six-month follow-up in the SPECTROM (7.5% and 2.4%, respectively) compared to the control arm (2.7% and 1.2%, respectively). There was a significant improvement in the overall PKQ-R scores (p<0.001) and MAVAS-R-ID scores at four weeks (p<0.01). The change-over-time analysis revealed a significant difference in mean scores across three different time points for both PKQ-R and MAVAS-R-ID scores (p < 0.001). The focus groups identified the following themes: a) improved knowledge, b) improved self-confidence, c) facilitated self-reflection, d) empowered staff to advocate for people they support, e) better attitude on medicine use for BtC, f) improved the support they provide, and (g) challenges of SPECTROM training.
Conclusion
The findings of this feasibility study support progression to a larger and more definitive RCT.
Overmedication of people with intellectual disabilities, particularly the off-licence use of psychotropic medicines for behaviours that challenge (BtC), is a significant public health concern. To address this issue, NHS England in the UK launched an initiative called ‘STopping Over-Medication of People with learning disabilities, autism or both (STOMP)’. However, limited resources are available to implement STOMP. Staff who support adults with intellectual disabilities play a pivotal role in the prescribing process. Thus, properly training staff should reduce the number of staff requests for medicines for BtC. Previous field tests on SPECTROM (N=60) showed a positive impact, but none of these were RCTs. Thus, there is a need for a feasibility RCT before a large-scale RCT.
Aims
The primary aim of the study was to evaluate the feasibility of conducting an appropriately powered cluster randomised controlled trial (RCT) involving SPECTROM.
Methods
Clusters (community homes and supported living accommodations) were randomised to SPECTROM or the control arm in a 2:1 ratio. Only participants in the SPECTROM arm received the SPECTROM training. Both groups received the standard training from their organisations. SPECTROM is a hybrid/blended learning program comprising 14 modules and includes internal and external resources. Two of these 14 modules were used for face-to-face training, through which the other modules and resources were introduced. These two core modules are Medicine/STOMP and Alternatives to medication (ATM). Anonymised psychotropic medicine prescriptions were collected pre and post-training at six months to detect any signal of SPECTROM’s effect. Changes in staff attitude toward BtC and psychotropic knowledge were assessed by analysing pre- and post-training data at 4 weeks and 6 months using the Management of Aggression and Violence Attitudes Scale-Revised-Intellectual Disabilities (MAVAS-R-ID) and the Psychotropic Knowledge Questionnaire-Revised (PKQ-R). A mixed-methods process evaluation involving a questionnaire and two focus groups, one with service managers (n = 7) and one with support staff (n = 7), was conducted to assess the barriers and facilitators of SPECTROM training.
Results
26 homes were randomised to the SPECTROM and 13 in the control arm. SPECTROM training was delivered to 140 staff. The training sessions were delivered online via MS Teams by the research team, each lasting 4 hours. There was a greater total antipsychotic and antidepressant dose reduction at the six-month follow-up in the SPECTROM (7.5% and 2.4%, respectively) compared to the control arm (2.7% and 1.2%, respectively). There was a significant improvement in the overall PKQ-R scores (p<0.001) and MAVAS-R-ID scores at four weeks (p<0.01). The change-over-time analysis revealed a significant difference in mean scores across three different time points for both PKQ-R and MAVAS-R-ID scores (p < 0.001). The focus groups identified the following themes: a) improved knowledge, b) improved self-confidence, c) facilitated self-reflection, d) empowered staff to advocate for people they support, e) better attitude on medicine use for BtC, f) improved the support they provide, and (g) challenges of SPECTROM training.
Conclusion
The findings of this feasibility study support progression to a larger and more definitive RCT.
| Original language | English |
|---|---|
| Publisher | NIHR Open Research |
| Number of pages | 20 |
| DOIs | |
| Publication status | Published - 8 Sept 2025 |
