Early Intervention Psychosis Communication and Engagement Trial
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|ClinicalTrials.gov Identifier: NCT03196128|
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : October 17, 2017
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.
(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.
|Condition or disease||Intervention/treatment||Phase|
|First Episode Psychosis||Other: Digital communication Other: Non digital||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Digital Media Versus Standard Method of Communication to Examine Engagement of Patients in Community Early Intervention Psychosis (EIP) Services|
|Actual Study Start Date :||July 18, 2017|
|Estimated Primary Completion Date :||December 30, 2017|
|Estimated Study Completion Date :||January 30, 2018|
|Active Comparator: Digital||
Other: Digital communication
Communicating with patients via email and text message.
|Active Comparator: Non Digital||
Other: Non digital
Communicating with patients via telephone and written appointment letters.
- Singh O'Brien Level of Engagement Scale [ Time Frame: Average completion time - 8-10 minutes. ]Self reporting scale 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.
- Service Engagement Scale [ Time Frame: Average completion time: 4- 6 minutes. ]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.
- Care Coordinator Feasibility Questionnaire [ Time Frame: Average completion Time: 10 minutes. ]Self reporting scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196128
|London, United Kingdom, SE11 5DL|
|Contact: Christina Clark 02032287266 firstname.lastname@example.org|
|Contact: Eduardo Iacoponi 02032287200 email@example.com|