- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01252316
Cardiopulmonary Resuscitation (CPR) Dissemination Study Using Nurses and Volunteers
31. oktober 2018 oppdatert av: University of Pennsylvania
An In-Hospital VSI CPR Dissemination Study Using Nurses and Volunteers
Each year in the United States, 300,000 people suffer from Cardiac Arrest (CA), and of them there is a 90% mortality rate.
Out-of-Hospital arrests in particular have a 1-5% survival to hospital discharge.
High quality CPR is crucial to lowering the mortality rate and increasing survival, yet only 15-30% of out-of-hospital CA victims receive bystander CPR.
Studies have shown that prompt administration of CPR dramatically improves outcomes.
In a recent study from Switzerland, lay bystander CPR doubled the survival rate at one month.
Our study will look to train family members of at-risk cardiac patients in the skills of CPR through the American Heart Associations (AHA) CPR Anytime Friends and Family Personal Learning Program (CPR Anytime) to see if these family members are able to learn and perform quality CPR in the event that their family member should suffer a cardiac arrest.
The unique feature of the CPR Anytime training is that it is a low-cost, self-learning, video-based program that can be completed in under 30 minutes, saving the time and expense of traditional CPR training courses.
While initial work has proven that teaching CPR in hospital using the VSI kit is feasible, little research has been conducted to make the program sustainable.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
The long term goal of our work is to implement real world CPR training strategies that match training locales with at-risk populations, maximize resuscitation skill retention, and promote willingness to act.
To accomplish this, we will empower stakeholders at UPHS hospitals to develop local implementation approaches, using either UPHS volunteers or nursing staff as VSI proctors.
These stakeholders will be studied as a research subset.
The VSI proctors will use the AHAs CPR Anytime kit, and will work with family members of patients at high risk for a CA to learn lifesaving CPR skills.
We will use a modified AHA CPR video using the new AHA recommendations for bystanders which suggests doing chest compression only CPR.
Using the original AHA video and the modified chest compression only video, we will randomize family members of patients at high risk for CA to one of these groups.
The VSI proctors will also be blinded to which video these subjects will be watching.
We will follow up with the family members at 1 month, 3 months, 6 months and 12 months to see if they retained their CPR knowledge and skills and to see if they had been in a situation where their CPR skills were needed and assess whether they performed their skills or not.
We will also measure the number of people with whom the subjects shared their CPR Anytime kits a quantity known as the multiplier effect to determine if they had shared the CPR Anytime kit with their family and friends, thereby increasing the possible number of lay persons trained in CPR and in turn able to perform bystander CPR if needed.
We will also assess the perceptions and attitudes of the nurses and volunteers regarding this project.
Studietype
Intervensjonell
Registrering (Faktiske)
500
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Penn Presbyterian Medical Center
-
Philadelphia, Pennsylvania, Forente stater, 19106
- Pennsylvania Hospital
-
-
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:
- Family Member's of Patients with known coronary disease or cardiovascular risk factors, such as history of diabetes and hypertension.
Exclusion Criteria:
- If someone is physically unable to undergo CPR Training
- Someone who has received CPR training in the past 2 years
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Standard CPR
Individuals will learn the Standard form of CPR (30:2, compressions:breathes) Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" 3) CPR Skills
|
Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit.
The subject's will undergo training in-hospital then they will be encouraged to take the kit home with them to practice CPR with their family members and friends.
|
|
Aktiv komparator: Recruitment with Volunteers
UPHS volunteer subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals.
|
UPHS Nurses and Volunteers will be trained in our in-hospital CPR Training Model using VSI Kits, and encouraged to implement the training program in their respective hospitals.
|
|
Aktiv komparator: Recruitment with Nurses
UPHS Nurse subjects will be identified by hospital stakeholders, and they will be given surveys to assess their confidence, attitudes and beliefs towards this program at 3-month integrals.
|
UPHS Nurses and Volunteers will be trained in our in-hospital CPR Training Model using VSI Kits, and encouraged to implement the training program in their respective hospitals.
|
|
Aktiv komparator: Chest Compressions Only CPR
Individuals will learn the chest compression only form of CPR (no rescue breathes) Main data points being collected at various increments over 12 months are: 1) Comfort Level with using CPR 2) Secondary Training "multiplier effect" 3) CPR Skills
|
Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit.
The subject's will undergo training in-hospital then they will be encouraged to take the kit home with them to practice CPR with their family members and friends.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessing Nurses and Volunteers implementation of the in-hospital CPR Training Program
Tidsramme: 2 years
|
To determine if volunteers or nursing staff can adequately implement a CPR Training Program for at risk family members of patients hospitalized for cardiac risk-factors.
Subjects will be given "enroller surveys" in 3-month integrals to assess comfort level with the program.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
CPR Skills Performance and Retention
Tidsramme: up to 1 year
|
To assess skill performance by subject family members and retention with chest compression only CPR versus standard CPR education.
Subjects will be asked to perform 2 minutes of CPR on a Laerdal SkillReporter ResusciAnne mannequin.
|
up to 1 year
|
|
Assessing bystander CPR training dissemination
Tidsramme: up to 1 year
|
To quantify the multiplier effect, an assessment of the number of people who received secondary CPR training via CPR Anytime kits shared with them by study subjects.
|
up to 1 year
|
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
1. oktober 2010
Primær fullføring (Faktiske)
1. oktober 2012
Studiet fullført (Faktiske)
1. oktober 2012
Datoer for studieregistrering
Først innsendt
29. november 2010
Først innsendt som oppfylte QC-kriteriene
30. november 2010
Først lagt ut (Anslag)
2. desember 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. november 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. oktober 2018
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CRS-812096
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. .