Reduction of overmedication in people with intellectual (learning) disabilities. Other
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: For different work packages (WP), there are different eligibility criteria. For WP2 randomisation (SPECTROM training), eligibility criteria are below: 1. Support staff, service managers, and PBS trainers working with adults with ID within Social Care provider organisations within a community setting. 2. Service care provider organisations that support adults with ID in a community setting. 3. Service care provider organisations located in England and Wales. For the WP4 mixed methods process evaluation, eligibility criteria are below: 1. Support staff and service managers who were in the SPECTROM arm of the trial. 2. Support staff and service managers who were in the control/TAU arm of the trial. 3. People with mild to moderate ID with good communication skills who resided in the homes where staff received SPECTROM training and their families. 4. People with ID who can provide informed consent. 5. Adults with ID aged 18 or over.
Exclusion criteria
Exclusion criteria: Different exclusion criteria for different WPs. For WP2 randomisation (SPECTROM training), exclusion criteria are below: 1. Support staff, service managers, and PBS trainers working solely with children with ID and/or within a hospital setting. 2. Service care provider organisations that do not support adults with ID. 3. Service care provider organisations located outside England and Wales. For WP4 mixed methods process evaluation, exclusion criteria are below: 1. People with ID and their families/advocates who were not involved in the SPECTROM project. 2. People with ID who do not have the capacity to consent. 3. Individuals with ID under the age of 18.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 06/03/2024: 1. Staff knowledge of psychotropic medicines measured using the Psychotropic Knowledge Questionnaire-Revised (PKQ-R) before and two weeks, three months, and six months after the training 2. Staff attitudes toward managing Behaviours that challenge (BtC) measured using the Management of Aggression and Violence Attitude Scale-Revised-ID (MAVAS-R-ID) will be used before and two weeks, three months, and six months after the training 3. The feasibility of implementing SPECTROM resources within the care service provider organisation’s existing programme will be measured by a monthly SPECTROM Implementation Log for six months 4. The acceptability and relevance of SPECTROM training to staff practice will be measured using the Trainee Feedback Questionnaire (TFQ) before and after the training at two weeks, three months, and six months 5. Anonymised prescription data from randomised services will be used to calculate the sample size for a future RCT involving SPECTROM training 6. The barriers and facilitators of SPECTROM training will be assessed using focus groups, interviews, and questionnaires at a six-month follow-up Previous primary outcome measures: 1. Staff knowledge of psychotropic medications measured using the Psychotropic Knowledge Questionnaire-Revised (PKQ-R) before and after the training at 2 weeks, 3 months and 6 months 2. Staff attitude toward the management of Behaviours that challenge (BtC) measured using the Management of Aggression and Violence Attitude Scale-Revised-ID (MAVAS-R-ID) before and after the training at 2 weeks, 3 months and 6 months 3. The feasibility of SPECTROM Implementation within the care service provider organisation’s existing training programme measured using the SPECTROM Implementation Log at the end of the study 4. SPECTROM acceptability and relevance measured using Trainee Feedback Questionnaire (TFQ) before and after the training at 2 weeks, 3 months and 6 months 5. Sample size ca | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/03/2024: 1. The recruitment rate, attrition and randomisation measured using research data at six months follow-up 2. The potential number of residents in each community home receiving psychotropics for BtC measured using research data at the end of the study 3. The feasibility of remote anonymised prescription data collection will be assessed by asking service managers from community homes to provide these data throughout the study 4. The ‘training the trainer’ model will be assessed from the number of such successful training sessions at the end of the study 5. The process evaluation interviews with people with ID and their families will be used to assess the best way to involve them in future RCT. Contamination between the two arms (if any) will be measured using focus group with staff from the control arm at the end of the study Previous secondary outcome measures: 1. Assessment of the feasibility of recruitment and randomisation measured using research data at the end of the study 2. Assessment of the feasibility of train the trainer model measured using research data at the end of the study 3. Assessment of the feasibility of anonymised remote prescription data collection from community homes measured using research data at the end of the study 4. Impact of training staff in SPECTROM measured using mixed methods process evaluation of questionnaires and conducting a focus group after training is complete 5. Assess how best to involve adults with ID and their families in the future RCT using research data at the end of the study 6. Assess the potential number of residents in each community home receiving psychotropics for Behaviours that challenge (BtC) using anonymised prescription proforma at the end of the study | — |
Countries
England, United Kingdom, Wales