Encouraging Blood Donation in Patients With a Blood Type in Short Supply - Part 2

July 3, 2023 updated by: Amir Goren, Geisinger Clinic
The goal of this study is to test whether emails that inform patients they have a blood type in need are more effective at encouraging patients to schedule and attend blood donation appointments, compared to email messages that do not mention the patient has a blood type in need.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

40486

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 Clinic

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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: 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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amir Goren, PhD, Geisinger Clinic

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)

April 10, 2023

Primary Completion (Actual)

July 3, 2023

Study Completion (Actual)

July 3, 2023

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

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)?

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

  • STUDY_PROTOCOL
  • SAP

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.

Subscribe