- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02081794
Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients
Tailoring Patient Education to Perceived Risk for Falls in Hospitalized Oncology Patients: A Pilot Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
PRIMARY OBJECTIVES:
I. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on perceived risk for falls in hospitalized hematology-oncology patients.
II. To evaluate the effect of a tailored, nurse-delivered intervention, as compared to the control group, on confidence to minimize falls in hospitalized hematology-oncology patients.
III. To evaluate the relationship between patients' perceived risk for falling and their willingness to call for assistance with ambulation.
SECONDARY OBJECTIVES:
I. To evaluate the relationship between patients' perceived risk for falls and nursing risk assessments when using the standard hospital assessment tool and the investigator-designed perceived risk survey.
II. To evaluate the relationship between a patients' perceived risk for falls and sustaining a fall.
III. To evaluate patient satisfaction with the intervention.
OUTLINE:
All participants complete the Perceived Risk Survey comprising the participants' perceived risk for falls, their confidence to prevent a fall, and their willingness to ask for assistance at baseline and at 24 and 72 hours (or at discharge if stay is less than 72 hours) post-intervention. Patients are then randomized to 1 of 2 arms.
ARM I: Participants receive tailored education comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception. Participants also receive printed education sheets based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk.
ARM II: Participants receive a generic educational instruction sheet on falls prevention and receive standard care by nurses comprising a falls risk assessment and verbal education.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of cancer
- Admitted to the third floor of Seidman Cancer Center (SCC)
- Cognitively intact (alert, oriented to self, place, and time, and able to participate in the intervention)
- Ability to speak, read, and comprehend English
Exclusion Criteria:
- Nonmalignant diagnosis
- Actively dying
- Patients with a physician order for bed rest
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm I (Tailored education intervention)
Participants receive a tailored educational intervention on the risk of falls comprising one of four two-minute videos determined by which educational group the participant is placed in: high risk/high perception, high risk/low perception, low risk/high perception, or low risk/low perception.
Participants also receive tailored printed educational information concerning hospital falls based on the participants' answers given on the Perceived Risk Survey and are tailored to the participants' perception of falls risk.
Participants also complete an investigator-constructed satisfaction survey at 24 and 72 hours post-intervention.
|
Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks
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Aktiv komparator: Arm II (standard fall care)
Participants receive standard care by nurses comprising a falls risk assessment and verbal education and receive an educational instruction sheet on falls prevention.
|
Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Perceived risk for falls grouped according to the nurses assessment of risk using the University Hospitals (UH) Falls Assessment Tool
Tidsramme: Up to 8 weeks
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Changes in pre vs post survey for the High Risk/Low Perception group will be compared to all others using a paired McNemar's test for both those receiving the intervention and controls.
Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.
|
Up to 8 weeks
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Confidence to minimize falls assessed using the UH Falls Assessment Tool and the investigator-constructed Perceived Risk Survey (Nurse version)
Tidsramme: Up to 8 weeks
|
Pre vs post survey changes will be compared in confidence group using a paired McNemar's test for both those receiving the intervention and controls.
Pre and post scores will be compared between those receiving the intervention and controls using chi square tests.
|
Up to 8 weeks
|
Willingness to call for assistance
Tidsramme: Up to 8 weeks
|
An eight-point Likert scale will be used.
Pre vs post survey changes in willingness group will be compared using a paired McNemars test.
Relationship between Risk/Perception group status and Willingness group will be assessed using a chi-square test stratified by pre or post survey results for both those receiving the intervention and controls.
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Up to 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Relationship between patients perceived risk for falls and nurses risk assessments
Tidsramme: Up to 8 weeks
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Descriptive statistics will be used to compare scores self-perceived risks of falling with a nurse's assessment of a patient falling
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Up to 8 weeks
|
Patient's satisfaction of the intervention using the final questions on the Perceived Risk Post-Survey
Tidsramme: Up to 8 weeks
|
Descriptive statistics will be used by the distribution of pre vs post perceived risk values.
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Up to 8 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Megan Kuhlenschmidt, Case Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CASE18Z13
- P30CA043703 (U.S. NIH-stipend/kontrakt)
- NCI-2014-00388 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
- CASE 18Z13 (Annen identifikator: Case Comprehensive Cancer Center)
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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