Alcohol and Drug Use, Depression and Suicide Ideation, Post Traumatic Concerns, Post Traumatic Stress Disorder
Conditions
Brief summary
The nation's trauma care system, which includes trauma center hospitals & emergency departments, is where over 30 million Americans receive care after traumatic injuries each year. Injury victims are diverse patients who suffer from complications of the initial injury as well as from multiple complex medical & mental health conditions. Currently, high-quality patient-centered care is not the standard of care throughout US trauma care systems. Injured trauma survivors treated in trauma care systems frequently receive fragmented care that is not coordinated across hospital, emergency department, outpatient, & community settings. Post-injury care is frequently not individualized to integrate the patient's most pressing post-traumatic concerns & preferences into medical decision making. The investigators, as a group of front-line trauma center providers, patients, researchers & policy makers, have been working together for over a decade to integrate patient-centered care into US trauma care systems. The investigators began this work by asking groups of injured patients the key patient-centered question: Of everything that has happened to you since your injury, what concerns you the most? The investigators developed scientifically sound assessment tools that allowed us to follow patient concerns after injury hospitalization. In May of 2011, the investigators convened an American College of Surgeons' policy summit that addressed mental health & patient-centered care integration across US trauma care systems. As part of this policy summit, patient members of our team presented their experiences of traumatic injury & recovery. While giving injured patients a voice at the summit, these narratives did not move surgical policy makers to develop mandates or guidelines for patient-centered care. In contrast, presentations that included information from randomized comparative effectiveness trials & standardized outcome assessments convinced surgical policy makers to develop US trauma care system policy mandates & best practice guidelines for post-traumatic stress disorder & alcohol use problems. Our team now realizes that in order to optimally integrate patient-centered care into US trauma care systems, the investigators must use the best scientific methods that capture the highest-quality data. This PCORI proposal aims to demonstrate that a patient-centered care management treatment that addresses patient's post-injury concerns & integrates patient concerns & preferences into medical decision making, while also coordinating care, can improve outcomes of great importance to patients & their caregivers, front-line providers & policy makers. This proposal directly addresses two PCORI patient-centered research questions: After a traumatic injury, what can I do to improve the outcomes that are most important to me? & How can front-line providers working in trauma care systems help me make the best decisions about my post-injury health & health care?
Interventions
Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Sponsors
Study design
Intervention model description
Patient-centered care transition intervention
Eligibility
Inclusion criteria
* Seen in acute care emergency department or trauma center setting for injury * At least three post traumatic concerns * AND One of the following PTSD Checklist Score (PCL-C) greater than or equal to 35 Patient Health Questionnaire 9 - greater than or equal to 10 Any endorsement of suicidal ideation on the PhQ-9 Item 9
Exclusion criteria
* Non-English speaking * Under 14 years of age * Incarcerated * Psychotic behavior * Suffered head, spinal cord, or other severe injuries that prevent participation in the inpatient ward interview.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | The investigators assessed at baseline, 1-, 3-, and 6-month. | The primary outcome is the endorsement of ≥1 severe posttraumatic concerns. |
| Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 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 minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used. |
| Change in Depression Symptoms Over the Course of the Six Months After Injury | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Carrying a Weapon | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigation used a single yes/no item to assess whether the patient was carrying a weapon. |
| Alcohol Use Problems | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigators used 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. No sub scales were used. |
| Drug Use Problems | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used. |
| Number of Participants With One or More Emergency Department Visits Over Time | The investigators assessed emergency department service use over the course of the study. | The investigators used population level data on emergency department health service use for the intent-to-treat sample |
| Functional Status | 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. |
| Number of Participants With Suicidal Ideation | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of \> 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns Randomized, nurse notified of high levels of psychological distress.
Will be blindly assessed. | 86 |
| Patient-centered Care Transition Randomized, case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
Will be blindly assessed. | 85 |
| Total | 171 |
Baseline characteristics
| Characteristic | Enhanced Usual Care - Nurse Notification of Patient Concerns | Patient-centered Care Transition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 10 Participants | 7 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 77 Participants | 151 Participants |
| Age, Continuous | 43.6 years STANDARD_DEVIATION 16 | 41.2 years STANDARD_DEVIATION 16.1 | 42.4 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 9 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 76 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 5 Participants | 15 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 10 Participants | 15 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) White | 51 Participants | 47 Participants | 98 Participants |
| Region of Enrollment United States | 86 participants | 85 participants | 171 participants |
| Sex: Female, Male Female | 47 Participants | 50 Participants | 97 Participants |
| Sex: Female, Male Male | 39 Participants | 35 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 2 / 85 |
| other Total, other adverse events | 39 / 86 | 39 / 85 |
| serious Total, serious adverse events | 1 / 86 | 2 / 85 |
Outcome results
Change in Depression Symptoms Over the Course of the Six Months After Injury
The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Depression Symptoms Over the Course of the Six Months After Injury | Baseline | 14.8 units on a scale | Standard Deviation 4.2 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Depression Symptoms Over the Course of the Six Months After Injury | 1-month | 12.1 units on a scale | Standard Deviation 6.2 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Depression Symptoms Over the Course of the Six Months After Injury | 3-month | 11.7 units on a scale | Standard Deviation 7.2 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Depression Symptoms Over the Course of the Six Months After Injury | 6-month | 10.7 units on a scale | Standard Deviation 6.4 |
| Patient-centered Care Transition | Change in Depression Symptoms Over the Course of the Six Months After Injury | 6-month | 9.3 units on a scale | Standard Deviation 6.8 |
| Patient-centered Care Transition | Change in Depression Symptoms Over the Course of the Six Months After Injury | Baseline | 14.3 units on a scale | Standard Deviation 4.5 |
| Patient-centered Care Transition | Change in Depression Symptoms Over the Course of the Six Months After Injury | 3-month | 10.8 units on a scale | Standard Deviation 6.9 |
| Patient-centered Care Transition | Change in Depression Symptoms Over the Course of the Six Months After Injury | 1-month | 13.2 units on a scale | Standard Deviation 6.5 |
Change in Post Traumatic Concerns Over the Course of the Six Months After Injury
The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | Baseline | 80 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | 1-month | 55 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | 3-month | 45 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | 6-month | 42 Participants |
| Patient-centered Care Transition | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | 6-month | 33 Participants |
| Patient-centered Care Transition | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | Baseline | 83 Participants |
| Patient-centered Care Transition | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | 3-month | 48 Participants |
| Patient-centered Care Transition | Change in Post Traumatic Concerns Over the Course of the Six Months After Injury | 1-month | 59 Participants |
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | Baseline | 42.9 units on a scale | Standard Deviation 11.2 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 1-month | 41.7 units on a scale | Standard Deviation 14.3 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 3-month | 40.7 units on a scale | Standard Deviation 14.7 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 6-month | 39.3 units on a scale | Standard Deviation 14.7 |
| Patient-centered Care Transition | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 6-month | 38.6 units on a scale | Standard Deviation 16 |
| Patient-centered Care Transition | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | Baseline | 42.5 units on a scale | Standard Deviation 11.3 |
| Patient-centered Care Transition | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 3-month | 38.7 units on a scale | Standard Deviation 13.7 |
| Patient-centered Care Transition | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 1-month | 43.7 units on a scale | Standard Deviation 14.9 |
Alcohol Use Problems
The investigators used 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. No sub scales were used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Alcohol Use Problems | Baseline | 3.7 units on a scale | Standard Deviation 3.2 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Alcohol Use Problems | 1-month | 1.1 units on a scale | Standard Deviation 2.6 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Alcohol Use Problems | 3-month | 1.7 units on a scale | Standard Deviation 2.8 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Alcohol Use Problems | 6-month | 2.3 units on a scale | Standard Deviation 2.9 |
| Patient-centered Care Transition | Alcohol Use Problems | 6-month | 1.6 units on a scale | Standard Deviation 2.5 |
| Patient-centered Care Transition | Alcohol Use Problems | Baseline | 3.4 units on a scale | Standard Deviation 3.2 |
| Patient-centered Care Transition | Alcohol Use Problems | 3-month | 1.1 units on a scale | Standard Deviation 1.9 |
| Patient-centered Care Transition | Alcohol Use Problems | 1-month | 0.5 units on a scale | Standard Deviation 1.6 |
Drug Use Problems
The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Drug Use Problems | Baseline | 2.0 units on a scale | Standard Deviation 1.9 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Drug Use Problems | 1-month | 1.4 units on a scale | Standard Deviation 1.2 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Drug Use Problems | 3-month | 1.4 units on a scale | Standard Deviation 1.4 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Drug Use Problems | 6-month | 1.3 units on a scale | Standard Deviation 1 |
| Patient-centered Care Transition | Drug Use Problems | 6-month | 1.5 units on a scale | Standard Deviation 1.4 |
| Patient-centered Care Transition | Drug Use Problems | Baseline | 2.2 units on a scale | Standard Deviation 2 |
| Patient-centered Care Transition | Drug Use Problems | 3-month | 1.3 units on a scale | Standard Deviation 1.1 |
| Patient-centered Care Transition | Drug Use Problems | 1-month | 1.3 units on a scale | Standard Deviation 1.2 |
Functional Status
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.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Functional Status | Baseline | 48.4 units on a scale | Standard Deviation 9.1 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Functional Status | 1-month | 38.3 units on a scale | Standard Deviation 10.4 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Functional Status | 3-month | 39.3 units on a scale | Standard Deviation 9.9 |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Functional Status | 6-month | 39.9 units on a scale | Standard Deviation 9.9 |
| Patient-centered Care Transition | Functional Status | 6-month | 42.3 units on a scale | Standard Deviation 8.4 |
| Patient-centered Care Transition | Functional Status | Baseline | 48.5 units on a scale | Standard Deviation 9.2 |
| Patient-centered Care Transition | Functional Status | 3-month | 39.8 units on a scale | Standard Deviation 8 |
| Patient-centered Care Transition | Functional Status | 1-month | 37.1 units on a scale | Standard Deviation 10.9 |
Number of Participants With One or More Emergency Department Visits Over Time
The investigators used population level data on emergency department health service use for the intent-to-treat sample
Time frame: The investigators assessed emergency department service use over the course of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With One or More Emergency Department Visits Over Time | Baseline | 41 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With One or More Emergency Department Visits Over Time | 3-6 month | 26 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With One or More Emergency Department Visits Over Time | 6-9 month | 27 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With One or More Emergency Department Visits Over Time | 9-12 month | 26 Participants |
| Patient-centered Care Transition | Number of Participants With One or More Emergency Department Visits Over Time | 9-12 month | 19 Participants |
| Patient-centered Care Transition | Number of Participants With One or More Emergency Department Visits Over Time | Baseline | 44 Participants |
| Patient-centered Care Transition | Number of Participants With One or More Emergency Department Visits Over Time | 6-9 month | 18 Participants |
| Patient-centered Care Transition | Number of Participants With One or More Emergency Department Visits Over Time | 3-6 month | 14 Participants |
Number of Participants With Suicidal Ideation
The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of \> 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With Suicidal Ideation | Baseline | 19 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With Suicidal Ideation | 1-month | 13 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With Suicidal Ideation | 6-month | 16 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Participants With Suicidal Ideation | 3-month | 21 Participants |
| Patient-centered Care Transition | Number of Participants With Suicidal Ideation | 6-month | 17 Participants |
| Patient-centered Care Transition | Number of Participants With Suicidal Ideation | Baseline | 22 Participants |
| Patient-centered Care Transition | Number of Participants With Suicidal Ideation | 1-month | 18 Participants |
| Patient-centered Care Transition | Number of Participants With Suicidal Ideation | 3-month | 14 Participants |
Number of Patients Carrying a Weapon
The investigation used a single yes/no item to assess whether the patient was carrying a weapon.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Patients Carrying a Weapon | Baseline | 7 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Patients Carrying a Weapon | 1-month | 4 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Patients Carrying a Weapon | 3-month | 7 Participants |
| Enhanced Usual Care - Nurse Notification of Patient Concerns | Number of Patients Carrying a Weapon | 6-month | 5 Participants |
| Patient-centered Care Transition | Number of Patients Carrying a Weapon | 6-month | 9 Participants |
| Patient-centered Care Transition | Number of Patients Carrying a Weapon | Baseline | 12 Participants |
| Patient-centered Care Transition | Number of Patients Carrying a Weapon | 3-month | 5 Participants |
| Patient-centered Care Transition | Number of Patients Carrying a Weapon | 1-month | 3 Participants |