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

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766841
• Other study ID #: PRO00031177
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2020
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communication

Intervention

Behavioral:
• Facilitated Enrollment
Research coordinator will assist patients in account creation and usage of the tool.

Locations

Country	Name	City	State
United States	Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.	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.	Post Visit ( 1 week)
Secondary	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.	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.	Pre/Post Visit (1 week)