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

NCT04255199 | Completed

• 1 other identifier: 1534721
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adjusted rate of spinal imaging during 18-month follow-up

  Rate of lumbar spinal x-ray, CT, or MRI during follow-up period, adjusted for imaging rate during 12 month pre-randomization period

  18 months following date of first SPI visit

Secondary Outcomes (7)

• Adjusted rate of advanced spinal imaging during 18-month follow-up

  18 months following date of first SPI visit

• Adjusted rate of lumbar x-ray imaging during 18-month follow-up

  18 months following date of first SPI visit

• Use of watchful waiting communication techniques based on coded transcripts

  6 months post-intervention

• Physician self-reported use of watchful waiting techniques in post-intervention questionnaires

  6 months post-intervention

• Adjusted rate of neck imaging during 18-month follow-up

  18 months following date of first SPI visit

Study Arms (2)

Intervention

EXPERIMENTAL

Primary care and urgent care clinicians randomized to the intervention arm will receive two to three visits with a standardized patient instructor who will physicians how to facilitate patient acceptance of a watchful waiting strategy with regard to spinal imaging in the context of acute low back pain.

Behavioral: Intervention

Control

PLACEBO COMPARATOR

Primary care and urgent care clinicians randomized to the control arm will receive a single visit with a standardized patient who simulates a visit with patient with acute low back pain but will deliver no instruction on patient communication or other content.

Behavioral: Control

Interventions

Control BEHAVIORAL

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.

Control

Intervention BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• they intend to practice either at least 50% full-time equivalent (FTE) adult primary or urgent care in one of the target clinics for the trial duration
• they have been in active full-time or 50% FTE practice within the health system for at least two years prior to enrollment (to enable collection of baseline testing rates).
• Nurse practitioners and physicians assistants will be eligible if they practice in the capacity of a primary care or urgent care clinicians and meet the other requirement above.

You may not qualify if:

• None.

Sponsors & Collaborators

• University of California, Davis: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UC Davis Center for Healthcare Policy and Research

Sacramento, California, 95817, United States

Location

Related Publications (2)

• Fenton JJ, Jerant A, Franks P, Gosdin M, Fridman I, Cipri C, Weinberg G, Hudnut A, Tancredi DJ. Watchful waiting as a strategy to reduce low-value spinal imaging: study protocol for a randomized trial. Trials. 2021 Feb 27;22(1):167. doi: 10.1186/s13063-021-05106-x.

  PMID: 33639993 BACKGROUND

• Fenton JJ, Cipri C, Gosdin M, Tancredi DJ, Jerant A, Robinson CA, Xing G, Fridman I, Weinberg G, Hudnut A. Standardized Patient Communication and Low-Value Spinal Imaging: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2441826. doi: 10.1001/jamanetworkopen.2024.41826.

  PMID: 39504026 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Joshua J Fenton, MD, MPH

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: February 5, 2020
• Study Start: October 21, 2020
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)