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

January 12, 2015 updated by: Fundación Universitaria de Ciencias de la Salud

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: Training
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four months
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.
Four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall satisfaction with care, measured with the instrument FS-ICU 24.
Time Frame: Four months
Measured with the instrument FS-ICU 24.
Four months
Overall satisfaction with decision-making measured with the instrument FS-ICU 24.
Time Frame: Four months
Measured with the instrument FS-ICU 24.
Four months
Global survey satisfaction measured with the instrument FS-ICU 24.
Time Frame: Four months
Measured with the instrument FS-ICU 24.
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Universitaria de Ciencias de la Salud

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 8, 2015

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 13, 2015

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DI-I-0734-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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