Hostname: page-component-8448b6f56d-sxzjt Total loading time: 0 Render date: 2024-04-24T20:02:45.262Z Has data issue: false hasContentIssue false
  • English
  • Français

Participation in Clinical Trials May Improve Care of Acute Schizophrenia Inpatients in a General Hospital

Published online by Cambridge University Press:  07 November 2014

Uriel Halbreich ,
Nancy Smail ,
Xin Tu  and
Judith Halbreich
Get access Rights & Permissions [Opens in a new window]

Abstract

Introduction: This report demonstrates parameters of quality of care and treatment outcome of acute schizophrenia patients who were involved as subjects in a clinical trial of two marketed widely used antipsychotics compared with their fellow patients who received routine clinical hospital care.

Methods: Patients were newly admitted severely agitated schizophrenia patients who agreed to participate in a double-blind randomized trial of short-term (5 days) rate of improvement in response to two second-generation oral antipsychotics. Treatment outcomes as measured by the Clinical Global Impression and parameters of quality of care were compared with the general population of inpatients in the same county hospital.

Results: Of 145 patients screened, 109 patients did not meet study inclusion and exclusion criteria. It is of note that systematic diagnostic interview did not confirm the clinical diagnosis of schizophrenia in 17 patients (11.7%). Study patients had shorter length of stay (6.75 days vs 15.3 days of total psychiatric patients at the hospital during the study period), no physical restraints (vs 21.9%), no use of antipsychotics as chemical restraints (vs 19.8%), and less recidivism following the trial (28.1%) compared with prior to the trial (64.3%).

Conclusion: Patients who participate in structured clinical research with well-delineated procedures, clinical outcome measures, and clear expectations, faired better than their fellow patients in the same non-research hospital wards. Application of some characteristics of clinical research to the diagnosis and treatment of clinical non-research patients may be considered.

Type
The Well-Rounded Brain
Information
CNS Spectrums , Volume 13 , Issue 9 , September 2008 , pp. 757 - 761
Copyright
Copyright © Cambridge University Press 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1.Ellis, PM. Attitudes towards and participation in randomized clinical trials in oncology: a review of the literature. Ann Oncol. 2000;11:939–945.CrossRefGoogle ScholarPubMed
2.Hunter, CP, Frelick, RW, Feldman, AR, et al.Selection factors in clinical trials: results from the Community Clinical Oncology Program Physician's Patient Log. Cancer Treatment Reports. 1987;71:559–565.Google Scholar
3.Antman, K, Amato, D, Wood, W, et al.Selection bias in clinical trials. J Clin Oncol. 1985;3:1142–1147.Google Scholar
4.Ketley, D, Woods, KL. Impact of clinical trials on clinical practice: example of thrombolysis for acute myocardial infarction. Lancet. 1993;342:891–894.Google Scholar
5.Segelov, E, Tatersall, MHN, Coats, AS. Redressing the balance—the ethics of not entering an eligible patient on a randomized clinical trial. Ann Oncol. 1992;3:103–105.CrossRefGoogle ScholarPubMed
6.Vinciguerra, V, Moore, T. Attitudes of CCOP physicians toward clinical trials and protocol accrual. Prog Clin Biol Res. 1990;339:401–407.Google Scholar
7.Baum, M. New approach for recruitment into randomized controlled trials. Lancet 1993;341:812–813.Google Scholar
8.Baum, M. Clinical trials–a brave new partnership: a response to Mrs. Thornton. J Med Ethics. 1994;20:23–24.Google Scholar
9.Johnson, RA, Wichern, DW. Applied Multivariate Statistical Analysis. Englewood Cliff, NJ: Prentice Hall; 2001.Google Scholar
10.Stokes, ME, Davis, CS, Koch, GG. Categorical Data Analysis–Using the SAS System. Cary, NJ: SAS Publishing; 2000.Google Scholar
11.Bickel, PJ, Duksum, KA. Mathematical Statistics: Basic Ideas and Selected Topics. San Francisco, Calif: Holden-Day; 1977.Google Scholar
12.Tu, XM, Litvak, F, Pagano, M. Studies of AIDS and HIV surveillance. Screening tests: can we get more by doing less? Stat Med. 1994;13:1905–1919.Google Scholar
13.Addington, D, McKenzie, E, Addington, J, Patten, S, Smith, H, Adair, C. Performance Measures for Early Psychosis Treatment Services. Psychiatr Serv. 2005;56:1570–1582.Google Scholar
14.Hermann, RC, Finnerty, M, Provost, S, et al.Process measures for the assessment and improvement of quality of care for schizophrenia. Schizophr Bull. 2002;28:95–104.Google Scholar
15.Center for Disease Control. QuickStats: average length of hospital stay, by diagnostic category—United States, 2003. MMWR Morb Mortal Wkly Rep. 2005;54:680.Google Scholar
16.Wray, NP, Petersen, NJ, Souchek, J, Ashton, CM, Hollingsworth, JC, Geraci, JM. The hospital multistay rate as an indicator of quality of care. Health Services Research. 1999;34:777–790.Google ScholarPubMed
17.Department of Health. 1999 Modern Standards and Service Models. National Service Framework for Mental Health. London, UK: Department of Health; 1999.Google Scholar
18.McEwan, K, Goldner, EM. Accountability and Performance Indicators for Mental Health Services and Supports: A Resource Kit. Ottawa, Canada: Government Services Canada; 2000.Google Scholar
19.Charlwood, P, Mason, A, Goldacre, M, et al.Health Outcome Indicators: Severe Mental Illness. Oxford, UK: National Centre for Health Outcomes Development; 1999.Google Scholar
20.Lehman, AF, Steinwachs, DM. Patterns of usual care for schizophrenia: Initial results from the schizophrenia patient outcomes research team (PORT) client survey. Schizophr Bull. 1998;24:11–20.Google ScholarPubMed
21.Australian Clinical Guidelines for Early Psychosis. Melbourne, Australia: National Early Psychosis Project; 2000.Google Scholar
22. Practice guidelines for the treatment of patients with schizophrenia. American Psychiatric Association. Am J Psychiatry. 1997;154(suppl 4):1–63.Google Scholar
23.Young, AS, Sullivan, G, Burnam, MA, et al.Measuring the quality of outpatient treatment for schizophrenia. Arch Gen Psychiatry. 1998;55:611–617.Google Scholar
24.Slade, M, McCrone, P, Kuipers, E, et al.Use of standardized outcome measures is adult mental health services: randomized controlled trial. Br J Psychiatry. 2006;189:330–336.CrossRefGoogle Scholar
25.Trauer, T. Routine outcome measurement by mental health care providers. Lancet. 2003;361:1137.Google Scholar
26.Valenstein, M, Mitchinson, A, Ronis, DL, et al.Am J Psychiatry. 2004;161:146–153.Google Scholar
27.Bilsker, D, Goldmer, EM. Routine outcome measurements by mental health-care providers: is it worth doing? Lancet. 2002;360:1689–1690.Google Scholar