- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02686411
Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit
A Prospective Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
PRIMARY OBJECTIVE:
I. To determine the change of satisfaction with quality of care after an experience on the palliative care unit (PCU) for both patients and caregivers, as determined by the global rating survey.
SECONDARY OBJECTIVES:
I. To determine the change of the quality of care as determined by patients and caregivers utilizing validated assessment tools and a global rating survey assessing different aspects of care after PCU.
II. To determine domains of care that are strongly or poorly provided by the PCU, as reported by patient and caregiver opinions on quality of care.
III. To determine which demographic features (i.e. cancer diagnosis; time since diagnosis; reason for transfer to the PCU; gender; caregiver ethnic group; comfort with the idea of transfer to the PCU; Memorial Delirium Assessment Scale [MDAS], Edmonton Symptom Assessment Scale [ESAS], and distress thermometer) may correlate with patient and caregiver satisfaction with PCU care measured by global survey and with the family satisfaction with end-of-life care.
OUTLINE:
Patients and caregivers complete surveys over 5-10 minutes before and after care in the PCU.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- M D Anderson Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients and/or patients' caregivers who have completed at least 2 weekdays on an in-patient service together with the assistance of the palliative care consult services (PCCS), and who then are transitioned to the care of the PCU team along with an admission order to that effect
- A caregiver (if participating) must have been present with the patient during 2 weekdays on the inpatient service and present for at least 2 weekdays of care on the PCU
- Both patient and caregiver participation is optional but both must be 18 years of age or older
- A caregiver will be defined by the patient as "the person most involved with their care". However, if the patient lacks capacity, the caregiver will be decided via discussion with individuals indicated in the patient's Medical Power of Attorney or the Texas rule of law if this is not present
- Both patient and caregiver (if participating) must understand, read and speak English
- Both patient (if actively participating) and caregiver (if participating) must sign an informed consent form
Exclusion Criteria:
- Patients or caregivers with physical limitations (visual or motor impairment) causing inability to read, complete or sign the consent form and surveys after considering appropriate aid and assistance
- Patients or caregivers who the research staff, bedside nurse, or palliative care physician or mid-level provider deems unable to participate due to poor cognitive capacity or acute physical distress
- Caregivers who are not able to attend the patient for at least 2 weekdays while on the PCU
- Patients who are imminently dying as determined by the palliative physician (or designated advanced practice provider [APP]/fellow)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Observational (survey)
Patients and caregivers complete surveys over 5-10 minutes before and after care in the PCU.
|
Sondaggio completo
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Relative satisfaction rate
Lasso di tempo: through study completion, an average of 1 year
|
Defined as the percentage of patients that answered "Better" and "Much Better" to the first question in the global rating on "overall care".
The relative satisfaction rate after palliative care unit (PCU) care in patients or caregivers will be estimated with 95% confidence interval.
|
through study completion, an average of 1 year
|
|
Patient Global Survey/Caregiver Global Survey
Lasso di tempo: through study completion, an average of 1 year
|
Assessed by Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS) distress thermometer will be summarized by descriptive analysis and/or tabulation.
|
through study completion, an average of 1 year
|
|
Distress thermometer
Lasso di tempo: through study completion, an average of 1 year
|
Measured by Family Satisfaction with end-of-life care will be summarized descriptively for each time point and may be compared within patients and within caregivers before and after the PCU by Wilcoxon signed-rank test, when the outcome is on Likert ordinal scales with 3, 5 levels or even 10 levels and the differences in the scales can be considered as continuous variables.
|
through study completion, an average of 1 year
|
|
Patients' and caregivers' opinions on quality of care
Lasso di tempo: through study completion, an average of 1 year
|
Measured by Family Satisfaction with end-of-life care will be summarized descriptively for each time point and may be compared within patients and within caregivers before and after the PCU by Wilcoxon signed-rank test, when the outcome is on Likert ordinal scales with 3, 5 levels or even 10 levels and the differences in the scales can be considered as continuous variables.
|
through study completion, an average of 1 year
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2015-1074 (Altro identificatore: M D Anderson Cancer Center)
- NCI-2020-11433 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .