Activity Monitor Feedback and Interactive Tours to Improve Postoperative Ambulation
27. mars 2019 oppdatert av: Timothy J. Daskivich, Cedars-Sinai Medical Center
Randomized Controlled Trial of Activity Monitor Feedback and Interactive Ambulation Tours to Improve Postoperative Ambulation and Efficiency Outcomes After Major Surgery
This is a randomized controlled trial that compares a system using activity monitors to provide real-time feedback on daily ambulation to patients undergoing major surgeries, paired with step-count-measured art tours of the surgical units, versus standard of care, on step count.
The hypothesis is that the feedback system + art tours will encourage patients to ambulate more.
Studieoversikt
Detaljert beskrivelse
After major surgery, patients are encouraged to walk early and often, since early ambulation is linked with improved clinical and efficiency outcomes.
This research study tests whether providing goal-directed feedback on daily ambulation to patients using activity monitors in combination with an app that provides step count-rated "art tours" of the surgical floors will increase the amount of steps taken after surgery.
Upon enrollment, all patients will be assigned to either the control (no intervention) or experimental (activity monitor feedback + art tours) group, stratified by surgery type.
This randomized controlled trial aims to determine if this feedback system/art tours approach improves: (1) daily step count, (2) length of stay, and (3) patient satisfaction compared with standard of care.
Studietype
Intervensjonell
Registrering (Forventet)
192
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Los Angeles, California, Forente stater, 90048
- Rekruttering
- Cedars-Sinai Medical Center
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Ta kontakt med:
- Mayra L Lopez, MPH
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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
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Undergoing one of the 14 surgeries: Gynecological (Total Abdominal Hysterectomy, Gyn Ex Lap); Orthopedic (Total Hip Replacement, Total Knee Replacement); Minimally Invasive Surgery (Hiatal Hernia Repair/Fundoplication, Gastric Bypass, Gastric Sleeve); Colorectal Surgery (Lap/Robotic Colectomy, Ileocolic Resection, Open Colectomy); Thoracic (Lung Lobectomy); Urologic (Robotic Cystectomy, Radical Prostatectomy, Partial Nephrectomy).
- Able to provide informed consent
- Non-English speakers will be included with the use of short forms in the 7 available languages
- Must have access to an IOS or Android device
Exclusion Criteria:
- Unable to provide consent
- Not undergoing procedure of interest
- Admitted to ICU directly after operation (except esophagectomy, where all patients are admitted to ICU directly after the operation)
- Use of walker, cane, or wheelchair at baseline
- Presence of physical limitations on walking (i.e. amputation)
- Usual place of residence is skilled nursing facility
- Cognitive inability to follow directions to maintain activity monitor in place
- Unable to place activity monitor on patient's wrist
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervention Arm
Intervention: Activity monitor feedback loop: (1) Subjects will receive activity monitor with feedback on daily step count from the in-room TV screen, and (2) access to the Art Tour application
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The intervention arm will test if the feedback system (i.e., activity monitor, real-time feedback, and art tours) increases daily step count, decreases length of stay, and improves patient and provider communication, patient awareness of step count goals, and patient confidence in accomplishment of daily goals.
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Ingen inngripen: Standard-of-care Arm
Subjects in the control arm will receive a "blinded" activity monitor post-op (without feedback on step count) and the usual standard of care.
Nurses and doctors will not monitor ambulation with the activity monitor, they will use standard methods of observation.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Daily Step Count
Tidsramme: During hospitalization within approximately 1-2 weeks
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Daily step count will be captured with activity monitor
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During hospitalization within approximately 1-2 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Length of stay
Tidsramme: Within approximately 1-2 weeks, Date patient was admitted through hospital discharge
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Length of stay in intervention arm compared to control
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Within approximately 1-2 weeks, Date patient was admitted through hospital discharge
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Patient Satisfaction
Tidsramme: Within approximately 1-2 weeks, Day patient is discharged from hospital
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Patient satisfaction measured using likert-scale rated items. Scale measures patient/physician communication, patient awareness of step goals, and patient confidence in accomplishment of daily goals. The following scale ranges will be used:
Positive answer in likert-scales indicate higher patient/physician communication, patient awareness, and patient confidence in accomplishing daily step goals. |
Within approximately 1-2 weeks, Day patient is discharged from hospital
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Timothy Daskivich, MD, MSHPM, Cedars-Sinai Medical Center
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)
5. desember 2018
Primær fullføring (Forventet)
22. oktober 2019
Studiet fullført (Forventet)
30. desember 2019
Datoer for studieregistrering
Først innsendt
11. oktober 2018
Først innsendt som oppfylte QC-kriteriene
17. oktober 2018
Først lagt ut (Faktiske)
18. oktober 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00051802
Legemiddel- og utstyrsinformasjon, studiedokumenter
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