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Completed

NCT Number: NCT02336893

A Semi-structured Interview PACIENTE Improves Communication With Family Members at the 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training

Behavioral

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.

Primary outcomes

  1. Comprehension of the information, measured with the instrument FS-ICU 24. Third question, second part.

    Time frame: Four months

    Measured with the instrument FS-ICU 24. Third question, second part.

  2. Adequate time to address concerns and answer questions, measured with the instrument FS-ICU 24. Tenth question, second part.

    Time frame: Four months

    Measured with the instrument FS-ICU 24. Tenth question, second part.

Secondary outcomes

  1. Overall satisfaction with care, measured with the instrument FS-ICU 24.

    Time frame: Four months

    Measured with the instrument FS-ICU 24.

  2. Overall satisfaction with decision-making measured with the instrument FS-ICU 24.

    Time frame: Four months

    Measured with the instrument FS-ICU 24.

  3. Global survey satisfaction measured with the instrument FS-ICU 24.

    Time frame: Four months

    Measured with the instrument FS-ICU 24.

Sponsors and collaborators

Lead sponsor

Fundación Universitaria de Ciencias de la Salud

Other

Registry information

Official study title

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

Acronym: PACIENTE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 13, 2015
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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