Watchful waiting as a strategy to reduce low-value spinal imaging: study protocol for a randomized trial.

BACKGROUND: Patients with acute low back pain frequently request diagnostic imaging, and clinicians feel pressure to acquiesce to such requests to sustain patient trust and satisfaction. Spinal imaging in patients with acute low back pain poses risks from diagnostic evaluation of false-positive findings, patient labeling and anxiety, and unnecessary treatment (including spinal surgery). Watchful waiting advice has been an effective strategy to reduce some low-value treatments, and some evidence suggests a watchful waiting approach would be acceptable to many patients requesting diagnostic tests.
METHODS: We will use key informant interviews of clinicians and focus groups with primary care patients to refine a theory-informed standardized patient-based intervention designed to teach clinicians how to advise watchful waiting when patients request low-value spinal imaging for low back pain. We will test the effectiveness of the intervention in a randomized clinical trial. We will recruit 8-10 primary care and urgent care clinics (~ 55 clinicians) in Sacramento, CA; clinicians will be randomized 1:1 to intervention and control groups. Over a 3- to 6-month period, clinicians in the intervention group will receive 3 visits with standardized patient instructors (SPIs) portraying patients with acute back pain; SPIs will instruct clinicians in a three-step model emphasizing establishing trust, empathic communication, and negotiation of a watchful waiting approach. Control physicians will receive no intervention. The primary outcome is the post-intervention rate of spinal imaging among actual patients with acute back pain seen by the clinicians adjusted for rate of imaging during a baseline period. Secondary outcomes are use of targeted communication techniques during a follow-up visit with an SP, clinician self-reported use of watchful waiting with actual low back pain patients, post-intervention rates of diagnostic imaging for other musculoskeletal pain syndromes (to test for generalization of intervention effects beyond back pain), and patient trust and satisfaction with physicians. DISCUSSION: This trial will determine whether standardized patient instructors can help clinicians develop skill in negotiating a watchful waiting approach with patients with acute low back pain, thereby reducing rates of low-value spinal imaging. The trial will also examine the possibility that intervention effects generalize to other diagnostic tests. TRIAL REGISTRATION: ClinicalTrials.gov NCT04255199 . Registered on January 20, 2020.

RCT Entities:   Population Interventions Outcomes