First Episode Psychosis Clinical Trial
Official title:
Digital Media Versus Standard Method of Communication to Examine Engagement of Patients in Community Early Intervention Psychosis (EIP) Services
This study will examine whether or not the use of digital communication methods (text
messages and emails) improves patient engagement with Early Intervention Psychosis (EIP)
Services, compared to standard communication methods (letters and telephone calls).
One of the biggest challenges of psychiatric services is patient disengagement. People with
psychosis, are often difficult to engage in community based mental health services (CMHTs).
Patient's who disengage from psychiatric care often have higher social care needs, are often
more unwell and are more likely to be detained under the Mental Health Act compared to those
who engage. It is important to examine the reasons for this for both research and clinical
reasons to establish the effectiveness of the service to its users. Importance must be placed
on the clinician's perspective of the engagement; the patient's perspective is vital.
This study is a pilot two-arm pragmatic Randomised Control Trial to examine the feasibility
of assessing engagement of EIP services through different communication methods. Patients and
care-coordinators will use self-reported scales to measure engagement to determine whether
this improves through the use of different communication methods.
Patients will be asked to consent to being randomly allocated to one of two groups:
(i.) Receive letters, phone calls and voicemail's from their care coordinator for standard
appointments.
OR
(ii.) Receive text messages and emails from their care-coordinator for standard appointments.
Patients eligible for this study will be in their first six months of care under an EIP CMHT
and who have consented to take part. They will be aged 18-35, not a hospital inpatient, have
access to the Internet, a mobile phone and who are fluent in the English language.
Care-coordinators will assess the feasibility and acceptability of the design and procedures
and determine an effective sample size calculation for a future large scale pragmatic
Randomised Controlled Trial.
Participants (patients and care-coordinators):
Instruments:
Patients:
SOLES (Singh O'Brien Level of Engagement Scale, O'Brien et al 2009). (Appendix 1) This
self-reporting scale is designed to measure the level of engagement in people with psychosis.
It contains 16 questions covering various aspects of engagement, each question scored in a
scale ranging from 0-10. This scale takes about 8-10 minutes to be completed.
Care Coordinators:
SES (Service Engagement Scale, Tait et al 2002). (Appendix 2) The SES is a scale completed by
clinicians to assess their perceived level of engagement of patients under their care. It is
a 14-question scale covering the same areas as the SOLES. The scale taken about 4-6 minutes
to be completed.
Care Coordinator Feasibility Questionnaire:
It would also be of interest to collect feedback from care coordinators about the ease of use
of the procedure along with the relevance and acceptability. This will be done through the
use of a self reporting scale of how feasible the intervention delivery was. (Appendix 3)
Interventions:
When arranging appointments or having any other communication outside face-to-face meetings,
care coordinators participating in this study will be expected to contact their patients in
two distinct ways:
(i) 20 patients will receive Standard contact: this will happen by means of letters,
telephone call and voicemail's only. Care co-ordinators already have trust mobile phones that
they can use.
(ii) 20 patients will receive Digital media contact: only text messages and e-mails will be
used to contact patients. Care coordinators will also be provided with i-pads (funded by the
British Research Council so that they can do this when also outside of clinic).
Both types of contact will be made explicit for care coordinators at the beginning of the
study, with frequent reminders occurring during the period of data collection. Care
coordinators will have immediate access to written information about each of the
interventions through participant information and consent forms provided (appendix 5).
Design:
A two-arm pragmatic pilot Randomised Controlled Trial. will be conducted comparing the
digital media contact methods with standard contact methods and will assess the potential for
progressing into a full pragmatic Randomised Controlled Trial. The co-primary outcome
measures are to determine whether engagement with care coordinator/services improves through
the use of digital media communication compared to standard methods of communication using
The Singh O'Brien Level of Engagement Scales (SOLES)(O'Brien et al 2009) (SOLES) and The
Service Engagement Scale (SES) (Tait et al 2002). These are self rating scales which will be
completed both pre and post intervention to examine whether or not there has been an increase
in engagement. Success of the study will be measured by an increase of scores in the scales
to determine whether or not increased engagement was achieved.
Procedures:
Consecutive patients accepted for care under EIP teams will be asked to consent to
participate in this study. If they consent, they will be allocated to one of two groups:
either the Standard group or the Digital Media group. It is expected that each group will
have approximately 20 patients. Care coordinator's will also be asked to consent to
participate in the study and will be briefed by chief investigator on procedures.
Two months after intake into the study, patients and care coordinators will complete their
respective engagement questionnaires. The level of engagement of each group, as measured by
the instruments, will be used to analyse and compare the impact of the interventions.
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