CommunicationNCT06971887
Feasibility Study of Use and Acceptability of New Clear Communication of Lab Test Results (CCLR) Letter for Older Adults
A study testing Clear Communication of Lab Test Result letter in people with Communication, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Clear Communication of Lab Test Result letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 11 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- provider determined potential participant does not have cognitive capacity to read or understand communication about lab test results
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: 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.
Read the 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.
- Conditions
- Communication
- Being tested
- Clear Communication of Lab Test Result letter
- Keywords
- Health Literacy, Lab test results communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Communication of Lab Test Result letterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Clear Communication of Lab Test Result letter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Investigators will recruit participants for the study and providers will use the Clear Communication of Lab Test Result Letter
Measured: 18 months
Secondary outcomes (4)
Global Anxiety-Visual Scale
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.
Measured: 2 weeks after blood test was drawn
Confidence
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.
Measured: 2 weeks after blood test was drawn
Comprehension of follow-up plans
Yes/No response to question, Was it clear if there were any next steps participant needs to do related to the blood test results?
Measured: 2 weeks after blood test was drawn
Patient Satisfaction
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.
Measured: 2 weeks after blood test was drawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start6 Nov 2023
- Primary completion27 Sep 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- First 30 participants received standard of care; 2nd 30 participants received the Clear Communication of Laboratory Result templated result note
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Morris, University of Massachusetts, Worcester
- Investigators
- Nancy Morris, PhD, RN, ANP-BC, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971887
- Sponsor's protocol ID
- 00000965
- Status last verified
- Aug 2025
- First submitted
- 6 May 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This was a feasibility trial and undertaken to learn what should be changed for a larger, powered study.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embedding Health Literacy Best Practices: A Feasibility Study Using the Clear Communication of Laboratory Test Results (CCLR) Template
- ClinicalTrials.gov ID
- NCT06971887
- Acronym / sponsor ID
- 00000965
- Conditions
- Communication
- Keywords
- Health Literacy, Lab test results communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- First 30 participants received standard of care; 2nd 30 participants received the Clear Communication of Laboratory Result templated result note
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Clear Communication of Lab Test Result letterParticipants received the results of their blood test on the Clear Communication of Lab Test Results (CCLR) letter |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- provider determined potential participant does not have cognitive capacity to read or understand communication about lab test results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear Communication of Lab Test Result letterThe 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. | Other | Clear Communication of Lab Test Result letter |
Primary outcome
Recruitment
Time frame: 18 months
Investigators will recruit participants for the study and providers will use the Clear Communication of Lab Test Result Letter
4 secondary outcomes
Global Anxiety-Visual Scale
Time frame: 2 weeks after blood test was drawn
Confidence
Time frame: 2 weeks after blood test was drawn
Comprehension of follow-up plans
Time frame: 2 weeks after blood test was drawn
Patient Satisfaction
Time frame: 2 weeks after blood test was drawn
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No. This was a feasibility trial and undertaken to learn what should be changed for a larger, powered study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Morris, PhD, RN, ANP-BC principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Communication of Lab Test Result letter in people with Communication, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.