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

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.

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Key information

Conditions

Communication Behavior Health Behavior Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facilitated Enrollment

Behavioral

Research coordinator will assist patients in account creation and usage of the tool.

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.

Time frame: Pre/Post Visit (1 week)

Short form developed by J Hibbard et al on patient activation Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005;40: 1918-1930.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Dec 6, 2018
Registry last updated: Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed