Social Worker Presence in Outpatient Fracture Clinics: A Batched Stepped-Wedge Cluster Randomized Trial
Phase: NA
Conditions: Orthopaedic Fractures, Socioeconomic Factors
Sponsor: Sheila Sprague

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Social Worker Presence in Outpatient Fracture Clinics:
A Batched Stepped-Wedge Cluster Randomized Trial
Protocol
Protocol Number: SWRCT-27-March-2025
Version: 2.0
Date: May 12, 2025
This protocol is the confidential intellectual property of the Principal Investigator and cannot be
used in any form without the express written permission of the Principal Investigator.
Reviewed and approved by:
Signature:
Date:
Dr. Sheila Sprague
Principal Investigator
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DOCUMENT REVISION HISTORY
Date
Version
Section
Summary of Changes
Author(s)
27March2025
1.0
All
Original Version
Natalie 
Fleming
12May2025
2.0
4.4
Removed “willing to provide informed 
consent” from the inclusion criteria, as it is 
also an exclusion criteria.
Natalie 
Fleming
4.5
Clarified that patients should be approached 
by a circle of care member. Clarified the
composition and process of the Central 
Adjudication Committee.
9.1
Added text to clarify that participants may
use other available social work services or 
referrals as part of usual care.
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TABLE OF CONTENTS
Contents
TRIAL SUMMARY ....................................................................................................................... 5 
1.0 INTRODUCTION .................................................................................................................... 6 
1.1 What is the problem to be addressed?................................................................................... 6 
1.2 Why is a trial needed now? ................................................................................................... 7 
2.0 OBJECTIVES........................................................................................................................... 8 
3.0 TRIAL DESIGN....................................................................................................................... 8 
3.1 Description of the Trial Design............................................................................................. 8 
4.0 METHODOLOGY ................................................................................................................. 10 
4.1 Trial Setting......................................................................................................................... 10 
4.2 Cluster Eligibility and Selection of Clusters....................................................................... 10 
4.3 Cluster Allocation and Concealment................................................................................... 11 
4.4 Participant Eligibility Criteria............................................................................................. 11 
4.5 Patient Screening and Informed Consent............................................................................ 11 
4.6 Intervention ......................................................................................................................... 12 
4.7 Outcomes............................................................................................................................. 13 
4.7.1 Number of Emergency Room and Urgent Care Center Visits ..................................... 13 
4.7.2 LIMB-Q........................................................................................................................ 14 
4.7.3 Satisfaction with Care Provided ................................................................................... 14 
4.7.4 Opioid Use.................................................................................................................... 14 
4.7.5 Missed Fracture Clinic Visits ....................................................................................... 14 
4.7.6 Economic Analysis....................................................................................................... 14 
4.7.7 Lived Experiences of Orthopaedic Trauma Patients, Social Workers, and Health Care 
Professionals in Fracture Clinics........................................................................................... 15 
4.8 Data Collection and Participant Follow-Up........................................................................ 15 
4.8.1 Data Collection Procedures .......................................................................................... 15 
4.8.2 Participant Follow-Up .................................................................................................. 15 
4.9 Blinding............................................................................................................................... 16 
5.0 SAMPLE SIZE ....................................................................................................................... 16 
6.0 DATA ANALYSIS................................................................................................................. 17 
6.1 Outcomes Analysis.............................................................................................................. 17 
6.2 Sensitivity Analyses............................................................................................................ 19 
6.3 Subgroup Analyses.............................................................................................................. 20 
6.4 Qualitative Analysis............................................................................................................ 21 
6.5 Interim Analysis Plan.......................................................................................................... 22 
7.0 DATA MANAGEMENT........................................................................................................ 22 
7.1 Case Report Forms and Data Transmission........................................................................ 22 
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7.2 Interview Management........................................................................................................ 22 
7.3 Data Integrity....................................................................................................................... 22 
7.4 Trial Monitoring.................................................................................................................. 22 
7.5 Records Retention ............................................................................................................... 22 
8.0 ETHICS AND DISSEMINATION......................................................................................... 23 
8.1 Research Ethics Approval................................................................................................... 23 
8.2 Confidentiality..................................................................................................................... 23 
8.3 Protocol Amendments......................................................................................................... 23 
8.4 Dissemination Policy........................................................................................................... 23 
9.0 SAFETY ................................................................................................................................. 23 
9.1 Risks to Participants............................................................................................................ 23 
9.2 Safety Monitoring ............................................................................................................... 24 
10.0 REFERENCES ..................................................................................................................... 25 
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TRIAL SUMMARY 
Name
Social Worker Presence in Outpatient Fracture Clinics: A Batched Stepped-Wedge Cluster 
Randomized, Trial
Methodology
Batched Stepped-Wedge Cluster Randomized Trial
Background
To address the unmet needs of orthopaedic trauma patients, we propose integrating a dedicated social 
worker within the fracture clinic setting. 
Primary 
Objective 
The primary objective is to determine if the integration of a dedicated social worker within the fracture 
clinic setting, compared to usual care, reduces all-cause return to emergency room or urgent care over 
6 months.
Secondary 
Objectives
The secondary objectives of the definitive trial are to determine if the integration of a dedicated social 
worker within the fracture clinic setting, compared to usual care:
1.
Reduces negative psychological impact;
2.
Reduces negative financial impact;
3.
Increases patient satisfaction with care;
4.
Reduces opioid use; and
5.
Reduces missed fracture clinic visits.
We will assess the economic value of the intervention from the hospital (payer) perspective. Finally, 
we will explore the lived experiences of orthopaedic trauma patients, social workers, and health care 
professionals in fracture clinics through structured interviews.
Key Eligibility 
Criteria
The key eligibility criteria are:
1. Adult patient over the age of 18.
2. Patient presenting within 12 weeks of injury with an appendicular fracture that required surgical 
management.
3. Willing to comply with the trial protocol.
Intervention
Participants enrolled into the treatment group will meet with the social worker, which may include 
the following interventions: intake and assessment; formulation of goals; treatment planning and 
intervention; evaluation and conclusion. Participants in the usual care group will receive standard 
fracture care as determined by their treating surgeon.
Primary and 
Secondary 
Outcomes
The primary outcome is all cause visits to an emergency room or urgent care center within 6 months 
of enrollment. The secondary outcomes are:
1.
LIMB-Q Psychological Impacts scale.
2.
LIMB-Q Financial Impacts scale.
3.
Satisfaction with care question.
4.
Opioid use at 3 months and 6 months.
5.
Fracture clinic visits attended and missed. 
6.
Economic analysis (EQ-5D and hospital use).
7.
Qualitative interviews with participants, social workers, and health care professionals.
Sample Size
2000 patients 
Significance
This trial has the potential for significant impact on patients including enhanced recovery and health 
outcomes, prevention of complications and improved long-term recovery. Specifically, this trial has 
the potential to identify areas in which social workers can have the most significant impact, providing 
evidence for hospital administrations to offer social work services in fracture clinics. 
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1.0 INTRODUCTION
1.1 What is the problem to be addressed? 
Each year, approximately 15% of Canadians experience an orthopaedic injury serious enough to 
affect their ability to engage in everyday activities1. These injuries include fractures and 
dislocations that are typically managed operatively by an orthopaedic trauma surgeon and 
frequently result in prolonged recovery periods. Despite a comprehensive and well-researched 
approach to medical aspects of recovery, this patient population seldom receives adequate social 
support for the non-physical consequences of their injuries.  
Following a serious orthopaedic injury, patients may face numerous life changes including 
negative impacts on relationships, independence, emotional well-being, financial stability, and 
ability to work or participate fully in daily activities. Patients may also experience new or 
worsening mental health problems. Studies have found orthopaedic trauma patients to have higher-
than-average rates of many types of mental health disorders, including depression and anxiety2. A 
2017 systematic review found that, post-injury, the weighted pooled prevalence of depression and 
post-traumatic stress disorder in orthopaedic trauma patients was 33% and 27%, respectively3.
Post-injury, there is a correlation between symptoms of depression and reduced physical function 
and magnitude of disability4.
As they often necessitate prolonged periods away from work, traumatic orthopaedic injuries 
significantly affect employment and income. For many, financial repercussions are immediate, 
leading to income loss even with minor injuries. It is not uncommon for physical impairment from 
orthopaedic injuries to keep patients from returning to work for 6 months or more, with 
compounding detrimental effects on relationships, self-worth, and future job prospects5. Research 
on the financial toll of orthopaedic injuries found that fractures were associated with substantial 
individual and household income loss up to 5 years after injury, and 1 in 5 patients sustained 
catastrophic income loss in the 2 years after their injury6. Navigating the bureaucratic and logistical 
challenges of securing employment insurance or Workplace Safety and Insurance Board benefits 
post-injury can be overwhelming, adding to the burden faced by the injured person or their 
caregivers.   
The stress of a serious orthopaedic injury may also lead to or exacerbate substance abuse problems, 
which may include increased alcohol intake and drug use. In addition, opioids are a ubiquitous part 
of perioperative pain management following an orthopaedic injury. Despite increasing regulations, 
more than 80% of orthopaedic trauma patients are prescribed opioids in the post-surgical period7.  
Patients may have low levels of information about safe opioid use, alternative methods of pain 
management, and what to expect during recovery8. When coupled with other post-injury 
challenges, including mental health issues, job loss, and income reduction, these factors may lead 
to opioid addiction, potentially resulting in permanent job loss, being without a home, and even 
death.  
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The combined stress of physical recovery, financial strain, risk of addiction, changes in 
relationship dynamics, and the intricacies of obtaining aid or services can be emotionally and 
mentally taxing for orthopaedic patients and their support networks. Orthopaedic trauma patients 
urgently need outpatient support for their recovery from injury. The orthopaedic fracture clinic is 
the only outpatient care that these patients receive. Supplementing medical treatment with a 
comprehensive support system and strategies to mitigate the non-physical impacts of orthopaedic 
injury has the potential to significantly reduce the negative impact of these traumatic injuries.  To 
address this urgent social need, we propose the integration of a dedicated social worker within the
fracture clinic setting to provide support to patients with serious orthopaedic injuries. A clinical 
trial is needed to evaluate the efficacy of having a social worker in the fracture clinic before 
widespread hospital policy changes can be implemented.
1.2 Why is a trial needed now?  
The functional impact of a serious orthopaedic injury significantly influences patients’ ability to 
work, participate in activities of daily living, engage in exercise and sports, maintain social 
relationships, and feel like a valued member of their family and society – all areas in which a social 
worker can have a pivotal impact. Post-pandemic, North America has faced growing mental health, 
opioid use, and cost of living crises which have left Canadians susceptible to a post-injury cascade 
of social and financial consequences9. In preparation for the proposed trial, we conducted a search 
of the literature, which identified a trial that evaluated rates of osteoporosis treatment in hip 
fracture patients. The results of this trial directly led to the addition of an osteoporosis coordinator 
to assess the bone health of fracture patients in many fracture clinics across Canada. The success 
of the osteoporosis coordinator model became the basis for our hypothesis that a similar model 
providing dedicated social worker support in fracture clinics will reduce the negative life impact 
of orthopaedic injury on patients. Our search did not identify any trials evaluating social worker 
support in fracture patients. 
We conducted a cross-sectional survey of practicing orthopaedic surgeons who treat patients with 
serious orthopaedic injuries and asked about their perceptions regarding the need for social worker 
support in their patient population. Orthopaedic surgeons identified that they are ‘often’ or 
‘always’ seeing patients who are financially strained (84%), experiencing substance abuse (53%), 
have mental health problems (38%), or are underhoused (35%). In addition, 84% of respondents 
indicated that at least one social support required by their fracture patients was currently inadequate 
to a point of crisis. 
To ensure that patients’ voices are heard, we conducted a cross-sectional study of 200 patients 
receiving treatment for an orthopaedic injury in the fracture clinic setting. Critically, 94% of 
patients surveyed indicated that they believe that fracture patients like them would benefit from 
the support of a social worker10. From the patient perspective, patients identified multiple areas of 
support that a social worker could provide, with over 60% of respondents indicating patients like 
them could use assistance with benefits/insurance, coordination of care, counselling and emotional 
support, referrals, post-traumatic stress disorder, patient education, needs assessments, anxiety, 
inability to pay for care, depression, family support, patient advocacy, advocacy for vulnerable 
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population, crisis intervention, substance misuse, financial strain, intimate partner violence, and 
being unhoused or underhoused. 
Our review of the literature, coupled with insights from orthopaedic surgeons and patients, has 
identified a critical gap in patient care in outpatient fracture clinic settings. Despite this need being 
recognized by many surgeons and patients with whom we have engaged, the current standard of 
care fails to address these non-physical concerns. Our body of work to date underscores the 
urgency and importance of bridging this gap: one in which social workers could enhance patient 
well-being and where they are uniquely poised to contribute to the current landscape of orthopaedic 
treatment. To address this issue, this trial aims to evaluate the impact of integrating a dedicated 
social worker into outpatient fracture clinics.
2.0 OBJECTIVES
The primary objective of this trial is to determine if the integration of a dedicated social worker 
within the fracture clinic setting, compared to usual care, reduces all-cause visits to the emergency 
room or urgent care over 6 months.
The secondary objectives of this trial are to determine if the integration of a dedicated social worker 
within the fracture clinic setting, compared to usual care:
1. Reduces negative psychological impact;
2. Reduces negative financial impact;
3. Increases patient satisfaction with care;
4. Reduces opioid use; and
5. Reduces missed fracture clinic visits.
We will assess the economic value of the intervention from the hospital (payer) perspective. We 
will also explore the lived experiences of orthopaedic trauma patients, social workers, and health 
care professionals in fracture clinics through structured interviews. 
3.0 TRIAL DESIGN 
3.1 Description of the Trial Design
To efficiently and effectively address the above objectives, we have designed this trial as a batched 
stepped-wedge cluster randomized trial. The batched stepped-wedge cluster randomized trial is a 
pragmatic design commonly used in the evaluation of service delivery interventions. In the batched 
stepped wedge trial, clusters (in this case, surgeon clinics) of patients can be randomized and move 
through the trial design in ‘batches’ (e.g. a group of four clusters), 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 patients 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. At the end of the batch period there is a period when the intervention is being 
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implemented at all clusters. Data collection takes place throughout the batch period, so that all
clusters contribute observations under both control and intervention observation periods. We will 
define a cluster as an individual orthopaedic surgeon fracture clinic. 
We will conduct this trial in two to four batches, with four clusters in each batch. The number of 
batches will depend on the enrollment rates during the previous batches. For each batch, before 
participant enrollment begins, the Methods Centre will randomize the clusters (i.e. clinics) to
determine when they will begin the intervention (i.e. social worker support in the fracture clinic). 
All clinics in the batch will begin participant enrollment into the non-intervention arm (i.e. usual 
care with no social worker services).  At 10 weeks, one clinic will begin the intervention while the 
others will continue enrolling in the non-intervention arm as per randomization. At 20 weeks the 
second clinic will cross over to begin treatment, and at 30 weeks the third clinic will crossover.  
The fourth clinic will cross over after 40 weeks.  All clinics (clusters) will enroll for 12 months.
To ensure feasibility of this design, we will conduct a Vanguard phase that will include two clusters
who will enroll for a period of 8 months. As per the above, both clusters will being participant 
enrollment into the non-intervention arm (i.e. usual care with no social worker services).  At 10
weeks, one cluster will begin the intervention while the other cluster will continue enrolling in the 
non-intervention arm as per randomization. At 20 weeks the second cluster will cross over to begin 
treatment. Participant enrollment in both clusters will continue for 10 additional weeks. 
Data 
from the vanguard phase will be included in the trial, if there are no significant changes to the 
protocol.   
Figure one shows the trial design, which includes the vanguard phase (in purple) and then a batched 
stepped-wedge design (in green).  Batch timelines may also overlap each other, and the timing will 
depend upon funding and the readiness of different clusters to begin recruitment. The overall 
sample size for the trial will be approximately 2,000 participants.
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4.0 METHODOLOGY
4.1 Trial Setting
The Surgery Methods Centre in the Department of Surgery at McMaster University will coordinate 
this trial.  The Methods Centre will register this trial on ClinicalTrials.gov prior to initiating 
enrollment. The Principal Investigator will chair the trial’s Steering Committee, which will provide 
oversight and guidance for the trial.  Methods Centre personnel will obtain research ethics board 
approval for the trial. Research personnel at each selected cluster (the institution affiliated with 
each cluster) will obtain local Research Ethics Board approval prior to initiating local trial 
activities. Clusters will be selected at hospitals in the United States and Canada.
4.2 Cluster Eligibility and Selection of Clusters
Clusters will be defined by orthopaedic surgeon clinical practices and participating sites may 
contribute one or more clusters. Clusters will be selected in batches of four. Methods Centre
personnel will carefully screen potential clusters for eligibility. Cluster inclusion criteria are: 1) 
adequate research personnel infrastructure to manage the trial; 2) adequate surgically managed
fracture volume to complete enrollment within the timelines; and 3) ability to secure a qualified 
social worker to perform the trial intervention. The exclusion criteria are: 1) lack of interest in the 
trial; 2) anticipated challenges with complying with the protocol; 3) conflicting studies that would 
inhibit patient participation; and 4) budgeting or contract constraints.
The screening process will begin with potential clusters (orthopaedic surgeons’ clinics) completing 
a feasibility questionnaire that includes the cluster eligibility criteria. Clusters that meet the 
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eligibility criteria at this stage will be invited to participate in a meeting to review local logistics 
and to confirm interest and eligibility. Study personnel will document reasons for cluster
ineligibility. 
Of note, clusters (individual orthopaedic surgeons clinic days) within the same batch and across 
the batches may be at the same or different hospital and/or university.  
We will document key demographic information for each cluster.
4.3 Cluster Allocation and Concealment
The Methods Centre will randomize each batch of clusters prior to the start of patient recruitment 
to determine when they will begin the intervention. At the time of randomization, Methods Centre 
personnel will notify each cluster of the timing of their crossover from usual care to the treatment 
phase of the trial.  
4.4 Participant Eligibility Criteria
The screening population for this trial is patients 18 years of age or older with an injury to the 
appendicular skeleton which occurred in past 12 weeks and required surgical management who 
present to a participating fracture clinic. 
The inclusion criteria are:
1. Aged 18 or older.
2. Had a fracture of the appendicular skeleton.
3. Fracture required surgical management.
4. Fracture occurred within the past 12 weeks.
5. Willing to comply with the protocol.
The exclusion criteria are:
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.
4.5 Patient Screening and Informed Consent
A member of the circle of care will screen patients for broad eligibility and approach them to see 
if they are interested in participating in a research study. If they agree, research personnel will 
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confirm their eligibility.  After an initial screening process following local research ethic board
guidelines, eligible patients will engage in the informed consent process. To obtain informed 
consent, personnel at each cluster will adhere to the following procedures:
1. Present trial information in a manner that is understandable to the patient.
2. Discuss the trial with the patient and answer any questions they have.
3. Confirm that the patient understands the risks and benefits of participating in the trial and 
that their participation is voluntary.
4. Complete the consent process and obtain signatures from the patient and person obtaining
consent.
Site research personnel will follow the process of obtaining and documenting informed consent 
forms in accordance with Good Clinical Practice11. Participants may withdraw their consent at any 
time.
If a potentially ineligible participant is enrolled, at least one member of the Central Adjudication 
Committee will review de-identified medical records to determine eligibility.  The Central 
Adjudication Committee will be comprised of three members who are orthopaedic surgeons. Their
decision will be based on the information available at the time of informed consent.
4.6 Intervention
Research personnel at each cluster will inform individual participants of their treatment allocation 
after they have provided informed consent. Participants enrolled during the usual care phase at 
their clinic will attend appointments as usual on a schedule determined by their surgeon and will 
not have access to social worker support in the fracture clinic.
Participants enrolled during the treatment phase at their clinic will receive social work support (see 
Table 1) 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. During this time, the social worker will make detailed notes on communication and 
referrals provided.
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Table 1: Social Worker Support
1. Intake and Assessment: The social worker will complete a standardized intake assessment 
questionnaire that will ask the participant about their social needs. This will include asking about 
safety, intimate partner violence, addictions, housing and utilities, finances, food insecurity, mental 
health, transportation, and injury recovery.
2. Formulation of goals: Based on the intake and assessment, the social worker will work with 
the participant to identify goals the social worker can help the participant achieve. An example of
a goal is “plans for childcare during physiotherapy appointments”; “manage my stress and anxiety 
since the car accident”; “help to stop drinking”; “try to get off pain medications”; or “get a walker 
while on a fixed income”.
3. Treatment planning and intervention: The social worker will perform interventions according 
to the established goals. These can include management of patient expectations, advocacy for 
participant, coordination of care and benefits, referrals to community service partners, patient and 
family education, and emotional support and brief counselling.
4. Evaluation and Termination: The social worker will revisit the planned goals with the 
participant at each follow-up appointment, discuss progress, and provide additional treatments,
resources, and referrals.
4.7 Outcomes
The primary outcome measure is all cause visits to an emergency room or urgent care centre within 
six months of enrollment. (See Section 4.7.1).
Secondary outcome measures are:
1. LIMB-Q Psychological Impacts scale (See Section 4.7.2).
2. LIMB-Q Financial Impacts scale (See Section 4.7.2).
3. Satisfaction with care provided (See Section 4.7.3)
4. Opioid use (See Section 4.7.4).
5. Fracture clinic visits attended and missed (See Section 4.7.5)
6. Economic analysis (EQ-5D-5L and hospital use) (See Section 4.7.6)
7. Qualitative interviews with participants, social workers, and health care 
professionals (See Section 4.7.7).
4.7.1 Number of Emergency Room and Urgent Care Center Visits
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. Additionally, 
research personnel will review the participant’s medical records for emergency room and urgent 
care visits. We will document the date of any visits 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.
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4.7.2 LIMB-Q
The LIMB-Q12,13 is a validated questionnaire with 16 independently functioning scales designed 
specifically for patients with extremity injuries. This trial will use the LIMB-Q Psychological and 
Financial impact 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-5D14. This is a 
standardized instrument for use as a measure of health status that has been validated in similar
patient populations. It uses a descriptive system composed of 5 dimensions of health (mobility, 
self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension is comprised
of five levels: no problems, slight problems, moderate problems, severe problems and extreme 
problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 
dimensions. It is also a cognitively simple test, taking only a few minutes to complete but with the 
capacity of collecting health utility data. Research coordinators will administer the EQ-5D at 
baseline, 6 weeks, 3 months and 6 months after consent.
4.7.3 Satisfaction with Care Provided
At each follow-up, participants will be asked a single, Likert-scale question about their level of 
satisfaction with the care they have received for their fracture(s).
4.7.4 Opioid Use
We will assess the use of opioid medications at baseline, 6 weeks, 3 months and 6 months post-
consent.
4.7.5 Missed Fracture Clinic Visits
We will assess the proportion of missed clinic visits by tracking the number of fracture 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.
4.7.6 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), the cost of the social 
worker, and the hospital care costs. The EQ-5D is a widely-used, standardized instrument for 
measuring health-related quality of life, which has been validated for the proposed patient 
population14. The EQ-5D-5L allows the calculation of a health utility score, which is necessary to 
calculate quality-adjusted life years (QALYs). QALYs combine quantity of life with Health-
Related Quality of Life 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 in their medical record.
This data will be modeled within the economic analysis to compare the social worker intervention 
versus usual care.
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4.7.7 Lived Experiences of Orthopaedic Trauma Patients, Social Workers, and Health Care 
Professionals in Fracture Clinics
We will conduct qualitative interviews in alignment with the CORE-Q guidelines for qualitative 
research15. We have selected qualitative description as the theoretical basis the qualitative 
component of this trial.  Qualitative description is a low-interpretation method of analyzing
qualitative interviews that does not describe themes in terms of a conceptual, philosophical or other 
highly abstract framework or system16. We will also use this approach for the social worker and 
health care professional interviews.
We will conduct one-on-one interviews with 25-30 participants who have completed the trial. The 
interviews will be structured, with approximately 20 questions expected to allow for 30-45 minutes 
interview length. Interviews will take place over Zoom, telephone, or in-person, depending on the 
preference of the participant.  The interviews will be audio-recorded for transcription. Sampling 
for the interviews will be split equally between participants from the intervention and usual care
groups and will follow a maximum variation technique, in order to provide information from a 
broad range of perspectives16.
Separately, we will conduct interviews with each of the social workers and 10-12 interviews with 
health care professionals in the fracture clinics.  These interviews will follow the same process as 
the participant interviews. We will follow an informed consent procedure with social workers and 
health care professionals who participate in qualitative interviews to address the exploratory
objective.
4.8 Data Collection and Participant Follow-Up
4.8.1 Data Collection Procedures
After obtaining informed consent from a participant, research personnel will complete the baseline 
case report forms (CRFs). Baseline data will be obtained from the participant, the participant’s 
medical record, and/or the participant’s treating physicians and entered by the Research 
Coordinator. Baseline data collection points include participant and injury characteristics such as 
age, sex, gender, socioeconomic status, co-morbidities, mechanism of injury, among others. At 
baseline, participants will also complete the LIMB-Q scales, the satisfaction with care question, 
opioid use question, and the EQ-5D.
4.8.2 Participant Follow-Up
We will follow participants for 6 months after enrollment, as this aligns with the usual clinical 
follow-up timeline for orthopaedic injuries. Table 1 below indicates the timeline for baseline and 
follow-up completion of CRFs. Follow-up may be completed in-person at the fracture clinic, by 
telephone, by mail, or via secure electronic methods. Research personnel may also review the 
participant’s medical records for emergency room and urgent care visits. 
The social worker at each clinic will document the social work interactions by maintaining a log 
that documents each point of contact they have with each participant. This log will include the 
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medium of contact, themes discussed, and number of referrals made.  At each trial follow-up visit, 
we will ask participants if they saw a social worker outside of the fracture clinic and document any 
care referrals that they received.
Table 1: Follow-up Schedule
Enrollment and 
Baseline
6 Weeks
(Day 42)
(22 to 62
days post-
enrollment)
3 Months
(Day 90)
(63 to 117
days post-
enrollment)
6 Months
(Day 180)
(118 to 242
days post-
enrollment)
Demographics and 
comorbidities
X
Injury and treatment 
details
X
Social worker interactions
and referrals
Ongoing
Emergency room and 
urgent care visits
X
X
X
LIMB-Q Psychological 
Impacts Scale
X
X
X
X
LIMB-Q Financial 
Impacts Scale
X
X
X
X
Satisfaction with care 
question
X
X
X
X
Opioid use
X
X
X
X
Fracture clinic visit 
attendance
X
X
X
X
EQ-5D questionnaire 
X
X
X
X
Hospital use questions
X
X
X
X
4.9 Blinding
Due to the nature of the intervention, it will not be possible to blind participants, trial personnel, 
or clinicians to treatment allocation. Data analysts and investigators responsible for interpreting 
results will be blinded to treatment allocation until all data have been analyzed and interpreted.
5.0 SAMPLE SIZE
We chose our sample size to detect differences between the social worker intervention and usual 
care groups for all-cause visits to emergency room or urgent care centers (primary outcome). We 
estimated our sample size in accordance with the methodology of Kasza et al. using the R swdpwr 
package.17,18 For a binary outcome, the required cluster period size in a batched stepped wedge 
cluster randomized trial for a desired level of power depends on the number of time periods, 
number of clusters assigned to each sequence, number of sequences, number of batches, number 
of periods of overlap between successive batches, effect size, and ICC parameters. We will assume
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80% study power with a two-sided Type I error rate of 5%, either two, three, or four batches of 
four sequences over five time periods, one cluster allocated to each sequence, no period overlaps, 
a 10% prevalence rate in the treatment group, a 14.8% prevalence rate in the control group19, and 
a within-period intra-cluster correlation coefficient of 0.05. Based on these assumptions, we will 
require a total sample size of 1880 patients (cluster size of 47 patients per period) for two batches, 
1800 patients (cluster size of 30 patients per period) for three batches, and 1760 patients (cluster 
size of 22 patients per period) for four batches. (Table 2). To account for a 10% loss to follow-up 
rate, the total sample size, regardless of the batch size, will be rounded to 2000.
Table 2: Sample Size Calculations
Prevalence of Outcome in Treatment Group
8%
10%
12%
Two Batches
Intracluster 
Correlation 
Coefficient 
(ICC)
0.005
760
1680
5560
0.01
800
1760
5680
0.05
880
1880
5840
0.1
920
1920
5880
Three Batches
0.005
720
1620
5400
0.01
780
1680
5580
0.05
840
1800
5700
0.1
900
1860
5760
Four Batches
0.005
720
1600
5360
0.01
720
1680
5520
0.05
800
1760
5680
0.1
880
1760
5520
Note: α = 0.05, power = 80%, sampling structure = cross-sectional sample, sequences = 4, periods=5, number of 
periods of overlap between successive batches = 0, prevalence of outcome in control group = 14.8%
6.0 DATA ANALYSIS
We will prepare a detailed statistical analysis plan (SAP) prior to completion of the trial which 
will provide a detailed description of all planned statistical analyses. Sections 6.1 to 6.5 provide a 
brief overview of the planned statistical approach. 
6.1 Outcomes Analysis
The primary and secondary analyses will be conducted following intention-to-treat (ITT) 
principles, ensuring that participants are analyzed in their originally assigned treatment groups, 
regardless of adherence or protocol deviations. Reporting of the trial results will follow the 2010 
CONSORT statement and the extension statements for a batched, stepped-wedge cluster 
randomized trial.20
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For the primary analysis of time to any all-cause return visits to emergency room or urgent care 
centers, we will perform a Cox proportional hazards regression model, with treatment included as 
the independent variable, and cluster pre-specified variables prognostic of the outcome, such as 
pre-injury work status, included as covariates. Results will be presented as a hazard ratio and 
corresponding 95% confidence interval (CI) (Table 3).
Table 3: Primary Analysis Overview
Objective
Outcome
Hypothesis
Method of
Analysis
Name
Type
To determine if a
dedicated social
worker within the
fracture clinic setting
reduces all-cause
return visits to
emergency room or
urgent care centers
over 6 months
Any all-cause
visits to the
emergency
room or
urgent care
centers
Binary
Participants receiving
social work support will
have fewer return visits to
emergency room and
urgent care centers in the
6 months following
enrollment.
Cox proportional
hazards
regression model
For secondary analyses, we will follow mixed effects linear regression modelling for the LIMB-Q
and satisfaction with care to account for repeated measures, with treatment, time of assessment, 
and pre-specified variables prognostic of each outcome included as independent variables in fixed 
effects. Each model will also include a cluster indicator as the random intercept. These secondary 
outcomes will be summarized as adjusted mean differences between groups with corresponding 
95% CIs.
We will use logistic regression modeling for self-reported opioid use at 3 and 6 months using. Self-
reported opioid use will be included as the dependent variable and each model will include the 
treatment variable, cluster, and pre-specified variables prognostic of the outcome as independent 
variables. We will present results as adjusted odds ratios with corresponding 95% CIs. 
We will conduct a cost-effectiveness analysis from the payer’s (hospital) perspective incorporating
both participant utilities and direct healthcare costs and intervention costs. We will obtain health 
utilities from the EQ-5D.  Costs will include the cost of employing a social worker, as well as 
healthcare use costs, such as fracture clinic visits, emergency room visits, urgent care facilities,
and hospitalizations. We will compare these costs between the social worker intervention versus 
usual care groups using a cost-effectiveness analysis framework. The SAP will provide additional 
details on economic analysis plans.
We will also descriptively report the interactions made between the social worker and participants 
regarding the medium of contact, themes discussed, and the number and types of referrals made.
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Table 4: Secondary Analyses Overview
Objective
Outcome
Hypothesis
Method of
Analysis
Name
Type
To determine if a
dedicated social worker
within the fracture clinic
setting reduces negative
psychological impact
over 6 months
LIMB-Q
Psychological
scale
Continuous
Participants receiving
social work support will
have higher LIMB-Q
Psychological scores over
6 months compared to
participants receiving
usual care.
Mixed effects
linear regression
To determine if a
dedicated social worker
within the fracture clinic
setting reduces negative
financial impact over 6
months
LIMB-Q
Financial
Impacts scale
Continuous
Participants receiving
social work support will
have higher LIMB-Q
Financial Impacts scores
over 6 months compared
to participants receiving
usual care.
Mixed effects
linear regression
To determine if a
dedicated social worker
within the fracture clinic
setting increases patient
satisfaction with care
over 6 months
Satisfaction
with care
Continuous
Participants receiving
social work support will
have higher level of
satisfaction with their care
compared to participants
receiving usual care.
Mixed effects
linear regression
To determine if a
dedicated social worker
within the fracture clinic
setting reduces self-
reported opioid use at 3
and 6 months
Opioid use at
3 months and
6 months
Binary
Participants receiving
social work support will
have lower opioid use at 3
and 6 months compared to
participants receiving
usual care.
Logistic
regression
To determine if a
dedicated social worker
within the fracture clinic
setting reduces the
number of missed
fracture clinic visits
over 6 months
Missed clinic
visits
Continuous
Participants receiving
social work support will
have fewer missed visits
over 6 months compared
to participants receiving
usual care.
Negative
binomial model
To determine the cost-
effectiveness of having
a dedicated social
worker within the
fracture clinic setting
over 6 months
Cost-
effectiveness
analysis from
a payer’s
perspective
Continuous
Social work support will
result in higher utilities
and lower cost compared
to the usual care group
over 6 months
Economic
analysis
6.2 Sensitivity Analyses
We will conduct a sensitivity analysis to include only those participants who had at least one visit 
with a social worker. This analysis will follow the same analyses methods as described for the 
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primary outcome, including appropriate regression models and adjustments for stratification 
variables.
We will conduct a sensitivity analysis that varies definition of return to emergency room and urgent
care centre to include only visits that occurred at the same hospital/health system where the 
participant is receiving care for their fracture (e.g. participating cluster location). This analysis will 
follow the same methods listed for the primary outcome, including appropriate regression models 
and adjustments for stratification variables.
We will conduct a third sensitivity analysis that will also vary the definition of return to the 
emergency room and urgent care centre to include all visits. We will follow mixed effects linear 
regression modeling to account for repeated measures, with treatment, time of assessment, and 
pre-specified variables prognostic of each outcome included as independent variables in fixed 
effects. The model will also include a cluster indicator as the random intercept. The outcome will 
be summarized as an adjusted mean difference between groups with corresponding 95% CIs.
6.3 Subgroup Analyses
We plan to conduct subgroup analyses on gender and sex as potential factors influencing the 
effectiveness of the social worker intervention. Extensive literature spanning the past two decades 
suggests that patients tend to respond differently to offers of assistance and may perceive the 
experience of being helped differently depending on their gender identity. Unfortunately, 
definitions of sex and gender in older research are often used interchangeably. We hypothesize 
that individuals identifying as women and those assigned female at birth may demonstrate a 
heightened receptiveness to assistance and engagement through social worker services. Using the 
currently accepted definitions, we will evaluate subgroups of female vs. male and women vs. men. 
Non-binary gender identities will be included in the baseline survey and will be analyzed 
separately where numbers permit. Additionally, we plan to conduct subgroup analyses based on 
injury severity, pre-injury work status and opioid use at enrollment (Table 5). These analyses will 
be approached and reported in accordance with best practices and guidelines for subgroup 
analyses.21–25 For positive subgroup effects, we will use the criteria suggested by Schandelmaier 
et al. to guide inferences about the credibility of our subgroup analyses.25
Table 5: Subgroup Analyses Overview
Objective
Outcome
Hypothesis
Method of
Analysis
Name
Type
Females versus males
Return to
ER/Urgent
Care Centre
Binary
Female participants
receiving social work
support will have fewer
return visits to ER/urgent
care centres over 6
months compared to male
participants.
Cox proportional
hazards
regression model
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Objective
Outcome
Hypothesis
Method of
Analysis
Name
Type
Women versus men
Return to
ER/Urgent
Care Centre
Binary
Women receiving social
work support will have
fewer return visits to
ER/urgent care centres
over 6 months compared
to men.
Cox proportional
hazards
regression model
Injury severity score
(<9 versus ≥9)
Return to
ER/Urgent
Care Centre
Binary
Participants with a lower
injury severity score (<9)
receiving social work
support will have fewer
return visits to ER/urgent
care centres 6 months
compared to participants
with a higher injury
severity score (≥9).
Cox proportional
hazards
regression model
Employed pre-injury
versus unemployed
pre-injury
Return to
ER/Urgent
Care Centre
Binary
Employed participants
receiving social work
support will have fewer
return visits to ER/urgent
care centres over 6
months compared to
unemployed participants.
Cox proportional
hazards
regression model
Opioid use at baseline
versus no opioid use
Return to
ER/Urgent
Care Centre
Binary
Participants not using
opioids at baseline
receiving social work
support will have fewer
return visits to ER/urgent
care centres over 6
months compared to
participants using opioids
at baseline.
Cox proportional
hazards
regression model
6.4 Qualitative Analysis
After the interviews have been conducted and transcribed, three Methods Centre personnel will 
independently review the text of each interview several times, in a process of inductive coding.  
Each reviewer will use these statements to identify larger subthemes individually, without 
consulting each other. They will then compare subthemes and work together to create overall 
themes that describe the experience of recovery from orthopaedic trauma.  Researchers, including 
the interviewer, will, at some point during the research process, complete a written summary of 
their own experiences and context and situations that have influenced their experiences with 
respect to this research, making sure to cover all information required by the CORE-Q checklist.
Researchers will engage in member-checking as part of the coding process, which will include 
sending themes and codes to participants to validate these findings. A separate SAP will fully 
describe the analysis plans for the qualitative components.
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6.5 Interim Analysis Plan
Analyses will be conducted at the completion of the trial. There will be no planned interim efficacy 
or safety analyses. 
7.0 DATA MANAGEMENT
7.1 Case Report Forms and Data Transmission
The Methods Centre will provide the research personnel at each institution with the trial case report 
forms (CRFs) prior to initiation of enrollment. Research personnel will submit the required data, 
as detailed on the CRFs, to the Methods Centre using the REDCap Cloud electronic data capture 
system. Research personnel will receive a unique login and password for the REDCap Cloud 
system and will be able to view and modify data for participants at their cluster(s).46
7.2 Interview Management
Interview data will be transcribed, and original interview recordings will be stored per the records 
retention procedures outlined in section 7.4.  Transcriptions will be de-identified and labelled with 
participant number, then uploaded into Dedoose software (or a similar program) in a password 
protected project.  Only those identified as performing the qualitative analysis of the data will have 
access to the project area.  Some quantitative information will be included in the database such as 
age, gender, and treatment group, or in the case of health care professionals, position at the clinic.
7.3 Data Integrity
The Methods Centre data manager will program the EDC with multiple mechanisms for checking 
data at the time of entry including skip logic, range checks, and data type checks.26 Upon receipt 
of new data, Methods Centre personnel will query all missing, implausible, or inconsistent data. 
Research personnel will be able to review open queries in the system and will be required to
respond promptly.
7.4 Trial Monitoring
Methods Centre personnel will develop and implement a monitoring plan to guide trial monitoring 
activities. The purpose of monitoring will be to verify that: 1) The rights and wellbeing of research 
participants are protected. 2) The reported data are accurate, complete, and verifiable from source 
documents. 3) The trial is conducted according to the currently approved protocol and International 
Council for Harmonization Good Clinical Practice (ICH GCP)11.
7.5 Records Retention
The Methods Centre will retain trial data and essential documents for 15 years after completion of 
the trial, in accordance with institutional requirements. Participating clusters will retain records 
and documents pertaining to the conduct of this trial, including eCRFs, informed consent forms, 
and source documents for the length of time required by local institutional policy. After the records 
retention period, the documents may be destroyed, in accordance with local policies. 
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8.0 ETHICS AND DISSEMINATION
8.1 Research Ethics Approval
The McMaster University Methods Centre and all participating institutions will obtain ethics 
approval prior to commencing participant enrollment. The Methods Centre will ensure they have 
received a copy of the relevant ethics approval prior to each cluster’s commencement.
8.2 Confidentiality
All trial personnel will treat information about trial participants as confidential and will manage it 
in accordance with the below:
x
All trial-related information will be stored securely.
x
All information containing participant identifiers will be stored in locked file cabinets and 
accessible only to trial personnel.
x
All electronic CRFs will contain only a coded participant number.
x
All databases will be password-protected.
If a participant revokes authorization to collect or use personal health information, the Methods 
Centre retains the ability to use all information collected prior to the revocation of participant 
authorization. 
8.3 Protocol Amendments
Any amendments to the protocol which may affect the conduct of the trial or the potential safety 
of or benefits to participants (e.g., changes to the trial objectives, design, sample size, or 
procedures) will require a formal amendment to the protocol. Any protocol amendments will be 
approved by the Principal Investigators and will require approval by all applicable ethics 
committees. Participating clusters will also be required to submit amendment requests to their local 
ethics committee to obtain approval for the amendment and to provide the Methods Centre with a 
copy of this approval. 
8.4 Dissemination Policy
The results of this trial will be submitted for publication, regardless of the significance of the
findings. Every attempt will be made to ensure that the amount of time between completion of data 
collection and release of study findings is minimized. We will also share the results of the trial 
with the participants who wish to learn the results.
9.0 SAFETY 
9.1 Risks to Participants
As this trial provides support and services in addition to usual care, we do not anticipate any 
significant safety risks to participants. For patients receiving the social work intervention, 
discussing and addressing issues with a social worker may bring up challenging emotions, 
potentially leading to a transient increase in distress. For example, helping a participant to better 
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understand their injuries and the recovery process could initially create heightened anxiety as they 
cope with upsetting information regarding their prognosis. To mitigate this risk, the social worker 
will perform standard safety and emotional wellness assessments as part of their interaction with 
the patient. These assessments will provide an opportunity for early assistance with any increased 
anxieties that the participant may be experiencing.  Participants in the usual care arm will receive 
care according to current practices at each participating cluster, including accessing any social 
work services currently available locally. Consequently, they will not experience any increased 
risk due to their participation in the trial.   
9.2 Safety Monitoring
This trial will not require a Data Safety and Monitoring Committee (DSMC) as the intervention is 
low risk to trial participants, and major morbidity, mortality, or other severe outcomes are not 
expected or evaluated. This decision aligns with the Food and Drug Administration guidelines for 
involving a DSMC in an RCT27.
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10.0 REFERENCES
1. Injuries in Canada: Insights from the Canadian Community Health Survey. Accessed February 
2, 2024. https://www150.statcan.gc.ca/n1/pub/82-624-x/2011001/article/11506-eng.htm
2. 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;51(1):15-
22.
3. 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. 
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Orthop 
Trauma. 
2017;31(1):47-55.
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4. Stinner DJ, Mir HR. Patient Mental Health and Well-being: Its Impact on Orthopaedic Trauma 
Outcomes. J Orthop Trauma. 2022;36:S16. doi:10.1097/BOT.0000000000002450
5. Taylor P, Morin R, Kochhar R, et al. The Impact of Long-Term Unemployment: Lost Income, 
Lost Friends - and Loss of Self-Respect. Pew Research Centre; 2010:1-20.
6. 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;50(7):1353-1357. doi:10.1016/j.injury.2019.05.029
7. Howard R, Brown CS, Lai YL, et al. Postoperative Opioid Prescribing and New Persistent 
Opioid Use: The Risk of Excessive Prescribing. Ann Surg. 2023;277(6):e1225. 
doi:10.1097/SLA.0000000000005392
8. Rahman R, Wallam S, Zhang B, et al. Appropriate Opioid Use After Spine Surgery: 
Psychobehavioral 
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9. Government of Canada SC. Food insecurity among Canadian families. November 14, 2023. 
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28, 
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x/2023001/article/00013-eng.htm
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Sprague S, Fleming N, Gonsalves M, et al. Patient perspectives on the desirability of social 
worker support in outpatient orthopaedic trauma clinics. OTA Int. 2025;8(1):e375. 
doi:10.1097/OI9.0000000000000375
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice 
E6(R2). Published online 2016.
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Mundy LR, Klassen AF, Pusic AL, et al. The LIMB-Q: Reliability and Validity of a Novel 
Patient-Reported Outcome Measure for Lower Extremity Trauma Patients. Plast Reconstr Surg.
Published online January 15, 2024. doi:10.1097/PRS.0000000000011293
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Mundy LR, Klassen A, Grier J, et al. Development of a Patient-Reported Outcome 
Instrument for Patients With Severe Lower Extremity Trauma (LIMB-Q): Protocol for a 
Multiphase Mixed Methods Study. JMIR Res Protoc. 2019;8(10):e14397. doi:10.2196/14397
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Hung MC, Lu WS, Chen SS, Hou WH, Hsieh CL, Wang JD. Validation of the EQ-5D in 
Patients 
with 
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Limb 
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Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research 
(COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care.
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Sandelowski M. Whatever happened to qualitative description? Res Nurs Health.
2000;23(4):334-340. doi:10.1002/1098-240X(200008)23:4<334::AID-NUR9>3.0.CO;2-G
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17.
Kasza J, Bowden R, Hooper R, Forbes AB. The batched stepped wedge design: A design 
robust to delays in cluster recruitment. Stat Med. 2022;41(18):3627-3641.
18.
Chen J, Zhou X, Li F, Spiegelman. D. swdpwr: Power Calculation for Stepped Wedge 
Cluster Randomized Trials. Published online October 26, 2020:1.11. Accessed March 7, 2025. 
https://CRAN.R-project.org/package=swdpwr
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