An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity

Douglas F. Zatzick, Joan Russo, Doyanne Darnell, David A. Chambers, Lawrence Palinkas, Erik Van Eaton, Jin Wang, Leah M. Ingraham, Roxanne Guiney, Patrick Heagerty, Bryan Comstock, Lauren K. Whiteside, Gregory Jurkovich

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivationalinterviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally. Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.

Original languageEnglish (US)
Article number58
JournalImplementation Science
Volume11
Issue number1
DOIs
StatePublished - Jan 1 2016

Fingerprint

Post-Traumatic Stress Disorders
Clinical Protocols
Comorbidity
Pragmatic Clinical Trials
Survivors
Wounds and Injuries
Trauma Centers
Depression
Suicidal Ideation
Electronic Health Records
Cognitive Therapy
Checklist
Alcohol Drinking
Inpatients
Patient Care
Hospitalization
Alcohols
Delivery of Health Care
Education
Pharmaceutical Preparations

Keywords

  • American College of Surgeons
  • Depression
  • Effectiveness-implementation hybrid
  • Multiple chronic conditions
  • Policy
  • Posttraumatic stress disorder
  • Pragmatic clinical trial
  • Substance abuse
  • Suicidal ideation
  • Traumatic injury

ASJC Scopus subject areas

  • Health Policy
  • Health Informatics
  • Public Health, Environmental and Occupational Health

Cite this

An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity. / Zatzick, Douglas F.; Russo, Joan; Darnell, Doyanne; Chambers, David A.; Palinkas, Lawrence; Van Eaton, Erik; Wang, Jin; Ingraham, Leah M.; Guiney, Roxanne; Heagerty, Patrick; Comstock, Bryan; Whiteside, Lauren K.; Jurkovich, Gregory.

In: Implementation Science, Vol. 11, No. 1, 58, 01.01.2016.

Research output: Contribution to journalArticle

Zatzick, DF, Russo, J, Darnell, D, Chambers, DA, Palinkas, L, Van Eaton, E, Wang, J, Ingraham, LM, Guiney, R, Heagerty, P, Comstock, B, Whiteside, LK & Jurkovich, G 2016, 'An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity', Implementation Science, vol. 11, no. 1, 58. https://doi.org/10.1186/S13012-016-0424-4
Zatzick, Douglas F. ; Russo, Joan ; Darnell, Doyanne ; Chambers, David A. ; Palinkas, Lawrence ; Van Eaton, Erik ; Wang, Jin ; Ingraham, Leah M. ; Guiney, Roxanne ; Heagerty, Patrick ; Comstock, Bryan ; Whiteside, Lauren K. ; Jurkovich, Gregory. / An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity. In: Implementation Science. 2016 ; Vol. 11, No. 1.
@article{5411d7e8fbca429fab59e35fc1572930,
title = "An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity",
abstract = "Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivationalinterviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally. Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.",
keywords = "American College of Surgeons, Depression, Effectiveness-implementation hybrid, Multiple chronic conditions, Policy, Posttraumatic stress disorder, Pragmatic clinical trial, Substance abuse, Suicidal ideation, Traumatic injury",
author = "Zatzick, {Douglas F.} and Joan Russo and Doyanne Darnell and Chambers, {David A.} and Lawrence Palinkas and {Van Eaton}, Erik and Jin Wang and Ingraham, {Leah M.} and Roxanne Guiney and Patrick Heagerty and Bryan Comstock and Whiteside, {Lauren K.} and Gregory Jurkovich",
year = "2016",
month = "1",
day = "1",
doi = "10.1186/S13012-016-0424-4",
language = "English (US)",
volume = "11",
journal = "Implementation Science",
issn = "1748-5908",
publisher = "BioMed Central",
number = "1",

}

TY - JOUR

T1 - An effectiveness-implementation hybrid trial study protocol targeting posttraumatic stress disorder and comorbidity

AU - Zatzick, Douglas F.

AU - Russo, Joan

AU - Darnell, Doyanne

AU - Chambers, David A.

AU - Palinkas, Lawrence

AU - Van Eaton, Erik

AU - Wang, Jin

AU - Ingraham, Leah M.

AU - Guiney, Roxanne

AU - Heagerty, Patrick

AU - Comstock, Bryan

AU - Whiteside, Lauren K.

AU - Jurkovich, Gregory

PY - 2016/1/1

Y1 - 2016/1/1

N2 - Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivationalinterviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally. Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.

AB - Background: Each year in the USA, 1.5-2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries. Methods/design: The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivationalinterviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons' policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally. Discussion: The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons' regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.

KW - American College of Surgeons

KW - Depression

KW - Effectiveness-implementation hybrid

KW - Multiple chronic conditions

KW - Policy

KW - Posttraumatic stress disorder

KW - Pragmatic clinical trial

KW - Substance abuse

KW - Suicidal ideation

KW - Traumatic injury

UR - http://www.scopus.com/inward/record.url?scp=85007489701&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85007489701&partnerID=8YFLogxK

U2 - 10.1186/S13012-016-0424-4

DO - 10.1186/S13012-016-0424-4

M3 - Article

C2 - 27130272

AN - SCOPUS:85007489701

VL - 11

JO - Implementation Science

JF - Implementation Science

SN - 1748-5908

IS - 1

M1 - 58

ER -