Development and preliminary evaluation of a Medication Review Tool for people taking antipsychotic medication

Plain English Summary

Background and study aims
Antipsychotic drugs are the main drugs prescribed to people who suffer from psychosis or schizophrenia. They can help reduce symptoms and rates of relapse, but they have some significant unpleasant and harmful effects. Existing research suggests that people are more troubled by the adverse physical and mental effects of drug treatment than professionals recognise and these effects reduce the overall quality of life. Despite these concerns, patients’ experiences of taking antipsychotic drugs have received little attention. Research on shared decision making for people with depression and schizophrenia shows benefits in patient participation, satisfaction, improved adherence and symptoms. A government report has highlighted that people should be more fully involved in their medication reviews and that there is a need for a more systematic consideration of the pros and cons of taking the medication, to improve their satisfaction, attitudes to treatment, adherence and rates of relapses. Furthermore, guidelines on the treatment of schizophrenia have also emphasised the importance of doctors and patients making joint decisions about their drug treatment, based on informed discussions. However, little research has been done on the process of making decisions in antipsychotic medication.
The first part of the study consisted of a survey of the views of people who are taking or have taken antipsychotic medications. People were asked about the main benefits and harms they experience when taking antipsychotic medication, as well as how much they are able to participate in discussions about medication with doctors and professionals, whether they are able to express their views and how far their views are taken into consideration. All this information was then used to construct a ‘Medication Review Tool’. This is an instrument to help people weigh up the likely benefits and harms of taking various types of antipsychotic drugs, so they can participate more fully in discussions and decisions about their medication. This study will assess whether using the Medication Review Tool helps people to participate more fully in discussions about medication, whether it changes people's attitudes to medication, and whether people are more or less likely to take the medication that is prescribed. It will also look at whether using the Medication Review Tool helps improve prescribing and whether it reduces side effects. The study will also explore the experiences of people who take or have taken antipsychotic drugs and assess which positive and negative effects are most important to them. This is an initial study which means that one aim of the study is to see if it is worthwhile conducting a larger study in the future.

Who can take part?
Adults aged 18 years or over who have a diagnosis of schizophrenia, psychosis or affective disorder (depression or mania) with psychotic symptoms that are currently on antipsychotic medication.

What does the study involve?
Participants will be randomly allocated to one of two groups: use the Medication Review Tool in their consultations with the psychiatrist or continue to receive their usual treatment. We will compare the two groups to see if using the Medication Review Tool helps participants to highlight their concerns and make decisions about their antipsychotic medication.

What are the potential benefits and risks to the participants?
The participants will have the opportunity to discuss any issues regarding side effects of their medication and to express their concerns about the medication that they may not have had the opportunity to do so previously. Overall, the direct risks of participation are minimal. It is however possible that answering particular questions, describing certain aspects of their mental disorder and/or side effects of the medication may cause some distress or feelings of embarrassment to some participants. It is hoped that this will be minimized by the experience and sensitivity of the researcher. Furthermore, if participants report suicidal thoughts, we will flag these up and encourage participants to seek help from their local doctor or health service. Participants may also find the interviews inconvenient and some may find it difficult to sustain their concentration or interest for as long as the interview requires. To minimize these inconveniences, interviews will be contacted at a place and time convenient to the participant and they will be informed that the interviews can be terminated if they feel unable to continue with them.

When does the study take place?
September 2012 to June 2014

Where does the study take place?
North East London NHS Foundation Trust (UK)

Who is funding the project?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Ms Kiran Azam, Research Assistant (kiran.azam@nelft.nhs.uk)
2. Dr Joanna Moncrieff, Principle Investigator (j.moncrieff@ucl.ac.uk)

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

North East London NHS Foundation Trust (UK)
Hospital/treatment centre

Goodmayes Hospital
157 Barley Lane
Ilford
London
IG3 8XJ
England
United Kingdom

"ROR"	https://ror.org/023e5m798

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

13/03/2020: Internal review.
06/07/2016: Publication reference added.