Zatzick 2001.
Methods | Design: RCT – bias unlikely | |
Participants |
Setting: level 1 hospital trauma centre Type of trauma exposure: injured MVA and assault victims. Inclusion criteria: hospitalised MVA or assault survivors aged 14–65 years, who were English speaking. Exclusion criteria: patients who sustained severe injuries. Sample size: 105 patients assessed for study participation; 57 eligible to take part; 34 randomised. Mean age: 33.8 (SD 12.1) years Gender: 20 (58.8%) men; 14 (41.7%) women Ethnicity: 61.8% white; 38.2% other Country: USA |
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Interventions |
Group 1: collaborative care intervention: n = 16 On the surgical ward, each patient was assigned to a trauma support specialist who met each intervention patient at the bedside. The trauma support specialists were instructed to develop a therapeutic relationship and follow patients for 4 months through primary care outpatient appointments and community rehabilitation. To establish a basis for collaborative problem definition and shared patient–provider treatment planning, the trauma support specialists were instructed to elicit and track patients' post‐traumatic concerns. Patients' post‐traumatic concerns were incorporated into joint problem definition and the trauma support specialists were instructed to intervene on behalf of the patients in the resolution of these concerns whenever possible. A psychotherapy module specifically targeting post‐traumatic distress and substance use was also delivered as part of the multifaceted collaborative intervention. A psychoeducational component of the intervention began with a review of the traumatic event, followed by a discussion of related emotions, cognitions and possible future post‐traumatic symptoms, and closed with suggested coping strategies including algorithms for contacting the support specialist. The motivational enhancement techniques focused on the evaluation of readiness to change and implementation of a motivational interview targeting post‐traumatic alcohol and drug use. Group 2: usual care: n = 18 |
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Outcomes |
PTSD: PCL‐C Other: CES‐D; ASI; PCS of the Medical Outcomes Study 12‐Item Short‐Form Health Survey Follow‐up: 1 and 4 months |
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Notes | Patients aged 14‐65 were eligible for inclusion in this study. We included it as the majority of participants were likely to have been aged 18 and over based on the mean age of participants (33.8; SD 12.1). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Low risk | The project co‐ordinator independently randomised new patients in blocks of 6 to the intervention or control group. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research associates conducting follow‐up telephone interviews remained blinded to patient group assignments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome analyses were conducted for the both the ITT sample and for those with complete data on each outcome measure at all time points. |
Selective reporting (reporting bias) | Unclear risk | No study protocol identified. |
Other bias | High risk | Sample size was small. The authors also acknowledge that "there were some difficulties implementing the collaborative care principles of continuous case management and active sustained follow‐up. For instance, patients with no insurance often required intensive service coordination efforts targeting linkage with community agencies. Because these activities required time availability and flexibility of scheduling that taxed the abilities of the highly trained, hospital‐based case managers, these efforts to insure continuity of care frequently fell short." The collaborative intervention was not manualised and was likely to be implemented with marked variability across trauma support specialists. |
ASI: Addiction Severity Index; AUDIT: Alcohol Use Disorders Identification Text; BDI: Beck Depression Inventory; CAPS: Clinician‐Administered PTSD Scale; CBT: cognitive behavioural therapy; CES‐D: Center for Epidemiological Studies Depression Scale; CISD‐A: Critical Incident Stress Debriefing – Adapted; DASS‐21: Depression Anxiety and Stress Scale‐21; DSM: Diagnostic and Statistical Manual of Mental Disorders; EmCS: emergency caesarean section; EPDS: Edinburgh Postnatal Depression Scale; EQ‐5D: EuroQol; GAD: generalised anxiety disorder; GAD‐7: Generalised Anxiety Disorder Assessment; HADS: Hospital Anxiety and Depression Scale; HRQoL: health‐related quality of life; HSCL: Hopkins Symptom Checklist depression scale; HTQ‐IV: Harvard Trauma Questionnaire; ICD: implantable cardioverter defibrillator; ICU: intensive care unit; IES: Impact of Events Scale; IES‐R: Impact of Events Scale – Revised; IPC: interpersonal counselling; ITT: intention‐to‐treat; MA: mortuary attendant; min: minute; MINI‐PTSD: Mini‐International Neuropsychiatric Interview – PTSD; MSI: memory structuring intervention; MSSS: Maternity Social Support Scale; MVA: motor vehicle accident; n: number; NBAS: Neonatal Behavioral Assessment Scale; NICU: neonatal intensive care unit; PCL: Post‐Traumatic Stress Disorder Checklist; PCS: Physical Components Summary; PDS: Posttraumatic Diagnostic Scale; PE: prolonged exposure; PFA: psychological first aid; PHQ: Patient Health Questionnaire; PICU: paediatric intensive care unit; PPQ: Perinatal Posttraumatic Stress Disorder Questionnaire; PRIME: Promoting Resilience In Mothers' Emotions; PROMIS: Patient‐Reported Outcomes Measurement Information System; PSS‐PICU: Parental Stressor Scale – Paediatric Intensive Care Unit; PSS‐I: PTSD Symptom Scale – Interview Version; PSS‐SR: Post‐traumatic Stress Symptom Scale – Self Report; PTGI: Posttraumatic Growth Inventory; PTSD: post‐traumatic stress disorder; PTSS: post‐traumatic stress syndrome; RCT: randomised controlled trial; SAS‐SR: Social Adjustment Scale – Self‐Report; SCCIP‐ND: Surviving Cancer Competently Intervention Program – Newly Diagnosed; SCID: Structured Clinical Interview for DSM; SCL: Symptoms Checklist; SCS: Social Constraints Scale; SD: standard deviation; SF‐36: Short‐Form 36; SOFA: Sequential Organ Failure Assessment; STAI: State‐Trait Anxiety Inventory; TAU: treatment as usual; VAS: visual analogue scale; WHOQOLBREF: World Health Organization Quality of Life Assessment – Brief Version.