An interventional study of Patient educaiton materials - Print based and Patient educaiton materials - Media based in Anterior Cruciate Ligament Injury, Pain; Catheter (Other) and Satisfaction, Personal, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-05-04.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
The present study aims to compare caregiver satisfaction and efficacy between two modes of patient education materials (PEMs): media based and print based. The caregivers of patient's who undergo ACL (anterior cruciate ligament) reconstruction surgery and receive an On-Q Catheter pain block receive both a hand-out (print based PEM) and watch a short video (media-based PEM) describing how to care for their child's On-Q Catheter at home. Upon enrollment into the study, caregivers are randomly assigned to either first view the hand-out or the video, then complete a 10 questions standardized assessment of information that was presented in the PEMs. Caregivers are called the next day to assess caregiver satisfaction with the PEMs, which mode of PEM was more helpful to them, and how comfortable they felt managing their child's pain pump at home.
The present study aims to compare the efficacy and caregiver satisfaction between two modes of patient education materials (PEMs): media based and print based. The PEMs are designed to education caregivers on how to manage their child's On-Q catheter pain block at home. After caregivers have enrolled in the study and have been randomized to an education group, study interventions take place in the private family waiting room. Immediately after viewing their assigned PEM, the caregiver completes a 10 question standardized assessment, formatted as a multiple-choice quiz, of their understanding and knowledge of the information conveyed in both modes of PEM. The following day, caregivers are contacted by phone call to answer a number of questions to assess their satisfaction with the PEMs they received, the mode of PEM they preferred, and how comfortable they felt managing their child's pain pump at home.
All information is stored in a secure database (REDCap).
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
This study's enrollment of 178 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
Patients are randomly assigned to view print based educational material.
Behavioral: Patient educaiton materials - Print based
Patients are randomly assigned to view media based educational material.
Behavioral: Patient educaiton materials - Media based
Print (paper) based materials
Also known as: Print based
Media (electronic) based materials
Also known as: Media based
Patient satisfaction with Patient Education Materials (PEM).
Determine whether one of these forms, print-based PEMs or media-based PEMs, results in greater patient satisfaction versus the other.
Time frame: Twenty-four to 48 hours post-operatively
Plan to share: Undecided — undecided
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Nov 2020, 39 months.
Of 277 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's 39 months is above that.
Counting every sponsor, half of 286 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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