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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
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

Arm Intervention/treatment
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.
Behavioral: Control
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Anticipated graduation in less than one year from enrollment.

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Joshua J Fenton, MD, MPH University of California, Davis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01808664     History of Changes
Other Study ID Numbers: 364498
364498-3 ( Other Identifier: UC Davis )
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
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Osteoporosis
Back Pain
Low Back Pain
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases