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

NCT ID: NCT06971887

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-06

Study Completion Date

2024-10-11

Brief Summary

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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

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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.

Conditions

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Communication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Participants received the standard communication letter for result of blood test

Providers send their usual result note related to a blood test

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Clear Communication of Lab Test Result letter

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Worcester

OTHER

Sponsor Role lead

Responsible Party

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Nancy Morris

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Morris, PhD, RN, ANP-BC

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

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University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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00000965

Identifier Type: -

Identifier Source: org_study_id

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