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The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and related comorbidity. Each year in the United States (US), over 30 million individuals present to trauma centers, emergency departments, and other acute care medical settings for the treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management treatment models for PTSD and related comorbidities exist. These care management models have the potential to be flexibly implemented in order to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries; care management models may also be effective in mitigating the impact of the acute injury event on symptom exacerbations in the large subpopulation of injury survivors who already carry a substantial pre-injury burden of multiple chronic medical conditions.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2021-07-02
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Primary Aims and Hypotheses The primary aim of the UH3 period is to conduct a pragmatic randomized effectiveness trial of a collaborative care intervention targeting PTSD and comorbid conditions after acute care injury hospitalization. The investigation aims to determine if injured patients receiving the collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared to control patients receiving care as usual. The study also aims to determine if the intervention patients when compared to control patients will demonstrate significant reductions in depressive symptoms, suicidal ideation, and alcohol use problems, and improvements in physical function. The primary hypothesis is that the intervention group when compared to the control group will demonstrate significant reductions in PTSD symptoms over the course of the year after injury. Secondary hypotheses are that intervention patients when compared to control patients will demonstrate, significant reductions in depressive symptoms, significant reductions in alcohol use problems, and improved post-injury physical function. A Priori Secondary Analyses The study team hypothesizes that a subgroup of patients will have persistent PTSD symptoms that will not remit over the longitudinal course of the investigation, regardless of randomization to intervention or control group conditions. The study team also anticipates that readily identifiable baseline clinical, injury and demographic characteristics will be associated with persistent PTSD symptoms over time (e.g., higher PTSD symptom levels, greater pre-injury trauma exposure, intentional injury including firearm related injury mechanisms and other characteristics such as unemployment, as well as other baseline factors). Derived from previous randomized clinical trials, a cumulative burden index has been developed from these baseline characteristics and will be adapted for the current investigation. The study team proposes a series of secondary analyses that adjust for and stratify by baseline characteristics that put patients at risk for persistent symptoms. It is hypothesized that these secondary analyses will identify a subgroup of intervention patients who are not at risk for persistent symptoms and who will demonstrate clinically and statistically significant treatment responses when compared to patients with similar baseline characteristics in the control condition. The study team also hypothesizes that the treatment effects will be greatest at the 1-6 month post-injury time points that are temporally correlated with the period of active intervention.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Research network
Interventions
Anti-depressant
Anti-depressant
Anti-depressant
Anti-depressant
Anti-depressant
Anti-depressant
Anti-depressant
Anti-depressant
Sleep medication
Sleep medication
Sleep medication
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | -1.65 | 0.86 |
| Usual Care | 370 | 0.08 | 0.74 |
| Intervention | 265 | -4.02 | 0.99 |
| Usual Care | 370 | -1.44 | 0.83 |
| Intervention | 265 | -5.51 | 1.18 |
| Usual Care | 370 | -4.25 | 0.97 |
The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | -0.79 | 0.40 |
| Usual Care | 370 | -0.50 | 0.35 |
| Intervention | 265 | -1.17 | 0.45 |
| Usual Care | 370 | -0.90 | 0.38 |
| Intervention | 265 | -1.84 | 0.52 |
| Usual Care | 370 | -2.16 | 0.43 |
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | -2.04 | 0.21 |
| Usual Care | 370 | -1.90 | 0.18 |
| Intervention | 265 | -1.69 | 0.22 |
| Usual Care | 370 | -1.63 | 0.19 |
| Intervention | 265 | -1.81 | 0.23 |
| Usual Care | 370 | -1.45 | 0.19 |
The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | -16.78 | 0.69 |
| Usual Care | 370 | -15.90 | 0.59 |
| Intervention | 265 | -14.17 | 0.79 |
| Usual Care | 370 | -13.83 | 0.66 |
| Intervention | 265 | -13.23 | 0.94 |
| Usual Care | 370 | -11.68 | 0.77 |
Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 67 | - |
| Usual Care | 370 | 90 | - |
| Intervention | 265 | 69 | - |
| Usual Care | 370 | 99 | - |
| Intervention | 265 | 63 | - |
| Usual Care | 370 | 106 | - |
| Intervention | 265 | 51 | - |
| Usual Care | 370 | 92 | - |
Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 18 | - |
| Usual Care | 370 | 44 | - |
| Intervention | 265 | 4 | - |
| Usual Care | 370 | 15 | - |
| Intervention | 265 | 4 | - |
| Usual Care | 370 | 20 | - |
| Intervention | 265 | 6 | - |
| Usual Care | 370 | 6 | - |
The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 13.5 | 4.6 |
| Usual Care | 370 | 13.4 | 4.5 |
| Intervention | 265 | 13.3 | 4.5 |
| Usual Care | 370 | 13.2 | 4.5 |
| Intervention | 265 | 13.2 | 4.7 |
| Usual Care | 370 | 13.4 | 4.1 |
| Intervention | 265 | 13.8 | 4.7 |
| Usual Care | 370 | 14.2 | 4.1 |
A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 6.8 | 2.4 |
| Usual Care | 370 | 6.7 | 2.7 |
| Intervention | 265 | 4.3 | 2.9 |
| Usual Care | 370 | 4.7 | 2.8 |
| Intervention | 265 | 4.1 | 3.1 |
| Usual Care | 370 | 4.5 | 3.0 |
| Intervention | 265 | 3.9 | 3.0 |
| Usual Care | 370 | 3.8 | 3.0 |
The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 44.3 | 13.9 |
| Usual Care | 370 | 45.1 | 13.0 |
| Intervention | 265 | 38.3 | 12.4 |
| Usual Care | 370 | 39.1 | 13.0 |
| Intervention | 265 | 38.4 | 14.0 |
| Usual Care | 370 | 39.5 | 12.2 |
| Intervention | 265 | 39.2 | 13.6 |
| Usual Care | 370 | 41.4 | 11.9 |
Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 4.4 | 0.9 |
| Usual Care | 370 | 4.4 | 0.9 |
| Intervention | 265 | 3.9 | 1.1 |
| Usual Care | 370 | 3.8 | 1.1 |
| Intervention | 265 | 4.0 | 1.1 |
| Usual Care | 370 | 3.8 | 1.1 |
| Intervention | 265 | 3.9 | 1.1 |
| Usual Care | 370 | 3.8 | 1.2 |
Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 58 | - |
| Usual Care | 370 | 77 | - |
| Intervention | 265 | 9 | - |
| Usual Care | 370 | 17 | - |
| Intervention | 265 | 7 | - |
| Usual Care | 370 | 22 | - |
| Intervention | 265 | 8 | - |
| Usual Care | 370 | 16 | - |
Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 125 | - |
| Usual Care | 370 | 177 | - |
| Intervention | 265 | 60 | - |
| Usual Care | 370 | 72 | - |
| Intervention | 265 | 60 | - |
| Usual Care | 370 | 82 | - |
| Intervention | 265 | 51 | - |
| Usual Care | 370 | 79 | - |
Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Intervention | 265 | 4.1 | 1.0 |
| Usual Care | 370 | 4.0 | 1.1 |
| Intervention | 265 | 3.6 | 1.1 |
| Usual Care | 370 | 3.5 | 1.1 |
| Intervention | 265 | 3.6 | 1.1 |
| Usual Care | 370 | 3.4 | 4.1 |
| Intervention | 265 | 3.7 | 1.1 |
| Usual Care | 370 | 3.5 | 1.1 |
| Milestone | Intervention | Usual Care |
|---|---|---|
| STARTED | 265 | 370 |
| COMPLETED | 188 | 289 |
| NOT COMPLETED | 77 | 81 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Suicide Attempt | Injury, poisoning and procedural complications | Intervention: 9 / 265 · Usual Care: 10 / 370 |
| Death | General disorders | Intervention: 6 / 265 · Usual Care: 3 / 370 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Intervention: 134 / 265 · Usual Care: 197 / 370 |
Eligibility
primary outcomes
Time frame: Baseline, 3-month, 6-month, 12-month
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Time frame: Baseline, 3-month, 6-month, 12-month
The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
secondary outcomes
Time frame: Baseline, 3-month, 6-month, 12-month
Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.
Time frame: Baseline, 3-month, 6-month, 12-month
The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.
Time frame: Baseline, 3-month, 6-month, 12-month
The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.
Time frame: Baseline, 3-month, 6-month, 12-month
Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Time frame: Baseline, 3-month, 6-month, 12-month
Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.
Time frame: Baseline, 3-month, 6-month, 12-month
Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.
Time frame: Baseline, 3 Month, 6 Month, 12 Month
Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Publications