Stepped care to support trauma recovery: A feasibility study

INTERVENTION: BRIEF NAME: Stepped Collaborative Care WHY: Participants in the intervention group will receive stepped care case management, adapted from the Trauma Survivor Outcome Support (TSOS) model, which provides timely referrals for medication and psychotherapeutic treatment for pain and mental health, depending on the participant's individual risk profile and treatment needs. The case management aims to reduce care fragmentation and enhance care coordination, particularly with primary care providers. WHAT: Materials: Participants may receive information and resources to support their recovery needs based on their individual needs, and will include existing publicly available fact sheets, booklets, and information on support groups. Examples include: “PTSD and Recoveryâ€? by Phoenix Australia, “Grief following road traumaâ€? by Road Trauma Support Services, and “Self‐managing chronic painâ€? by Pain Australia. Participants may also receive a trauma recovery booklet focused on in‐hospital and early post‐discharge expectations and planning, which was developed as part of another project by researchers at Monash University and is currently being evaluated at Alfred Health. Procedures: Participants will receive stepped collaborative care in addition to the enhanced usual care provided to the control condition as summarised below. Enhanced usual care: 1. The participant will be informed that they may need further treatment for their pain or mental health, and they will be given information on a range of recommendations relevant to their risk profile. 2. If the participant has not been discharged the study team will inform the treating team in the hospital of the patient’s risk profile, their enrolment in the study, and that they may require ongoing care. 3. The participant’s primary care provider in the community, if they have one, will be informed of the participant’s risk profile, their enrolment in the study, and recommendations on how to suppor CONDITION: Injuries and Accidents ‐ Other injuries and accidents Mental Health ‐ Other mental health disorders Musculoskeletal ‐ Other muscular and skeletal disorders Physical Medicine / Rehabilitation ‐ Other physical medicine / rehabilitation Posttraumatic stress disorder;pain; ; Posttraumatic stress disorder ; pain Public Health ‐ Health service research PRIMARY OUTCOME: Acceptability: Number and proportion of participants who are randomized to each group who complete the six month follow‐up interview.[Measured at 6‐months post‐recruitment for each participant.] Acceptability: The total number and proportion of patients who are enrolled and randomized out of those who are screened and identified to be eligible will be measured, in accordance with the following calculation: total number of patients recruited and randomized/total number of patients screened and eligible[Measured during active recruitment of patients until recruitment completion, 12‐18 months.] ; [At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment. INCLUSION CRITERIA: The recruiting study team will consult regularly with the trauma team to identify recent trauma admissions, and will review Electronic Medical Records (EMR) to identify cases who meet the following INCLUSION CRITERIA: • Aged >16 years old at the time of injury • Survive to hospital discharge • Speak English Major trauma defined by trauma admission with one or more of the following criteria following injury admission: • Provisional ISS>12 • Urgent Surgery for intracranial, intrathoracic or intra‐abdominal injury, or for fixation of pelvic or spinal fractures • ICU admission for more than 24 hours with mechanical ventilation Patients will be eligible for interview screening if they meet the following risk criteria for PTSD AND/OR Persistent Pain. SECONDARY OUTCOME: Effectiveness: effects on activity limitations using the World Health Organisation (WHO) Disability Assessment Schedule 2.0 (WHO‐DAS 2.0)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on anxiety‐related cognitive, emotional, and behavioural reactions to pain using the Sensitivity to Pain Traumatisation Scale (SPTS)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on depression and suicidal ideation using the 9‐item Patient Health Questionnaire (PHQ)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on general health status using the Euroqol‐5 dimensions‐5 level (EQ‐5D‐5L)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on neuropathic pain symptoms using the Neuropathic Pain Diagnostic Questionnaire (DN4)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on pain severity and pain‐related disability using the Pain severity, interference with Enjoyment of life and General activity (PEG) tool RISK CRITERIA for PTSD (3 or more of the following criteria are indicated (clinical and socioeconomic): Clinical PTSD risk criteria: 1. Pre‐existing PTS ; ] Effectiveness: effects on pain‐related catastrophising using the Pain Catastrophizing Scale (PCS)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on probable alcohol use disorders using the Alcohol Use Disorders Identification Test (AUDIT‐C)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on probable drug use disorders using the NIDA modified‐ASSIST screening tool.[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on PTSD symptoms using the Posttraumatic Checklist (PCL‐C), including additional items from the PCL‐5 to measure DSM‐5 PTSD symptoms.[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: effects on Symptoms of anxiety using the 7‐item Generalized Anxiety Disorder scale (GAD)[At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment.] Effectiveness: The number of participants in each group who have a regular primary care provider by the end of the intervention, measured using structured questions in the 6 month follow up interview.[Measured at baseline and 6‐months post‐recruitment for each participant.] Implementation (acceptability): participant satisfaction after completing the intervention measured using a modified Client Satisfaction Questionnaire in the follow up interview.[Measured at 6‐months post‐recruitment for each participant in the intervention group] Implementation: administrative records of health service use, measured through linkage with the Medicare Benefit Schedule, Pharmaceutical Benefits Scheme, Transport Accident Commission, Worksafe Victoria and Victorian Admitted Episodes Dataset records of health care services or medications received.[Baseline to 6‐months post‐recruitment, adjusting for pre‐injury health‐related costs.] Implementation: self‐reported health care utilisation by participants in each group, measured in structured follow‐up interviews. These interviews measure the number and duration of inpatient, outpatient, rehabilitation and other health service encounters, and are based on the interview schedule for Post‐Injury Inpatient Hospitalisations and Post‐Injury Health Service Use questionnaires from the NIH‐funded Trauma Survivor Outcome Support project (ClinicalTrials.gov identifier: NCT02655354; NIH project ID: UH3MH106338‐02). [At baseline (recruitment), 1 month, 3 months, and 6 months post‐recruitment:] Implementation: The cost of healthcare use measured by linkage with the Medicare Benefit Schedule, Pharmaceutical Benefits Scheme, Transport Accident Commission, Worksafe Victoria and Victorian Admitted Episodes Dataset records of health care services or medications received.[Baseline to 6‐months post‐recruitment, adjusting for pre‐injury health‐related costs.] Implementation: The cost of providing the intervention to participants in each group, measured through research staff logs of the time spent in direct communication with participants (e.g., case management interactions), letter writing, sourcing resources, or engaging with healthcare providers. [Baseline to 6‐months post‐recruitment]