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.

Study Overview

• Status: Completed
• Conditions: Communication
• Intervention / Treatment: Behavioral: Facilitated Enrollment

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facilitated Enrollment; 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	Behavioral: Facilitated Enrollment; Research coordinator will assist patients in account creation and usage of the tool.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Bradley H Crotty, MD MPH, Medical College of Wisconsin

Publications and helpful links

General Publications

• Holt JM, Cusatis R, Winn A, Asan O, Spanbauer C, Williams JS, Flynn KE, Somai M, Talsma A, Laud P, Makoul G, Crotty BH. Impact of Pre-visit Contextual Data Collection on Patient-Physician Communication and Patient Activation: a Randomized Trial. J Gen Intern Med. 2021 Nov;36(11):3321-3329. doi: 10.1007/s11606-020-06583-7. Epub 2021 Feb 9.
• Holt JM, Winn A, Cusatis R, Talsma A, Crotty BH. Racial Disparities in Patient Activation: The Role of Economic Diversity. West J Nurs Res. 2021 Jun;43(6):517-529. doi: 10.1177/0193945920963130. Epub 2020 Oct 5.
• Holt JM, Cusatis R, Winn A, Asan O, Spanbauer C, Williams JS, Flynn KE, Somai M, Laud P, Crotty BH. The Impact of Previsit Contextual Data Collection on Patient-Provider Communication and Patient Activation: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 23;9(9):e20309. doi: 10.2196/20309.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: communication; patient engagement; consumer informatics
• Other Study ID Numbers: PRO00031177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No