Patient-centered Precision Medicine Lab Result Communication for Older Adults

Официальное название

Patient-centered Precision Medicine Lab Result Communication for Older Adults - User Experience Testing

Обзор

For adults ≥65 years and their providers, the investigators will test the usability and design of a tool to replace standard uniform reporting of lab results to patients and their providers with a new personalized Electronic Health Record (EHR) lab result communication tool that: 1) extracts patient-level data from the EHR; 2) calculates individual risk; and 3) for patients with very low risk, communicates the individualized risk information. The investigators will employ a range of User Experience (UX) research methods to understand how patient and provider users interact with the new lab result communication tool and to assess their comprehension of the lab results. This study will be conducted with both patient and provider participants. The patient participant portion of this study uses a four-arm, design to evaluate three newly designed laboratory result communication template reports compared with the current standard (control) communication. The provider participant portion of this study is non-randomized; all provider participants will review all four template reports. This will include live semi-structured interviews with the participants and review of the template report(s) of the Chronic Kidney Disease (CKD) lab result communication tool. An anonymous in-person template report feedback survey will be provided to the participants to gauge their understanding of the template report(s), clarity of the information presented, and overall satisfaction with the tool. This will be a single-visit interaction with the participant in the UCLA Health geriatric or general medicine patient waiting room. The survey was revised after an initial pilot.

Подробное описание

At UCLA Health over 80% of all patients \>65 years view their lab results through the patient portal within one day of their availability, making this a potentially very powerful way to communicate with patients (in contrast to patient portal messaging which generally has much lower rates of viewing/uptake). Currently, lab results displayed to patients and providers via the EHR include a reference range; results outside this range are printed in red and marked by a red arrow indicator ("flagged"). Though there is a disclaimer in small text at the bottom of the report explaining that "\[a\] test result listed as 'abnormal' may be normal for you," the header of the report prominently features a large yellow box with the text "Abnormal."

In 2023, the investigators conducted a formal community engagement studio (CES) using well-tested methods to learn more about older adults' lived experiences with communication of lab results. The CES included 11 community stakeholders representing aging and health services organizations including but not limited to the LA County Aging and Disabilities Department, the local Area Agency on Aging (AAA), AARP California, and Watts Labor Community Action Center. Results from that CES include consensus around two key conclusions: 1) older adults want more "useful information" to accompany their lab results; 2) there is tremendous enthusiasm around the idea of individualizing communication of the results of diagnostic lab tests.

For this study, the primary analysis is to compare self-report attitudes in response to behavioral-science grounded new template reports versus each other. Four arm Randomized Controlled Trial (RCT) between unique participants. The primary analyses will assess differences between each new template report and the control communication. Secondary analyses include testing the acceptability/preference of the new template reports combined versus control across participants and also a within participant analysis for the 3 arms who receive one of the new communications first followed by the control.

The revised survey improves wording and participant understanding. The current study uses the amended version for confirmatory analyses.

Вмешательства

• Поведенческое Chronic Kidney Disease (CKD) Lab Result Communication Tool
  A behavioral intervention delivered through a personalized Electronic Health Record (EHR)-integrated lab result communication tool designed to improve emotional and cognitive responses to lab results among adults aged 65+. The tool applies behavioral science principles such as risk personalization, simplified messaging, and visual framing to reduce patient anxiety, enhance understanding, and support informed decision-making.

Первичные конечные точки

• Compare self-report attitudes in response to behavioral-science grounded new template reports versus each other. Four arm Randomized Controlled Trial (RCT) between unique participants. [Срок оценки: 12 months]
• Providers Feedback using the new communication tool. [Срок оценки: 12 months]

Вторичные конечные точки (1)

• Test the acceptability of the new template reports [Срок оценки: 12 months]

Критерии участия

Patient Inclusion Criteria:

• Older adults (aged ≥65 years);
• Currently have a UCLA primary care provider (PCP);
• Enrolled in the patient portal;
• English-speaking (as the language of the tool is currently only in English, and it would be impractical to have validated translations created for all of the potential variations and derivatives of the tool template reports); and
• Without dementia or other neurocognitive disease.
• Does not have End-Stage Kidney Disease (ESKD)

Provider Inclusion Criteria:

\- UCLA Health providers who care for large numbers of older adults in outpatient settings.

Patient Exclusion Criteria:

• Are under the age of 65
• Do not have a UCLA PCP;
• Are not enrolled in the patient portal;
• Are not English speaking (as the tool prototypes are only in English until final verbiage is determined);
• Are diagnosed with dementia or other neurocognitive disease.
• Have ESKD

Provider Exclusion:

\- Do not care for large numbers of older adults in outpatient settings

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• UCLA Healthy System — Los Angeles

Идентификаторы

NCT: NCT07391904 · IRB-25-0471 · P30AG073104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗