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

NCT03766841 | Completed

• 1 other identifier: PRO00031177
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication

Keywords

consumer informatics; communication; patient engagement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

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

Behavioral: Facilitated Enrollment

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.

Interventions

Facilitated Enrollment BEHAVIORAL

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

Facilitated Enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (3)

• 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.

  PMID: 33559067 DERIVED

• 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.

  PMID: 33012264 DERIVED

• 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.

  PMID: 32965223 DERIVED

MeSH Terms

Conditions

Communication; Patient Participation

Condition Hierarchy (Ancestors)

Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Bradley H Crotty, MD MPH

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 6, 2018
• Study Start: April 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

US (1)