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?

This trial aims to identify the most effective ways to encourage people to complete forms tracking their shoulder surgery recovery. Participants will receive various reminders or incentives, such as email reminders, Amazon gift cards, or discussions with healthcare providers, to determine which method is most effective. The trial targets patients planning shoulder surgery for conditions like rotator cuff tears. Individuals scheduled for shoulder surgery who can complete forms in English may be suitable candidates. As an unphased trial, it offers participants the chance to contribute to enhancing post-surgery care and communication methods.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatments in this trial are generally safe. The incentive treatment, which involves giving small gift cards, carries no known health risks and simply rewards participants for completing forms.

Studies have demonstrated that discussions before and after surgery with a care provider help patients better understand their health outcomes. This type of communication is well-tolerated and has no reported negative effects.

Overall, these treatments aim to enhance patient involvement without posing direct health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores novel ways to improve patient outcomes for shoulder pain, beyond the typical focus on medications or surgeries. This trial investigates the impact of non-medical interventions, such as email reminders, incentives, and discussions with healthcare providers, on patient engagement and recovery. The use of incentives like Amazon gift cards is particularly innovative, as it aims to motivate patients to adhere to their treatment plans and complete necessary forms. Additionally, incorporating pre- and post-operative discussions offers a personalized approach, potentially enhancing patient understanding and satisfaction with their care. This trial could reveal how these strategies might improve recovery and overall patient experience compared to traditional methods.

What evidence suggests that this trial's treatments could be effective for improving patient-reported outcomes in shoulder pain?

Research has shown that offering rewards can effectively encourage patients to complete their forms. In this trial, participants in the incentivized group will receive up to $30 in Amazon gift cards if they complete their forms before surgery, as well as at 6 months and 1 year after surgery. This approach suggests that rewards might increase participation and help patients adhere to their treatment plans.

Conversely, studies have indicated that discussions with healthcare providers before and after surgery can positively impact outcomes. Participants in the pre- and post-operative discussion group will engage in these conversations, which often lead to better expectations and greater satisfaction. These discussions can result in improved recovery and reduced pain. Both methods aim to enhance patient involvement and improve overall treatment success. ^{2 6 7 8 9}

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 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]

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 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 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 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 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]

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 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 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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12279684/

Durable Shoulder Pain Relief and Avoidance of Surgery Up ...

Within this subset, 87% reported ongoing improvement in at least one domain at follow-up, including 71% who maintained ≥ 50% pain relief, and ...

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research.bond.edu.au

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The impact of a patient decision aid on intention to undergo ...

The main strength of this study is that we recruited a large sample of people with shoulder pain considering shoulder surgery that had similar or higher pain ...

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Online Information About the Effectiveness of Shoulder ...

Online Information About the Effectiveness of Shoulder Surgery Is Not Based on the Best Available Evidence: A Content Analysis.

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amazon.com

amazon.com/-/es/Shoulder-Surgery-Recovery-Record-Decompression/dp/B0CCCKW2SK

Shoulder Surgery Recovery Record: for Rotator Cuff, ...

This tracker provides an easy, supportive and structured way to track physical effects, pain, medications, issues and wound care, therapy, activities and meals ...

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sec.gov

sec.gov/Archives/edgar/data/1699350/000162828025035833/shoulderinnovation-sx1a2.htm

Shoulder Innovations

There is a significant body of clinical evidence that supports the safety, efficacy, and durability of our implants in shoulder arthroplasty, including our ...

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withpower.com

withpower.com/trial/phase-shoulder-pain-3-2019-e2e0a

Improving Patient Outcomes for Shoulder Pain

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 ...

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help.senate.gov

help.senate.gov/imo/media/doc/amazon_investigation.pdf

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As discussed in Section IV, Amazon manipulates its workplace safety data to make it appear as though its warehouses are safer than they are ...

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Prospectus

... data and four clinical studies and articles published in the Journal of Shoulder and Elbow Surgery demonstrating its significant impact on patient outcomes.

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Surprise Billing in Elective Shoulder Surgery and Its Effect ...

Patients who received surprise bills reported being significantly less satisfied with their surgery ( P <.001) and felt their billing experience affected ...