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Early Intervention Psychosis Communication and Engagement Trial

Primary Purpose

First Episode Psychosis

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Digital communication
Non digital
Sponsored by
South London and Maudsley NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for First Episode Psychosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Christina ClarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Digital

Non Digital

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Care Coordinator Feasibility Questionnaire
Self reporting scale.

Full Information

First Posted
June 20, 2017
Last Updated
October 14, 2017
Sponsor
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03196128
Brief Title
Early Intervention Psychosis Communication and Engagement Trial
Official Title
Digital Media Versus Standard Method of Communication to Examine Engagement of Patients in Community Early Intervention Psychosis (EIP) Services
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Anticipated)
Study Completion Date
January 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South London and Maudsley NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
First Episode Psychosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital
Arm Type
Active Comparator
Arm Title
Non Digital
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Digital communication
Intervention Description
Communicating with patients via email and text message.
Intervention Type
Other
Intervention Name(s)
Non digital
Intervention Description
Communicating with patients via telephone and written appointment letters.
Primary Outcome Measure Information:
Title
Singh O'Brien Level of Engagement Scale
Description
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.
Time Frame
Average completion time - 8-10 minutes.
Title
Service Engagement Scale
Description
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.
Time Frame
Average completion time: 4- 6 minutes.
Secondary Outcome Measure Information:
Title
Care Coordinator Feasibility Questionnaire
Description
Self reporting scale.
Time Frame
Average completion Time: 10 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Christina Clark
City
London
ZIP/Postal Code
SE11 5DL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Clark
Phone
02032287266
Email
christina.clark@slam.nhs.uk
First Name & Middle Initial & Last Name & Degree
Eduardo Iacoponi
Phone
02032287200
Email
eduardo.iacoponi@slam.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Intervention Psychosis Communication and Engagement Trial

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