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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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

245

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2013

Primær færdiggørelse (Faktiske)

1. august 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

8. januar 2015

Først indsendt, der opfyldte QC-kriterier

12. januar 2015

Først opslået (Skøn)

13. januar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. januar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2015

Sidst verificeret

1. januar 2015

Mere information

Begreber relateret til denne undersøgelse

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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