400 Participants Needed

Improving Patient Outcomes for Shoulder Pain

Recruiting at 1 trial location
PM
BM
CM
NV
Overseen ByNikhil Verma, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rush University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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?

Research shows that patient-specific emails after surgery can improve patient satisfaction and understanding of their procedure. Additionally, aligning patient and surgeon expectations before surgery can lead to better outcomes and increased satisfaction.12345

Is the treatment generally safe for humans?

The research articles focus on adverse events related to shoulder surgeries, but they do not provide specific safety data for treatments like email reminders or preoperative discussions. Therefore, there is no relevant safety information available for these treatments.678910

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.

Research Team

Nikhil Verma, MD - Rush University ...

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.

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
  • Incentive
  • Pre- and Post-operative discussion
  • pre-operative discussion
Trial Overview 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.
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

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+

American Orthopaedic Society for Sports Medicine

Collaborator

Trials
8
Recruited
2,100+

Findings from Research

In a study of 205 patients undergoing total knee arthroplasty (TKA), 37% had significantly higher postoperative expectations compared to their surgeons, which could affect satisfaction and outcomes.
Patients were more likely to have these discordantly high expectations if they completed their expectations survey before attending a preoperative educational class, suggesting that such classes could help align expectations and improve patient-surgeon communication.
Discordance in TKA expectations between patients and surgeons.Ghomrawi, HM., Mancuso, CA., Westrich, GH., et al.[2022]
In a study of 658 patients undergoing thyroid or parathyroid surgery, those who received information promoting email communication were significantly more likely to use email to contact their surgeon (16% vs. 3%).
Email communication was found to be an effective way for patients to raise questions and concerns prior to surgery, with most emails addressing single issues, suggesting it can enhance patient engagement and information exchange.
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.
Higher preoperative expectations predict better outcomes in shoulder surgery patients.Kaveeshwar, S., Stevens, KN., Ventimiglia, DJ., et al.[2023]

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]
10.United Statespubmed.ncbi.nlm.nih.gov
Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. [2022]
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