Completed

Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests: Randomized Clinical Trial

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What is being tested

Standardized Patient Instructor Intervention

+ Control

Behavioral
Who is being recruted

Back Pain+10

+ Bone Diseases

+ Bone Diseases, Metabolic

+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of California, Davis
Last updated: February 26, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01808664
Principal SponsorUniversity of California, Davis
Last updated: February 26, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

61 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainBone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesPainSigns and SymptomsPathological Conditions, Signs and SymptomsHeadacheOsteoporosisLow Back Pain

Criteria

1 inclusion criteria required to participate
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
1 exclusion criteria prevent from participating
Anticipated graduation in less than one year from enrollment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers