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Trauma Survivors Outcomes and Support Study IV (TSOS IV)

17 november 2017 uppdaterad av: Douglas Zatzick, University of Washington

Integrating Information Technology Advancements Into Early PTSD Interventions

After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.

Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Clinical feasibility randomized clinical trial (RCT) pilot of integrating information technology advancements into Early PTSD Screening and Intervention. Design Overview: Between 30-200 injured trauma survivors who are initially admitted to either the Harborview inpatient wards or emergency department acute care settings will be enrolled in the study. If patients agree to participate, they will be engaged by a research assistant to complete a baseline assessment battery. Following the battery, all patients will be engaged in an initial technology readiness assessment to gauge comfort and skill using a variety of devices (e.g., smartphones, cellular phones, tablets, and laptop computers) that could potentially be utilized for delivery of interventions. Patients will then be randomized to either care as usual or to the stepped-care technology-based educational intervention. Patients randomized to the intervention condition will be met by a trauma support specialist. Intervention patients who endorse elevated substance use and/or mental health symptoms, including PTSD, depression, suicidal ideation, chronic pain, and postconcussive symptoms, will receive up to 3 months of motivational interviewing and/or cognitive behavioral therapy delivered by the trauma support specialist in person or over the telephone. The trauma support specialist may utilize mHealth technologies including websites and applications available on smartphones and tablet devices, as strategies to compliment CBT approaches that target specific areas of concern. However, the psychotherapeutic intervention embedded within the Stepped Care protocol is conceived of being fundamentally separate from the mHealth tools that may also be mentioned during discussions between the trauma support specialist and the patient. Inherent throughout the intervention is a focus on obtaining acceptability information from patients related to all aspects of the intervention and interpersonal experiences with the trauma support specialist, as well as any technology-based assessments and mHealth tools that may compliment the stepped care protocol. Patients will receive up to 3 consecutive months of trauma support specialist support post-injury. Follow-up assessments will occur at 1, 3, and 6 months following the baseline assessment, with additional acceptability assessments completed for specific aspects of the intervention listed above.

Studietyp

Interventionell

Inskrivning (Faktisk)

121

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Harborview Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Score ≥3 on PTSD automated screening algorithm
  • Score ≥35 on PTSD checklist (PCL-C)

Exclusion Criteria:

  • Non-English speaking
  • Under 14 years of age
  • Patients in need of acute psychiatric intervention (e.g., suicide attempt, psychosis)
  • Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Stepped Care Management
All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
Beteende: Stepped Care Management
All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
Inget ingripande: Usual Care
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Förändring i depressionssymtom under loppet av sex månader efter skada
Tidsram: Utredarna bedömde vid baslinjen, 1-, 3- och 6-månader.
Utredarna använde Patient Health Questionnaire (PHQ-9) som ett kontinuerligt mått, med poäng från 1 till 27. Högre poäng representerar ett sämre resultat. Inga subskalor användes.
Utredarna bedömde vid baslinjen, 1-, 3- och 6-månader.
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
Tidsram: The investigators assessed at baseline, 1-, 3-, and 6-month.
The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.
The investigators assessed at baseline, 1-, 3-, and 6-month.
Technology Use
Tidsram: Baseline to 6 months
The investigators used laptop tracking software to determine technology usage.
Baseline to 6 months
Feasibility/Acceptability of Intervention
Tidsram: Baseline to 6 months
The investigators used laptop tracking software to assess number of patients using laptops.
Baseline to 6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Problem med alkoholbruk
Tidsram: Utredarna bedömde vid baslinjen, 1-, 3- och 6-månader.
Utredarna använde testet för identifiering av alkoholmissbruk (AUDIT) som en kontinuerlig åtgärd. Poängen på 10-skala sträcker sig från 0-40, med högre värden som indikerar ett sämre resultat. Inga underskalor användes.
Utredarna bedömde vid baslinjen, 1-, 3- och 6-månader.
Physical Functioning
Tidsram: The investigators assessed at baseline, 1-, 3-, and 6-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. No other subscales will be used.
The investigators assessed at baseline, 1-, 3-, and 6-month.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Washington

Samarbetspartners

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)

Utredare

  • Huvudutredare: Douglas Zatzick, M.D., University of Washington

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2012

Primärt slutförande (Faktisk)

1 augusti 2013

Avslutad studie (Faktisk)

1 oktober 2015

Studieregistreringsdatum

Först inskickad

19 juni 2012

Först inskickad som uppfyllde QC-kriterierna

20 juni 2012

Första postat (Uppskatta)

21 juni 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 november 2017

Senast verifierad

1 november 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00001473
  • 1R01AA016102-01 (U.S.S. NIH-anslag/kontrakt)
  • 1K24MH086814-01 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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