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

NCT ID: NCT03766841

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Facilitated Enrollment

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Facilitated Enrollment

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Bradley Crotty

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bradley H Crotty, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33559067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33012264 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32965223 (View on PubMed)

Other Identifiers

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PRO00031177

Identifier Type: -

Identifier Source: org_study_id

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