Low Back PainNCT04255199
Watchful Waiting as a Strategy for Reducing Low-value Spinal Imaging
A study testing Intervention in people with Low Back Pain, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Center for Healthcare Policy and Research
Sacramento, California, 95817
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Control, Intervention
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
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.
InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months following date of first SPI visit
Secondary outcomes (7)
Adjusted rate of advanced spinal imaging during 18-month follow-up
Rate of lumbar CT or MRI during follow-up period, adjusted for imaging rate during 12 month pre-randomization period
Measured: 18 months following date of first SPI visit
Adjusted rate of lumbar x-ray imaging during 18-month follow-up
Rate of lumbar x-ray during follow-up period, adjusted for imaging rate during 12 month pre-randomization period
Measured: 18 months following date of first SPI visit
Use of watchful waiting communication techniques based on coded transcripts
Using transcripts of audio-recordings of a single post-intervention SP visit per randomized physician, investigators will identify physicians' use of communication techniques targeted by the intervention based on coding conducted by trained research assistants. Communication techniques will be identified based on a coding manual that will be developed by the investigators using transcripts of baseline standardized patient visits prior to instruction. The outcome will be a count of targeted communication techniques used during the follow-up visits. Investigators will report the relative rate of technique use adjusted for counts of techniques used during baseline standardized patient visits.
Measured: 6 months post-intervention
Physician self-reported use of watchful waiting techniques in post-intervention questionnaires
Study physicians will complete an on-line survey 6 months after final SPI visits and will report the frequency of use of watchful waiting techniques on Likert scales created by the investigators for this project.
Measured: 6 months post-intervention
Adjusted rate of neck imaging during 18-month follow-up
Rate of neck x-ray, CT, or MRI during follow-up period, adjusted for imaging rate during 12 month pre-randomization period
Measured: 18 months following date of first SPI visit
Adjusted rate of diagnostic test ordering during 18-month follow-up
Rate of diagnostic test ordering (laboratory, imaging, cardiac, gastrointestinal and vascular tests) during 18 month follow-up period, adjusted for diagnostic test ordering rate during 12 month pre-randomization period
Measured: 18 months following date of first SPI visit
Patient experience ratings during 18-month follow-up
Mean difference (vs. baseline period) in percent of patients rating clinicians either 9 or 10 on the Consumer Assessment of Healthcare Providers and Systems Overall Doctor Rating Scale
Measured: 18 months following date of first SPI visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start21 Oct 2020
- Primary completion30 Jun 2023
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Joshua J Fenton, MD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255199
- Sponsor's protocol ID
- 1534721
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2020
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data would be shared with other researchers if their research protocols were institutional review board approved, and our team had sufficient time and resources to generate the individual participant data for secure data transfer.
Publications
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.
PubMed 33639993Fenton 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.
PubMed 39504026
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watchful Waiting as a Strategy for Reducing Low-value Spinal Imaging
- ClinicalTrials.gov ID
- NCT04255199
- Acronym / sponsor ID
- 1534721
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionPrimary 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. |
| Control | Placebo comparator | Behavioral: ControlPrimary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlClinicians 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. | Behavioural | Control |
| InterventionClinicians 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. | Behavioural | Intervention |
Primary outcome
Adjusted rate of spinal imaging during 18-month follow-up
Time frame: 18 months following date of first SPI visit
Rate of lumbar spinal x-ray, CT, or MRI during follow-up period, adjusted for imaging rate during 12 month pre-randomization period
7 secondary outcomes
Adjusted rate of advanced spinal imaging during 18-month follow-up
Time frame: 18 months following date of first SPI visit
Adjusted rate of lumbar x-ray imaging during 18-month follow-up
Time frame: 18 months following date of first SPI visit
Use of watchful waiting communication techniques based on coded transcripts
Time frame: 6 months post-intervention
Physician self-reported use of watchful waiting techniques in post-intervention questionnaires
Time frame: 6 months post-intervention
Adjusted rate of neck imaging during 18-month follow-up
Time frame: 18 months following date of first SPI visit
Adjusted rate of diagnostic test ordering during 18-month follow-up
Time frame: 18 months following date of first SPI visit
Patient experience ratings during 18-month follow-up
Time frame: 18 months following date of first SPI visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 33639993Fenton 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.
- Results publication: PubMed 39504026Fenton 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.
- Individual participant dataSharing planned: No. Individual participant data would be shared with other researchers if their research protocols were institutional review board approved, and our team had sufficient time and resources to generate the individual participant data for secure data transfer.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua J Fenton, MD, MPH principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Low Back Pain, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adjusted rate of spinal imaging during 18-month follow-up (time frame: 18 months following date of first SPI visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04255199, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.