Piloting Acute Care to Primary Care Linkage of Safety Net Patients

Study Overview
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Brief Summary
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This pilot study will evaluate the implementation of a stepped care intervention that combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications, and information technology innovations at a level 1 trauma center to community linkage components to reduce the symptoms of posttraumatic stress disorder and related comorbidities in injured trauma survivors treated in the emergency department and surgical inpatient settings.

Detailed Description
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The investigators plan to implement a pilot linkage program in which trauma center based care facilitators will use a population-based recruitment strategy to facilitate outpatient follow-up for acutely injured trauma center inpatients and emergency department patients. All patients recruited into the trial will be low income patients with one or more of the following characteristics: being uninsured, low income older adults, low income mothers, and other high risk individuals who lack health insurance. Patients will be linked for care to one of the community health centers participating in Washington State. In phase I, patients will be recruited from the trauma center inpatient trauma surgery service and emergency departments. In phase one, no randomization will occur; patients will be linked to one of the community health centers. Patients who consent to the protocol will be assessed in the surgical inpatient units or emergency department. After the baseline assessment, all patients will be immediately assigned a bachelor's, MSW, or RN level care manager. The care managers will elicit and address posttraumatic concerns, and attempt linkage of patients to community programs. Care managers may also deliver motivational interviewing and cognitive behavioral therapy interventions. Patient may also be linked to psychopharmacologic interventions targeting PTSD. Follow-up assessments will occur in the weeks and months after the injury and will assess patterns of health service utilization and symptomatic outcomes. Phase I will establish the feasibility of recruitment and follow-up, acceptability of care management for patients, as well as the pragmatics of linkage to community programs. Piloting in phase II will depend on the results of phase I; the phase II pilot will build and extend upon phase I. In phase II, patients will be randomized to either intervention or control conditions. Patients randomized to the intervention condition will be met by a care manager who may address patients' initial needs and concerns. Care managers may also deliver Motivational Interviewing and Cognitive Behavioral Therapy interventions. Patients may also be linked to psychopharmacologic interventions targeting PTSD. The care manager will attempt to link patients to participating community health centers. Linkages may occur by the telephone, or through web-based clinical registry tools that are under development by the intervention team. Some linkages may occur in person. To determine if intervention patients are successfully linked more frequently than controls, all patients will be followed from the time of designation at hospital admission to outpatient primary care appointments. Follow-up outcome assessments will occur in the weeks and months post-injury and will includes assessments of patterns of health service utilization, function, and symptomatic outcomes.

Official Title
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Piloting Acute Care to Primary Care Linkage of Safety Net Patients

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy
* Behavioral: Motivational Interviewing
* Drug: FDA-Approved Anti-Anxiety Medications
* Behavioral: Standard Care Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking Admitted to Harborview Medical Center with injuries sufficiently severe enough to require inpatient admission Experienced a traumatic injury Exhibits symptoms of PTSD while in the hospital ward Low-income Exclusion Criteria: History of head, spinal, or other injury that may prevent participation in the ward interview Requires immediate intervention due to conditions such as self-inflicted injury, active psychosis, or active mania Currently incarcerated Likely to face criminal charges Lives outside of the state of Washington Not low-income

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped care<br>Combination of behavioral therapy and drug therapy | Behavioral: Cognitive Behavioral Therapy<br>* Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.<br>* Other names: CBT;Behavioral: Motivational Interviewing<br>* Motivational interviewing is designed to address alcohol and drug use.<br>* Other names: MI;Drug: FDA-Approved Anti-Anxiety Medications<br>* Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.<br>|
| Active Comparator: Standard care provided to injured trauma survivors<br> | Behavioral: Standard Care Control<br>* Standard care control includes the usual treatment for injured trauma survivors<br>* Other names: BA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Alcohol Use Disorders Identification at 1 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. | Baseline, Up to 12 months after injury | 
| Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 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. | Baseline, Up to 12 months after injury | 
| Change in Functional Status at 1 Month | The investigators will use 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. | Baseline, Up to 12 months after injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Satisfaction With Global Care | Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT) | Up to 12 months after injury | 
| Injury Relapse | Assessed using Healthcare Utilization Questions (NSCOT) | Up to 5 years after injury | 
| Work, Disability, and Legal Outcomes | Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS) | Up to 12 months after injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD