Trial Outcomes & Findings for Violence and Stress Assessment (ViStA) Project to Improve Post Traumatic Stress Disorder Management in Primary Care (NCT NCT01401101)

Last Updated: 2016-09-02

Results Overview

Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

404 participants

Primary outcome timeframe

0 months (baseline)

Results posted on

2016-09-02

Participant Flow

Participant milestones

Participant milestones
Measure	PTSD Care Management (PCM) There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions. quality improvement: Care Manager (CM) intervention	Treatment-as-Usual (TAU) The TAU condition will consist of only the clinician education and patient screening without written feedback. Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback.
Overall Study STARTED	206	198
Overall Study COMPLETED	184	171
Overall Study NOT COMPLETED	22	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Violence and Stress Assessment (ViStA) Project to Improve Post Traumatic Stress Disorder Management in Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PTSD Care Management (PCM) n=184 Participants There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions. quality improvement: Care Manager (CM) intervention	Treatment-as-Usual (TAU) n=171 Participants The TAU condition will consist of only the clinician education and patient screening without written feedback. Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback.	Total n=355 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 12.4 • n=39 Participants	42.2 years STANDARD_DEVIATION 12.0 • n=41 Participants	42.4 years STANDARD_DEVIATION 12.2 • n=35 Participants
Sex: Female, Male Female	150 Participants n=39 Participants	136 Participants n=41 Participants	286 Participants n=35 Participants
Sex: Female, Male Male	34 Participants n=39 Participants	35 Participants n=41 Participants	69 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	95 Participants n=39 Participants	90 Participants n=41 Participants	185 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=39 Participants	67 Participants n=41 Participants	146 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=39 Participants	14 Participants n=41 Participants	24 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	95 Participants n=39 Participants	88 Participants n=41 Participants	183 Participants n=35 Participants
Race (NIH/OMB) Asian	64 Participants n=39 Participants	60 Participants n=41 Participants	124 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Black or African American	14 Participants n=39 Participants	7 Participants n=41 Participants	21 Participants n=35 Participants
Race (NIH/OMB) White	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) More than one race	6 Participants n=39 Participants	4 Participants n=41 Participants	10 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=39 Participants	10 Participants n=41 Participants	15 Participants n=35 Participants
Region of Enrollment United States	184 participants n=39 Participants	171 participants n=41 Participants	355 participants n=35 Participants

PRIMARY outcome

Timeframe: 0 months (baseline)

Population: all patients who completed the assessment

Outcome measures

Outcome measures
Measure	PTSD Care Management (PCM) n=184 Participants There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions. quality improvement: Care Manager (CM) intervention	Treatment-as-Usual (TAU) n=171 Participants The TAU condition will consist of only the clinician education and patient screening without written feedback. Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback.
PTSD Symptoms	71.1 CAPS scores Interval 67.9 to 74.3	71.0 CAPS scores Interval 67.9 to 74.2

PRIMARY outcome

Timeframe: 6 months

Population: Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.

same as baseline

Outcome measures

Outcome measures
Measure	PTSD Care Management (PCM) n=184 Participants There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions. quality improvement: Care Manager (CM) intervention	Treatment-as-Usual (TAU) n=171 Participants The TAU condition will consist of only the clinician education and patient screening without written feedback. Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback.
PTSD Symptoms	47.8 CAPS scores Interval 44.2 to 51.3	49.5 CAPS scores Interval 46.4 to 52.6

PRIMARY outcome

Timeframe: 12 months

same as baseline and 6 months

Outcome measures

Outcome measures
Measure	PTSD Care Management (PCM) n=184 Participants There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions. quality improvement: Care Manager (CM) intervention	Treatment-as-Usual (TAU) n=171 Participants The TAU condition will consist of only the clinician education and patient screening without written feedback. Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback.
PTSD Symptoms	46.9 CAPS scores Interval 42.8 to 50.9	44.2 CAPS scores Interval 41.2 to 47.1

Adverse Events

PTSD Care Management (PCM)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Treatment-as-Usual (TAU)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PTSD Care Management (PCM) n=206 participants at risk There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.	Treatment-as-Usual (TAU) n=198 participants at risk The TAU condition consists of only the clinician education and patient screening without written feedback.
Psychiatric disorders suicidal ideation	9.7% 20/206 This study only monitored suicidal ideation as a non-serious adverse event. we also monitored suicide as a serious adverse events.	11.6% 23/198 This study only monitored suicidal ideation as a non-serious adverse event. we also monitored suicide as a serious adverse events.

Additional Information

Lisa S. Meredith, PhD

RAND Corporation

Phone: 310.393.0411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place