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Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests

24 februari 2020 bijgewerkt door: University of California, Davis

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

Fase

Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Kind
Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Onderzoek naar gezondheidsdiensten
Toewijzing: Gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Dubbele

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: 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.	Gedragsmatig: 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.
Actieve vergelijker: 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.	Gedragsmatig: 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.

Deelnemersgroep / Arm

Interventie / Behandeling

Experimenteel: 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.

Gedragsmatig: 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.

Actieve vergelijker: 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.

Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Number of inappropriate diagnostic tests ordered Tijdsspanne: 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.	9 months

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Use of patient-centered counseling techniques Tijdsspanne: 9 months	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 Tijdsspanne: 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.	9 months post-intervention

Andere uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Standardized Patient Satisfaction Tijdsspanne: 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	9 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, Davis

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2013

Primaire voltooiing (Werkelijk)

1 september 2014

Studie voltooiing (Werkelijk)

1 december 2014

Studieregistratiedata

Eerst ingediend

20 november 2012

Eerst ingediend dat voldeed aan de QC-criteria

7 maart 2013

Eerst geplaatst (Schatting)

11 maart 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 februari 2020

Laatste update ingediend die voldeed aan QC-criteria

24 februari 2020

Laatst geverifieerd

1 februari 2020

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

364498
364498-3 (Andere identificatie: UC Davis)

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Promoting Patient-Centered Counseling to Reduce Inappropriate Diagnostic Tests