- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05825300
Encouraging Blood Donation in Patients With a Blood Type in Short Supply - Part 2
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There has been a years-long national shortage of several blood types in the U.S., including in the Geisinger community. Previously, the study team collaborated with Miller Keystone, where Geisinger refers patients who wish to donate blood and from whom Geisinger receives blood for clinical purposes, on an outreach study to encourage blood donation in patients with needed blood types. The study demonstrated that, compared to a no-message control group, patient portal messages sent to patients with needed blood types increase patients' likelihood of attending donation appointments. However, results were ambiguous with respect to which of two message versions was most effective. One version, which stated that the patient had a needed blood type (blood-type message), caused a numerically, but not significantly, higher number of patients who attended appointments compared to the other version, which did not state that the patient had a blood type in need but rather informed the recipient of a general blood shortage (no-blood-type message).
Because Miller Keystone particularly values reaching new donors, the team ran a preregistered exploratory analysis to test whether the messages were differently effective for new donors compared to those who had previously donated at a Miller Keystone site. There was a significant interaction between previous donor status (previous donor, previous non-donor) and message type, such that previous non-donors were relatively more responsive to the blood-type message, while previous donors were more responsive to the no-blood-type message. However, the groups were uneven with respect to the number of patients that had previously donated. Moreover, when the analysis was limited to patients who opened their messages, this interaction effect disappeared: blood-type messages were still most effective in previous non-donors, and there was no difference in message effectiveness among previous donors. These follow-up analyses, and the unevenness of previous donors across groups, call into question the robustness of the interaction effect.
The present study will again test whether the blood-type message is more effective than the no-blood-type message for patients with needed blood types overall, and separately for previous donors and non-donors. Messages will be sent via email rather than via patient portal in the present study. Randomization will occur at the email-address level to one of the two message types to ensure everyone using the same email address receives the same message (although each patient will be sent an individualized message with their name; there will be no no-contact control condition this time). Email addresses will be excluded if they are shared by patients with different blood types. Randomization will be stratified by whether all patients using the same email address are previous donors or not (email addresses shared by previous donors and non-donors will be excluded).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pennsylvania
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Danville, Pennsylvania, United States, 17822
- Geisinger Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Documented blood type in short supply
- Age 18+
- Can be contacted via email
Exclusion Criteria:
- Hemoglobin test result < 12.5 within the 3 months prior to list creation
- Shares an email address with a patient of a different needed blood type
- Email address associated with at least one previous donor and one non-previous donor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: No-blood-type message
This group will receive a message that does not mention that the patient's blood type is in short supply.
|
Email message encourages patients to donate blood
|
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Experimental: Blood-type message
This group will receive a message that states their blood type is in short supply.
|
Message specifies that there is a shortage of the patient's blood type
Email message encourages patients to donate blood
|
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 patient's 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 patient's message send date
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Successfully Donated Blood
Time Frame: Within 6 weeks of the patient's 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 patient's message send date
|
|
Number of Participants Who Scheduled a Blood Donation Appointment
Time Frame: Within 2 weeks of the patient's message send date
|
Scheduled an appointment within 2 weeks of their message send date.
|
Within 2 weeks of the patient's message send date
|
|
Number of Participants Who Scheduled a Blood Donation Appointment
Time Frame: Within 6 weeks of the patient's message send date
|
Scheduled an appointment within 6 weeks of their message send date.
|
Within 6 weeks of the patient's message send date
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amir Goren, PhD, Geisinger Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2021-0476-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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