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Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests

Primary Purpose

Unnecessary Procedures, Low Back Pain, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standardized Patient Instructor Intervention
Control
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Unnecessary Procedures

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Standardized Patient Instructor Intervention

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Use of patient-centered counseling techniques
    Physician use of patient-centered counseling techniques as assessed via masked recordings of three standardized patient visits
    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.

    Full Information

    First Posted
    November 20, 2012
    Last Updated
    February 24, 2020
    Sponsor
    University of California, Davis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01808664
    Brief Title
    Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests
    Official Title
    Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Davis

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unnecessary Procedures, Low Back Pain, Osteoporosis, Headache, Magnetic Resonance Imaging, Primary Care

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standardized Patient Instructor Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standardized Patient Instructor Intervention
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Control
    Intervention Description
    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 Measure Information:
    Title
    Number of inappropriate diagnostic tests ordered
    Description
    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.
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Use of patient-centered counseling techniques
    Description
    Physician use of patient-centered counseling techniques as assessed via masked recordings of three standardized patient visits
    Time Frame
    9 months
    Title
    Actual diagnostic test ordering among real patients
    Description
    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.
    Time Frame
    9 months post-intervention
    Other Pre-specified Outcome Measures:
    Title
    Standardized Patient Satisfaction
    Description
    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
    Time Frame
    9 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joshua J Fenton, MD, MPH
    Organizational Affiliation
    University of California, Davis
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28076254
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26640973
    Citation
    Fenton 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.
    Results Reference
    result

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