None listed
Conditions
Brief summary
Pain and mental health conditions, especially posttraumatic stress disorder (PTSD), are common and disabling after injury. This study is evaluating an adaptation of the Trauma Survivor Outcome Support (TSOS) model that was developed in Seattle, USA. The intervention that we are evaluating will provide tailored psychological support and coordinated care through a case manager, and aims to reduce the prevalence and impact of persistent pain and symptoms of mental health conditions after major trauma. The control group receives enhanced usual care in which the participant's primary care provider receives a letter summarising the participants potential ongoing treatment needs when they enter the study. The study hypothesis is that the TSOS model of care will be acceptable to patients after major trauma, and that it will reduce the severity of pain and mental health symptoms compared with enhanced usual care.
Interventions
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 Recovery” by Phoenix Australia, “Grief following road trauma” by Road Trauma Support Services, and “Self-managing chronic pain” 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 support their patient’s ongoing care. Stepped collaborative care involves first informing the participant that they will receive support from a case manager who is based at Alfred Health for the next six months. If participants have been discharged to rehabilitation, the case manager will maintain contact with the participant, but will not provide additional treatment or referrals until they are discharged home. While in hospital, and after discharge, the care coordination team will: 1. Make regular contact with participants via telephone, or face to face during inpatient or outpatient admissions at The Alfred, to help support their pain or mental health treatment needs and risk behaviours. Participants will be encouraged to contact the case manager via a dedicated mobile phone number for ongoing assistance. Contact frequency will be approximately weekly in the first 2-4 months, but will vary with each participant’s level of need and engagement. 2. Liaise with the primary care provider regarding potential ongoing medication needs in accordance with recommendations from the study doctors. If the participant does not have a primary care provider the case manager will help them to find one. 3. Liaise with any additional case managers (e.g., with the TAC or WSV) involved with their ongoing care to ensure that the participant receives coordinated care. 4. Use motivational interviewing (MI) techniques and basic cognitive behavioural therapy (CBT) principles during case coordination to address high risk behaviours, to improve readiness for therapy, and encourage behaviour change, or medication adherence. 5. Assess pain and mental health symptoms during case management encounters using validated screening tools to support case management decision making. The tools used during case management symptom assessment differ to those in the outcome assessment battery, with the exception of the NM-ASSIST, and may include: a. Brief Pain Inventory to collect ratings of pain severity (four items) and pain interference (7 items); b. PTSD Symptom Scale – Interview Version for DSM-5 (PSSI-5), or the five item Primary care PTSD screen for DSM-5 (PC-PTSD-5) to assess PTSD symptoms; c. Hospital Anxiety and Depression Scale to measure anxiety and depression symptoms. 6. Arrange referrals via the study doctors for appropriate treatment in the community, through hospital outpatient or telehealth services, or in collaboration with the participant’s primary care provider who may be asked to make referrals (e.g., via a mental health care plan). 7. Provide recommendations for smartphone applications or web-based treatment programs (e.g., AfterTrauma recovery app, PTSD coach, Manage My Pain) that may support recovery through self-management of pain and mental health symptoms if the participant has a smart phone with internet connection and want to try those resources. WHO PROVIDED: The case manager must have strong interpersonal and empathic skills in building rapport, and prior knowledge, experience and training in supporting people with complex treatment needs for pain, mental health and substance abuse conditions, as defined in the TSOS treatment manual. The case manager needs to be able to interface with numerous and diverse individuals including participants and their families, surgical and primary care providers, staff in hospital and community agencies, mental health professionals, and other members of the clinical and investigative team. They must therefore have sufficient skills and experience in liaising with those providers and agencies in order to co-ordinate each participant’s care. The case manager could be a social worker, registered nurse or a non-healthcare professional who possesses the attributes required for the role (e.g., an allied health assistant who has worked in a related field). The case manager will receive training, coaching and supervision by the clinical and academic investigators. Training for the case manager comprises an initial interactive workshop, via zoom, led by TSOS investigators at Harbourview Medical Centre, which will provide an overview of the core elements of providing the modified trauma survivors outcomes and support program. This includes understanding posttraumatic stress disorder, pain, case management, the role of study doctors in identifying and recommending suitable medications, MI and CBT principles, and community linkage for referral and treatment provision. During the trial, the case manager will have access to coaching from psychologists and study doctors in the study team and their collaborative network. Remote coaching for the case manager(s) will be provided by the Harborview team, and may include discussion about concern elicitation, providing motivational interviewing or cognitive behavioural therapy-based guidance, as well as problem-solving barriers to screening and intervention implementation to manage and treat PTSD and pain symptoms. The case manager will be able to contact a clinical member of the study team to discuss any urgent issues as needed, and all other queries will be discussed at team case conferencing meetings every 1-2 weeks. The case conferencing meetings will provide an opportunity for the collaborative care team to review patient symptoms and concerns, and to identify additional strategies that the case manager could use to help the patient to manage their symptoms and improve their recovery. HOW: While in hospital, and after discharge, the care co-ordination team will make regular contact with participants via telephone or face to face at hospital during inpatient admissions or outpatient appointments to identify and address pain and mental health treatment needs. Participants will be encouraged to contact the case manager via a dedicated mobile phone number for ongoing assistance. WHERE: Case management will be provided from within a single major trauma service (The Alfred) in metropolitan Melbourne, and refer patients for evidence based treatment either in the hospital, in the community or via e-health (e.g., telehealth, web or application-based treatments), according to the participants needs and preferences. The case manager will be located at the hospital, and will use resources within REDCap to facilitate participant screening, referrals and communication between the care coordination team and primary care providers. WHEN and HOW MUCH: Participants will be recruited within 28 days post-injury, or within 28 days of becoming medically stable and conscious post-injury. The case manager will maintain regular contact with participants in the intervention group up to six months after recruitment. Overall it is expected that case management will spend between 10 to 15 hours supporting each participant. TAILORING: Treatments offered will be stratified and tailored for each participant based on their risk profile, their treatment readiness and preferences, and will be arranged in accordance with national and international evidence based guidelines for post-traumatic mental health and pain management. HOW WELL: Planned: To enable assessment of adherence, all case manager initiated referrals and recommendations for treatment will be recorded in the REDCap database. Adherence with referred treatments and medications in the intervention group will be recorded by cross referencing referrals and recommendations made by the case management team with attendance reported by participants in follow-up interviews or case management meetings, and via linkage with administrative treatment records (i.e., via Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Victorian Admitted Episodes Dataset and the Transport Accident Commission). Additional insights regarding the acceptability of the intervention will be explored in qualitative interviews with participants from both groups at 3-6 months post-injury.
Sponsors
Study design
Eligibility
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. RISK CRITERIA for PTSD (3 or more of the following criteria are indicated (clinical and socioeconomic): Clinical PTSD risk criteria: 1. Pre-existing PTSD diagnosis at admission 2. Any other psychiatric diagnosis at admission 3. Any substance use disorder diagnosis or positive BAC or illicit drug test on admission 4. Current or prior tobacco use 5. Intentional injury 6. Intensive care unit (ICU) admission with mechanical ventilation 7. One or more prior trauma hospital admissions 8. A death occurred in the injury event Socioeconomic risk criteria: 1. Funding source: Transport Accident Commission or WorkSafe Victoria 2. Non-male gender 3. Non-white ethnicity 4. Middle aged (35 to 65 years) 5. Socioeconomic disadvantage (e.g., unemployed, living in a disadvantaged neighbourhood (IRSAD state decile ranking < 5), unemployed, report being at risk of job loss) PAIN RISK CRITERIA (one or more of the following clinical criteria are indicated): 1. Neuropathic injury 2. Prior psychiatric or substance use condition a. Pre-existing PTSD diagnosis at admission b. Any other psychiatric diagnosis at admission c. Any substance use disorder diagnosis or positive BAC or illicit drug test on admission 3. Prior chronic pain 4. Prior treatment for opioid-addiction disorder a. Methadone or buprenorphine treatment pre-injury 5. Intense post-injury or post-surgical pain: a. Persistent intense pain requiring breakthrough analgesia beyond expected level for injury b. Acute pain consultations at or after discharge for severe pain c. Patient is medically stable but discharge is delayed due to complex pain 6. High post-injury opioid consumption a. >= 90 mg/day of oral morphine equivalence post-discharge b. Prescription for a long acting opioid medication at or post-discharge c. Referral for interventional postsurgical procedures for pain (e.g., stump catheters for post-amputation) 7. Patient displays or reports high levels of distress Patients who meet the above criteria will then undergo an interview screen, Any one of the following criteria warrant enrollment: 1. Severe and/or disabling pain (PEG>=4) 2. Post-injury pain has neuropathic qualities (DN4>=3) 3. Clinically elevated psychological symptoms a. PTSD (PCL-C>=35) b. Depression (PHQ>14) c. Suicidality: (PHQ item 9>=1) d. Drug/alcohol (NM-ASSIST>4) e. Prior/current opioid misuse (COMM>=1) 4. Catastrophizing (PCS>30)
Exclusion criteria
Potential participants will be excluded if they: • Have recorded that they do not want to be contacted about research projects at Alfred Health • Do not have a Medicare number • Have no capacity to give consent due to: • Sustained moderate to severe brain injury (i.e., GCS 3 – 12 and head AIS>2) • Temporary incapacity (e.g., due to intoxication, delirium or medication side-effects) • Permanent cognitive impairment (e.g., dementia or Alzheimer’s Disease) • Moderate to severe cognitive impairment (i.e., a score of >=5 on the SPMSQ) • Were injured during an episode of suicidal or non-suicidal self-harm • Were injured during an episode of acute psychosis, while committing a crime, or while incarcerated • Have a history of violence (as a perpetrator of violent crime or harm to others) or behave violently during the hospital admission. • Have no usual place of residence or no regular means for contact at baseline (e.g., no mobile or landline telephone). * Patients aged 65 and over injured in a low fall * People with posttraumatic amnesia of more than 24 hours * People with a pre-existing case manager