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

August 19, 2025 updated by: Nancy Morris, University of Massachusetts, Worcester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Participants received the standard communication letter for result of blood test
Providers send their usual result note related to a blood test
Experimental: Clear Communication of Lab Test Result letter
Participants received the results of their blood test on the Clear Communication of Lab Test Results (CCLR) letter
Other: Clear 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: 18 months
Investigators will recruit participants for the study and providers will use the Clear Communication of Lab Test Result Letter
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks after blood test was drawn
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.
2 weeks after blood test was drawn
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?
2 weeks after blood test was drawn
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.
2 weeks after blood test was drawn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Investigators

  • Principal Investigator: Nancy Morris, PhD, RN, ANP-BC, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Actual)

September 27, 2024

Study Completion (Actual)

October 11, 2024

Study Registration Dates

First Submitted

May 6, 2025

First Submitted That Met QC Criteria

May 13, 2025

First Posted (Actual)

May 14, 2025

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00000965

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This was a feasibility trial and undertaken to learn what should be changed for a larger, powered study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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