The ethical challenges of a randomized controlled trial of involuntary outpatient commitment

• Published in: Journal of mental health administration 1997, Vol.24 (1), p.35-43
• Main Authors: Swartz, M S, Burns, B J, George, L K, Swanson, J, Hiday, V A, Borum, R, Wagner, H R
• Format: Article
• Language: English
• Subjects: Ambulatory Care - organization & administration; Behavioral Research; Bias; Bioethics; Case management; Case Management - organization & administration; Civil justice; Clinical trials; Coercion; Commitment of Mentally Ill; Commitments; Community Mental Health; Community mental health services; Community Mental Health Services - organization & administration; Community-based programs; Compliance; Confounding factors; Confounding Factors, Epidemiologic; Debates; Deinstitutionalization; Effectiveness studies; Ethical dilemmas; Ethics; Ethics, Medical; Health services; Health Services Research - methods; Health Services Research - standards; Humans; Involuntary; Laboratories; Length of stay; Mandatory treatment; Medical ethics; Mental disorders; Mental health; Mental health care; Mental Health Services; Mental institutions; Mentally ill people; Mentally Ill Persons; Negotiation; North Carolina; Operational definitions; Outcome Assessment, Health Care; Outpatient commitment; Outpatients; Patient Selection; Psychiatry; Randomized controlled trials; Randomized Controlled Trials as Topic - standards; Recidivism; Recurrent; Reproducibility of Results; Research Ethics; Research Subjects; Selection bias; Specification; Statistical power; Studies; Treatment compliance; Validity
• ISSN: 0092-8623; 1094-3412; 1556-3308
• DOI: 10.1007/BF02790478

Involuntary outpatient commitment (OPC) is a civil justice procedure intended to enhance compliance with community mental health treatment, to improve functioning, and to reduce recurrent dangerousness and hospital recidivism. The research literature on OPC indicates that it appears to improve outcomes in rates of rehospitalization and length of stay. However, all studies to date have serious methodological limitations because of selection bias; lack of specification of target populations; unclear operationalization of OPC; unmeasured variability in type, frequency, and intensity of treatment; as well as other confounding factors. To address limitations in these studies, the authors designed a randomized controlled trial (RCT) of OPC, combined with community-based case management, which is now under way in North Carolina. This article describes ethical dilemmas in designing and implementing an RCT of a legally coercive intervention in community-based settings. These ethical dilemmas challenge the experimental validity of an RCT but can be successfully addressed with careful planning and negotiation.