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Piloting Acute Care to Primary Care Linkage of Safety Net Patients

Piloting Acute Care to Primary Care Linkage of Safety Net Patients

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01347541
Acronym
TSOS III
Enrollment
4
Registered
2011-05-04
Start date
2011-01-31
Completion date
2011-11-30
Last updated
2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD

Brief summary

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

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

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.

BEHAVIORALMotivational Interviewing

Motivational interviewing is designed to address alcohol and drug use.

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.

Standard care control includes the usual treatment for injured trauma survivors

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Alcohol Use Disorders Identification at 1 MonthBaseline, Up to 12 months after injuryThe 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.
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 MonthBaseline, Up to 12 months after injuryThe 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.
Change in Functional Status at 1 MonthBaseline, Up to 12 months after injuryThe 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.

Secondary

MeasureTime frameDescription
Increased Satisfaction With Global CareUp to 12 months after injuryAssessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
Injury RelapseUp to 5 years after injuryAssessed using Healthcare Utilization Questions (NSCOT)
Work, Disability, and Legal OutcomesUp to 12 months after injuryAssessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)

Countries

United States

Participant flow

Participants by arm

ArmCount
Stepped Care
Combination of behavioral therapy and drug therapy Cognitive Behavioral Therapy: 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. Motivational Interviewing: Motivational interviewing is designed to address alcohol and drug use. FDA-Approved Anti-Anxiety Medications: 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.
3
Standard Care Provided to Injured Trauma Survivors
Standard Care Control: Standard care control includes the usual treatment for injured trauma survivors
1
Total4

Baseline characteristics

CharacteristicStandard Care Provided to Injured Trauma SurvivorsTotalStepped Care
Age, Continuous31 years35.75 years
STANDARD_DEVIATION 15.04
37.33 years
STANDARD_DEVIATION 18.01
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants3 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
0 Participants1 Participants1 Participants
Sex: Female, Male
Female
0 Participants2 Participants2 Participants
Sex: Female, Male
Male
1 Participants2 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 30 / 1
serious
Total, serious adverse events
0 / 30 / 1

Outcome results

Primary

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.

Time frame: Baseline, Up to 12 months after injury

ArmMeasureValue (MEAN)
Stepped CareChange From Baseline Alcohol Use Disorders Identification at 1 Month-1.7 score on a scale
Standard Care Provided to Injured Trauma SurvivorsChange From Baseline Alcohol Use Disorders Identification at 1 Month-2.0 score on a scale
Primary

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.

Time frame: Baseline, Up to 12 months after injury

ArmMeasureValue (MEAN)
Stepped CareChange From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month-4.0 score on a scale
Standard Care Provided to Injured Trauma SurvivorsChange From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month-14.0 score on a scale
Primary

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.

Time frame: Baseline, Up to 12 months after injury

ArmMeasureValue (MEAN)
Stepped CareChange in Functional Status at 1 Month-1.9 score on a scale
Standard Care Provided to Injured Trauma SurvivorsChange in Functional Status at 1 Month4.0 score on a scale
Secondary

Increased Satisfaction With Global Care

Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)

Time frame: Up to 12 months after injury

Population: Data were not collected

Secondary

Injury Relapse

Assessed using Healthcare Utilization Questions (NSCOT)

Time frame: Up to 5 years after injury

Population: Data were not collected

Secondary

Work, Disability, and Legal Outcomes

Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)

Time frame: Up to 12 months after injury

Population: Data were not collected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026