Improving Patient Outcomes for Shoulder Pain

Recruiting at 1 trial location

Overseen By Nikhil Verma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Minors, Over 80, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

400 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Who Is on the Research Team?

Nikhil Verma, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Pre- and post-operative discussion group Experimental Treatment 2 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 group Experimental Treatment 2 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 group Experimental Treatment 1 Intervention

Patients will only receive email reminders to complete their forms, if they haven't done so.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

Patient compliance with electronic patient-reported outcome measures (PROMs) following arthroscopic shoulder surgery was highest before surgery (91.1%) but significantly decreased over time, dropping to 51% by the 2-year follow-up.

Demographic factors such as age, sex, race, and ethnicity did not predict compliance rates, indicating that the decline in PROMs completion may be a broader issue affecting the utility of these measures in clinical practice.

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]

In a study of 1464 patients who underwent outpatient orthopedic surgery, 10% experienced adverse events (AEs) within 90 days, with surgical site infections being the most common at 3.3%.

Electronic health record triggers, such as antibiotic prescriptions and emergency department visits, showed high positive predictive values for detecting AEs, suggesting that these triggers could improve monitoring and quality of care in outpatient orthopedic surgery.

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]

In a study of 4063 shoulder arthroplasties, immediate postoperative radiographs identified complications in only 0.2% of cases, indicating that these images rarely provide useful diagnostic information for managing postoperative care.

Among the few complications detected, none led to a change in immediate postoperative management, suggesting that routine use of these radiographs may not be necessary and could be reconsidered in clinical practice.

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]

In a study of 3,807 surgical patients over 22 months, 30.9% experienced adverse events, with 6.9% of admissions linked to errors, highlighting a significant incidence of complications in surgical care.

Implementing continuous data collection on adverse events led to a reduction in error rates from 11.1% to 4.5%, demonstrating that systematic monitoring can enhance patient safety and quality of care.

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Discordance in TKA expectations between patients and surgeons. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

How effective is email communication for patients requiring elective surgery? [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

Higher preoperative expectations predict better outcomes in shoulder surgery patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Patient-Specific E-mailed Discharge Instructions Improve Patient Satisfaction and Patient Understanding After Surgical Arthroscopy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Compliance with Electronic Patient Reported Outcome Measure System Data Collection Is 51% Two-years After Shoulder Arthroscopy. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Electronic health record-based triggers to detect adverse events after outpatient orthopaedic surgery. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Serious adverse event rates and reoperation after arthroscopic shoulder surgery: population based cohort study. [2022]

8. England 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Routine immediate postoperative radiographs rarely identify unknown complications after shoulder arthroplasty. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Continuous monitoring of adverse events: influence on the quality of care and the incidence of errors in general surgery. [2022]