Psychiatric Advance Directives for Improved Mental Health Care

Schizophrenia Clinical Trial

Official title:

Psychiatric Advance Directives for Improved Healthcare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105794
• Other study ID #: PCC 02-054
• Status: Completed
• Phase: N/A
• First received: March 16, 2005
• Last updated: April 6, 2015
• Start date: March 2004
• Est. completion date: June 2007

Study information

• Verified date: June 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background:

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.

Objectives:

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.

Methods:

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.

Status:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

veteran diagnosis of schizophrenia, schizoaffective disorder, psychosis NOS, major depression with psychosis, bipolar I, PTSD.

At enrollment, hospitalized at the Durham VAMC psychiatric inpatient unit and receiving or anticipating outpatient treatment at the Durham or Raleigh VA facilities after discharge.

Exclusion Criteria:

Not competent (dementia, guardian, does not pass competency screen) Not followed in VA system for mental health care or available for follow-uo.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizoaffective
• Schizophrenia
• Stress Disorders, Post-traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Psychiatric Advance Directives intervention

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zervakis JB, Stechuchak KM, Olsen MK, Swanson JW, Oddone EZ, Weinberger M, Bryce ER, Butterfield ML, Swartz MS, Strauss JL. Previous Involuntary Commitment is Associated with Current Perceptions of Coercion in Voluntarily Hospitalized Patients. Internatio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of involuntary commitment (12 months), perceived coercion (baseline, 1, 6, 12, and rehospitalization), and treatment adherence (baseline and 12 months and record review)			No
Secondary	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).			No

External Links

•   Click here for more information about this study: Psychiatric Advance Directives for Improved Healthcare
•   Duke University Medical Center, Department of Psychiatry and Behavioral Sciences, Services Effectivewness Research Program
•   Duke university program on psychiatric advance directives. Includes facts about PADs, a tool kit, resources, and research on PADs