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Completed

NCT Number: NCT06971887

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

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.

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Key information

Conditions

Communication Behavior

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clear Communication of Lab Test Result letter

Other

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.

Primary outcomes

  1. Recruitment

    Time frame: 18 months

    Investigators will recruit participants for the study and providers will use the Clear Communication of Lab Test Result Letter

Secondary outcomes

  1. Global Anxiety-Visual Scale

    Time frame: 2 weeks after blood test was drawn

    Measure 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.

  2. Confidence

    Time frame: 2 weeks after blood test was drawn

    Visual 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.

  3. Comprehension of follow-up plans

    Time frame: 2 weeks after blood test was drawn

    Yes/No response to question, Was it clear if there were any next steps participant needs to do related to the blood test results?

  4. Patient Satisfaction

    Time frame: 2 weeks after blood test was drawn

    Visual 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 14, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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