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Improving Patient Outcomes for Shoulder Pain
N/A
Recruiting
Led By Nikhil Verma, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in pro compliance rate between pre-surgery and 1-year post surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at ways to improve how often patients fill out forms about their health (PRO forms).
Who is the study for?
This trial is for adults under 80 who are fluent in English and scheduled for shoulder surgery to treat rotator cuff conditions. It's not suitable for minors, those over 80, or patients with medical histories that prevent safe surgery.
What is being tested?
The study explores ways to improve patient completion rates of self-reported outcome surveys. Interventions include email reminders, discussions before and after surgery, and incentives for completing the surveys.
What are the potential side effects?
Since this trial focuses on survey completion rather than medication or invasive procedures, there are no direct side effects related to traditional clinical interventions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in pro compliance rate between pre-surgery and 1-year post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in pro compliance rate between pre-surgery and 1-year post surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Does patient engagement, through education or monetary incentivization, increase PRO compliance rate at 1 year after surgery, when compared to PRO compliance rate before surgery?
Secondary study objectives
Effects of English proficiency on PRO compliance rate.
Effects of age on PRO compliance rate.
Effects of technological literacy on PRO compliance rate.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Pre- and post-operative discussion groupExperimental Treatment2 Interventions
Patients will discuss with their care provider their health outcomes before and at 6-months after their surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.
Group II: Incentivised groupExperimental Treatment2 Interventions
Patients will receive up to $30 in amazon gift cards as an incentive if they complete their forms before surgery, as well as at 6-months and 1-year after surgery. In addition, patients will receive email reminders to complete their forms, if they haven't done so.
Group III: Control groupExperimental Treatment1 Intervention
Patients will only receive email reminders to complete their forms, if they haven't done so.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Incentive
2008
Completed Phase 3
~67070
Find a Location
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
248,852 Total Patients Enrolled
1 Trials studying Shoulder Pain
American Orthopaedic Society for Sports MedicineOTHER
6 Previous Clinical Trials
857 Total Patients Enrolled
Nikhil Verma, MDPrincipal InvestigatorRush University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 or over 80 years old.I am scheduled for shoulder surgery to treat a rotator cuff condition.I have no health issues that would prevent me from having surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Control group
- Group 2: Incentivised group
- Group 3: Pre- and post-operative discussion group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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