Clinical trial NCT03178279: The Evaluation of the Use of a New Physical Health Plan
Official title: An Evaluation of the Use of a Physical Health Plan With People With Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Schizophrenia
Keywords: physical health
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2017-06-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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 Healthlocker 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* unable to give informed consent

Primary outcomes:
measure: Change in uptake of physical healthcare by service users
timeFrame: Baseline and six months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
citation: 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.