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Financial incentives to improve adherence to anti-psychotic medication
ISRCTN ISRCTN77769281
DOI 10.1186/ISRCTN77769281
ClinicalTrials.gov identifier
EudraCT number
Public title Financial incentives to improve adherence to anti-psychotic medication
Scientific title Financial incentives to improve adherence to anti-psychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial
Acronym MfM
Serial number at source HTA 07/60/43
Study hypothesis 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.hta.ac.uk/1855
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Multicentre cluster randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Severe mental illness (psychosis)
Participants - 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
Participants - exclusion criteria 1. Learning difficulty
2. Poor command of English so that clinical communication and discussion of agreements is impaired
Anticipated start date 01/09/2009
Anticipated end date 30/11/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 136 patients from 34 assertive outreach teams
Interventions 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.
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.
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
2. Clinical improvement as assessed on the Clinical Global Impression Scale (CGI) by the treating consultant psychiatrist at the end of the 12-month period
3. Number of involuntary and voluntary hospital admissions during the trial period
4. Costs of care: data on the use and frequency of use of inpatient care, outpatient care (including home visits, home treatment), and other health services during the 12-month treatment period will be obtained from case notes and electronic administrative data bases. Costs for the intervention will be estimated for each participating team from information provided by staff. Established national unit costs will be used to estimate direct health care.
5. The number of attempted and completed suicides, incidences of physical violence, police arrests and days spent at work/training/education will also be recorded over the 12-month trial period
6. Subjective quality of life and satisfaction with medication which will be assessed at the beginning and end of the intervention period using the 11-item scale established in the DIALOG trial. The scale contains 11 items asking patients to rate their satisfaction with eight life domains and three treatment aspects, one of which is medication, on a scale ranging from 1 (lowest satisfaction) to 7 (highest satisfaction).
7. Continuation with MfM (in intervention group only) and adherence during a 6-month follow up period will be taken from the medical records
8. Teams in the intervention group will be asked after 6 months, 12 months and 18 months about all aspects of experiences with the scheme including whether patients on MfM asked for an increase of the incentive, and whether other patients with hitherto good adherence also asked for financial incentives and/or became poorly adherent in order to be eligible for MfM. This will be done using open questions with a written documentation of the answers.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19785727
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24100934
Contact name Prof  Stefan  Priebe
  Address Academic Unit
Newham Centre for Mental Health
Glen Road
  City/town London
  Zip/Postcode E13 8SP
  Country United Kingdom
Sponsor Barts and The London Queen Mary's School of Medicine and Dentistry (UK)
  Address c/o Gerry Leonard
The Joint R&D Office
1st Floor Portakabins
24-26 Walden Street
Whitechapel
  City/town London
  Zip/Postcode E1 2AN
  Country United Kingdom
  Sponsor website: http://www.smd.qmul.ac.uk/
Date applied 02/04/2009
Last edited 23/10/2013
Date ISRCTN assigned 06/04/2009
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