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Feasibility Study of Use and Acceptability of New Clear Communication of Lab Test Results (CCLR) Letter for Older Adults

Embedding Health Literacy Best Practices: A Feasibility Study Using the Clear Communication of Laboratory Test Results (CCLR) Template

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06971887
Enrollment
61
Registered
2025-05-14
Start date
2023-11-06
Completion date
2024-10-11
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication

Keywords

Health Literacy, Lab test results communication

Brief summary

This study will try out a new way of writing a blood test result letter to patients explaining the results in a way to help them understand what the results mean and any next steps to be taken.

Detailed description

The primary goal of this study was to help healthcare providers more effectively communicate the meaning of laboratory test results and any need for follow-up, facilitating patient engagement in their healthcare. The investigators propose that using an innovative laboratory test result template integrating health literacy best practices, specifically the Clear Communication of Lab Results (CCLR) template, has the potential to improve health outcomes and health care processes. The purpose of this study was to create and assess the feasibility of using the CCLR template for 3 common laboratory tests to increase knowledge and confidence, decrease anxiety, activate follow-up, and improve satisfaction among older adults.

Interventions

OTHERClear Communication of Lab Test Result letter

The Clear Communication of Lab Test Result letter (CCLR) was designed using clear communication and health literacy best practices to explain test done, meaning of results, and any future action recommended.

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

First 30 participants received standard of care; 2nd 30 participants received the Clear Communication of Laboratory Result templated result note

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age 70 or older * English fluency * order for CBC, BMP, or FLP * capacity to provide informed consent * willingness to participate in follow-up phone survey

Exclusion criteria

* provider determined potential participant does not have cognitive capacity to read or understand communication about lab test results

Design outcomes

Primary

MeasureTime frameDescription
Recruitment18 monthsInvestigators will recruit participants for the study and providers will use the Clear Communication of Lab Test Result Letter

Secondary

MeasureTime frameDescription
Global Anxiety-Visual Scale2 weeks after blood test was drawnMeasure of anxiety after receiving the lab result letter. The minimum value is zero (0) and the maximum value is 100; higher scores mean greater anxiety.
Confidence2 weeks after blood test was drawnVisual analogue scale to assess confidence in understanding meaning of lab test result. The minimum score is 1 (not at all satisfied) and the maximum score is 10 (extremely satisfied). Higher score reflects higher confidence.
Comprehension of follow-up plans2 weeks after blood test was drawnYes/No response to question, Was it clear if there were any next steps participant needs to do related to the blood test results?
Patient Satisfaction2 weeks after blood test was drawnVisual analogue scale response to question, how satisfied was the participant with the letter describing lab test results? Minium response is one (1) not at all satisfied and the maximum response is 10, extremely satisfied. A higher score reflects higher satisfaction.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026