Financial incentives to improve adherence to anti-psychotic medication
| ISRCTN | ISRCTN77769281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77769281 |
| Protocol serial number | HTA 07/60/43 |
| Sponsor | Barts and The London Queen Mary's School of Medicine and Dentistry (UK) |
| Funder | Health Technology Assessment Programme |
- Submission date
- 02/04/2009
- Registration date
- 06/04/2009
- Last edited
- 30/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Academic Unit
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial |
| Study acronym | MfM |
| Study objectives | The objective of the study is to establish the effectiveness and cost-effectiveness of using financial incentives to improve adherence to anti-psychotic maintenance medication in patients with poor adherence with whom all conventional methods to achieve adherence have failed. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/076043 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/51902/PRO-07-60-43.pdf |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Severe mental illness (psychosis) |
| Intervention | Patients in the assertive outreach teams that have been allocated to the intervention will be offered a financial incentive for each depot injection of anti-psychotic medication they receive, for a 12-month period. Patients will receive £15 for one injection with the total sum not exceeding £60 for a four-week period (the maximum number of injections is 4 per month). The control group will receive treatment as usual. The total duration of the intervention will be 12 months with a 6-month follow-up period. |
| Intervention type | Other |
| Primary outcome measure(s) |
Adherence to anti-psychotic maintenance medication during the 12-month trial period. Adherence will be measured, objectively, as the percentage of prescribed depot injections actually taken. As the primary outcome, the percentage will be used as a continuous variable. However, we will also analyse the percentage in a dichotomised way, comparing the ratio of patients with 'good' adherence (i.e., greater than or equal to 80% of prescribed depots taken) in the two conditions. |
| Key secondary outcome measure(s) |
1. The time 'slippage' of taking depots, defined as the percentage of the prescribed time interval that has expired before the depot is taken |
| Completion date | 30/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 136 |
| Key inclusion criteria | The only inclusion criterion for teams is that they are a dedicated assertive outreach team (AOT) and operate a corresponding policy. The only exclusion criteria are lack of willingness to participate and an already existing practice of money for medication (MfM). For patients in the AOTs there are the following inclusion criteria: 1. Being cared in the AOT for at least 4 months 2. Aged between 18 and 65 years of age, either sex 3. Capacity to give informed consent to participate in the study and actual written informed consent 4. An established diagnosis of schizophrenia, schizo-affective psychosis, or bipolar illness according to the International Classification of Diseases, 10th Edition (ICD-10) 5. Being prescribed depot injections of anti-psychotic medication 6. Poor adherence to anti-psychotic medication, i.e., missed 50% or more of prescribed depot injections, over the last 4 months (so that the percentage of taken depots is based on a minimum of 4 prescribed depots) 7. Failure of all other methods available to the team to ensure adherence to medication |
| Key exclusion criteria | 1. Learning difficulty 2. Poor command of English so that clinical communication and discussion of agreements is impaired |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 30/11/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
E13 8SP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/10/2013 | Yes | No | |
| Results article | results | 01/04/2015 | Yes | No | |
| Results article | results | 01/08/2015 | Yes | No | |
| Results article | results | 08/10/2015 | Yes | No | |
| Results article | results | 01/09/2016 | Yes | No | |
| Results article | results | 21/09/2016 | Yes | No | |
| Protocol article | protocol | 28/09/2009 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/09/2016: Publication reference added.
23/09/2016: Publication reference added.