Clinical trial NCT02336893: A Semi-structured Interview PACIENTE Improves Communication With Family Members at the Intensive Care Unit
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Quality of Life
Keywords: Communication Barriers
Total Communication Methods
Quality Improvement
Quality of Health Care
Critical Care
Lead sponsor: Fundación Universitaria de Ciencias de la Salud
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comprehension of the information, measured with the instrument FS-ICU 24. Third question, second part.
timeFrame: Four months
measure: Adequate time to address concerns and answer questions, measured with the instrument FS-ICU 24. Tenth question, second part.
timeFrame: Four months
Secondary outcomes:
measure: Overall satisfaction with care, measured with the instrument FS-ICU 24.
timeFrame: Four months
measure: Overall satisfaction with decision-making measured with the instrument FS-ICU 24.
timeFrame: Four months
measure: Global survey satisfaction measured with the instrument FS-ICU 24.
timeFrame: Four months
Other outcomes:
Locations:
Study officials:
affiliation: Fundación Universitaria de Ciencias de la Salud
name: Miguel H Coral, MD
role: PRINCIPAL_INVESTIGATOR
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