Veterans Individual Placement and Support Towards Advancing Recovery

NCT01817712 | Completed Results DMC

• 1 other identifier: 589
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 13

Brief Summary

The primary objective of CSP#589 VIP-STAR is to evaluate the effectiveness of Individual Placement \& Support (IPS) in unemployed Veterans with PTSD. The primary hypothesis is that, compared to those treated with transitional work program (TWP), unemployed Veterans with PTSD treated with IPS will be significantly more likely to become a steady worker. A steady worker is defined as holding a competitive job for greater than or equal to 50% of the 18-month study follow-up period (i.e., greater than or equal to 39 of the 78 weeks). All participants will be followed for 18 months post-randomization. 12/14/12: Analytic plan augmented to allow for a sensitivity analysis of the primary outcome that would exclude the first 12 weeks post-randomization, and evaluate between group proportion of steady worker status, as defined by working in a competitive job for greater than or equal to 50% of the weeks during week 13-78. 7/1/13: Analysis plan has been augmented to include a logistic regression analysis of the primary outcome, adjusted for participating medical center. 10/4/13: Addition of the IPS-25 Fidelity Scale. The addition of the IPS-25 scale should increase the validity of study results. 1/15/15: Addition of an Interactive Voice Recognition/Web-based (IVR/Web) System; as an option for weekly data capture of the primary outcome data (employment history). 8/17/15: Approval of Supplemental Data Collection at Participant Study Exit; use of the data collected will supplement the study analysis plan and, provide further insight into the impact of vocational rehab. A Participant Satisfaction Survey will allow study participants to indicate their level of satisfaction with the study, vocational rehabilitation intervention and, suggestions for future research.

Conditions

Posttraumatic Stress Disorder (PTSD)

Keywords

Posttraumatic neuroses; posttraumatic stress disorder; PTSD; Supported employment; IPS; CWT; TWP; Individual placement and support; Compensated work therapy; Transitional work program

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period

  The primary outcome will be achievement of a "steady worker" status, defined as obtaining and maintaining competitive employment for at least 50% of the active follow-up period (i.e., greater than or equal to 39 weeks).

  78 weeks

Secondary Outcomes (2)

• Cumulative Gross Income

  Weekly for 78 weeks

• Change in PCL-5 Score of PTSD Symptoms

  18-months (Change from baseline)

Study Arms (2)

Individual Placement and Support (IPS)

EXPERIMENTAL

The IPS intervention must achieve a rating of \>66 of a possible 75 points on the Supported Employment Fidelity Scale. The fidelity ratings are conducted by the National IPS Fidelity Monitor at biannual on-site monitoring visits.

Behavioral: Individual Placement & Support

VA Transitional Work Program (TWP)

ACTIVE COMPARATOR

TWP will adhere to a lower rating (less than or equal to 55 of a possible 75 points) on the Supported Employment Fidelity Scale rated by the National Fidelity Monitor. The TWP specialist participates in face-to-face supervision with the local Compensated Work Therapy (CWT) team according to the CWT manager's schedule.

Behavioral: VA Transitional Work Program

Interventions

Individual Placement & Support BEHAVIORAL

IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.

Also known as: Supported Employment, IPS

Individual Placement and Support (IPS)

VA Transitional Work Program BEHAVIORAL

The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.

Also known as: TWP

VA Transitional Work Program (TWP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• Age greater than or equal to 18\* (\*18 or 19 depending on state legal definition of a minor) to age 65
• Eligible for VA TWP services
• Diagnosis of PTSD, as confirmed by Clinician Administered PTSD Scale (CAPS)
• Currently unemployed (and not participating in TWP - Impact Statement #3 10/4/13)
• Expression of interest in competitive employment (part-time or full-time - Impact Statement #3 10/4/13)
• Willing and able to give informed consent

You may not qualify if:

• Lifetime diagnosis if (i) schizophrenia, (ii) schizoaffective or (iii) bipolar I disorder
• Diagnosis of dementia or severe cognitive disorder (evidenced in the medical record)
• Unlikely that participant can complete the study; reasons may include: expected deployment, expected incarceration, expected long-term hospitalization, or expected relocation from the vicinity of the participating medical center (PMC) during the study period
• Active suicidal or homicidal ideation
• Current participation in another interventional trial

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (13)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233, United States

Location

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

• Davis LL, Resnick SG, Maieritsch KP, Weber KC, Erbes CR, Strom TQ, McCall KP, Kyriakides TC. Employment outcomes from VA vocational services involving transitional work for veterans with a diagnosis of posttraumatic stress disorder. Psychiatr Rehabil J. 2019 Sep;42(3):257-267. doi: 10.1037/prj0000357. Epub 2019 Apr 4.

  PMID: 30945920 DERIVED

• Mueller L, Wolfe WR, Neylan TC, McCaslin SE, Yehuda R, Flory JD, Kyriakides TC, Toscano R, Davis LL. Positive impact of IPS supported employment on PTSD-related occupational-psychosocial functional outcomes: Results from a VA randomized-controlled trial. Psychiatr Rehabil J. 2019 Sep;42(3):246-256. doi: 10.1037/prj0000345. Epub 2019 Apr 1.

  PMID: 30932508 DERIVED

• Davis LL, Kyriakides TC, Suris AM, Ottomanelli LA, Mueller L, Parker PE, Resnick SG, Toscano R, Scrymgeour AA, Drake RE; VA CSP #589 Veterans Individual Placement and Support Toward Advancing Recovery Investigators. Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Apr 1;75(4):316-324. doi: 10.1001/jamapsychiatry.2017.4472.

  PMID: 29490371 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Palliative Care; Employment, Supported; Myo-Inositol-1-Phosphate Synthase

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Employment; Socioeconomic Factors; Population Characteristics; Rehabilitation, Vocational; Rehabilitation; Intramolecular Lyases; Isomerases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Tassos C. Kyriakides, Ph.D, Biostatistician
• Organization: VA Cooperative Studies Program

tassos.kyriakides@va.gov

203-932-5711

Study Officials

• Lori Lynne Davis, MD AB

  Tuscaloosa VA Medical Center, Tuscaloosa, AL

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 25, 2013
• Study Start: December 31, 2013
• Primary Completion: December 20, 2016
• Study Completion: February 3, 2017
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)