An interventional study of Educational program and patient navigator in Knee Injury, ACL Injury and Meniscus Tear, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Not yet recruiting at 1 site in United States. Open to participants aged 14 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Other
Hundreds of thousands of youth athletes require surgery for knee injuries annually. The incidence of operative knee injuries has skyrocketed, but surgery can be delayed due to late recognition and barriers, such as insurance, language, and difficulty navigating the healthcare system. Delays may have lifelong effects, including arthritis, persistent instability, poor patient reported outcomes, and reoperation. There is little patient-centered research on barriers to orthopaedic care, and none on interventions to reduce disparities in pediatric sports medicine. This study will focus on Hispanic children, a growing population nationally and 38% of the Chicago's children, who are at increased risk of delayed knee surgery and its sequelae compared to white, non-Hispanic patients. The overall objectives are to identify barriers to timely knee surgery in Hispanic athletes and develop an intervention to implement evidence on expedient treatment. The aim of this study is to evaluate feasibility, acceptability, and appropriateness of a culturally-tailored intervention in a pilot study of Hispanic youth soccer leagues. The proposed study will drive creation of a future community trial of a culturally-tailored intervention.
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. We 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. We will focus on soccer leagues because this was by far the most common sport in which patients were injured in our previous research.
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, we 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. We 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, we 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. We 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. We 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: We 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. Deductively, we will apply implementation framework domains, and inductively, we will identify codes directly from the data. 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, we expect that 8 teams/80 players and their families as well as at least 8 coaches will provide sufficient quantitative and qualitative data.
249 studies on the registry are indexed under Knee Injuries; 48 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 160 interventional studies indexed under Knee Injuries.
Browse Knee Injuries studies →Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-Players younger than 14 or older than 18 years of age
Players, coaches, and families randomized to the intervention arm will participate in a brief evidence-based presentation on surgical knee injuries led by a bilingual navigator and be encouraged to contact the navigator with injury concerns throughout the season.
Behavioral: Educational program and patient navigator
Players, coaches, and families randomized to the control arm will only receive the navigator's contact information.
Players, coaches, and families randomized to the intervention arm will participate in a brief evidence-based presentation on surgical knee injuries led by a bilingual navigator and be encouraged to contact the navigator with injury concerns throughout the season.
Feasibility of Intervention Measure, Intervention Appropriateness Measure, and Acceptability of Intervention Measure
The primary outcomes of interest are intervention feasibility, appropriateness, and acceptability, as measured by these three brief, reliable, and valid tools. They include a total of 12 items using a 5-point Likert scale).
Time frame: One soccer season
Plan to share: Undecided
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Ann & Robert H Lurie Children's Hospital of Chicago