Trial of Social Work Services in Fracture Clinic Setting
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheila Sprague
About this trial
Every year, many Canadians sustain a fracture that requires surgical treatment and results in a long recovery period. During this recovery period, patients may experience new or worsening mental health issues including depression, anxiety, or post-traumatic stress disorder. Additionally, patients may experience new or worsening social and financial problems, such as food and housing insecurity, due to being unable to work or take care of other daily responsibilities. Current care for fracture patients is focused on treating their physical injuries and overlooks these other challenges. To address this gap in care, the investigators propose having a social worker available in the fracture clinic to provide patients with support beyond the care of their physical injury.
The investigators propose a trial of 2,000 patients to determine if social worker support improves recovery for patients after a serious fracture by reducing the number of times they return to the emergency room or urgent care centre. This trial will also determine if social work support improves patients' mental health, financial security, ability to work, and level of satisfaction with the care they receive, and whether it reduces the amount of opioid medication they use and number of missed visits during their recovery. Patients will be randomly assigned to receive either support from a social worker or usual care. For patients assigned to receive social worker support, the social worker will assess their individual needs and provide support, information, and referrals to social support services. The social worker will continue to support patients for up to one year after they join the trial. Patients will complete questionnaires at enrollment and at 6 weeks and 3, 6, 9, and 12 months after enrollment.
If this trial shows that support from a social worker in the fracture clinic during their recovery period is beneficial to patients who have experienced a serious fracture requiring surgery, it has the potential to change care for patients who experience these potentially life-changing injuries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 or older.
Has fracture of the appendicular skeleton
Fracture required surgical management.
Fracture occurred within the past 12 weeks.
Disqualifiers
Incarceration.
Expected injury survival of less than 6 months.
Terminal illness with expected survival of less than 6 months.
Currently enrolled in a trial that does not permit co-enrollment.
Trial design
Design model
Sequential
Treatments tested in this trial
Social Work support
Other interventionParticipants enrolled during the treatment phase at their clinic will receive social work support for 6 months from the time of enrollment. They will have an intake appointment with the social worker before or during their initial fracture clinic visit to assess their needs, identify goals that they can address with the support of the social worker, and collaboratively formulate a personalized care plan tailored to their specific circumstances. The social worker will then implement the plan, which may involve educating participants and their support network, coordinating delivery of care and benefits, making referrals to community services, advocating for the participant, and providing emotional support and brief counselling. The social worker will be accessible to participants for 6 months post-enrollment, following up via telephone, telemedicine or in-person to evaluate the effectiveness of the care plan and offer sustained ongoing support.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Usual Care ArmNo intervention 0 interventions
Group B: Social Work Intervention GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of visits to emergency room or urgent care
Research personnel will ask participants if they went to the emergency room or to an urgent care facility at each of the follow-up visits 6 weeks, 3 months, and 6 months after consent. Research personnel will review the participant's medical records for emergency room and urgent care visits . We will document the date of the visit and the reason for the visit. We will also document whether the visit occurred at the same or different hospital and hospital system where the participant is receiving care for the fracture.
Time frame
For 6 months from the date of enrollmentSecondary outcomes
1
LIMB-Q Questionnaire
The LIMB-Q is a validated questionnaire with 16 independently functioning scales. This trial will use the LIMB-Q Psychological and Financial scales as secondary outcome measures. Research coordinators will administer all LIMB-Q scales at baseline, 6 weeks, 3 months and 6 months after consent. LIMB-Q scale scores range from 0 (worst) to 100 (best). Higher scores for LIMB-Q scales reflect a better outcome. To provide a point of reference for the LIMB-Q, we will also administer the EQ-5D.
Time frame
For 6 months from the date of enrollment2
Opioid Use
We will assess opioid use in the past 2 weeks by self-report as a binary Y/N variable at each of the following timepoints: baseline, 6 weeks, 3 months and 6 months post-consent.
Time frame
For 6 months from the date of enrollment3
Number of Missed Clinic Visits
We will assess missed visits by tracking the number of clinic visits each participant attends as well as tracking any missed clinic visits. We will ask the participant about appointment attendance as well as verify information from their medical record.
Time frame
For 6 months from the date of enrollment4
Number and characteristics of interactions with social worker
(TREATMENT ARM ONLY) The social worker will complete a log of each point of contact they have with each participant. This log will include the medium of contact, themes discussed, and number of referrals made. We will ask participants if they saw a social worker outside of the fracture clinic.
Time frame
For 6 months from the date of enrollmentOther outcomes
1
Lived Experiences of Orthopaedic Trauma Patients and Social workers in Fracture Clinics
Qualitative interviews of randomly selected participants and staff affected by this trial will be conducted in alignment with the CORE-Q guidelines for qualitative research. We have selected qualitative description as the theoretical basis of the qualitative component of this trial. Qualitative description is a low-interpretation method of describing qualitative interviews that does not describe themes in terms of a conceptual, philosophical or other highly abstract framework or system. The interviews will be structured, with approximately 20 questions expected to allow for 30-45 minutes interview length.
Time frame
One interview, approximately 45 minutes, after 6 month study activities have concluded2
Economic Analysis
We will conduct a cost-effectiveness analysis from the payer's perspective which will include utilities obtained from the Euro-Quol-5 Dimensions 5 Levels (EQ-5D-5L) and the cost of the social worker and the hospital care costs.The EQ-5D-5L allows the calculation of a health utility score ranging from 0 to 1, where 0 represents death and 1 the best imaginable health state, which is necessary to calculate quality-adjusted life years (QALYs). QALYs combine quantity of life with HRQoL and are used in cost-effectiveness analyses to compare outcomes between interventions. We will calculate QALYs for each intervention by weighing the utility scores by time spent in health states using an area under the curve approach. Participants will be asked to record hospital visits and research personnel will verify this information from the medical record. This data will be modeled within the economic analysis to compare the social worker intervention versus usual care.
Time frame
6 months following enrollmentSponsors and contacts
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Sheila Sprague
Lead sponsor
McMaster University
Sponsor institution
McMaster Surgical Associates
Collaborator
Orthopaedic Trauma Association
Collaborator
Source ClinicalTrials.gov