Psychiatric Advance Directives for Improved Mental Health Care
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|ClinicalTrials.gov Identifier: NCT00105794|
Recruitment Status : Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Bipolar Disorder Stress Disorders, Post-traumatic Psychotic Disorders||Procedure: Psychiatric Advance Directives intervention||Not Applicable|
During a psychiatric crisis, persons with severe mental illness (SMI) confront complex challenges concerning treatment choices and are often ill equipped or unable to make mental health care decisions. Psychiatric Advance Directives (PADs) are legal documents that allow competent persons to declare their treatment preferences in advance of a mental health crisis, when they may lose capacity to make reliable health care decisions. The use of PADs is consistent with recommendations of the President�s New Freedom Commission on Mental Illness and the Patient Self-Determination Act; 25 states have now adopted PAD legislation. VA does not have a specific policy for PADs or mechanisms to notify veterans of their right to prepare PADs. The downstream effects of PADs on patient care, crisis management, service use, and clinical outcomes are unknown.
This project examined the effects of a facilitated PAD intervention on guiding patients� treatment during a future mental health crisis, patients� treatment engagement, and patients� mental health service use and clinical outcomes. An additional objective was to describe veterans� preferences for PAD content and completion. Study hypotheses predicted that, as compared to controls, veterans with PAD would have fewer involuntary hospitalizations, great satisfaction with care, less coercion and more autonomy, greater treatment motivation, stronger working alliances, less ER use and fewer rehospitalizations, and improved clinical outcomes.
A total of 240 psychiatrically hospitalized veterans with severe mental illness were enrolled in this prospective, randomized, clinical intervention trial: 120 were randomized to �usual care� and received information about PADs; 120 were randomized to the PAD condition. All participants and their clinicians received information about PADs. Those randomized to the PAD condition were also offered the opportunity to complete a facilitated PAD. The facilitated PAD consisted of a 60-minute meeting with a clinician, who provided education about PADs and conducted a semi-structured interview to assess the patient�s wishes and preferences for future treatment during a mental health crisis. The clinician then assisted the patient to prepare a PAD document. Patients in both groups completed follow-up assessments at 1, 6, and 12 months post-enrollment. Those rehospitalized at Durham VAMC during the 12-month follow up period completed an additional assessment interview at each rehospitalization.
Complete. Activities completed in the past 12 months include collection of follow-up data on final subset of enrollees, extraction of utilization data (clinic stops) at one-year post-enrollment from VA system healthcare database (Austin, TX) and from local healthcare database (CPRS), completion of statistical analyses of outcome measures and preparation of scientific reports summarizing final results.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Psychiatric Advance Directives for Improved Healthcare|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||June 2007|
|Arm 1||Procedure: Psychiatric Advance Directives intervention|
- Rate of involuntary commitment (12 months), perceived coercion (baseline, 1, 6, 12, and rehospitalization), and treatment adherence (baseline and 12 months and record review)
- Satisfaction with inpatient care (baseline, rehospitalization), treatment motivation, working alliance, psychiatric symptoms, PAD completion, PAD content, PAD consulted (hospital record review), psychiatric ER use (12 month record review).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105794
|United States, North Carolina|
|Durham VA Medical Center, Durham, NC|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Jennifer L. Strauss, BA MS PhD||Durham VA Medical Center, Durham, NC|