Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Headache; Osteoporosis; Magnetic Resonance Imaging; Primary Care; Unnecessary Procedures
• Intervention / Treatment: Behavioral: Standardized Patient Instructor Intervention; Behavioral: Control

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of patient-centered counseling techniques	Physician use of patient-centered counseling techniques as assessed via masked recordings of three standardized patient visits	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.	9 months post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Patient Satisfaction	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	9 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Back Pain; Low Back Pain; Headache; Osteoporosis
• Other Study ID Numbers: 364498; 364498-3 (Other Identifier: UC Davis)