Psychiatric Advance Directives for Improved Mental Health Care
|ClinicalTrials.gov Identifier: NCT00105794|
Recruitment Status : Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
|First Submitted Date ICMJE||March 16, 2005|
|First Posted Date ICMJE||March 17, 2005|
|Last Update Posted Date||April 7, 2015|
|Study Start Date ICMJE||March 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Rate of involuntary commitment (12 months), perceived coercion (baseline, 1, 6, 12, and rehospitalization), and treatment adherence (baseline and 12 months and record review)|
|Original Primary Outcome Measures ICMJE
||Involuntary commitment rate|
|Change History||Complete list of historical versions of study NCT00105794 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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).|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Psychiatric Advance Directives for Improved Mental Health Care|
|Official Title ICMJE||Psychiatric Advance Directives for Improved Healthcare|
|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.|
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 ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: Psychiatric Advance Directives intervention|
|Study Arms||Arm 1
Intervention: Procedure: Psychiatric Advance Directives intervention
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
Not competent (dementia, guardian, does not pass competency screen) Not followed in VA system for mental health care or available for follow-uo.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00105794|
|Other Study ID Numbers ICMJE||PCC 02-054|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||VA Office of Research and Development|
|Study Sponsor ICMJE||VA Office of Research and Development|
|Collaborators ICMJE||Not Provided|
|PRS Account||VA Office of Research and Development|
|Verification Date||June 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP