Unnecessary ProceduresNCT01808664
Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests
A study testing Standardized Patient Instructor Intervention in people with Unnecessary Procedures and Low Back Pain, run by University of California, Davis.
Trial summary
In this study, the investigators will develop and evaluate a novel intervention using standardized patients (SPs) -- or actors playing the roles of patients -- to enhance physicians' patient-centered counseling skills regarding two frequently overused, potentially inappropriate services in primary care: magnetic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Unnecessary Procedures, Low Back Pain, Osteoporosis
- What is being tested?
- Standardized Patient Instructor Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Resident physician in family medicine or internal medicine who deliver primary care at one of two hospital-based primary care clinics at the University of California, Davis Medical Center Sacramento
Who cannot join
- Anticipated graduation in less than one year from enrollment.
About this study
Official title: Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests: Randomized Clinical Trial
In this study, the investigators will develop and evaluate a novel intervention using standardized patients (SPs) -- or actors playing the roles of patients -- to enhance physicians' patient-centered counseling skills regarding two frequently overused, potentially inappropriate services in primary care: magnetic resonance imaging (MRI) for acute low back pain and bone densitometry in women at low-risk for osteoporosis. The investigators will further evaluate whether intervention effects on physician patient-centeredness generalize to counseling regarding other costly, unnecessary diagnostic tests.
- Conditions
- Unnecessary Procedures, Low Back Pain, Osteoporosis, Headache, Magnetic Resonance Imaging, Primary Care
- Being tested
- Standardized Patient Instructor Intervention, Control
- Medical subject headings
- Low Back Pain, Osteoporosis, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Patient Instructor InterventionBehavioural
In each case, patients will harbor underlying concerns about a serious underlying condition (e.g., either disc herniation or osteoporosis) and will request inappropriate tests. Standardized patient instructors (SPIs) will portray new patients visiting the clinic for the first time, and electronic medical records will be identical to that of actual new patients.
During the initial part of intervention visits, SPIs will assess the extent to which PCPs engage in patient-centered techniques specified in the final intervention model. SPIs will then break of their role and either teach or reinforce PCP use of the techniques, presenting techniques in a logical sequence while emphasizing flexibility in their use. SPIs will use scripts to deliver the interventions, providing opportunities for PCPs to ask questions, discuss concepts, and practice (by role playing) patient-centered techniques.
ControlBehavioural
In the latter half of visits with control PCPs, standardized patient instructors will share information with physicians regarding the acute low back pain self-care and bone health, but will not discuss patient-centered techniques or conduct training. The total duration of the control "information sharing" will be about one-third the SPI intervention to enhance patient-centeredness.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Patient Instructor Intervention | Experimental | Primary care physicians (PCPs) randomized to intervention will receive over a three month run-in period two visits by standardized patient instructors portraying: 1) a 48 year-old patient with low back pain for less than six-weeks and no "red flags" for immediate spinal imaging; and 2) a 50 year-old recently menopausal woman establishing care with concerns about osteoporosis risk. Receives: Behavioral: Standardized Patient Instructor Intervention |
| Control | Active comparator | In the latter half of visits with control PCPs, standardized patient instructors (SPIs) will share information regarding low back pain or bone health that are unrelated to diagnostic testing, but will not discuss patient-centered techniques or conduct training. The total duration of the control "information sharing" will be about one-third the SPI intervention to enhance patient-centeredness. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inappropriate diagnostic tests ordered
Investigators will assess via blinded, standardized chart review whether study physicians ordered inappropriate diagnostic tests for unannounced standardized patients who request testing during three follow-up visits occurring 3 to 9 months post-randomization.
Measured: 9 months
Secondary outcomes (2)
Use of patient-centered counseling techniques
Physician use of patient-centered counseling techniques as assessed via masked recordings of three standardized patient visits
Measured: 9 months
Actual diagnostic test ordering among real patients
Among real patients seen by study physicians, we will assess diagnostic test ordering among actual adult patients during the post-intervention period. We will also assess comparable diagnostic test ordering during the pre-intervention period to enable adjustment for baseline test ordering.
Measured: 9 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2014
- Study completionDec 2014
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 Unnecessary ProceduresStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua J Fenton, MD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808664
- Sponsor's protocol ID
- 364498
- Other IDs
- 364498-3
- Status last verified
- Feb 2020
- First submitted
- 20 Nov 2012
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
May L, Franks P, Jerant A, Fenton J. Watchful Waiting Strategy May Reduce Low-Value Diagnostic Testing. J Am Board Fam Med. 2016 Nov 12;29(6):710-717. doi: 10.3122/jabfm.2016.06.160056.
PubMed 28076254Fenton JJ, Kravitz RL, Jerant A, Paterniti DA, Bang H, Williams D, Epstein RM, Franks P. Promoting Patient-Centered Counseling to Reduce Use of Low-Value Diagnostic Tests: A Randomized Clinical Trial. JAMA Intern Med. 2016 Feb;176(2):191-7. doi: 10.1001/jamainternmed.2015.6840.
PubMed 26640973
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01808664
- Acronym / sponsor ID
- 364498
- Conditions
- Unnecessary Procedures, Low Back Pain, Osteoporosis, Headache, Magnetic Resonance Imaging, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Mar 2013 (estimated)
- 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.
In this study, the investigators will develop and evaluate a novel intervention using standardized patients (SPs) -- or actors playing the roles of patients -- to enhance physicians' patient-centered counseling skills regarding two frequently overused, potentially inappropriate services in primary care: magnetic resonance imaging (MRI) for acute low back pain and bone densitometry in women at low-risk for osteoporosis. The investigators will further evaluate whether intervention effects on physician patient-centeredness generalize to counseling regarding other costly, unnecessary diagnostic tests.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized Patient Instructor Intervention | Experimental | Behavioral: Standardized Patient Instructor InterventionPrimary care physicians (PCPs) randomized to intervention will receive over a three month run-in period two visits by standardized patient instructors portraying: 1) a 48 year-old patient with low back pain for less than six-weeks and no "red flags" for immediate spinal imaging; and 2) a 50 year-old recently menopausal woman establishing care with concerns about osteoporosis risk. |
| Control | Active comparator | Behavioral: ControlIn the latter half of visits with control PCPs, standardized patient instructors (SPIs) will share information regarding low back pain or bone health that are unrelated to diagnostic testing, but will not discuss patient-centered techniques or conduct training. The total duration of the control "information sharing" will be about one-third the SPI intervention to enhance patient-centeredness. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident physician in family medicine or internal medicine who deliver primary care at one of two hospital-based primary care clinics at the University of California, Davis Medical Center Sacramento
Key exclusion criteria (1 listed)
- Anticipated graduation in less than one year from enrollment.
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 |
|---|---|---|
| Standardized Patient Instructor InterventionIn each case, patients will harbor underlying concerns about a serious underlying condition (e.g., either disc herniation or osteoporosis) and will request inappropriate tests. Standardized patient instructors (SPIs) will portray new patients visiting the clinic for the first time, and electronic medical records will be identical to that of actual new patients. During the initial part of intervention visits, SPIs will assess the extent to which PCPs engage in patient-centered techniques specified in the final intervention model. SPIs will then break of their role and either teach or reinforce PCP use of the techniques, presenting techniques in a logical sequence while emphasizing flexibility in their use. SPIs will use scripts to deliver the interventions, providing opportunities for PCPs to ask questions, discuss concepts, and practice (by role playing) patient-centered techniques. | Behavioural | Standardized Patient Instructor Intervention |
| ControlIn the latter half of visits with control PCPs, standardized patient instructors will share information with physicians regarding the acute low back pain self-care and bone health, but will not discuss patient-centered techniques or conduct training. The total duration of the control "information sharing" will be about one-third the SPI intervention to enhance patient-centeredness. | Behavioural | Control |
Primary outcome
Number of inappropriate diagnostic tests ordered
Time frame: 9 months
Investigators will assess via blinded, standardized chart review whether study physicians ordered inappropriate diagnostic tests for unannounced standardized patients who request testing during three follow-up visits occurring 3 to 9 months post-randomization.
2 secondary outcomes
Use of patient-centered counseling techniques
Time frame: 9 months
Actual diagnostic test ordering among real patients
Time frame: 9 months post-intervention
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 26 Feb 2020.
- Background: PubMed 28076254May L, Franks P, Jerant A, Fenton J. Watchful Waiting Strategy May Reduce Low-Value Diagnostic Testing. J Am Board Fam Med. 2016 Nov 12;29(6):710-717. doi: 10.3122/jabfm.2016.06.160056.
- Results publication: PubMed 26640973Fenton JJ, Kravitz RL, Jerant A, Paterniti DA, Bang H, Williams D, Epstein RM, Franks P. Promoting Patient-Centered Counseling to Reduce Use of Low-Value Diagnostic Tests: A Randomized Clinical Trial. JAMA Intern Med. 2016 Feb;176(2):191-7. doi: 10.1001/jamainternmed.2015.6840.
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Recruiting
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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
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Patient Instructor Intervention in people with Unnecessary Procedures and Low Back Pain, run by University of California, Davis.
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 1 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Number of inappropriate diagnostic tests ordered (time frame: 9 months). 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 NCT01808664, 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 26 Feb 2020.