The Evaluation of the Use of a New Physical Health Plan

NCT03178279 | Completed

• 1 other identifier: IRAS194626
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

People suffering from psychotic illnesses (e.g. schizophrenia) have poorer physical health than the general population. The reasons include a lack of service user motivation to attend physical health checks and the tendency of health professionals to focus mainly on the mental disorder thus delaying the detection of physical health conditions. Identifying people who have physical health needs is increasingly recognised as a priority. The investigators have developed a Physical Health Plan (PHP) which is completed by service users and identifies areas of physical health need. An action plan is then completed by the service user and care co-ordinator to address these issues. The PHP is designed to be very simple to use and there will be 3 versions, 1. paper version, 2. 1 version implemented via the 'IMPARTS' computerised 'tablet' based system that has been separately evaluated (REC Ref 12/SC/0422) and 3. 1 version on an iPad via the MHL2 system via Mindwaves. The investigators wish to pilot the use of this PHP in two community teams in the South London and Maudsley (SLaM) Trust. The pilot will be done in three stages. Stage One: The investigators will undertake an initial qualitative study to refine the process of using the PHP using focus group consultations with staff and service users. Stage Two: The investigators will then undertake a six month study to evaluate the uptake and use of the PHP. This will involve collecting data on how many people complete the PHP and what actions are taken following the completion of the PHP. Stage Three: At the end of this six month period the investigators will undertake qualitative interviews with a selection of service users and staff to understand their experience of using the PHP. The investigators hope to be able to use the results of this pilot study to introduce the use of the PHP into routine care.

Conditions

Psychosis; Schizophrenia

Keywords

physical health

Outcome Measures

Primary Outcomes (1)

• Change in uptake of physical healthcare by service users

  Service users will have increased their access to physical healthcare services

  Baseline and six months

Study Arms (1)

Use of the Physical Health Plan

EXPERIMENTAL

Use of the Physical Health Plan

Other: Physical Health Plan

Interventions

Physical Health Plan OTHER

Use of a Physical Health Plan by service users

Use of the Physical Health Plan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• using one of the community mental health teams recruiting in the study

You may not qualify if:

• unable to give informed consent

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

King's College London

London, SE5 8AF, United Kingdom

Location

Related Publications (1)

• Williams J, Sevdalis N, Gaughran F. Evaluation of a Physical health plan for people with psychosis: a protocol for a quality improvement study. Pilot Feasibility Stud. 2019 Jan 15;5:8. doi: 10.1186/s40814-019-0396-7. eCollection 2019.

  PMID: 30675375 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will take place in 2 community mental health teams and have 3 main stages. Stage 1: The investigators will undertake focus groups with service users and staff to test out the assumptions in the Theory of Change. Stage 2: The PHP will be available as a paper version and on iPad and smartphone. Each team will be asked to work with all of the people on their caseload to complete the PHP. Service users will be encouraged to complete the PHP whilst waiting for their appointment with their care co-ordinator. The completed PHP will then be emailed to the service user and to their care co-ordinator and they will then be asked to develop an action plan to address any gaps in the completed PHP. Each action plan and the progress made with the action plan will be recorded. This exploratory trial will last six months. Stage 3 The investigators will evaluate the experience of using the PHP using interviews with a random selection of service users and clinical staff.

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 6, 2017
• Study Start: December 6, 2017
• Primary Completion: March 30, 2019
• Study Completion: September 30, 2019
• Last Updated: February 20, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)