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Watchful Waiting as a Strategy for Reducing Low-value Spinal Imaging

NCT04255199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-12-10

No results posted yet for this study

Summary

The investigators will learn from the study whether actors playing the roles of patients (standardized patients) can help primary care and urgent care clinicians develop skill in offering watchful waiting to patients with acute low back pain as a means of averting low-value spinal imaging. Using patient and physician feedback, this study will refine and evaluate -- in a controlled experiment -- a simulated standardized patient intervention to enhance primary care physician use of watchful waiting when patients request low-value spinal imaging. The long-term goal of this study is to discover communication strategies primary care physicians can use to avert costly, potentially harmful testing while maintaining the patient-doctor relationship.

Conditions

  • Low Back Pain

Interventions

BEHAVIORAL

Control

Clinicians randomized to the control group will receive a single visit with a standardized patient instructor (SPI) scheduled during usual office hours. SPIs will portray a patients with acute back pain but will deliver no formative training or feedback to the primary care physicians randomized to the control arm.

BEHAVIORAL

Intervention

Clinicians randomized to the intervention group will receive 2-3 visits with a standardized patient instructor (SPI) scheduled during usual office hours over \~3 month period. For intervention physicians, SPIs will portray patients with acute back pain and will provide formative feedback to physicians and specific instruction in communication techniques to facilitate patient acceptance of a watchful waiting strategy with respect to spinal imaging. The specific communication techniques and sequence will be determined based on pre-trial literature review, patient focus groups, and interviews of primary care physicians who will not participate in the trial.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Joshua J Fenton, MD, MPH · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-21
Primary Completion
2023-06-30
Completion
2024-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04255199 on ClinicalTrials.gov