Behavior, HealthNCT05825300
Encouraging Blood Donation in Patients With a Blood Type in Short Supply - Part 2
A study testing Email message and Social responsibility in people with Behavior, Health, run by Geisinger Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavior, Health
- What is being tested?
- Email message and Social responsibility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,486 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 3 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented blood type in short supply
- Age 18+
- Can be contacted via email
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Behavior, Health
- Being tested
- Email message, Social responsibility
- Keywords
- Blood donation
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Email messageBehavioural
Email message encourages patients to donate blood
Social responsibilityBehavioural
Message specifies that there is a shortage of the patient's blood type
| Study group | Role | What they receive |
|---|---|---|
| No-blood-type message | Experimental | This group will receive a message that does not mention that the patient's blood type is in short supply. Receives: Behavioral: Email message |
| Blood-type message | Experimental | This group will receive a message that states their blood type is in short supply. Receives: Behavioral: Email message; Behavioral: Social responsibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Attended a Donation Appointment
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.
Measured: Within 6 weeks of the patient's message send date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start10 Apr 2023
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40,486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Goren, Geisinger Clinic
- Investigators
- Amir Goren, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825300
- Sponsor's protocol ID
- 2021-0476-2
- Status last verified
- Jul 2023
- First submitted
- 10 Apr 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Blood Donation in Patients With a Blood Type in Short Supply - Part 2
- ClinicalTrials.gov ID
- NCT05825300
- Acronym / sponsor ID
- 2021-0476-2
- Conditions
- Behavior, Health
- Keywords
- Blood donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40,486 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 24 Apr 2023 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No-blood-type message | Experimental | Behavioral: Email messageThis group will receive a message that does not mention that the patient's blood type is in short supply. |
| Blood-type message | Experimental | Behavioral: Email message, Behavioral: Social responsibilityThis group will receive a message that states their blood type is in short supply. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented blood type in short supply
- Age 18+
- Can be contacted via email
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Email messageEmail message encourages patients to donate blood | Behavioural | Blood-type message, No-blood-type message |
| Social responsibilityMessage specifies that there is a shortage of the patient's blood type | Behavioural | Blood-type message |
Primary outcome
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.
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 6 Jul 2023.
- Individual participant dataSharing planned: Yes. Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency.
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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.
Amir Goren, PhD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Email message and Social responsibility in people with Behavior, Health, run by Geisinger Clinic 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 3 inclusion and 3 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 6 Jul 2023. 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?
Number of Participants Who Attended a Donation Appointment (time frame: Within 6 weeks of the patient's message send date). 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 6 Jul 2023.