Trial of Social Work Services in Fracture Clinic Setting

NCT06973655 | Recruiting

• 1 other identifier: SWRCT-27-March-2025
• Study Type: interventional
• Target: 2,000
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Orthopaedic Fractures; Socioeconomic Factors

Keywords

social work; fractures; addiction; social determinants of health

Outcome Measures

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.

  For 6 months from the date of enrollment

Secondary Outcomes (4)

• LIMB-Q Questionnaire

  For 6 months from the date of enrollment

• Opioid Use

  For 6 months from the date of enrollment

• Number of Missed Clinic Visits

  For 6 months from the date of enrollment

• Number and characteristics of interactions with social worker

  For 6 months from the date of enrollment

Other Outcomes (2)

• Lived Experiences of Orthopaedic Trauma Patients and Social workers in Fracture Clinics

  One interview, approximately 45 minutes, after 6 month study activities have concluded

• Economic Analysis

  6 months following enrollment

Study Arms (2)

Usual Care Arm

NO INTERVENTION

Participants enrolled during the usual care phase will receive the current standard treatment for their fracture. The current standard of care post-surgery for fractures, in the fracture clinic, is to provide medical treatment for injuries including casts, monitoring for infection, x-rays, etc. This is provided by surgeons, nurses and technicians. Any psychosocial needs are managed at patient request either by the surgeon or another clinic health care professional (in the case of simple forms) or by a hospital social worker, who usually has a full-time workload outside of the fracture clinic.

Social Work Intervention Group

ACTIVE COMPARATOR

Participants 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.

Other: Social Work support

Interventions

Social Work support OTHER

Participants 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.

Social Work Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older.
• Has fracture of the appendicular skeleton
• Fracture required surgical management.
• Fracture occurred within the past 12 weeks.
• \. Willing to comply with the protocol. 4. Willing to provide informed consent.

You may not qualify if:

• 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.
• Unable to engage in protocol in the languages available in the local cluster.
• Prior enrollment in the trial.
• Declined to provide informed consent.
• Not approached at (or prior to) the first post-surgery fracture clinic visit (missed participant).
• Other reason to exclude the patient, as approved by the Methods Centre.

Sponsors & Collaborators

• Sheila Sprague: lead
• McMaster Surgical Associates: collaborator
• Orthopaedic Trauma Association: collaborator

Study Sites (2)

Zuckerberg San Francisco General Hospital and Trauma Centre

San Francisco, California, 94110, United States

RECRUITING

Hamilton Health Sciences - Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

NOT YET RECRUITING

Related Publications (7)

• Sprague S, Fleming N, Gonsalves M, Al-Asiri J, Johal H, Williams D, Al-Zahrani F, Gallant JL, Renaud S, Pusztai K, MacRae S, Zalzal M, Bzovsky S, Petrisor B. Patient perspectives on the desirability of social worker support in outpatient orthopaedic trauma clinics. OTA Int. 2025 Feb 17;8(1):e375. doi: 10.1097/OI9.0000000000000375. eCollection 2025 Mar.

  PMID: 39963362 BACKGROUND

• Rahman R, Wallam S, Zhang B, Sachdev R, McNeely EL, Kebaish KM, Riley LH 3rd, Cohen DB, Jain A, Lee SH, Sciubba DM, Skolasky RL, Neuman BJ. Appropriate Opioid Use After Spine Surgery: Psychobehavioral Barriers and Patient Knowledge. World Neurosurg. 2021 Jun;150:e600-e612. doi: 10.1016/j.wneu.2021.03.066. Epub 2021 Mar 19.

  PMID: 33753317 BACKGROUND

• Howard R, Brown CS, Lai YL, Gunaseelan V, Brummett CM, Englesbe M, Waljee J, Bicket MC. Postoperative Opioid Prescribing and New Persistent Opioid Use: The Risk of Excessive Prescribing. Ann Surg. 2023 Jun 1;277(6):e1225-e1231. doi: 10.1097/SLA.0000000000005392. Epub 2022 Jan 21.

  PMID: 35129474 BACKGROUND

• O'Hara NN, Slobogean GP, Stockton DJ, Stewart CC, Klazinga NS. The socioeconomic impact of a femoral neck fracture on patients aged 18-50: A population-based study. Injury. 2019 Jul;50(7):1353-1357. doi: 10.1016/j.injury.2019.05.029. Epub 2019 May 28.

  PMID: 31164220 BACKGROUND

• Stinner DJ, Mir HR. Patient Mental Health and Well-being: Its Impact on Orthopaedic Trauma Outcomes. J Orthop Trauma. 2022 Oct 1;36(Suppl 5):S16-S18. doi: 10.1097/BOT.0000000000002450.

  PMID: 36121326 BACKGROUND

• Muscatelli S, Spurr H, O'Hara NN, O'Hara LM, Sprague SA, Slobogean GP. Prevalence of Depression and Posttraumatic Stress Disorder After Acute Orthopaedic Trauma: A Systematic Review and Meta-Analysis. J Orthop Trauma. 2017 Jan;31(1):47-55. doi: 10.1097/BOT.0000000000000664.

  PMID: 27997466 BACKGROUND

• Bhandari M, Busse JW, Hanson BP, Leece P, Ayeni OR, Schemitsch EH. Psychological distress and quality of life after orthopedic trauma: an observational study. Can J Surg. 2008 Feb;51(1):15-22.

  PMID: 18248701 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Behavior, Addictive

Condition Hierarchy (Ancestors)

Wounds and Injuries; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

Paula McKay, BSc

CONTACT

1-289-237-0791; mckayp@mcmaster.ca

Natalie Fleming, MSW

CONTACT

flemin3@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director / Associate Professor

Model Details: To efficiently and effectively address the above objectives, we have designed this trial as a batched stepped-wedge cluster randomized trial. In the batched stepped wedge trial, clusters can be randomized and move through the trial design in 'batches', which allows for flexibility in the timing of initiation of different clusters. The stepped wedge design itself begins with each cluster in the batch being given a date for crossover into the treatment group, in a randomly determined order. All clusters then enter an initial period in which no clusters are exposed to the intervention. Subsequently, at regular intervals ("steps"), clusters cross from the control to the intervention under evaluation. This process continues until all clusters have crossed over to the intervention.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 15, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (1); US (1)