Chronic Kidney Disease (CKD)NCT07391904
Patient-centered Precision Medicine Lab Result Communication for Older Adults
A study testing Chronic Kidney Disease (CKD) Lab Result Communication Tool in people with Chronic Kidney Disease (CKD) and Health Communication, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD), Health Communication, Patient Comprehension
- What is being tested?
- Chronic Kidney Disease (CKD) Lab Result Communication Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient-centered Precision Medicine Lab Result Communication for Older Adults - User Experience Testing
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.
Read the detailed description
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.
- Being tested
- Chronic Kidney Disease (CKD) Lab Result Communication Tool
- Keywords
- chronic kidney disease, lab result communication, Electronic Health Records, Patient Comprehension, Predictive Modeling
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Kidney Disease (CKD) Lab Result Communication ToolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Anxiety - A higher score indicates extremely anxious
- Understanding of Information - A higher score indicates understanding completely
- Trust - A higher score indicates trust completely
- Urgency - A higher score indicates extremely urgent
- 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.
Measured: 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).
Measured: 12 months
Secondary outcomes (1)
Test the acceptability of the new template reports
Acceptability and preference of the new template reports will be assessed among participants randomized to intervention arms 1-3. After completing the initial post-review anonymous survey of the newly designed template report, participants will additionally review the status quo lab result template report and complete a follow-up survey comparing the two versions. All patient surveys will be anonymous.
Comparative items will assess the following:
- Overall preference between two designs
- Strength of preference - measured using a 4-point Likert-scale with a higher score indicates stronger preference
- Perceived clarity and ease of understanding
- Relative anxiety elicited by each version.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start21 Apr 2026
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Catherine A. Sarkisian, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391904
- Sponsor's protocol ID
- IRB-25-0471
- Other IDs
- P30AG073104
- Status last verified
- Jul 2026
- First submitted
- 22 Jan 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Precision Medicine Lab Result Communication for Older Adults - User Experience Testing
- ClinicalTrials.gov ID
- NCT07391904
- Acronym / sponsor ID
- IRB-25-0471
- Keywords
- chronic kidney disease, lab result communication, Electronic Health Records, Patient Comprehension, Predictive Modeling
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute on Aging (NIA)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Outcome Expectancy Condition | Experimental | Behavioral: Chronic Kidney Disease (CKD) Lab Result Communication ToolParticipants 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. |
| Normalization Condition | Experimental | Behavioral: Chronic Kidney Disease (CKD) Lab Result Communication ToolParticipants 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. |
| Combined Condition (Outcome Expectancy + Normalization) | Experimental | Behavioral: Chronic Kidney Disease (CKD) Lab Result Communication ToolParticipants 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Kidney Disease (CKD) Lab Result Communication ToolA 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. | Behavioural | Combined Condition (Outcome Expectancy + Normalization), Normalization Condition, Outcome Expectancy Condition |
Primary outcome
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.
Time frame: 12 months
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.
Providers Feedback using the new communication tool.
Time frame: 12 months
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).
1 secondary outcome
Test the acceptability of the new template reports
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Kidney Disease (CKD) Lab Result Communication Tool in people with Chronic Kidney Disease (CKD) and Health Communication, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.