Image Reviews for Patient Satisfaction After Spine Procedures

Overseen By Michele Cordero

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Sedation, Non-English speakers

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether discussing post-procedure images with patients affects their satisfaction and perception after a spine procedure. Participants will be divided into two groups: one group will review their images, while the other will not. Those with ongoing back pain due to nerve issues (lumbosacral radiculopathy) who have received a specific injection for pain relief might be suitable candidates. The trial aims to determine if showing patients their images enhances their perception of care two weeks later. As an unphased trial, participants can contribute to understanding patient care and satisfaction, potentially improving future treatment experiences.

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 prior data suggests that reviewing imaging with participants is safe?

Research has shown that reviewing X-ray images with patients after spine procedures is generally safe. In similar procedures, studies have found that examining these images does not introduce new risks. For example, one study on spinal injections guided by images found that reviewing the images confirmed the treatment's accuracy and did not cause additional problems. Another study on discussing images post-procedure showed increased patient satisfaction without a rise in complications.

Reviewing images primarily helps patients understand their treatment better and feel more satisfied. Since there is no exposure to new treatments or drugs, safety concerns are much lower compared to other clinical trials. Overall, discussing images after the procedure has been well-received by patients, with no reported safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how discussing imaging results with patients after spine procedures might boost patient satisfaction. Unlike standard care, which often involves little to no explanation of post-procedural images, this approach aims to engage patients directly in understanding their treatment. By involving patients in the review of their own images, the trial could lead to increased patient empowerment and satisfaction, potentially setting a new standard for patient interaction in spine care.

What evidence suggests that reviewing imaging with participants is effective for improving patient satisfaction after spine procedures?

Research has shown that reviewing X-ray images with patients after spine procedures can boost their satisfaction and understanding. In this trial, participants in one arm will discuss their post-procedural images, helping them feel more informed about their procedure. While this approach doesn't directly reduce pain, it enhances the overall patient experience. This method is unique because it focuses on improving patients' perceptions of their treatment. Although it might not alter physical outcomes, it can increase patients' sense of being informed and satisfied. ^{5 6 7 8 9}

Who Is on the Research Team?

David Kohns, DO

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with lumbosacral radiculopathy symptoms who have received a transforaminal epidural steroid injection. It's designed to see if showing patients their post-procedure images affects how satisfied they feel and their overall impression of the treatment's change.

Inclusion Criteria

I have received a steroid injection in my spine.

I have pain that extends from my lower back down through my leg.

Exclusion Criteria

Patients who are unable to read or understand English-language survey

I will be sedated for a spine injection to reduce pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo a lumbar epidural steroid injection under fluoroscopic guidance

1 day

1 visit (in-person)

Post-procedure Review

Surgeons discuss post-procedural fluoroscopic images with participants

Up to 2 hours following procedure

1 visit (in-person)

Follow-up

Participants' satisfaction and global impression of change are assessed

2 weeks

1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Reviewing Imaging with Participant

Trial Overview

The study is testing whether reviewing fluoroscopic images (a type of X-ray) with patients after spine procedures can improve patient satisfaction and perception of improvement, measured two weeks following the procedure.

How Is the Trial Designed?

Group I: Post-Procedural Images Discussed with Participants Experimental Treatment 1 Intervention

During a lumbar epidural steroid injection under fluoroscopic guidance, images are taken as part of the procedure. Following the procedure, the surgeon who performed it will discuss the images with the participants in this arm.

Group II: Post-Procedural Images Not Discussed with Participants Active Control 1 Intervention

During a lumbar epidural steroid injection under fluoroscopic guidance, images are taken as part of the procedure. Following the procedure, the surgeon who performed it will not discuss the images with the participants in this arm. If participants request an explanation of the images, they will not be included in the analysis.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a study involving 1055 reported adverse events from a clinical trial on spinal surgery, an independent Clinical Events Committee (CEC) reclassified 37.3% of these events, primarily upgrading their severity or relatedness to the surgery or device.

The CEC was significantly more likely to upgrade adverse events than downgrade them, indicating that their involvement can help reduce investigator bias and improve the accuracy of safety assessments in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitigating adverse event reporting bias in spine surgery. Auerbach, JD., McGowan, KB., Halevi, M., et al.[2017]

Patients who viewed their own radiographic images during counseling reported higher satisfaction, although the difference was not statistically significant compared to those who viewed a diagram.

Almost all patients understood the images and felt that viewing them improved their understanding of their condition, with female patients showing a greater preference for being shown their images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reviewing radiographic images with patients: results of a trial on patient preferences, understanding, and satisfaction. Nasser, FS., Ritsema, DF., Cheney, S., et al.[2016]

Clinical registries can provide valuable evidence for treatment options in neurosurgery, particularly for conditions like lumbar spondylolisthesis, where traditional randomized controlled trials may not be feasible.

The integration of patient-reported outcomes and advanced data collection methods, including artificial intelligence, can enhance the quality of spine care by enabling personalized treatment approaches based on robust clinical data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar spondylolisthesis: modern registries and the development of artificial intelligence. Ghogawala, Z., Dunbar, MR., Essa, I.[2019]

A survey of 377 patients in Saudi Arabia revealed that a significant number (37.4%) preferred to receive their imaging reports on the same day, with a stronger desire for same-day communication for abnormal results compared to normal ones.

The study found that 68.7% of patients preferred to discuss their reports with their physician, especially for abnormal findings, highlighting the importance of timely communication in improving mental health, particularly among female patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saudi patients' preferred modes of receiving radio imaging reports from radiologists, their impact, and determinants - a survey. Alduraibi, AK., Alduraibi, SK., Alghofaily, KA., et al.[2023]

In a study of patients undergoing elective spine surgery, 58% reported being extremely satisfied, with satisfaction closely linked to the fulfillment of preoperative expectations and improvements in disability and pain.

Higher preoperative expectations significantly correlated with greater satisfaction post-surgery, suggesting that managing patient expectations could enhance overall satisfaction with surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fulfillment of Patient Expectations After Spine Surgery is Critical to Patient Satisfaction: A Cohort Study of Spine Surgery Patients. Rampersaud, YR., Canizares, M., Perruccio, AV., et al.[2023]

A study of 121 patients referred to a neurosurgery clinic revealed that over 50% believed they would need surgery based solely on MRI findings, indicating a significant misunderstanding of the role of imaging in diagnosing lumbar spondylosis.

Many patients also incorrectly perceived that surgery was more effective than physical therapy for back pain, and 17% thought that injections were riskier than surgery, highlighting the need for better patient education to align expectations with actual treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient misconceptions concerning lumbar spondylosis diagnosis and treatment. Franz, EW., Bentley, JN., Yee, PP., et al.[2015]

A study involving 100 patients after acute fracture fixation found that not performing routine early postoperative radiographs did not negatively impact overall patient satisfaction with their clinic visit.

While eliminating these radiographs did not affect overall satisfaction, patients who received radiographs reported higher satisfaction with the surgeon's explanations about their injury, suggesting the need for alternative educational tools to maintain understanding without unnecessary imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Postoperative Radiographs Have No Effect on Orthopaedic Trauma Patient's Satisfaction With Their Clinic Visit. Schultz, BJ., Bishop, JA., Hall, K., et al.[2020]

Inserting epidemiological information into lumbar spine imaging reports did not significantly change the rates of nonsurgical or surgical procedures for patients, based on a study involving 238,886 patients across multiple healthcare systems.

The study found no impact on the utilization of specific spine procedures, indicating that providing additional context in imaging reports may not influence treatment decisions for low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial. Suri, P., Meier, EN., Gold, LS., et al.[2022]

A study of 17,853 patients who underwent spinal procedures found that factors like the type of surgery and length of stay significantly influenced participation in patient satisfaction surveys, with fusion procedures leading to higher participation rates.

No specific factors were identified that could predict perfect satisfaction scores on the Press Ganey surveys, indicating that aspects like comorbidity and time since surgery negatively impacted patient satisfaction, while surgeon skill did not play a significant role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of patient satisfaction and survey participation after spine surgery: a retrospective review of 17,853 consecutive spinal patients from a single academic institution. Part 1: Press Ganey. Hopkins, BS., Patel, MR., Yamaguchi, JT., et al.[2019]

In a study involving 247 participants, adding epidemiological information to standard lumbar imaging reports led to more positive perceptions about back-related issues, suggesting it could help reduce anxiety about imaging findings.

This approach may improve patient outcomes by providing reassurance, especially since many imaging findings are normal age-related changes rather than indicators of serious problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online investigation into the impact of adding epidemiological information to imaging reports for low back pain. Medalian, Y., Moseley, GL., Karran, EL.[2021]

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