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

NCT06971887 | Completed

• 1 other identifier: 00000965
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication

Keywords

Health Literacy; Lab test results communication

Outcome Measures

Primary Outcomes (1)

• Recruitment

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

  18 months

Secondary Outcomes (4)

• Global Anxiety-Visual Scale

  2 weeks after blood test was drawn

• Confidence

  2 weeks after blood test was drawn

• Comprehension of follow-up plans

  2 weeks after blood test was drawn

• Patient Satisfaction

  2 weeks after blood test was drawn

Study Arms (2)

Participants received the standard communication letter for result of blood test

NO INTERVENTION

Providers send their usual result note related to a blood test

Clear Communication of Lab Test Result letter

EXPERIMENTAL

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

Interventions

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.

Clear Communication of Lab Test Result letter

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Nancy Morris, PhD, RN, ANP-BC

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: November 6, 2023
• Primary Completion: September 27, 2024
• Study Completion: October 11, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)