Clinical trial NCT03766841: Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research
Official title: Avoiding Health Disparities When Collecting Patient Contextual Data for Clinical Care and Pragmatic Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: consumer informatics
communication
patient engagement
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite Communication Score As Assessed by Communication Assessment Tool, a validated 14-item patient-reported outcome.
timeFrame: Post Visit ( 1 week)
Secondary outcomes:
measure: 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.
timeFrame: Pre/Post Visit (1 week)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Bradley H Crotty, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.