Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests
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|ClinicalTrials.gov Identifier: NCT01808664|
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Unnecessary Procedures Low Back Pain Osteoporosis Headache Magnetic Resonance Imaging Primary Care||Behavioral: Standardized Patient Instructor Intervention Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests: Randomized Clinical Trial|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Standardized Patient Instructor Intervention
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.
Behavioral: Standardized Patient Instructor Intervention
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.
Active Comparator: Control
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.
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.
- 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.
- Use of patient-centered counseling techniques [ Time Frame: 9 months ]Physician use of patient-centered counseling techniques as assessed via masked recordings of three standardized patient visits
- Actual diagnostic test ordering among real patients [ Time Frame: 9 months post-intervention ]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.
- Standardized Patient Satisfaction [ Time Frame: 9 months ]Standardized patients will complete a measure of patient satisfaction based on the Consumer Assessment of Health Plans Survey (CAHPS) during each of three unannounced visits occuring during the follow-up period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808664
|Principal Investigator:||Joshua J Fenton, MD, MPH||University of California, Davis|