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Clinical Trials/NCT03766841
NCT03766841CompletedNot Applicable

Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research

Medical College of Wisconsin1 site in 1 country301 target enrollmentStarted: April 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
301
Locations
1
Primary Endpoint
Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.

Study Overview

Brief Summary

To assess whether the routine collection of patient-contextual data improves patient activation and communication, and can mitigate racial disparities in communication and engagement, we are inviting patients who have upcoming appointments at the participating health system to participate in a communication study. Patients will be randomized to having guided (facilitated) enrollment in a tool that collects patient contextual data, or to usual care. All patients are invited directly by the health system to use the tool. Statistical methods will be used to determine the impact of the tool's use on outcomes of interest, as well as the impact on completion by the use of the facilitated enrollment. The study will particularly focus on assessing the impact of patient-contextual data and communication on heath disparities.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •aged 18 or older
  • •able to speak and understand English,
  • •a patient at a selected Froedtert & Medical College of Wisconson primary care or internal medicine clinic (i.e., General Internal Medicine On Campus of Milwaukee Regional Medical Center, Sargeant Health Center, or Tosa Health Center (Plank Road Clinic) with an upcoming (> 4 weeks away) appointment and at least 1 previous appointment with the same provider in the previous 12 months.
  • •Patients with cognitive impairment (e.g. dementia) are eligible to participate through the use of proxies who would ordinarily accompany them to appointments and complete forms or post-visit surveys on their behalf.

Exclusion Criteria

  • •Minors and non-English speaking patients are not eligible to participate

Arms & Interventions

Facilitated Enrollment

Experimental

Patients will be aided in the account creation and usage of a consumer informatics tool to collect and report patient-contextual data within the electronic health record

Intervention: Facilitated Enrollment (Behavioral)

Usual Care

No Intervention

Patients will be invited to use the patient contextual data tool as per usual care, but will not receive additional assistance in account creation and usage.

Outcomes

Primary Outcomes

Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.

Time Frame: Post Visit ( 1 week)

Use of Communication Assessment Tool (CAT), a 14-item instrument that reports patient-views of clinician communication Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007;67: 333-342.

Secondary Outcomes

  • Change in the composite score of the patient activation measure, a validated instrument to assess a patient's engagement and activation in their health issues.(Pre/Post Visit (1 week))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bradley Crotty

Assistant Professor

Medical College of Wisconsin

Study Sites (1)

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