RESPECT-PTSD: Re-Engineering Systems for the Primary Care Treatment for PTSD

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00373698
• Collaborator: (none)
• Enrollment: 195
• Locations: 4
• Arms: 2
• Duration (Months): 49
• Patients Per Site: 48.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate objectives are to (1) implement three component model (3CM) in VA primary care clinics; and (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term objectives are to generate information to support implementation research on the RESPECT model for treating PTSD in primary care and ultimately, the implementation of the model in VHA to provide care to veterans with PTSD.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Posttraumatic; Depression	Behavioral: Three Component Model of Collaborative Care	Phase 3

Detailed Description

3CM consists of (1) a prepared practice, (2) care management, and (3) enhanced mental health support. A prepared practice refers to education for primary care clinicians and office staff about practice guidelines and evidence-based care, the skills needed for use of assessment measures, and the use of communication forms and routines. The education plan consists of predisposing activities, including active teaching and learning, and enabling and reinforcing activities in order to help clinicians use newly acquired skills and to reinforce the continued use of these skills in practice. Care management is accomplished by telephone, usually by a centrally located care manager during acute phase treatment and follow up to answer patient questions, promote adherence to the clinician's management plan, and help patients overcome barriers to adherence. Enhanced mental health support is provided by a psychiatrist who supervises care managers by telephone, provides informal consultation to primary care clinicians, and helps to increase the quantity or quality of mental health referral resources.

Study Design

• Study Type: Interventional
• Actual Enrollment: 195 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Reengineering Systems for the Primary Care Treatment of PTSD
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Three Component Model Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.	Behavioral: Three Component Model of Collaborative Care; Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
No Intervention: Usual Care Patients randomized to "Usual Care" will receive care as usual by VA clinicians.

Outcome Measures

Primary Outcome Measures

1. PTSD Symptom Severity [3 and 6 months after initial assessment]

   PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)

Secondary Outcome Measures

1. Depression [3 and 6 months after initial assessment]

   Measure using the Hopkins Symptom Checklist-20

2. SF-36 Mental Component [3 and 6 months after initial assessment]

3. SF-36 Physical Component [3 and 6 months after initial assessment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Military Veterans in Primary Care Clinics who meet diagnostic criteria for PTSD in one of the 5 sites in Texas where this study is being conducted.

• Must have regular access to a telephone and speak English.

Exclusion Criteria:

• Cognitive impairment

• A history of psychosis or mania

• Prominent current suicidal ideation

• Current substance dependence

• Current engagement in mental health treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX	Dallas	Texas	United States	75216
2	Central Texas Veterans Health Care System, Temple, TX	Temple	Texas	United States	76504
3	Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX	Waco	Texas	United States	76711
4	White River Junction VA Medical Center, White River Junction, VT	White River Junction	Vermont	United States	05009-0001

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

• Principal Investigator: Paula P Schnurr, PhD, White River Junction VA Medical Center, White River Junction, VT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00373698
• Other Study ID Numbers: IAC 06-073
• First Posted: Sep 8, 2006
• Last Update Posted: Apr 24, 2015
• Last Verified: Jun 1, 2014

• Keywords provided by US Department of Veterans Affairs: Stress Disorders, Posttraumatic; Delivery of Health Care, Integrated; Primary Health Care; Veterans; Depression
• Additional relevant MeSH terms: Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Three Component Model of Collaborative Care and Usual Care	Usual Care
Arm/Group Description	Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's "Usual Care" is at the VA provider's discretion and could include referral to mental health specialty care.specialty care.	Participants randomized to "Usual Care" received care at the VA provider's discretion and could include referral to mental health specialty care.
Period Title: Overall Study
STARTED	96	99
COMPLETED	85	99
NOT COMPLETED	11	0

Baseline Characteristics

Arm/Group Title	Three Component Model	Usual Care	Total
Arm/Group Description	Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.	Patients randomized to "Usual Care" will receive care as usual by VA clinicians.	Total of all reporting groups
Overall Participants	96	99	195
Age, Customized (years) [Mean (Full Range) ]
Age, >=18	46.1	44.4	NA
Sex: Female, Male (Count of Participants)
Female	7 7.3%	10 10.1%	17 8.7%
Male	89 92.7%	89 89.9%	178 91.3%
Region of Enrollment (participants) [Number]
United States	96 100%	99 100%	195 100%
PTSD symptom severity (used Posttraumatic Diagnostic Scale (PDS)) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	33.2 (8.3)	34.0 (9.7)	NA (NA)
Depression (Hopkins Symptom Checklist-20) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.98 (0.69)	2.06 (0.78)	NA (NA)
SF-36 Mental Component (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	33.8 (8.8)	32.7 (8.1)	NA (NA)
SF-36 Physical Component (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	42.2 (13.0)	43.4 (12.6)	NA (NA)

Outcome Measures

1. Primary Outcome

Title	PTSD Symptom Severity
Description	PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Time Frame	3 and 6 months after initial assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm1/Three Component Model of Care Collaborative Care	Arm 2/Usual Care
Arm/Group Description	Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.	Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Measure Participants	96	99
3 months after initial assessment	31.4 (10.2)	31.5 (10.3)
6 months after initial assessment	30.2 (10.3)	29.9 (10.8)

2. Secondary Outcome

Title	Depression
Description	Measure using the Hopkins Symptom Checklist-20
Time Frame	3 and 6 months after initial assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm1/Three Component Model of Care Collaborative Care	Arm 2/Usual Care
Arm/Group Description	Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.	Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Measure Participants	96	99
3 months after initial assessment	1.8 (0.8)	1.84 (0.82)
6 months after initial assessment	1.81 (0.84)	1.83 (0.90)

3. Secondary Outcome

Title	SF-36 Mental Component
Time Frame	3 and 6 months after initial assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm1/Three Component Model of Care Collaborative Care	Arm 2/Usual Care
Arm/Group Description	Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.	Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Measure Participants	96	99
Mental Component-3 months after initial assessment	33.9 (8.3)	33.8 (8.1)
Mental Component-6 months after initial assessment	33.7 (9.4)	33.4 (8.1)

4. Secondary Outcome

Title	SF-36 Physical Component
Time Frame	3 and 6 months after initial assessment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Three Component Model	Usual Care
Arm/Group Description	Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.	Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
Measure Participants	96	99
Physical Component-3 months after initial assessme	43.8 (13.1)	43.7 (12.2)
Physical Component-6 monthsafter initial assessmen	44.4 (12.6)	44.8 (11.8)

Adverse Events

Arm/Group Title	Three Component Model		Usual Care
Arm/Group Description	Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.		Patients randomized to "Usual Care" will receive care as usual by VA clinicians.
All Cause Mortality
	Three Component Model		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Three Component Model		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/96 (5.2%)		4/99 (4%)
Surgical and medical procedures
hospitalization	5/96 (5.2%)		4/99 (4%)
Other (Not Including Serious) Adverse Events
	Three Component Model		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/96 (0%)		0/99 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.