Clinical trial NCT04255199: Watchful Waiting as a Strategy for Reducing Low-value Spinal Imaging
Official title: Watchful Waiting as a Strategy for Reducing Low-value Spinal Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-02-05
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: Overutilization is increasingly viewed within the framework of patient safety. In primary care, patients with acute low back pain frequently request diagnostic imaging, and primary and urgent care 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) with potential downstream complications.

Watchful waiting advice has been found an effective strategy to reduce low-value treatment (e.g., pediatric ear infections), and some evidence suggests a watchful waiting approach would be acceptable to many patients requesting tests. Meanwhile, psychological theory suggests that physician messages could be tailored to magnify patient acceptance of a watchful waiting strategy.

The investigators will refine and evaluate a novel simulated intervention using standardized patients (SPs) -- or actors playing the roles of patients - to teach clinicians to endorse a watchful waiting approach when patients request low-value spinal imaging for low back pain. Specific aims are:

Aim 1: To use key informant interviews of front-line clinicians and focus groups with primary care patients to refine a theory-informed standardized patient-based intervention designed to teach practicing clinicians how to advise watchful waiting when patients request low-value spinal imaging for low back pain.

Aim 2: To test the effectiveness of standardized patient instructor (SPI)-delivered clinician training in the use of watchful waiting in a randomized clinical trial.

The investigators hypothesize that the intervention will: a) reduce rates of low-value spinal imaging among actual patients with acute back pain seen by clinicians post-intervention (adjusting for pre-trial rates); b) increase clinician advice to pursue watchful waiting during a followup visit with an unannounced SP; c) increase clinician self-reported use and efficacy of advising watchful waiting with actual low back pain patients; and d) have no adverse impact on actual patient trust and satisfaction with physicians; and e) reduce rates of neck imaging (among neck pain patients) and overall diagnostic testing (among all adult patients).

Aim 3: To assess whether the intervention effects generalize to other low-value imaging tests and diagnostic tests in general.

The investigators hypothesize that the SP intervention will: a) decrease rates of neck imaging among actual patients with neck pain seen by study clinicians during the follow-up period (adjusting for baseline rates); b) decrease rates of overall diagnostic tests among all adult patient seen by study clinicians during the follow-up period (adjusting for baseline rates); and c) increase PCP self-reported use and efficacy of advising watchful waiting for patients with neck pain, other musculoskeletal pain, and other non-musculoskeletal somatic complaints.

Eligibility criteria: Inclusion Criteria: Primary care and urgent care clinicians in the two health systems will be eligible if:

1. 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
2. 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).
3. 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.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Adjusted rate of spinal imaging during 18-month follow-up
timeFrame: 18 months following date of first SPI visit
Secondary outcomes:
measure: Adjusted rate of advanced spinal imaging during 18-month follow-up
timeFrame: 18 months following date of first SPI visit
measure: Adjusted rate of lumbar x-ray imaging during 18-month follow-up
timeFrame: 18 months following date of first SPI visit
measure: Use of watchful waiting communication techniques based on coded transcripts
timeFrame: 6 months post-intervention
measure: Physician self-reported use of watchful waiting techniques in post-intervention questionnaires
timeFrame: 6 months post-intervention
measure: Adjusted rate of neck imaging during 18-month follow-up
timeFrame: 18 months following date of first SPI visit
measure: Adjusted rate of diagnostic test ordering during 18-month follow-up
timeFrame: 18 months following date of first SPI visit
measure: Patient experience ratings during 18-month follow-up
timeFrame: 18 months following date of first SPI visit
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Center for Healthcare Policy and Research
state: California
Study officials:
affiliation: University of California, Davis
name: Joshua J Fenton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.