Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000138684
Ethics application status
Approved
Date submitted
28/01/2014
Date registered
5/02/2014
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pathways to primary care: Improving the physical health outcomes of people with severe mental illness
Scientific title
Comparison of the health outcomes of patients with severe mental illness and at least one co-morbid chronic physical health problem who attend a physical health clinic at Fremantle Mental Health Services with a similar group of patients who are managed by a general practitioner in the community
Secondary ID [1] 283990 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 291022 0
obesity 291024 0
COPD 291046 0
Diabetes 291047 0
Nutritional disorders 291048 0
metabolic syndrome 291049 0
Condition category
Condition code
Mental Health 291366 291366 0 0
Schizophrenia
Public Health 291389 291389 0 0
Health service research
Physical Medicine / Rehabilitation 291390 291390 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exploratory comparative 12 month study of the physical and mental health outcomes of patients being case managed by Fremantle Mental Health Services who attend a Physical Health Clinic at the service and a similar group of patients who see a general practitioner in the community setting using a within subject and between group design.
Intervention code [1] 288676 0
Not applicable
Comparator / control treatment
Compare the health outcomes of 175 people with severe mental illness and at least one co-morbid chronic physical health problem who attend a physical health clinic with a control group of 175 similar people who do not attend the clinic but are managed by their general practioner in the community setting
Control group
Active

Outcomes
Primary outcome [1] 291361 0
Improved physical health outcomes assessed by:

Mental state - ICD10 Diagnosis, symptom rating using the Brief Psychiatric Rating Scale (BPRS) and Health of the Nation Outcome Scale (HoNOS) and self-rating of anxiety and depression using the Kessler 10

Metabolic and endocrine monitoring - FBC, U&E, Lipids, glucose, LFT, TFT, weight, BMI, waist circumference, waist/hip or hip/chest ratio

Cardiovascular - Baseline ECG, Sitting and Standing BP, Pulse

Respiratory - Cigarette smoking history (pack years), Peak flow and carbon monoxide level

Drug and alcohol assessment using the Alcohol Smoking and Substance Involvement Screening Tool (ASSIST)

Medications – type, dose, frequency. Side effects will be measured using the Self rated UKU side effects rating scale.

Quality of life data will be collected using the World Health Organisation Quality of Life (WHOQOL – BREF).

WA health data bases and patient medical records will be accessed gather demographic data, to confirm ICD 10 diagnoses and gather data related to medication and blood results.

Standard Measures
The Health of the Nation Outcome Scale (HoNOS) was developed in the United Kingdom to measure severity of symptoms for people with mental illness. The scale comprises 12 items covering a range of common problems often experienced by people with a mental illness. Each item is rated on a five-point scale (0 = no problem; 1 = minor problem; 2 =mild problem; 3 = moderately severe problem; 4 = very severe problem). The HoNOS data is collected routinely as part of the National Outcome and Case mix Collection – a national reporting requirement of all mental health services in Australia (Australian Mental Health Outcomes and Classification Network 2012)

The Kessler Psychological Distress Scale (K10): Measures both depression and anxiety across 10 items and has been utilised in the measurement of psychological distress in survey research and clinical settings (Andrews & Slade, 2001). It has been found to have moderate to strong internal consistency (a=.93) and significantly associated to the CIDI (see Andrews & Slade, 2001) with good specificity and sensitivity found between (.8 -.88) indicating good validity.

The Brief Psychiatric Rating Scale (BPRS) is clinician rated scale in the public domain that measures psychiatric symptoms such as depression, anxiety, hallucinations and unusual behaviour. This test consists of 24 symptom constructs, each to be rated in a 7-point scale of severity ranging from 'not present' to 'extremely severe'. The BPRS takes approximately 25-30 minutes to administer (Lukoff, Liberman, & Nuechterlein, 1986).

The self-rated UKU side effects rating scale (UKU SERS Pat) (Lindstrom et al., 2001) is a comprehensive side effect rating scale developed to be used in clinical drug trials and in routine clinical practice. It comprises ratings (0-4) of 48 single items, a global assessment of the influence of the reported side effects on daily performance, and a statement of the effects of the adverse events on continuation of the medication. The items are clustered into four sub-groups: Psychic, Neurological, Autonomic and Other side effects. This scale takes approximately 15-20 minutes to complete.

The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST V3.0) consists of eight questions or items that can be answered by most patients in around ten minutes. The ASSIST (V3.0) is able to discriminate between substance use, abuse and dependence (Newcombe, Humeniuk, & Ali, 2005) and is a valid screening test for identifying psychoactive substance use in individuals who use a number of substances (Humeniuk et al., 2008). Eight questions cover tobacco, alcohol, cannabis, cocaine, amphetamine, sedative, hallucinogen, opioid and ‘other’ drug use, misuse and abuse. This ASSIST is in the public domain and may be amended with due reference to the original documents.

The World Health Organisation Quality of Life (WHOQOL – BREF) (Skevington, Lotfy, O'Connell, & Group, 2004) is a 26-item version of the WHOQOL-100. It produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health.
Medication effects
To enable comparisons of medications and doses, antipsychotic medication will be converted to chlorpromazine equivalents (CPZE). The conversion of antipsychotic doses into CPZE’s is generally accepted and widely practiced in schizophrenia research (Centorrino et al., 2002) (Hargreaves, Zachary, LeGoullon, Binder, & Reus, 1987) (Humberstone, Wheeler, & Lambert, 2004) (Owen et al., 2002) (Woods, 2003). CPZE will be calculated using Table 3, (Andreasen, Pressler, Nopoulos, Miller, & Ho, 2010).



Statistical analysis
Demographic data will be analysed using descriptive statistics and Chi Square analysis to examine between group differences.

The following statistical analyses will be completed to address the hypotheses posed
1. Paired sample t-test will be used to compare baseline BMI with BMI at12 months

2. Paired sample t-test will be used to compare baseline smoke rates to rates at 12 months.

3. Paired sample t-test will be used to compare incidents of COPD, diabetes, nutritional disorders or hypertension during 12 month study period with the 12 months prior.

4. Between group differences in BMI, Smoking levels and incidence of COPD, diabetes, nutritional disorders or hypertension will be analysed using analysis of variance (ANOVA) with participant group as the dependent variable.

5. Between group differences in mental health outcomes as measured by BPRS and HoNOS scores will be analysed using analysis of variance (ANOVA) with participant group as the dependent variable.

6. All antipsychotic medications will be converted to CPZE and compared according to medication type. Medication group differences in CPZE will be compared using analysis of variance (ANOVA) with medication type as the dependent variable. All other medications will be analysed according to daily doses and compared using analysis of variance (ANOVA) with participant group as the dependent variable.

7. Between group differences in quality of life as measured by WHOQOL-BREF scores will be analysed using analysis of variance (ANOVA) with participant group as the dependent variable.

In all statistical analyses p <0.05 will be considered statistically significant.

References

Andrew, G. Slade, I. (2001). Interpreting scores on the Kessler Psychological Distress Scale. Australian and New Zealand Journal of Public Health, 25(6): 494-497.

Andreasen, N. C., Pressler, M., Nopoulos, P., Miller, D., & Ho, B. C. (2010). Antipsychotic dose equivalents and dose-years: a standardized method for comparing exposure to different drugs. Biol Psychiatry, 67(3), 255-262. doi: 10.1016/j.biopsych.2009.08.040

Australian Bureau of Statistics (2008). National survey of mental health and wellbeing: summary of results, Australia, 2007. ABS catalogue no. 4326.0. Canberra: ABS.

Australian Medical Association (2009). Mental health – greater awareness and more funding needed http://www.ama.com.au/node/5019

Australian Mental Health Outcomes and Classification Network (2012). Sharing information to improve outcomes - An Australian Government Initiative Canberra: Australian Department of Health and Ageing; Accessed 4th August 2012 from http:amhocn.org/home/useful-resources.

Centorrino, F., Eakin, M., Bahk, W. M., Kelleher, J. P., Goren, J., Salvatore, P., Baldessarini, R. J. (2002). Inpatient antipsychotic drug use in 1998, 1993, and 1989. Am J Psychiatry, 159(11), 1932-1935.

Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences. New York: Academic Press.

Cormac, I., Martin, D., & Ferriter, M. (2004). Improving the physical health of long-stay psychiatric in-patients. Advances in Psychiatric Treatment, 10:107-115

Cormac, I., Ferriter, M., Benning, R., & Saul, C. (2005). Physical health and health risk factors in a population of long-stay psychiatric patients. Psychiatric Bulletin, 29:18-20

Goodwin, R., Kroenke, K. Hoven, C. & Spitzer, R. (2003). Major depression, physical illness and suicide ideation in primary care Psychosomatic medicine 65(4): 501-505.

Hargreaves, W. A., Zachary, R., LeGoullon, M., Binder, R., & Reus, V. (1987). Neuroleptic dose: a statistical model for analyzing historical trends. J Psychiatr Res, 21(3), 199-214.

Humberstone, V., Wheeler, A., & Lambert, T. (2004). An audit of outpatient antipsychotic usage in the three health sectors of Auckland, New Zealand. Aust N Z J Psychiatry, 38(4), 240-245. doi: 10.1111/j.1440-1614.2004.01340.x

Humeniuk, R., Ali, R., Babor, T. F., Farrell, M., Formigoni, M. L., Jittiwutikarn, J., Simon, S. (2008). Validation of the Alcohol, Smoking And Substance Involvement Screening Test (ASSIST). Addiction, 103(6), 1039-1047. doi: ADD2114 [pii]10.1111/j.1360-0443.2007.02114.x [doi]

Lawrence, D.M., Holman, C.D., Jablensky, A.V., Hobbs, M.S.T. (2003). Death rate from ischaemic heart disease in Western Australian psychiatric patients 1980-1998. The British Journal of Psychiatry, 182:31-36

Lindstrom, E., Lewander, T., Malm, U., Malt, U. F., Lublin, H., & Ahlfors, U. G. (2001). Patient-rated versus clinician-rated side effects of drug treatment in schizophrenia. Clinical validation of a self-rating version of the UKU Side Effect Rating Scale (UKU-SERS-Pat). Nord J Psychiatry, 55 Suppl 44, 5-69. doi: 10.1080/080394801317084428

Lukoff, D., Liberman, R. P., & Nuechterlein, K. H. (1986). Symptom monitoring in the rehabilitation of schizophrenic patients. Schizophr Bull, 12(4), 578-602.

Newcombe, D. A., Humeniuk, R. E., & Ali, R. (2005). Validation of the World Health Organization Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): report of results from the Australian site. Drug Alcohol Rev, 24(3), 217-226. doi: R411M042743H8794 [pii]10.1080/09595230500170266 [doi]

Owen, R. R., Thrush, C. R., Hudson, T. J., Mallory, S. R., Fischer, E. P., Clardy, J. A., & Williams, D. K. (2002). Using an explicit guideline-based criterion and implicit review to assess antipsychotic dosing performance for schizophrenia. Int J Qual Health Care, 14(3), 199-206.

Phelan, M., Stradins, L., & Morrison, S. (2001). Physical health of people with severe mental illness, [Editorial]. British Medical Journal, 322:443-444

Sartorius N, Ustun TB, Lecrubier Y, Wittchen HV. (1996). Depression comorbid with anxiety: Results from the WHO study on psychological disorders in primary health care. Br J Psychiatry168 S30: S38-S43.

Skevington, S. M., Lotfy, M., O'Connell, K. A., & Group, W. (2004). The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res, 13(2), 299-310.


Woods, S. W. (2003). Chlorpromazine equivalent doses for the newer atypical antipsychotics. J Clin Psychiatry, 64(6), 663-667.

Timepoint [1] 291361 0
baseline and 12 months comparison within subject and between group
Secondary outcome [1] 306700 0
Evaluation of new model of care - Nurse Practitioner/GP versus GP
Timepoint [1] 306700 0
24 months
Between group differences between experimental group (nurse practitioner and GP) and control group (GP in the community) using the measures outlined in priimary outcomes.

Eligibility
Key inclusion criteria
Severe mental Illness with at least one co-morbid chronic physical health problem and speak and understand English and being case managed by Fremantle Mental Health Services
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
under 18 years and over 65 years and do not speak English
clinical recommendation of the treating psychiatrist
Well engaged with a general practitioner

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Paired sample t-tests
Analysis of variance
Descriptive stats
Chi-square analsyis

Calculation of sample size
Using local data reported in (Stanley, Laugharne, Addis, & Sherwood, 2013) where the BMI in patients with Schizophrenia and Bipolar Disorder (M=28.32, SD 6.84) was compared with a group of patients with mild mental illness (M= 26.79, SD 5.3) the sample size estimate for testing differences between two means, was calculated according to Cohen’s calculation where sample estimate is the difference between two population means divided by the population standard deviation (Cohen, 1988). Thus the effect size d = 28.32 – 26.79 / 6.07 = 0.252. Using Cohen’s table (1988, p55) it was estimated for an effect size of 0.3 at a significance level 0.05 and a power of 0.80 that approximately 175 participants would be needed in each group.



Reference:
Stanley, S. H., Laugharne, J. D., Addis, S., & Sherwood, D. (2013). Assessing overweight and obesity across mental disorders: personality disorders at high risk. Soc Psychiatry Psychiatr Epidemiol, 48(3), 487-492. doi: 10.1007/s00127-012-0546-1

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2014
Actual
2/06/2014
Date of last participant enrolment
Anticipated
15/12/2015
Actual
15/12/2016
Date of last data collection
Anticipated
Actual
15/12/2016
Sample size
Target
350
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2002 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 7721 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 288615 0
Self funded/Unfunded
Name [1] 288615 0
Country [1] 288615 0
Funding source category [2] 288781 0
Government body
Name [2] 288781 0
Western Australian Department of Health Targeted Research Funding Round 3 2013
Country [2] 288781 0
Australia
Primary sponsor type
Individual
Name
Professor Dianne Wynaden
Address
School of Nursing and Midwifery
Curtin University
GPO Box U 1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 287325 0
None
Name [1] 287325 0
none
Address [1] 287325 0
none
Country [1] 287325 0
Secondary sponsor category [2] 287479 0
University
Name [2] 287479 0
Curtin University
Address [2] 287479 0
GPO Box U 1987
Perth WA 6845
Country [2] 287479 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290475 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 290475 0
Fremantle Hospital
Alma Street
Fremantle WA
6160
Ethics committee country [1] 290475 0
Australia
Date submitted for ethics approval [1] 290475 0
04/02/2014
Approval date [1] 290475 0
31/03/2014
Ethics approval number [1] 290475 0
14/12

Summary
Brief summary
Compare health outcomes of people with a severe mental illness and at least one co-morbid chronic physical health problem who attend the Physical Health Clinic at Fremantle Hospital with a similar group of people who are engaged with a general practitioner in the community.
Trial website
none
Trial related presentations / publications
none at present
Public notes
none at present

Contacts
Principal investigator
Name 45874 0
Prof Dianne Wynaden
Address 45874 0
School of Nursing and Midwifery
Curtin University
GPO Box U 1987
Perth
Western Australia 6845
Country 45874 0
Australia
Phone 45874 0
+61 8 92662203
Fax 45874 0
Email 45874 0
[email protected]
Contact person for public queries
Name 45875 0
Prof Dianne Wynaden
Address 45875 0
School of Nursing and Midwifery
Curtin University
GPO Box U 1987
Perth
Western Australia 6845
Country 45875 0
Australia
Phone 45875 0
+61 8 92662203
Fax 45875 0
Email 45875 0
[email protected]
Contact person for scientific queries
Name 45876 0
Prof Dianne Wynaden
Address 45876 0
School of Nursing and Midwifery
Curtin University
GPO Box U 1987
Perth
Western Australia 6845
Country 45876 0
Australia
Phone 45876 0
+61 8 92662203
Fax 45876 0
Email 45876 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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