Description

1. Significance Nearly 8 million athletes participate in high school sports nationally and over 1.2 million sustained knee injuries during a 6-year period. The knee is the most common site for a season- or career-ending injury, and 21% may require surgery. Examples of arthroscopically treated injuries include anterior cruciate ligament (ACL) ruptures, meniscus tears, and cartilage injuries. The incidence of surgical knee injuries in the pediatric population has increased dramatically. For instance, pediatric ACL tears tripled over the last decade. In fact, year-round soccer players can have a 19% risk of ACL injury over the course of a high school career. Knee injuries during youth have major implications on health, function, and quality of life.

Delayed treatment of surgical knee injuries in children and adolescents may have substantial, lifelong sequelae. For example, late surgery for combined ACL and meniscus injury results in at least 8 times higher risk of arthritis than acute surgery and a higher likelihood of total knee arthroplasty 18 years later. Prolonged time to ACL reconstruction also risks persistent joint instability, worse patient reported outcomes scores, lower likelihood of returning to previous activity levels, and reoperation. When considering isolated meniscus tears, surgery for a chronic injury is associated with 5-times higher risk of premature arthritis than early treatment. Delayed surgical fixation of pediatric tibial spine fractures is associated with a higher rate of meniscal pathology, longer procedure duration, and a higher risk of post-operative stiffness requiring reoperation. Such sequelae may have lifelong effects on young patients, making timely surgical care critical.

Specific populations experience delays in treatment of surgical knee injuries. Previous research shows that there are large, growing populations both nationally and locally that experience these delays as well as increased risk of concomitant meniscus pathology. In another study, 58% of patients whose families preferred a language other than English waited \>90 days for ACL reconstruction compared to 36% of those preferring English. Others have reported differences in peri-operative pain management for these children when undergoing arthroscopy and that they are negatively affected by the rising costs of high-level youth sports. However, the literature lacks research on the etiology of these problems or potential solutions.

Timely surgical care relies on prompt diagnosis and referral to a surgeon, but structural factors result in delays in timing of knee surgery. The conceptual framework for this study adapts domains from a previously published implementation framework to the clinical process leading to knee surgery. Several factors may the treatment of pediatric knee injuries and implementation strategies. These include insurance, neighborhood conditions, household income, and other markers. These findings suggest that specific populations are at disproportionate risk for the long-term sequelae of delayed surgery.

There is very limited patient-centered research on factors preventing timely pediatric sports medicine care or interventions to address them. There has been an increase in research on this topic in pediatric sports medicine, with nearly 70% of the current literature published between 2020 and 2022. However, none of it focuses on patient perspectives, implements interventions to improve timely treatment, or utilizes a community engaged approach to study surgical injuries. These wide gaps suggest a need for interventions to address difficulties obtaining care in pediatric sports medicine. Patient and community input are critical prerequisites, as interventions developed collaboratively with community members are more likely to succeed than those without constituent participation. Patient-centered data will elucidate factors affecting care, priorities, and knowledge to inform the design of acceptable, effective interventions.

The proposed research will implement clinical evidence on timely care of knee injuries by engaging communities and testing a community-based intervention. This work will lead to a future, larger trial of an intervention that has the potential to narrow the gaps in surgical treatment of knee injuries. The approaches utilized in this research will be useful in the future development of additional community interventions to increase access to evidence-based care in other populations and for orthopaedic pathologies other than knee injuries. 2. Approach 2.1 Aim 1: Identify factors preventing or facilitating timely care of knee injuries for high school athletes.

Overview of study design: To obtain detail on multilevel factors, the investigators will conduct semi-structured interviews with patients, their parents, local pediatricians, and coaches from soccer leagues. Aim 1 will provide data on the needs and expectations of community members for user-centered design of an intervention to reduce treatment delays. The investigators will also identify potential factors affecting implementation in order to design for dissemination and sustainability.

Preliminary data: Previous research shows that some patients are at increased risk of delayed ACLR as well as concomitant meniscus injury even when controlling for insurance. While the existence of these differences has been established, there is no patient- or community-centered data on the multilevel factors that lead to them.

Inclusion and exclusion criteria: Soccer players who were (1) in high school at the time of injury, (2) underwent arthroscopic surgery for an acute knee injury at LCH, and (3) whose caregivers prefer to speak Spanish will be eligible for this study. The population will be limited to high school soccer players, as this is the highest-risk age group for surgical knee injuries and soccer was by far the most common sport in which these patients were injured in previous research. Soccer is the highest-risk sport for knee injury for females and third highest for males. Patients that had surgery both within and beyond 90 days of injury will be included to identify factors preventing or facilitating timely care. Those treated prior to 2022 will be excluded to lower the risk of recall issues. The pediatricians of included patients will be eligible, as will their coaches from soccer leagues.

Participants and recruitment: Patients and families will be recruited via telephone or at outpatient clinic visits. The study team will recruit patients that had surgery within 90 days of injury and their parents, patients that had surgery \>90 days after injury and their parents, pediatricians, and coaches (n=60 to 80 total). Half of the included patients will be female. The investigators will conduct semi-structured interviews with each participant. Pediatrician input is crucial since they are deeply embedded in their communities and often the first medical professional seen by an injured child. Coaches, however, are frequently the first and only adult present when the injury occurs.

Data collection and procedures: The conceptual framework will inform the focus group interview guide, which will be pilot tested and refined prior to administration. The guide will include semi-structured questions that assess multilevel factors at each step of the pre-surgical timeline. The interviews will assess knowledge of surgical knee injuries, initial perceived injury severity, course of action after injury, perceived risks and benefits of surgery before and after treatment, structural factors affecting referral and surgical timing (insurance, language, location, financial considerations, navigating the healthcare system), and potential factors preventing or facilitating intervention implementation. Pediatricians will be asked about experiences with healthcare systems other than ours. All materials will be translated into Spanish. Interviews will be conducted in Spanish with the assistance of a bilingual facilitator. Demographic data will be collected at the end of the sessions and clinical data will be obtained from chart review. Interviews will be audio-recorded and last 1 hour.

Data analysis: Interviews will be digitally recorded and transcribed to ensure the accuracy of collected data. Transcripts will be analyzed using a mixed methods data analysis application (Dedoose). Categorical themes will be identified and applied to further transcripts. We will conduct a hybrid form of textual analysis which will combine inductive and deductive logics. Deductively, the analysts will apply the framework domains, and inductively, reviewers will identify codes directly from the data. The analytic strategy will allow unanticipated themes to be identified in the data and to allow participants' understandings to come to the fore.

Sample size and power: The purpose of this qualitative research is to generate hypotheses for explanations of an existing finding and provide a basis for future intervention design. 60-80 participants including athletes, families, pediatricians, and coaches will provide sufficient data for informational power.

2.2 Aim 2: Design an evidence-based intervention for athletes, families, and coaches to reduce delays in evaluation of acute knee injuries via user-centered principles.

Overview of study design: Data on multilevel factors preventing timely surgery from aim 1 will ascertain community needs and priorities to drive user-centered design (UCD) of an intervention optimized in acceptability, feasibility, and appropriateness. It will also identify potential factors affecting implementation in order to design for dissemination and sustainability. A community advisory board (CAB) of athletes, parents, coaches, and pediatricians will be integral to this process. Using the ADAPT-ITT model and data from aim 1, the investigators will adapt a previously published non-orthopaedic intervention to: (1) incorporate evidence on timely knee surgery into an educational program for athletes, families, and coaches; and (2) utilize a bilingual patient navigator to facilitate appointments with sports medicine specialists. This combination can address knowledge gaps regarding knee injuries, insurance issues, and language challenges while providing streamlined access between the sideline and specialists. However, the specific content of the intervention will depend on data from aim 1 and CAB input.

Community advisory board: The investigators will assemble a CAB consisting of three each of the following: high school soccer players (both boys and girls), parents of these athletes, local pediatricians, and soccer coaches. While this specific intervention will not directly target pediatricians, they will be a key part of the design process and implementation since they are embedded in communities and often provide the necessary referrals to specialists. The CAB will initially meet every 6-8 weeks for a total of 5 meetings. The CAB will be integral to intervention design and advise on recruitment and implementation strategies, data collection, and future research approaches.

Intervention design: The investigators will partner with the CAB to design an intervention utilizing the following UCD principles: a clear understanding of the user, incorporation of CAB feedback to define requirements and design, active involvement of the CAB to evaluate intervention design, integration of UCD with other development activities, and iterative design. We will employ iterative UCD to make logistical, operational, and other adaptations to optimize acceptability, feasibility, and appropriateness. Using the ADAPT-ITT model, the intervention will be adapted from a previously described non-orthopaedic program ("De Casa en Casa"), as no such literature exists in sports medicine. While the design will ultimately be based on data from aim 1 and CAB input, the investigators propose that it will consist of (1) an evidence-based educational program and (2) a bilingual patient navigator to target factors at multiple levels (similar components to "De Casa en Casa"). The tentative approach for the educational program will be a brief presentation to high school-aged soccer players, families, and coaches at the start of the season. This will incorporate evidence on identification of surgical knee injuries and the negative consequences of delayed treatment, with encouragement to contact the navigator for any concerns throughout the season. The navigator will have a dedicated phone number and email address and will facilitate appointments with the 6 sports medicine specialists at LCH, coordinate referrals with primary care clinicians when needed, track patients after initial contact and subsequent appointments at LCH, explain the diagnostic process to ensure completion, and connect patients with LCH social workers or financial services when necessary. The navigator will complete courses from an established patient navigator curriculum as well as clinical and research training with the principal investigator. They will participate in introductory meetings with LCH social workers and financial services to understand the role of these departments and establish relationships. The navigator will attend CAB meetings and meet with teams and families during the educational program.

Outcomes: At the conclusion, the investigators will have partnered with community members to adapt an evidence-based intervention for athletes, families, and coaches that provides education on knee injuries and streamlined access to sports medicine specialists via a bilingual navigator.

2.3 Aim 3: Evaluate feasibility, acceptability, and appropriateness of the intervention (aim 2) in a pilot study of youth soccer leagues.

Overview of study design: Teams from soccer leagues will be randomized to either participate in the intervention (aim 2) or only receive navigator information. Post-season surveys and focus groups will assess feasibility, acceptability, and appropriateness of the intervention as well as feedback for further iterative UCD. Data completeness will be tracked to assess study feasibility. Baseline and post-season surveys will compare athletes' attitudes and familiarity with surgical knee injuries and likeliness to seek care. The investigators will collect data on injuries and clinical care, but these are secondary outcomes for this pilot study.

Inclusion and exclusion criteria: Boys and girls soccer teams from the high school divisions of soccer leagues in the Chicagoland area will be eligible for the study. Teams that are younger and older than high school-age will be excluded, since this is the highest-risk age group for surgical knee injuries.

Participants and recruitment: Based on the preferences of the league leadership, teams will either be approached directly by the research team or by league personnel. Many of these leagues run year-round and include 6 to 20 high school-age teams with 7- and 11-player rosters. For this pilot study, the investigators will recruit at least eight high school-age teams (four boys and four girls teams) to include a total of at least 80 players. At the end of the season, players, coaches, and families who received the intervention will be approached to participate in focus groups to provide feedback for further iterative UCD. The study team will collect feedback from with 20 male players, 20 female players, 20 family members and 8 coaches (total of 10 focus groups with 6-8 participants in each).

Data collection and procedures: Teams will be randomized to either receive the intervention designed in aim 2 or only receive the patient navigator's contact information. Randomization will be performed via REDCap (Research Electronic Data Capture), allocated in a 1:1 ratio, and stratified by gender. Prior to the first game of the season, the study team will administer surveys on attitudes and familiarity with surgical knee injuries and likeliness to seek care to players, coaches, and families in both study arms. Players, coaches, and families randomized to the intervention arm will then participate in a brief evidence-based presentation on surgical knee injuries led by the bilingual navigator and be encouraged to contact the navigator with injury concerns throughout the season. The control group will receive the navigator's contact information without any direct engagement. Once the season begins, data will be collected on a weekly basis from coaches via REDCap with phone support and reminders by a research coordinator. This includes information about the previous week's activities (number/duration of games and practices), the number of players that participated, if any injuries occurred, and if/when medical care was sought. At the conclusion of the season, the preseason survey will be re-administered to all participants. Additionally, participants in the intervention arm will be surveyed regarding feasibility, acceptability, and appropriateness of the intervention. The investigators will then conduct focus groups with male and female players, families, and coaches from the intervention arm to obtain qualitative feedback on intervention acceptability and appropriateness. A Spanish facilitator will be present. These sessions will be audio-recorded and last approximately 1 hour. Using explanatory sequential design to integrate mixed methods, qualitative data will provide further explanation of quantitative findings to drive further UCD. Finally, all data will be reviewed with the CAB for further iterative optimization of intervention and study design.

Outcomes: The primary outcomes of interest are intervention feasibility, appropriateness, and acceptability, as measured by three brief, reliable, and valid tools: the Feasibility of Intervention Measure, Intervention Appropriateness Measure, and Acceptability of Intervention Measure (total of 12 items using a 5-point Likert scale). Study feasibility will be measured by weekly data completeness. The investigators will compare pre- and post-season survey responses to identify changes in attitudes and familiarity with surgical knee injuries or likeliness to seek care, and compare this data between study arms. Secondary outcomes, which will be the focus of a future, larger trial, include comparisons of frequency at which care is sought for knee injuries, time to initial medical evaluation, and time to knee surgery. Pilot data for these secondary outcomes will aid in planning a future trial.

Statistical analysis: The investigators will use descriptive statistics to summarize data completeness and participant retention. Feasibility, appropriateness, and acceptability will be compared between groups with independent samples t-tests or Mann Whitney U-tests, depending on normality of the distributions. Methods for analyzing correlated data will be used to compare attitudes and familiarity with surgical knee injuries and likeliness to seek care. The pilot data will be used to develop effect size estimates to power a future trial. Focus group recordings will be transcribed verbatim, deidentified, and analyzed using thematic analysis. We will use a blend of inductive and deductive coding. Two researchers will independently review all transcripts and differences in coding will be resolved by consensus. Dedoose, a mixed methods analysis program, will be used for analysis.

Sample size and power: As this is a pilot study to determine feasibility and acceptability, 8 teams/80 players and their families as well as at least 8 coaches will provide sufficient quantitative and qualitative data.

2.4 Summary \& Future Directions There is currently no literature on interventions to reduce factors that delay care in pediatric sports medicine. The current project will lead to a larger community-based, cluster trial of an evidence-based intervention. Information gathered during the current research will also start the process of designing interventions for pediatricians and other clinicians. There may be other factors uncovered by our qualitative work that are not addressed by the proposed initiative. These will be the targets of future interventions. Finally, the approaches used in this study will facilitate development of interventions to optimize care in other populations.