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A Semi-structured Interview PACIENTE Improves Communication With Family Members at the Intensive Care Unit (PACIENTE)

Result of an Intervention for the Group of Physicians Responsible for Providing Information on the Satisfaction of the Relatives of Patients Hospitalized in an Intensive Care Unit

The purpose of this study is to assess whether a formal training strategy using an interview PACIENTE may improve physician's skills and quality of communication with family members at the ICU.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Introduction: Effective communication with physicians is an important factor for families at intensive care unit. Although physicians should have adequate communication skills, training programs are not available that would enable them to enhance this competence. Formal training using a semi-structured interview to improve skills and quality of communication was provided to physicians in charge of supplying information to families at the intensive care unit (ICU).

Objective: To assess whether a formal training strategy using an interview PACIENTE may improve physician's skills and quality of communication with family members at the ICU.

Methods: A pre- and post- intervention study was designed for a university hospital mixed ICU (medical and surgical). Training was provided to 34 resident physicians in charge of giving information to families at the ICU using interview PACIENTE. The interview was done conjointly with participation in simulated difficult clinical cases with actors posing as family members.

Patient registries: Family satisfaction was assessed with a validated survey, FS-ICU 24, in 122 and 123 family members pre- and post-intervention training, respectively, on the fourth day after patient admission to the ICU. The surveys were identified with consecutive numbers and not collected data that would allow subsequent identification of patients or their families. After the intervention, structures of interviews were monitored with checklists designed for this purpose. The meetings were always in the same place for this activity.

The surveys were answered on paper and the data included in an SPSS database by one of the researchers. Single questions in the 24-FS-ICU survey were analyzed according to the author's suggestions with minor modifications. Scores from items 1-6 in the published survey were transformed to scores from 0 to 100. The Mann-Whitney U test was used to determine any score differences between pre- and post-interventions. Differences of P<0.05 were considered statistically significant.

The sample size was calculated to be 122 participants for pre-intervention and 122 participants for post-intervention to detect α coefficient of 0.05 and with a power of 0.90. The survey was performed in the waiting room and questionnaires were collected immediately; thus, there were no missing questionnaires.

Studietype

Intervensjonell

Registrering (Faktiske)

245

Fase

  • Ikke aktuelt

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:

  • That consented to participate in the satisfaction survey
  • That whom had been in the ICU for 72 h.

Exclusion Criteria:

  • Family members with language barriers (requiring assistance to answer a question in writing)
  • Previous ICU admission within the study period
  • Patient's death by the fourth day of admission
  • Proved reasons for risk of judicial proceedings.

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: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Pre-intervention
Family members of patients admitted to the ICU from August to December 2013 that consented to participate in the satisfaction survey and had been in the ICU for 72 h.
Eksperimentell: Post-intervention
Family members of patients admitted to the ICU from March to August 2014 that consented to participate in the satisfaction survey and had been in the ICU for 72 h.
The final training was provided to a group of 34 residents --from internal medicine, anesthesiology, gynecology, and intensive care-- in charge of giving information to the patient's family members in the ICU. They were trained in the semi-structured interview PACIENTE (Present oneself and greet, Attend and listen, Call diagnosis, Inform treatment, Expose prognosis, Name introductory phrases to bad news, Take time to provide empathetic comfort, Explain an action plan involving the family) conjointly while participating in simulated difficult clinical cases with family members-actors. Four training programs were performed from February to September 2014.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Comprehension of the information, measured with the instrument FS-ICU 24. Third question, second part.
Tidsramme: Four months
Measured with the instrument FS-ICU 24. Third question, second part.
Four months
Adequate time to address concerns and answer questions, measured with the instrument FS-ICU 24. Tenth question, second part.
Tidsramme: Four months
Measured with the instrument FS-ICU 24. Tenth question, second part.
Four months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall satisfaction with care, measured with the instrument FS-ICU 24.
Tidsramme: Four months
Measured with the instrument FS-ICU 24.
Four months
Overall satisfaction with decision-making measured with the instrument FS-ICU 24.
Tidsramme: Four months
Measured with the instrument FS-ICU 24.
Four months
Global survey satisfaction measured with the instrument FS-ICU 24.
Tidsramme: Four months
Measured with the instrument FS-ICU 24.
Four months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Miguel H Coral, MD, Fundación Universitaria de Ciencias de la Salud

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. august 2013

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. august 2014

Datoer for studieregistrering

Først innsendt

8. januar 2015

Først innsendt som oppfylte QC-kriteriene

12. januar 2015

Først lagt ut (Anslag)

13. januar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. januar 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. januar 2015

Sist bekreftet

1. januar 2015

Mer informasjon

Begreper knyttet til denne studien

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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