Medical Phenotyping of NHS General Adult Psychiatry (GAP) Inpatients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rates of comorbid physical illnesses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adults aged between 18 and 65 years admitted to GAP wards during recruitment period
排除标准
- •- Admissions to non-GAP wards (e.g., forensic psychiatry, young people's units, perinatal, old age psychiatry, or general medical wards)
研究组 & 干预措施
Group 1 - Schizophrenia Group
- Schizophrenia - 6A20
- Schizoaffective disorder - 6A21
- Delusional disorder - 6A24
- Other primary psychotic disorders (psychosis NOS) - 6A2Z
- Schizotypal disorder - 6A23
干预措施: Questionnaires, rating scales, & review of notes (Other)
Group 3 -Depression Group
- Recurrent depressive disorder, current severe episode without psychotic symptoms - 6A71.3
- Single episode depressive disorder, moderate with psychotic symptoms - 6A70.2
- Recurrent depressive disorder (not otherwise specified) - 6A71
- Mixed depressive and anxiety disorder - 6A73
干预措施: Questionnaires, rating scales, & review of notes (Other)
Group 2 - Bipolar Group
- Bipolar type I disorder, current episode manic - 6A60 • without psychotic symptoms - 6A60.0 • with psychotic symptoms - 6A60.2
- Bipolar type II disorder, current episode depressed, with psychotic symptoms - 6A60.6
干预措施: Questionnaires, rating scales, & review of notes (Other)
Group 4 - Personality Group
- Personality disorder - 6D10, 6D10.Z
- Complex post-traumatic stress disorder - 6B41
- Substance use disorders - 6C4* codes (e.g., 6C4G.1 alcohol, 6C45.6 sedative-hypnotic, 6C43.2 cannabis, 6C44.2 stimulants, 6C4Z unspecified)
干预措施: Questionnaires, rating scales, & review of notes (Other)
结局指标
主要结局
Rates of comorbid physical illnesses
时间窗: At enrolment
As per medical note review and physical examination - BMI
Psychiatric diagnosis
时间窗: At enrolment
ICD-11 codes
Severity of psychosis
时间窗: At enrolment
Brief Psychiatric Rating Scale (BPRS) score; 18 to 126, higher scores indicate more severe symptoms
Depression of severity
时间窗: At enrolment
Inventory of Depressive Symptomatology Self Report (IDS-SR); 0 to 84, higher scores indicate more severe symptoms
Severity of mania
时间窗: At enrolment
Young Mania Rating Scale score; 0 to 60, higher scores indicate more severe symptoms
Severity of anxiety
时间窗: At enrolment
General Anxiety Scale (GAD-7) score; 0 to 21, higher scores indicate more severe symptoms
Substance use
时间窗: At enrolment
Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool score; tobacco 0 to 3, alcohol 0 to 4, others 0 to 21, higher scores indicate more risky use
Mental Health Act status
时间窗: At enrolment
MHA detention status; informal or detained
Treatment resistance indicators
时间窗: At enrolment
Clozapine for psychosis, and ECT treatment and Massachusetts General Hospital Staging (MGH-S) score for depression. MGH-S uses the number of failed trials with the intensity/optimization of each trial to produce a score where \>3.5 defines treatment resistant depression
Rates of abnormal findings on physical examination
时间窗: At enrolment
When psychiatric patients are admitted to hospital, they are examined by a resident doctor, including inspection, auscultation, and palpation. Rates of abnormal findings on cardiovascular , respiratory, abdominal, and neurological examination will be noted..
Abnormal laboratory values
时间窗: At enrolment
When psychiatric patients are admitted to hospital, screening blood tests, including full blood count, urea and electrolytes (kidney), liver function tests, random glucose, cholesterol, triglycerides, and thyroid function tests.
Rates of comorbid physical illness
时间窗: At enrolment
As per medical note review and physical examination - blood pressure mmHg
次要结局
未报告次要终点