Post-traumatic Stress DisorderNCT01984515
Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans
A study testing Referral Management System in people with Post-traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to implement an evidence-based Referral Management System that will address patient and system-level barriers to the uptake of evidence-based psychotherapy for PTSD by Veterans Affairs primary care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Referral Management System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Team Red primary care patients,
- have a score of at least 44 on PCL-S and
- able to give informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
About this study
The purpose of this study is to implement an evidence-based Referral Management System that will address patient and system-level barriers to the uptake of evidence-based psychotherapy for PTSD by Veterans Affairs primary care patients.
Read the detailed description
Within the Veteran's Health Administration (VHA), primary care (PC) patients with PTSD have low rates of engagement in evidence-based psychotherapy (EBP) for PTSD. Low engagement rates are due to a variety of patient-level (e.g., belief that treatment will not be helpful, stigma) and system-level barriers (e.g., lack of tracking of referral process, knowledge gaps on how to manage PTSD). We propose to conduct a pilot hybrid effectiveness- implementation study to implement an evidence-based Referral Management System (RMS) that will address patient and system-level barriers to the uptake of EBP for PTSD by VHA primary care patients. RMS will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me"). This CBT intervention has been previously found to be effective for increasing treatment engagement with Veterans with PTSD. Depending on Veteran preference, it will be delivered by the PC-MHI provider within the PC clinic or a Behavioral Health Lab (BHL) care manager by phone. RMS will be initiated by PACT staff and will address system-level barriers by having a BHL technician track the progress of RMS referrals and contact Veterans who have not followed thought on their chosen referral options. PACT staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD. Our aims, implementation strategy, data collection, and analyses will be guided by established strategies. The Consolidated Framework for Implementation Research (CFIR) will identify organization variables. RE-AIM will investigate program uptake and patient/ system-level impact. An Implementation Mapping approach will guide our implementation strategy. We propose to conduct this study in 3 phases. Phase 1 includes interviews with PC and MH leadership about the relevance of CFIR constructs to RMS implementation and a meeting with PACT staff to train them on RMS and gather their input on how RMS should be adapted to their clinic. A PC medical provider will serve as a clinical champion who is knowledgeable, communicative, and a leader in promoting RMS among his/her peers. Phase 2 consists of implementing RMS for 6 months in one Syracuse PC clinic and then measuring RE-AIM outcomes. Some RE-AIM outcomes compared participants who received RMS to those who did not receive RMS in a historical control group. Phase 3 involves meeting with PACT and MH Leadership and PACT staff to share a formal report of study results and gather information about potential barriers and facilitators to long-term maintenance and future expansion of RMS within the CFIR framework. An expert national stakeholder panel will also be convened to guide development of a SDP that will investigate multi-VISN implementation.
Our long-term aim of this line of research is to increase implementation of evidence-based psychotherapy for PTSD by getting more primary care patients with PTSD to engage in treatment.
Our Specific Aims for this Rapid Response Project are to:
- Assess and improve the feasibility of implementing RMS in PC-MHI/PACT settings
1A. Diagnose organizational and staff-level barriers and facilitators to implementing RMS.
1B. Adapt RMS for the local context based on information gathered about barriers and facilitators.
- Evaluate initial impact of implementing RMS in PC-MHI/PACT settings. Assess impact of RMS on RE-AIM measures of Reach, Efficacy/Effectiveness, Adoption, Implementation and Maintenance 3. Refine implementation strategy based on study findings for planned efforts to spread RMS to additional VISNs in a QUERI Phase 2 Service-Directed Project (SDP) to follow.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Referral Management System
- Keywords
- Post-traumatic Stress Disorder, Evidence-Based Psychotherapy, Treatment Engagement, Cognitive Behavioral Therapy, Implementation Science
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral Management SystemBehavioural
Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.
| Study group | Role | What they receive |
|---|---|---|
| Team Red Primary Care | Experimental | Eligible patients will receive the Referral Management System in primary care Receives: Behavioral: Referral Management System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Evidence-based Psychotherapy for PTSD
Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.
Measured: From initiation of the Referral Management System to 6 months after initiation
Secondary outcomes (2)
PTSD Checklist-Specific
Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.
Measured: Referral Management Initiation, 1 month post initiation, 3 months post initiation
Patient Health Questionnaire-9 Item
9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.
Measured: Referral Management Initiation, 1 month post initiation, 3 months post initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kyle Possemato, PhD, Principal investigator, Syracuse VA Medical Center, Syracuse, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984515
- Sponsor's protocol ID
- RRP 13-204
- Status last verified
- Nov 2015
- First submitted
- 7 Nov 2013
- Last updated
- 16 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans
- ClinicalTrials.gov ID
- NCT01984515
- Acronym / sponsor ID
- RRP 13-204
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Post-traumatic Stress Disorder, Evidence-Based Psychotherapy, Treatment Engagement, Cognitive Behavioral Therapy, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Posted 16 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to implement an evidence-based Referral Management System that will address patient and system-level barriers to the uptake of evidence-based psychotherapy for PTSD by Veterans Affairs primary care patients.
Detailed description
Within the Veteran's Health Administration (VHA), primary care (PC) patients with PTSD have low rates of engagement in evidence-based psychotherapy (EBP) for PTSD. Low engagement rates are due to a variety of patient-level (e.g., belief that treatment will not be helpful, stigma) and system-level barriers (e.g., lack of tracking of referral process, knowledge gaps on how to manage PTSD). We propose to conduct a pilot hybrid effectiveness- implementation study to implement an evidence-based Referral Management System (RMS) that will address patient and system-level barriers to the uptake of EBP for PTSD by VHA primary care patients. RMS will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me"). This CBT intervention has been previously found to be effective for increasing treatment engagement with Veterans with PTSD. Depending on Veteran preference, it will be delivered by the PC-MHI provider within the PC clinic or a Behavioral Health Lab (BHL) care manager by phone. RMS will be initiated by PACT staff and will address system-level barriers by having a BHL technician track the progress of RMS referrals and contact Veterans who have not followed thought on their chosen referral options. PACT staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD. Our aims, implementation strategy, data collection, and analyses will be guided by established strategies. The Consolidated Framework for Implementation Research (CFIR) will identify organization variables. RE-AIM will investigate program uptake and patient/ system-level impact. An Implementation Mapping approach will guide our implementation strategy. We propose to conduct this study in 3 phases. Phase 1 includes interviews with PC and MH leadership about the relevance of CFIR constructs to RMS implementation and a meeting with PACT staff to train them on RMS and gather their input on how RMS should be adapted to their clinic. A PC medical provider will serve as a clinical champion who is knowledgeable, communicative, and a leader in promoting RMS among his/her peers. Phase 2 consists of implementing RMS for 6 months in one Syracuse PC clinic and then measuring RE-AIM outcomes. Some RE-AIM outcomes compared participants who received RMS to those who did not receive RMS in a historical control group. Phase 3 involves meeting with PACT and MH Leadership and PACT staff to share a formal report of study results and gather information about potential barriers and facilitators to long-term maintenance and future expansion of RMS within the CFIR framework. An expert national stakeholder panel will also be convened to guide development of a SDP that will investigate multi-VISN implementation.
Our long-term aim of this line of research is to increase implementation of evidence-based psychotherapy for PTSD by getting more primary care patients with PTSD to engage in treatment.
Our Specific Aims for this Rapid Response Project are to:
- Assess and improve the feasibility of implementing RMS in PC-MHI/PACT settings
1A. Diagnose organizational and staff-level barriers and facilitators to implementing RMS.
1B. Adapt RMS for the local context based on information gathered about barriers and facilitators.
- Evaluate initial impact of implementing RMS in PC-MHI/PACT settings. Assess impact of RMS on RE-AIM measures of Reach, Efficacy/Effectiveness, Adoption, Implementation and Maintenance 3. Refine implementation strategy based on study findings for planned efforts to spread RMS to additional VISNs in a QUERI Phase 2 Service-Directed Project (SDP) to follow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Team Red Primary Care | Experimental | Behavioral: Referral Management SystemEligible patients will receive the Referral Management System in primary care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Team Red primary care patients,
- have a score of at least 44 on PCL-S and
- able to give informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral Management SystemReferral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD. | Behavioural | Team Red Primary Care |
Primary outcome
Engagement in Evidence-based Psychotherapy for PTSD
Time frame: From initiation of the Referral Management System to 6 months after initiation
Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.
2 secondary outcomes
PTSD Checklist-Specific
Time frame: Referral Management Initiation, 1 month post initiation, 3 months post initiation
Patient Health Questionnaire-9 Item
Time frame: Referral Management Initiation, 1 month post initiation, 3 months post initiation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Possemato, PhD principal investigator
Syracuse VA Medical Center, Syracuse, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral Management System in people with Post-traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Evidence-based Psychotherapy for PTSD (time frame: From initiation of the Referral Management System to 6 months after initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.