Financial incentives to improve adherence to anti-psychotic medication

ISRCTN	ISRCTN77769281
DOI	https://doi.org/10.1186/ISRCTN77769281
Secondary identifying numbers	HTA 07/60/43

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stefan Priebe
Scientific

Academic Unit
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom

Study information

Study design	Multicentre cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	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 measures	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.
Overall study start date	01/09/2009
Completion date	30/11/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	136 patients from 34 assertive outreach teams
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

England
United Kingdom

Study participating centre

Newham Centre for Mental Health

London
E13 8SP
United Kingdom

Sponsor information

Barts and The London Queen Mary's School of Medicine and Dentistry (UK)
University/education

c/o Gerry Leonard
The Joint R&D Office
1st Floor Portakabins
24-26 Walden Street
Whitechapel
London
E1 2AN
England
United Kingdom

Website	http://www.smd.qmul.ac.uk/
"ROR"	https://ror.org/00b31g692

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	28/09/2009	Yes	No
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

Editorial Notes

30/09/2016: Publication reference added.
23/09/2016: Publication reference added.