Early Intervention Psychosis Communication and Engagement Trial

NCT03196128 | Unknown

• 1 other identifier: 17/EM/0093
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

First Episode Psychosis

Outcome Measures

Primary Outcomes (2)

• Singh O'Brien Level of Engagement Scale

  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.

  Average completion time - 8-10 minutes.

• Service Engagement Scale

  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.

  Average completion time: 4- 6 minutes.

Secondary Outcomes (1)

• Care Coordinator Feasibility Questionnaire

  Average completion Time: 10 minutes.

Study Arms (2)

Digital

ACTIVE COMPARATOR

Other: Digital communication

Non Digital

ACTIVE COMPARATOR

Other: Non digital

Interventions

Digital communication OTHER

Communicating with patients via email and text message.

Digital

Non digital OTHER

Communicating with patients via telephone and written appointment letters.

Non Digital

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First Episode Psychosis under the care of Early Intervention Psychosis Team Community Mental Health Team.
• Aged 18 - 65
• Fluent in the English language
• In first six months of service
• Has a mobile phone and access to the internet/email

You may not qualify if:

• Currently an inpatient in hospital
• Nearing discharge from EIP services
• Is not fluent in the English Language
• In acute crisis at the time of participant recruitment
• Does not have a mobile phone or access to the internet/email

Sponsors & Collaborators

• South London and Maudsley NHS Foundation Trust: lead

Study Sites (1)

Christina Clark

London, SE11 5DL, United Kingdom

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: July 18, 2017
• Primary Completion: December 30, 2017
• Study Completion: January 30, 2018
• Last Updated: October 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)