An intervention to improve psychiatrist-patient communication
| ISRCTN | ISRCTN94846422 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94846422 |
| Secondary identifying numbers | PB-PG-0408-16279 |
- Submission date
- 30/11/2009
- Registration date
- 15/01/2010
- Last edited
- 29/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The benefit of psychiatric treatment is strongly influenced by the quality of the relationship between the psychiatrist and the patient. This can be an even stronger effect than the effect of medication or other treatments. The quality of psychiatrist-patient communication also influences adherence to treatment. However, communication often breaks down in consultations with psychotic patients because their unusual experiences (e.g., hallucinations, delusions) lie outside of ordinary human experience. Until recently, there was a lack of evidence about good communication with such patients. In previous studies we have shown that effective psychiatrist communication with psychotic patients depends on how well psychiatrists try to understand the patient’s psychotic experiences. Moreover, we have shown that this leads to a better patient outcome (i.e., higher patient satisfaction), a better therapeutic relationship and treatment adherence, and fewer relapses. We will use our findings to develop a new intervention to train psychiatrists in communicating with patients who experience hallucinations and delusions. The training package will be developed with and delivered in collaboration with service users and psychiatrists. Psychiatrists will learn specific communicative strategies to help them reach a shared understanding with their patients about psychotic symptoms. We will test the training package to assess feasibility and determine how we could conduct a larger study using these methods. We will identify whether psychiatrists can improve their communication skills through training, whether they can use these skills appropriately in consultations with psychotic patients, and whether this improves patient clinical outcomes.
Who can participate?
Higher/advanced psychiatric trainees and patients aged 18 - 65 with schizophrenia or schizoaffective disorder.
What does the study involve?
Psychiatrists are randomly allocated to one of two groups. One group undergoes the training programme and the other does not. The training programme consists of four training sessions taking place one week apart and lasting 4 hours each. During the training period, at least one consultation with a participating patient per psychiatrist is recorded for training purposes. These consultations are viewed and psychiatrists receive and discuss feedback in the training sessions. There are also follow-up sessions four and eight weeks after the fourth training session. At the end of the training the next consultation between each participating psychiatrist and patient is recorded and assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Newham Centre for Mental Health, East London NHS Foundation Trust and North East London NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2010 to March 2013
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Rose McCabe
r.mccabe@qmul.ac.uk
Contact information
Scientific
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0003-2041-7383 |
|---|---|
| r.mccabe@qmul.ac.uk |
Study information
| Study design | Exploratory 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 contact details to request a participant information sheet |
| Scientific title | Developing and piloting a new intervention to improve psychiatrist-patient communication about psychosis: an exploratory cluster-randomised controlled trial |
| Study objectives | We wish to address the following research questions: 1. Can psychiatrists learn to use a particular communicative mechanism (repair) to communicate more effectively with patients with psychosis? 2. Can they apply this new way of communicating with their patients? 3. Does it have an effect on the following intermediate outcomes: psychiatrist confidence in communicating with psychotic patients, patient experience of the communication and patient centredness in the first consultation with each relevant patient after the 12 week training period 4. Does it have an effect on the following patient clinical outcomes: patient satisfaction with treatment, the therapeutic relationship, treatment adherence and relapse at 6 months follow-up |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Schizophrenia/schizoaffective disorder |
| Intervention | Psychiatrists will be randomised to the intervention group (training programme) or control group (no training programme). Training programme: The proposed training programme is as follows. Training will be provided by the lead applicant, a psychiatrist and a service user in interactive groups with a maximum of 6 psychiatrists per group. Small groups are to facilitate some one-to-one work with each psychiatrist on their own recorded consultations. There will be 4 training sessions lasting 4 hours each. They will take place one week apart. During the training period, at least one consultation with a participating patient per psychiatrist will be recorded for training purposes. These consultation(s) will be viewed and psychiatrists will receive and discuss feedback in the training sessions. Four weeks after training session 4, there will be one follow-up refresher/supervision session, followed by a final refresher session eight weeks after training session 4. The proposed training schedule is: 1. Training session 1 at baseline 2. Training session 2 after one week 3. Training session 3 after two weeks 4. Training session 4 after three weeks 5. Refresher session after 8 weeks 6. Refresher session after 12 weeks At the end of the training, the next consultation between each participating psychiatrist and patient will be recorded and communicative behaviours assessed. |
| Intervention type | Other |
| Primary outcome measure | Psychiatrists use of repair will be assessed using the Repair Protocol, which is a standardised and validated measure. |
| Secondary outcome measures | Intermediate outcomes: 1. Psychiatrist confidence in communicating with psychotic patients 2. Patient experience of the communication 3. Patient centredness Measured in the first consultation with each relevant patient after the 12 week training period Final outcomes: 4. Patient satisfaction with treatment 5. Therapeutic relationship 6. Treatment adherence and relapse Measured at 6 months follow-up |
| Overall study start date | 01/03/2010 |
| Completion date | 01/03/2013 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 84 (72 patients and 12 psychiatrists) |
| Key inclusion criteria | Psychiatrists: Higher/advanced psychiatric trainees (ST4-6) working in outpatients or community mental health teams. Doctors in higher psychiatric training (ST4-6) already have basic knowledge and experience in psychiatry gained through core psychiatric training. During higher training they practice without direct supervision and aim to further develop specific competencies including communication skills. Hence, they are at the formative stage of their training, preparing to take up a consultant role in a few years time. We will focus on trainees in this pilot trial, because the effectiveness of an intervention on changing their communicative practice may be higher at this stage of their professional development. Patients: 1. ICD-10 criteria for a diagnosis of schizophrenia or schizoaffective disorder 2. Currently attending outpatients or being cared for by community mental health teams 3. Capable of giving informed consent 4. Aged 18 - 65 years, both females and males |
| Key exclusion criteria | Patients: 1. Organic impairment 2. Require an interpreter |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 01/10/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
E13 8SP
United Kingdom
E1 8DE
United Kingdom
IG3 8XJ
United Kingdom
Sponsor information
University/education
Queen Mary's Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
England
United Kingdom
| Website | http://www.qmul.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Manuscript in press |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2016 | Yes | No |
Editorial Notes
29/07/2016: Publication reference added.
