- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05135325
Encouraging Blood Donation in Patients With a Blood Type in Short Supply
July 25, 2022 updated by: Geisinger Clinic
As of November 2021, partly due to the COVID-19 pandemic, there has been a months-long national shortage of several types of blood in the U.S. (O-Pos, O-Neg, A-Neg, B-Neg, and AB-Neg), which has extended to a local blood shortage within the Geisinger community.
The broad aim of this collaborative healthcare operations quality improvement project is to determine whether a message indicating that a patient's own blood type is in short supply increases the likelihood that they will donate, compared to a message that mentions a blood shortage without referencing the patient's blood type, or no message at all.
Scientists in Geisinger's Behavioral Insights Team (BIT), part of Geisinger's Steele Institute for Health Innovation, will collaborate with Miller Keystone, where Geisinger refers patients who wish to donate blood and from whom Geisinger receives blood for clinical purposes.
Patients with one of the needed blood types will be randomized to receive 1) a message about a blood shortage that does not specify the blood types in short supply or their own blood type (no-blood-type message), 2) the same message modified slightly to specify the recipient's blood type, and to mention that their blood type is in short supply (blood-type message), or 3) no message (shortage control group).
A second no-contact control group of patients without any of the needed blood types will also be observed (no-shortage control group).
Both the blood-type and no-blood-type messages are informed by behavioral science, emphasizing supply needs in local hospitals and providing community-relevant examples of why someone might need blood (e.g., farming or industrial accidents).
The BIT will compare how many patients in each group choose to donate blood.
They hypothesize that: 1) patients who receive either message will be more likely to donate than patients who receive no message; and 2) patients who receive the blood-type message will be more likely to donate than those who receive the no-blood-type message.
With respect to the latter hypothesis, informing the recipient that they have one of the needed blood types may increase their perception that they are in a semi-unique position to help someone in need as compared to a more general message that may suffer from a diffusion of responsibility effect.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59093
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
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Geisinger
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented blood type in short supply (for message groups and shortage control group)
- Documented blood type not in short supply (for no-shortage control group)
- Age 18+
Exclusion Criteria:
- Hemoglobin test result < 12.5 within the 3 months prior to list creation
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: No-blood-type message
This group will receive a message that does not mention the patient's blood type, or that the patient's blood type is in short supply.
|
Portal message encourages patients to donate blood
|
|
Experimental: Blood-type message
This group will receive a message that mentions the patient's blood type and that states their blood type is in short supply.
|
Portal message encourages patients to donate blood
Message specifies that there is a shortage of the patient's blood type
|
|
No Intervention: Shortage control
This group will not receive a message.
|
|
|
No Intervention: No-shortage control
This group will not receive a message.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Attended a Donation Appointment
Time Frame: Within 6 weeks of the final message send date
|
Attended a donation appointment within 6 weeks of their message send date, regardless of whether they donated.
This outcome includes patients who were unable to donate for any reason (e.g.
low hemoglobin) or patients who showed up to the appointment but decided to leave before donating.
|
Within 6 weeks of the final message send date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Successfully Donated Blood
Time Frame: Within 6 weeks of the final message send date
|
Attended a donation appointment within 6 weeks of their message send date and successfully donated, excluding patients who were turned away from or left their appointment without donating.
|
Within 6 weeks of the final message send date
|
|
Number of Participants Who Scheduled a Blood Donation Appointment
Time Frame: Within 2 weeks of the final message send date
|
Scheduled an appointment within 2 weeks of their message send date.
|
Within 2 weeks of the final message send date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 15, 2021
Primary Completion (Actual)
June 6, 2022
Study Completion (Actual)
June 6, 2022
Study Registration Dates
First Submitted
November 15, 2021
First Submitted That Met QC Criteria
November 15, 2021
First Posted (Actual)
November 26, 2021
Study Record Updates
Last Update Posted (Actual)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-0476
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency.
IPD Sharing Time Frame
The data will become available after publication of study results in a scientific journal and will be available as long as the Open Science Framework hosts the data.
IPD Sharing Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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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