Final Protocol Nirisha

Final Protocol Nirisha

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE

KARNATAKA, BANGALORE

PROTOCOL FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1NAME OF THE CANDIDATE AND ADDRESS

DR. LAKSHMI NIRISHA P

Postgraduate

Department Of Psychiatry,

St. John’s MedicalCollegeHospital

Sarjapur road, Bangalore -560034

2NAME OF THE INSTITUTION

ST.JOHN’S MEDICAL COLLEGE

3COURSE OF STUDY AND SUBJECT

M.D. Psychiatry

4DATE OF ADMISSION

16st April 2012

5TITLE OF THE TOPIC

“Trends in in-patient care in department of psychiatry before and after implementation of ICD 10 in a tertiary care centre.”

6. Brief resume of the Intended work:

6.1 Need for the study

There has been a significant change in the assessment and management of psychiatric disorders in the past two decades. There has been introduction of psychiatric classification system, newer psychiatric medications and newer treatment guidelines. All these changes can be expected to have an impact on the duration of stay in hospital, quality of life, rehabilitation, mortality and morbidity. Western literature has contributed significantly in this regard. This study is an attempt to understand the impact of the above changes on in-patient care, using patient case files in a general hospital psychiatry unit. Such information can help understand the role of classificatory systems in general and provide valuable insights to prepare for ICD11 which is expected in a few years time.

6.2 Review of literature

Mental disorders often result in profound disability. The World Health Organization has determined that mental illness is one of the largest contributors to disability worldwide1. Studies have shown that mental health arena underwent major changes in the treatment during 1990s 2 along with changes in the Classificatory system. Comprehension of illnesses is a key purpose of a classificatory system. The changing comprehension of disorders with changes in classification could be expected to impact practice. Becoming aware of changing trends in practice following implementation of ICD10 will help plan for changes following the upcoming ICD11.

One of the hallmarks of epidemiologic analysis is the understanding that health outcomes in a population can only be fully understood if their frequency and distribution is examined in terms of person, place, and time. Trend analysis is used for public health surveillance and monitoring, for forecasting, for program evaluation, for policy analysis, and for etiologic analysis (investigation of potentially causal relationships between risk factors and outcomes). Some of the aspects that one can focus on study of time trends include:

1Comparing one time period to another time period: This form of trend analysis is carried out in order to assess the level of an indicator before and after an event. Evaluating the impact of programs, policy shifts, or medical and other technical advances are carried out using interrupted time series analysis. This is described later.

2Making future projections: Projecting rates into the future is a means of monitoring progress toward a national or local objective or simply providing an estimate of the rate of future occurrence. Projecting the potential number of future cases can aid in the planning of needed health and other related services and in defining corresponding resource requirements.

Interrupted time series analysis (ITS)

Interrupted time-series analysis is a statistical method for analyzing temporally ordered scores to determine if an experimental manipulation, a clinical intervention, or even a serendipitous intrusion, has produced a reliable change in the scores. It is a research design that collects observations at multiple time points before and after an intervention (interruption). It detects whether an intervention has had an effect significantly than the underlying trend. Policy makers may find ITS designs a useful way to assess the impact of specific policies that could remain un-assessable otherwise3.

Global literature on trend analysis in Psychiatry

Trend analysis has been used in numerous prospective and retrospective studies globally. Country specific data registers either electronic or manual have been extensively used for research purposes in psychiatry in many countries4.

In a study by Arndt S et al (2011), who studied the trends of substance abuse using substance abuse database (1998-2008) whether the percentage of older adults entering substance abuse treatment for their first time was increasing and whether there were changes in the use patterns leading to the treatment episode, particularly an increase in illicit drugs. They concluded that onlylittle is known about the long-time users, their current medical state, cognitive abilities, andpsychiatric symptoms after such a long exposure time. Previous studies on heroin and cocaine exposure focused on individuals identified much earlier in life, and that aging long-term users might represent a relatively large but unknown population 5.

A retrospective analysis of hospital statistics done by Patrick Keown et al concluded Psychiatric inpatient care changed considerably from 1996 to 2006, with more involuntary patients admitted to fewer NHS beds and increasing proportions of involuntary patients admitted to private facilities6.

A retrospective study done by Jan Vevera et al (2005) to study the violent behaviour in schizophrenia; they studied four independent samples from Prague in time period of 1949-2000.They used data from the years 1949,1969,1989 and 2000.They studied various aspects of in-patient care in schizophrenia. They found there was no significant linear trend in violence between 1949 and 2000 cohort. They found that 83 patients from the 1949 cohort never received antipsychotics. These had markedly longer total duration of hospitalisation (9.23 years; s.d=11.54) than patients who received antipsychotics (1.74years; s.d=4.04).The limitation of the study was that it included only hospital admissions, therefore violence when the patient is in community is left out, as the data were taken from urban psychiatric settings, rural populations might be different 7.

A time trend study was done by Colleshaw et al in 1999, in adolescent mental health for 25 year period. This study set out to assess whether adolescent emotional and behavioural problems have become more common in the UK, by comparing parent ratings collected from general population samples in 1974, 1986 and 1999. Conduct scores increased markedly for both genders, for all family types, and across all social class categories over this 25-year period. Overall, each successive cohort had increased odds of high conduct problems of around 1.5. Time trends appeared more marked for non-aggressive conduct problems than for aggressive problems. They found rates of emotional problems remained stable between 1974 and 1986, and then increased between 1986 and 1999, both for males and females. Analyses that accounted for the overlap between conduct problems, emotional difficulties, and hyperactive behaviour confirmed a strong independent effect of cohort on the rate of conduct problems. They concluded evidence on secular change in the prevalence of psychosocial disorders provides strong support for the role of environmental influences on psychosocial development. An examination of broader societal trends affecting the lives of children and adolescents seems likely to provide important clues as to possible reasons for trends in mental health8 .

A study done by Centorrini F et al, to test the hypothesis that combinations and total daily doses of psychotropics are rising (2009 versus 2004). In 2009, Clinical Global Impression (CGI)-severity scores were 6% lower at intake and improved 1.7 times more than in 2004, as hospitalization-length decreased by 12%. Polytherapy (> or = 2 psychotropics) increased in 2009. Total psychotropics per patient (3.1-3.2) remained stable but mood-stabilizers/patient increased markedly and antipsychotics/patient decreased somewhat in 2009. In 2009, final total antipsychotic doses (mg/day) increased by 97%, and mood-stabilizers by 75%.They concluded combinations and doses of antipsychotic and mood-stabilizing drugs forinpatientsincreased markedly (2004 vs. 2009) without consistent correspondence of agents/person and doses, without apparent increase in major adverse effects, and with possibly superior clinical improvement 9.

Indian literature

A review study was done by Suresh Bada Math et al with respect to the psychiatric epidemiological studies done in India.. They found the prevalence of mental illness ranged from 9.5 to 370/1000 population. They found most of the studies were done in small population around 6000. It is seen that Psychiatric epidemiology lags behind other branches of epidemiology due to difficulties encountered in conceptualizing, diagnosing, defining a case, sampling, selecting an instrument, lack of resources and stigma. They found that descriptive epidemiological studies had undergone unprecedented growth in India, but at the same time advances with respect to cost effective, analytical and prospective experimental epidemiological studies have been minimal10.

Mental health problems constitute a wide spectrum ranging from sub-clinical states to very severe forms of disorders. Majority of the epidemiological studies focused on visible mental health problems. Invisible mental health problems continue to remain unexplored and unaddressed. Mental healthcare priorities need to be shifted from psychotic disorders to common mental disorders and from mental hospitals to primary health centres11.

In India not many studies have been done with respect to time trends in psychiatry patient care, although changes across time with specific cohorts have been attempted in few studies such as the Madras Longitudinal study12.

A retrospective study done by Dr Savita Malhotra et al to study the sociodemographic and clinical profile of patients, who presented to the child and adolescent psychiatric services of a tertiary care centre over a 26-year period (1980-2005) in three time periods using case records of patients. There was a trend towards decrease in number of cases in younger age group (0-5 years) and those with diagnosis of mental retardation, epilepsy and organic brain disorder. There was a trend towards increase in number of cases in the older age group (10-15 years) and those with diagnosis of psychotic disorders, affective disorders, disorders of psychological development, and hyperkinetic and conduct disorders. They concluded that time trends revealed a significant shifts in demographic and diagnostic profile of a CAP clinic. The study suggested that there is a need to strengthen services for disorders like depression, specific learning disorders and hyperkinetic disorders13.

Hospital based epidemiological studies using time trends can reflect changes in help-seeking, clinical practice and priority areas. Therefore our study aims to utilise the data available over the past three decades and study various trends in inpatient care in a general hospital psychiatry department.

6.3 OBJECTIVES

Primary Objective

To study the diagnostic trends in in-patient care in the department of psychiatry in three time points (years) each before and after the implementation of ICD 10.

Secondary objectives

●To study admission trends- emergency/elective

●To study the use of ECT and various other interventions.

●To assess duration of hospital stay.

7.MATERIALS AND METHODS

STUDY DESIGN

Retrospective study

STUDY SITE

Department Of Psychiatry In St John’s Medical College Hospital, Bangalore

DURATION OF STUDY

Two Years

7.1 SOURCE OF DATA

Case files of psychiatry department at the St John’s Medical College Hospital over 25 years period.

Records of Out-patient cards and In-patient charts are maintained by the Medical records department of the hospital. OP and IP charts are maintained for a stipulated period as recommended by Medical Council of India. However, Psychiatry case files have been separately stored since 1982.From the year 1985 a semi-structured Proforma has been used to record the case details. Each psychiatry case file is allotted a specific number and arranged according to the number, month and year of admission in a safe and secure room in our hospital. It can be accessed only by mental health professionals with prior permission from the HOD due to confidentiality purpose. The data for the proposed study is being obtained from these files.

SAMPLE SIZE

It was found that 6 years of psychiatry case files constitute approximately 4500 files, a minimum of 2000 in the three sampled years each before and after implementation of ICD10.

7.2 METHOD OF COLLECTION OF DATA

Three time points, (which will be the minimum needed to show a trend) will be selected before ICD 10 (1986, 1989, 1992) and after introduction of ICD 10 (2005, 2008, 2011). The time periods chosen are based on two aspects: 1) A time-lag after the ICD9 and ICD 10 implementation respectively, so that the classificatory system is influencing the practice and 2) Availability of adequate records since 1985. Case records of in-patients admitted during that time period will be studied and data of interest would be collected.

DATA COLLECTED FROM THE CASE FILE

1Age

2Gender

3Type of admission: emergency/elective / readmission

4Duration of stay

5Diagnosis : ICD Code / Category

6Documented Medical co-morbidities

7Treatment given: Nature of medications and dosages across major psychiatric categories

8Use of ECT

9Other documented interventions like Psychotherapy, Psychiatric Social Work intervention.

In order to plan for this study, 30 Case files from the time periods of interest were randomly picked and studied for availability of data of interest. Almost all the data were available in all the files selected. A sample of the proforma for the data collection from the case file is enclosed.

QUALITY OF DATA

A quality of data measure will be created that documents the completion of data and reliability of different types of data of interest. This will be applied for every record. The time trends will be constrained through this quality measure, before drawing conclusions.

CONFIDENTIALITY

Case records will be kept in locked store room in the department and will be studied by the student and guides only.

STATISTICAL ANALYSIS

Data would be analyzed for normality. Descriptive statistics would be used. Mean and proportions will be obtained and changes in time trends will be evaluated using chi-squares statistics.Also segmented (or piece wise regression) as described by Gillings et al14 (or its non - parametric equivalent) will be carried out for each variable of interest.

7.3 Does the study require any investigations or interventions to b e conducted on humans or animals? No

7.4 Has ethical clearance been obtained from your institution in case of 7.3. Yes

REFERENCES

1.Rafael H, Candiago I,Paulo Belmonte de Abreu II. Use of DATASUS to evaluate psychiatric inpatient care patterns in Southern Brazil. Rev Saúde Pública 2007;41(5):821-829.

2.Kessler RC and Merikangas KR. The National Comorbidity Survey Replication (NCS-R): background and aims. Int. J. Methods Psychiatr. Res., 2004; 13(2):60–68.

3.Craig RR, Lloyd M, Roberto G, Jeremy MG, Ruth ET. Interrupted time series Designs in health Technology assessment: Lessons from two Systematic reviews of Behaviour change strategies.International Journal of Technology Assessment in Health Care, 2003; 19:4: 613–623.

4.Vera AM and Assen VJ. From inventory to benchmark: quality of psychiatric case registers in research.Br J psychiatry, 2010; 197:8-10

5.Arndt S, Clayton R, Schultz SK. Trendsin substance abuse treatment 1998-2008: Increasing older adult first-time admissions for illicit drugs. Am J Geriatric Psychiatry2011; 19(8):704-711.

6.Patrick K, Gavin M, Jan S. Retrospective analysis of hospital episode statistics ,involuntary admissions under the Mental Health Act 1983,and number of psychiatric beds in England 1996-2006. BMJ 2008; 337:a1837.

7.Jan V, Alan H, Arnost V and Hana P. Violent behaviour in schizophrenia Retrospective study of four independent samples from Prague, 1949 to 2000. Br J psychiatry,2005 ;187:426-430

8.Collishaw S, Maughan B, Goodman R and Pickles A. Time trends in adolescent mental health. Journal of Child Psychology and Psychiatry .2004; 45(8):1350–1362.

9.Centorrino F., Ventriglio A., Vincenti A., Talamo A. and Baldessarini, R. J. Changes in medication practices for hospitalized psychiatric patients: 2009 versus 2004. Hum. Psychopharmacol. Clin. Exp. 2010; 25:179–186.

10.Suresh BM, CR Chandrashekar and Dinesh B. Psychiatric epidemiology in India. Indian J Med Res 126, September 2007, 183-192

11.Suresh B M, Ravindra S. Indian Psychiatric epidemiological studies: Learning from the past. Indian J Psy 2010; 52(Suppl 1): S95–S103.

12.Rangaswamy.T. Twenty-five years of schizophrenia. The Madras longitudinal study. Indian J Psy 2012;54:134-7

13. Savita M, Parthasarathy B, Pratap S, Sandeep G. Characteristics of Patients Visitingthe Child & Adolescent Psychiatric Clinic: A 26-year Study from North India. J Indian Assoc. Child Adolesc. Ment. Health 2007; 3(3): 53-60.

14.Gillings D, Diane M and Earl S. Analysis of Interrupted Time SeriesMortality Trends: An Example to Evaluate Regionalized Perinatal Care. Am J Public Health 1981; 71:38-46.

9. Signature of the candidate :

10. Remarks of the guide :

11. Name and designation of

11.1 Guide : DR. ASHOK. M.V

PROFESSOR

DEPARTMENT OF PSYCHIATRY

11.2 Signature :

11.3 Co-Guide : DR. JOHNSON PRADEEP

ASSISTANT PROFESSOR

DEPARTMENT OF PSYCHIATRY

11.4 Signature :

11.5 Head of the department: DR SUNITA SIMON KURPAD

PROFESSOR AND HOD

DEPARTMENT OF PSYCHIATRY

11.6 Signature :

12.1 Remarks of the chairman and principal:

12.2 Signature :

PROFORMA FOR DATA COLLECTION

YEAR :

SL.no :

1PSYCHIATRY FILE NO. :

2NAME OF THE PATIENT :

3AGE (in years) :

4GENDER : MALE( ) FEMALE( )

5TYPE OF ADMISSION :

(EMERGENCY/ELECTIVE/READMISSION)

6DIAGNOSIS ICD CODE/CATEGORY) :

7DURATION OF STAY(No. of days) :

8MEDICAL COMORBIDITY :

9TREATMENT GIVEN

a.NATURE OF MEDICATION :

b.DOSAGE :

10 ECT :

11 OTHER INTERVENTIONS :