Image Reviews for Patient Satisfaction After Spine Procedures

Overseen By Michele Cordero

Age: Any Age

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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to explore the impact of spine physicians reviewing post-procedural fluoroscopic images with patients. The outcome measure to be assessed will be the potential impact the patient satisfaction and the patient's global impression of change (PGIC) 2 weeks after the spine procedure.

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 Reviewing Imaging with Participant, Post-procedure Image Review, Patient Imaging Review for patient satisfaction after spine procedures?

Research shows that reviewing radiographic images with patients can improve their understanding and satisfaction during medical consultations. Improved communication and patient education, especially regarding radiological studies, can help address misconceptions and enhance patient satisfaction, which is crucial for better outcomes. ^{1 2 3 4 5}

Is reviewing imaging with patients after spine procedures safe?

The research does not provide specific safety data for reviewing imaging with patients after spine procedures, but it suggests that including additional information in imaging reports can positively impact patient perceptions, which may indirectly support safety by improving patient understanding and satisfaction. ^{2 6 7 8 9}

How does this treatment differ from other treatments for spine procedures?

This treatment is unique because it involves reviewing radiographic images with patients to enhance their understanding and satisfaction after spine procedures, which is not a standard practice in traditional treatments. This approach focuses on improving patient education and satisfaction by directly involving them in the review of their own medical images. ^{1 2 3 4 10}

Research Team

David Kohns, DO

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Reviewing radiographic images with patients: results of a trial on patient preferences, understanding, and satisfaction. [2016]

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

Patient misconceptions concerning lumbar spondylosis diagnosis and treatment. [2015]

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

Early Postoperative Radiographs Have No Effect on Orthopaedic Trauma Patient's Satisfaction With Their Clinic Visit. [2020]

4. United States 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. [2019]

5. Italy pubmed.ncbi.nlm.nih.gov

Saudi patients' preferred modes of receiving radio imaging reports from radiologists, their impact, and determinants - a survey. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

An online investigation into the impact of adding epidemiological information to imaging reports for low back pain. [2021]

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

Mitigating adverse event reporting bias in spine surgery. [2017]

8. England 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. [2022]

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

Lumbar spondylolisthesis: modern registries and the development of artificial intelligence. [2019]

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

Fulfillment of Patient Expectations After Spine Surgery is Critical to Patient Satisfaction: A Cohort Study of Spine Surgery Patients. [2023]