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Psychiatric Advance Directives for Improved Mental Health Care

Primary Purpose

Schizophrenia, Schizoaffective, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychiatric Advance Directives intervention
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring advance directives, advance directive adherence, patient-centered care, patient satisfaction, coercion, informed consent, commitment of mentally ill, physician-patient relations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durham VA Medical Center, Durham, NC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Rate of involuntary commitment (12 months), perceived coercion (baseline, 1, 6, 12, and rehospitalization), and treatment adherence (baseline and 12 months and record review)

Secondary Outcome Measures

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).

Full Information

First Posted
March 16, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00105794
Brief Title
Psychiatric Advance Directives for Improved Mental Health Care
Official Title
Psychiatric Advance Directives for Improved Healthcare
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective, Bipolar Disorder, Stress Disorders, Post-traumatic, Psychotic Disorders
Keywords
advance directives, advance directive adherence, patient-centered care, patient satisfaction, coercion, informed consent, commitment of mentally ill, physician-patient relations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Psychiatric Advance Directives intervention
Primary Outcome Measure Information:
Title
Rate of involuntary commitment (12 months), perceived coercion (baseline, 1, 6, 12, and rehospitalization), and treatment adherence (baseline and 12 months and record review)
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L. Strauss, BA MS PhD
Organizational Affiliation
Durham VA Medical Center, Durham, NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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. International Journal of Forensic Mental Health. 2007 Nov 1; 6(No. 2):105-112.
Results Reference
result
Links:
URL
http://www.hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141692550&UnderReview-no
Description
Click here for more information about this study: Psychiatric Advance Directives for Improved Healthcare

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