Recruiting

Social Worker Support

Sponsor:

Sheila Sprague

Code:

NCT06973655

Conditions

Orthopaedic Fractures

Socioeconomic Factors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Social Work support

Study Details

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

Study ID

NCT06973655

Start date

Oct 6, 2025

Status verified date

Dec, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

The inclusion criteria are:

1. Aged 18 or older.
2. Has fracture of the appendicular skeleton
3. Fracture required surgical management.
4. Fracture occurred within the past 12 weeks.

3\. Willing to comply with the protocol. 4. Willing to provide informed consent.

Exclusion Criteria:

1. Incarceration.
2. Expected injury survival of less than 6 months.
3. Terminal illness with expected survival of less than 6 months.
4. Currently enrolled in a trial that does not permit co-enrollment.
5. Unable to engage in protocol in the languages available in the local cluster.
6. Prior enrollment in the trial.
7. Declined to provide informed consent.
8. Not approached at (or prior to) the first post-surgery fracture clinic visit (missed participant).
9. Other reason to exclude the patient, as approved by the Methods Centre.

Study Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Usual Care Arm

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.

active comparator: Social Work Intervention Group

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.

Interventions

Social Work support

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.

Primary outcome measure

  • Number of visits to emergency room or urgent care [ Time Frame: For 6 months from the date of enrollment ]

Central Contacts and Locations

Central contacts

Paula McKay, BSc

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

Natalie Fleming, MSW

flemin3@mcmaster.ca

Locations

Zuckerberg San Francisco General Hospital and Trauma Centre

Recruiting

San Francisco, California, United States, 94110

Contacts

Eleni Berhaneselase, BA

415-476-1997eleni.berhaneselase@ucsf.edu

Tigist Belaye, MPA

415-205-5375Tigist.belaye@ucsf.edu

Principal Investigator:

Saam Morshed, MD, PhD, MPH

More Information

Sponsor

Sheila Sprague

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Keywords

  • social work
  • fractures
  • addiction
  • social determinants of health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sheila Sprague on 2025-12-10.