- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05135325
Encouraging Blood Donation in Patients With a Blood Type in Short Supply
25. juli 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
59093
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
Danville, Pennsylvania, Forente stater, 17822
- Geisinger
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
|
Eksperimentell: 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
Melding spesifiserer at det er mangel på pasientens blodtype
|
Ingen inngripen: Shortage control
This group will not receive a message.
|
|
Ingen inngripen: No-shortage control
This group will not receive a message.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Who Attended a Donation Appointment
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Who Successfully Donated Blood
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. november 2021
Primær fullføring (Faktiske)
6. juni 2022
Studiet fullført (Faktiske)
6. juni 2022
Datoer for studieregistrering
Først innsendt
15. november 2021
Først innsendt som oppfylte QC-kriteriene
15. november 2021
Først lagt ut (Faktiske)
26. november 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2021-0476
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency.
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
The data on the Open Science Framework will be open to anyone requesting that information.
IPD-deling Støtteinformasjonstype
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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