Patient-centered Precision Medicine Lab Result Communication for Older Adults

NCT07391904 | Enrolling By Invitation

• 2 other identifiers: IRB-25-0471-AM-003P30AG073104
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Communication; Chronic Kidney Disease (CKD); Patient Comprehension

Keywords

chronic kidney disease; lab result communication; Electronic Health Records; Patient Comprehension; Predictive Modeling

Outcome Measures

Primary Outcomes (2)

• 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.

  Participants will complete a structured post-session anonymous survey using a 4-point Likert scale titled "Emotional Response to Lab Results". The survey will assess emotional response and will be measured using a 4-point Likert-scale: 1. Anxiety - A higher score indicates extremely anxious 2. Understanding of Information - A higher score indicates understanding completely 3. Trust - A higher score indicates trust completely 4. Urgency - A higher score indicates extremely urgent 5. Overall preference of new template report - A higher score indicates that the participant liked it very much. Responses will be compared to participants' recalled or expected emotional responses based on past experiences with standard lab result communication formats.

  12 months

• Providers Feedback using the new communication tool.

  Understand how providers would feel about using the new communication tool. Document findings to support claims about preferred template report and tool effectiveness over the status quo. The anonymous survey will assess providers perceptions of the new designs compared with existing communication approach, including perceived improvement over the status quo, clarity of information presented, perceived preference among older adult patients, and likelihood of recommending each version for clinical use. Reponses will be collected using a 4-point Likert scale. The scale ranges from 1 (Strongly Disagree) to 4 (Strongly Agree).

  12 months

Secondary Outcomes (1)

• Test the acceptability of the new template reports

  12 months

Study Arms (4)

Outcome Expectancy Condition

EXPERIMENTAL

Participants in this arm will first be shown a new user interface template report for communication Chronic Kidney Disease (CKD) lab results. This version emphasizes functional interpretation of kidney health and likelihood of progression over the next two years. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation. Their responses will be locked in. Immediately afterward, participants will be shown the control version and asked to re-evaluate their responses with reference to their earlier answers.

Behavioral: Chronic Kidney Disease (CKD) Lab Result Communication Tool

Normalization Condition

EXPERIMENTAL

Participants in this arm will first be shown a new user interface template report for communication CKD lab results. This version emphasizes comparative normalization by presenting personalized CKD risk in relation to results commonly observed among similar adults of comparable age and clinical characteristics. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation. Their responses will be locked in. Immediately afterward, participants will be shown the control version and asked to re-evaluate their responses with reference to their earlier answers.

Behavioral: Chronic Kidney Disease (CKD) Lab Result Communication Tool

Combined Condition (Outcome Expectancy + Normalization)

EXPERIMENTAL

Participants in this arm will first be shown a new user interface template report for communication CKD lab results. This version integrates both outcome expectancy and comparative normalization by presenting personalized CKD risk alongside functional interpretation of kidney health and contextual comparison of similar adults. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation. Their responses will be locked in. Immediately afterward, participants will be shown the control version and asked to re-evaluate their responses with reference to their earlier answers.

Behavioral: Chronic Kidney Disease (CKD) Lab Result Communication Tool

Control

NO INTERVENTION

Participants in this arm will only be shown control version, the standard communication CKD lab results. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation.

Interventions

Chronic Kidney Disease (CKD) Lab Result Communication Tool BEHAVIORAL

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.

Combined Condition (Outcome Expectancy + Normalization); Normalization Condition; Outcome Expectancy Condition

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Johns Hopkins University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

UCLA Healthy System

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patient participants will not be informed which version of the CKD lab result communication tool represents the newly designed version and which represents the control version.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Participants will be randomized to one of the four arms: Arm 1: Outcome Expectancy Condition Arm 2: Normalized Condition Arm 3: Combined Condition (Outcome Expectancy + Normalized) Arm 4: Control (current standard communication)

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 6, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)