Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires, rating scales, & review of notes.
- Who it may be relevant to
- Registry conditions: Bipolar Affective Disorder, Schizophrenia Disorders, Depression Disorders, Personality Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This observational study will characterise the general psychiatric and general medical phenotypes of 100 adults, sequentially admitted to NHS General Adult Psychiatry (GAP) "mental health" inpatient wards, providing the first detailed information on morbidity in this patient population.
Detailed description
It is often supposed that most patients who attend secondary care General Adult Psychiatry (GAP) services would be excluded from clinical trials because they have too many co-morbidities, they are 'treatment resistant' (have a condition that does not improve despite trying two or more standard treatments), and their conditions are too severe. Hence, it would be helpful to properly measure these variables in GAP patients using questionnaires and a review of the case notes to see how many GAP patients would indeed be excluded from clinical trials. It is anticipated that this will show that the participants in clinical trials are very different from 'real life' GAP patients, and that could explain why some promising results from clinical trials do not translate into useful new treatments. Also, this data could act as a benchmark or baseline against which to measure the efficacy of novel treatments and interventions.
PRIMARY OBJECTIVE
Using the most commonly employed diagnostic tools, severity rating scales, and a systematic review of the case notes, the typical characteristics of GAP patients will be described.
SECONDARY OBJECTIVES
The above data will be used to compared 'typical/real life' patients with the participants in impactful clinical trials.
This is a cross sectional quantitative study. Participants will spend about an hour attending to the questionnaires and talking to their clinician.
STUDY SETTING
The study will take place in St John's Hospital, Livingston, West Lothian, on the acute psychiatric ward, and the outpatient department.
STUDY POPULATION
100 patients who attend the West Lothian NHS GAP service will be consecutively recruited. These participants will be between 18 and 65 years old and suffering from mental disorders that their GP could not treat.
IDENTIFYING PARTICIPANTS
The usual clinical team will ask eligible patients if they would like to participate.
CONSENTING PARTICIPANTS
Consent will be thoroughly informed by an information leaflet and subsequent discussion with the involved clinician. Participants will take the information leaflet away with them and express their consent, or not, in their own time by using the contact details on the information leaflet, or when they next see their clinician.
WITHDRAWAL OF STUDY PARTICIPANTS
Participants will have the option of withdrawal from all aspects of the trial, but the data collected up to that point could be used. To safeguard rights, the minimum personally identifiable information possible will be collected. There are no stopping rules. Participants could withdraw at any time.
Interventions
- Other Questionnaires, rating scales, & review of notes
Observational - questionnaires, rating scales, \& review of notes
Primary outcome measures
- Rates of comorbid physical illnesses [Time frame: At enrolment]
- Psychiatric diagnosis [Time frame: At enrolment]
- Severity of psychosis [Time frame: At enrolment]
- Depression of severity [Time frame: At enrolment]
- Severity of mania [Time frame: At enrolment]
- Severity of anxiety [Time frame: At enrolment]
- Substance use [Time frame: At enrolment]
- Mental Health Act status [Time frame: At enrolment]
- Treatment resistance indicators [Time frame: At enrolment]
- Rates of abnormal findings on physical examination [Time frame: At enrolment]
Eligibility criteria
Inclusion:
\- Adults aged between 18 and 65 years admitted to GAP wards during recruitment period
Exclusion:
\- Admissions to non-GAP wards (e.g., forensic psychiatry, young people's units, perinatal, old age psychiatry, or general medical wards)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United Kingdom · 1 center
- St John's Hospital — Livingston
Identifiers
NCT: NCT07398365 · 337967