TY - JOUR
T1 - Watchful waiting as a strategy to reduce low-value spinal imaging
T2 - study protocol for a randomized trial
AU - Fenton, Joshua J.
AU - Jerant, Anthony
AU - Franks, Peter
AU - Gosdin, Melissa
AU - Fridman, Ilona
AU - Cipri, Camille
AU - Weinberg, Gary
AU - Hudnut, Andrew
AU - Tancredi, Daniel J.
N1 - Funding Information:
None JJF is the principal investigator; he conceived the study, obtained funding, led the proposal and protocol development, and composed the manuscript. AF contributed to the study conception and design and assisted in manuscript preparation and revision. PF contributed to the study conception and design and assisted in manuscript preparation and revision. MG contributed to the acquisition and analysis of qualitative data and the development of the intervention and assisted in manuscript preparation and revision. IF contributed to the analysis of qualitative data and the development of the intervention and assisted in manuscript preparation. CC and GW contributed to the analysis of qualitative data and the development of the intervention and assisted in manuscript preparation. AH (site-PI for the Sutter Health System) contributed to the study conception and design and assisted in manuscript preparation and revision. DJT (the study statistician) contributed to the study conception and design and assisted in manuscript preparation and revision. All authors read and approved the final manuscript. The authors declare no competing interests. Funded by the Agency for Healthcare Quality and Research (R18HS026415). The funder had no role in the design of the study or the data collection and will have no role in the data analysis or interpretation or manuscript development and submission. The study authors will have access to the study data and materials. The authors will be willing to share the individual-level study data after completion and publication of primary and secondary analyses. No consent for publication is required. The study has been approved by the University of California, Davis Institutional Review Board (protocol #1466348-3). All participants will provide verbal assent upon receipt of the informed consent form.
Publisher Copyright:
© 2021, The Author(s).
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/12
Y1 - 2021/12
N2 - 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.govNCT 04255199. Registered on January 20, 2020
AB - 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.govNCT 04255199. Registered on January 20, 2020
KW - Back pain
KW - Computed tomography
KW - Diagnostic testing
KW - Magnetic resonance imaging
KW - Overuse
KW - Patient-doctor communication
KW - Primary care
KW - Randomized controlled trial
KW - X-rays/roentgenography
UR - http://www.scopus.com/inward/record.url?scp=85101826309&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85101826309&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05106-x
DO - 10.1186/s13063-021-05106-x
M3 - Article
C2 - 33639993
AN - SCOPUS:85101826309
VL - 22
JO - Trials
JF - Trials
SN - 1745-6215
IS - 1
M1 - 167
ER -