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Piloting Acute Care to Primary Care Linkage of Safety Net Patients (TSOS III)

18 februari 2021 bijgewerkt door: Douglas Zatzick, University of Washington
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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

4

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Harborview Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Stepped care
Combination of behavioral therapy and drug 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.
Andere namen:
  • CBT
Motivational interviewing is designed to address alcohol and drug use.
Andere namen:
  • MI
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.
Actieve vergelijker: Standard care provided to injured trauma survivors
Standard care control includes the usual treatment for injured trauma survivors
Andere namen:
  • BA

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline Alcohol Use Disorders Identification at 1 Month
Tijdsspanne: Baseline, Up to 12 months after injury
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
Tijdsspanne: Baseline, Up to 12 months after injury
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
Tijdsspanne: Baseline, Up to 12 months after injury
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Increased Satisfaction With Global Care
Tijdsspanne: Up to 12 months after injury
Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care (NSCOT)
Up to 12 months after injury
Injury Relapse
Tijdsspanne: Up to 5 years after injury
Assessed using Healthcare Utilization Questions (NSCOT)
Up to 5 years after injury
Work, Disability, and Legal Outcomes
Tijdsspanne: Up to 12 months after injury
Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
Up to 12 months after injury

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2011

Primaire voltooiing (Werkelijk)

1 november 2011

Studie voltooiing (Werkelijk)

1 november 2011

Studieregistratiedata

Eerst ingediend

29 april 2011

Eerst ingediend dat voldeed aan de QC-criteria

2 mei 2011

Eerst geplaatst (Schatting)

4 mei 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 maart 2021

Laatste update ingediend die voldeed aan QC-criteria

18 februari 2021

Laatst geverifieerd

1 februari 2021

Meer informatie

Termen gerelateerd aan deze studie

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