Improving Patient Outcomes for Shoulder Pain
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rush University Medical Center
Disqualifiers: Minors, Over 80, Non-English speakers, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Patient reported outcomes (PROs) are widely used by clinical providers as important tools to help inform their clinical and research practice, and to improve quality of care for patients. In this study, the investigators aim to investigate ways by which patient PRO completion rates may be improved.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment involving email reminders and preoperative discussions for improving patient outcomes for shoulder pain?
Is the treatment generally safe for humans?
Research Team
Nikhil Verma, MD
Principal Investigator
Rush University Medical Center
Eligibility Criteria
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.Inclusion Criteria
I am scheduled for shoulder surgery to treat a rotator cuff condition.
Exclusion Criteria
I am under 18 or over 80 years old.
Subjects lacking English proficiency to complete the PROs of interest.
I have no health issues that would prevent me from having surgery.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pre-operative
Participants receive email reminders and may receive incentives to complete PROs before surgery
4 weeks
1 visit (in-person)
Post-operative
Participants receive email reminders and may receive incentives to complete PROs at 6 months and 1 year after surgery
12 months
2 visits (in-person)
Follow-up
Participants are monitored for PRO compliance and outcomes 1 year post-surgery
4 weeks
Treatment Details
Interventions
- Email reminders (Behavioral Intervention)
- Incentive (Behavioral Intervention)
- Pre- and Post-operative discussion (Behavioral Intervention)
- pre-operative discussion (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Midwest Orthopedics at RUSHChicago, IL
Carla M. EdwardsEvanston, IL
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Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Trials
448
Patients Recruited
247,000+
American Orthopaedic Society for Sports Medicine
Collaborator
Trials
8
Patients Recruited
2,100+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Discordance in TKA expectations between patients and surgeons.Ghomrawi, HM., Mancuso, CA., Westrich, GH., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
How effective is email communication for patients requiring elective surgery?Ketteridge, G., Delbridge, H., Delbridge, L.[2018]
In a study of 216 shoulder surgery patients, higher preoperative expectations (PE) were linked to significantly better outcomes at the 2-year mark, including improvements in pain relief and shoulder function.
The research indicates that preoperative counseling to set realistic expectations can enhance patient satisfaction and overall recovery, making PE an important factor in surgical outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Higher preoperative expectations predict better outcomes in shoulder surgery patients.Kaveeshwar, S., Stevens, KN., Ventimiglia, DJ., et al.[2023]
Patients who received personalized e-mails after surgical arthroscopy reported significantly higher satisfaction levels and better understanding of their procedure compared to those who received standard printed instructions, with median satisfaction scores of 5 versus 4.
The e-mail cohort also found the instructions more helpful for their recovery and were more likely to recommend this method to others, indicating that personalized communication can enhance patient engagement and outcomes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Patient-Specific E-mailed Discharge Instructions Improve Patient Satisfaction and Patient Understanding After Surgical Arthroscopy.Santoro, AJ., Ford, EA., Pontes, M., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Compliance with Electronic Patient Reported Outcome Measure System Data Collection Is 51% Two-years After Shoulder Arthroscopy.Smith, MD., Madden, RN., Proffitt, MJ., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Electronic health record-based triggers to detect adverse events after outpatient orthopaedic surgery.Menendez, ME., Janssen, SJ., Ring, D.[2017]
In a study of 288,250 shoulder arthroscopic procedures, the overall rate of serious complications within 90 days was low at 1.2%, with pneumonia being the most common adverse event at 0.3%.
The rate of reoperation within one year was 3.8%, indicating that while serious adverse events are infrequent, there is still a notable risk of needing further surgery, particularly after certain procedures like frozen shoulder release.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study.Rees, JL., Craig, R., Nagra, N., et al.[2022]
In a study of 58,054 elective shoulder replacements over nearly 20 years, the lifetime risk of needing revision surgery varied significantly, with men aged 55-59 having a 23.6% risk, while women aged 85 and older had a 2.7% risk, highlighting the importance of age and sex in surgical outcomes.
The risk of serious adverse events within 90 days post-surgery was found to be 4.6%, with older age and male sex increasing the likelihood of complications, suggesting that patients should be thoroughly counseled about these risks before undergoing surgery.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England.Craig, RS., Lane, JCE., Carr, AJ., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Routine immediate postoperative radiographs rarely identify unknown complications after shoulder arthroplasty.Moses, AM., Guier, C., Wright, TW., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery.Rebasa, P., Mora, L., Luna, A., et al.[2022]
References
Discordance in TKA expectations between patients and surgeons. [2022]
How effective is email communication for patients requiring elective surgery? [2018]
Higher preoperative expectations predict better outcomes in shoulder surgery patients. [2023]
Patient-Specific E-mailed Discharge Instructions Improve Patient Satisfaction and Patient Understanding After Surgical Arthroscopy. [2022]
Compliance with Electronic Patient Reported Outcome Measure System Data Collection Is 51% Two-years After Shoulder Arthroscopy. [2023]
Electronic health record-based triggers to detect adverse events after outpatient orthopaedic surgery. [2017]
Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study. [2022]
Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England. [2023]
Routine immediate postoperative radiographs rarely identify unknown complications after shoulder arthroplasty. [2023]
Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. [2022]