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

Quality of Life Clinical Trial

— PACIENTE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336893
• Other study ID #: DI-I-0734-13
• Status: Completed
• Phase: N/A
• First received: January 8, 2015
• Last updated: January 12, 2015
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Fundación Universitaria de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Communication
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria de Ciencias de la Salud

References & Publications (17)

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Azoulay E, Pochard F, Chevret S, Lemaire F, Mokhtari M, Le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Meeting the needs of intensive care unit patient families: a multicenter study. Am J Respir Crit Care Med. 2001 Jan;163(1):135-9. — View Citation

Back AL, Arnold RM, Baile WF, Fryer-Edwards KA, Alexander SC, Barley GE, Gooley TA, Tulsky JA. Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Arch Intern Med. 2007 Mar 12;167(5):453-60. — View Citation

Baile WF, Buckman R, Lenzi R, Glober G, Beale EA, Kudelka AP. SPIKES-A six-step protocol for delivering bad news: application to the patient with cancer. Oncologist. 2000;5(4):302-11. — View Citation

Bailey JJ, Sabbagh M, Loiselle CG, Boileau J, McVey L. Supporting families in the ICU: a descriptive correlational study of informational support, anxiety, and satisfaction with care. Intensive Crit Care Nurs. 2010 Apr;26(2):114-22. doi: 10.1016/j.iccn.20 — View Citation

Brown A, Hijazi M. Arabic translation and adaptation of Critical Care Family Satisfaction Survey. Int J Qual Health Care. 2008 Aug;20(4):291-6. doi: 10.1093/intqhc/mzn013. Epub 2008 Apr 10. — View Citation

Curtis JR, Engelberg RA, Wenrich MD, Nielsen EL, Shannon SE, Treece PD, Tonelli MR, Patrick DL, Robins LS, McGrath BB, Rubenfeld GD. Studying communication about end-of-life care during the ICU family conference: development of a framework. J Crit Care. 2 — View Citation

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Fumis RR, Nishimoto IN, Deheinzelin D. Families' interactions with physicians in the intensive care unit: the impact on family's satisfaction. J Crit Care. 2008 Sep;23(3):281-6. doi: 10.1016/j.jcrc.2007.04.004. Epub 2007 Jul 5. — View Citation

Heyland DK, Tranmer JE; Kingston General Hospital ICU Research Working Group. Measuring family satisfaction with care in the intensive care unit: the development of a questionnaire and preliminary results. J Crit Care. 2001 Dec;16(4):142-9. — View Citation

Karlsson C, Tisell A, Engström A, Andershed B. Family members' satisfaction with critical care: a pilot study. Nurs Crit Care. 2011 Jan-Feb;16(1):11-8. doi: 10.1111/j.1478-5153.2010.00388.x. — View Citation

Lorin S, Rho L, Wisnivesky JP, Nierman DM. Improving medical student intensive care unit communication skills: a novel educational initiative using standardized family members. Crit Care Med. 2006 Sep;34(9):2386-91. — View Citation

Shaw DJ, Davidson JE, Smilde RI, Sondoozi T, Agan D. Multidisciplinary team training to enhance family communication in the ICU. Crit Care Med. 2014 Feb;42(2):265-71. doi: 10.1097/CCM.0b013e3182a26ea5. — View Citation

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Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension of the information, measured with the instrument FS-ICU 24. Third question, second part.	Measured with the instrument FS-ICU 24. Third question, second part.	Four months	No
Primary	Adequate time to address concerns and answer questions, measured with the instrument FS-ICU 24. Tenth question, second part.	Measured with the instrument FS-ICU 24. Tenth question, second part.	Four months	No
Secondary	Overall satisfaction with care, measured with the instrument FS-ICU 24.	Measured with the instrument FS-ICU 24.	Four months	No
Secondary	Overall satisfaction with decision-making measured with the instrument FS-ICU 24.	Measured with the instrument FS-ICU 24.	Four months	No
Secondary	Global survey satisfaction measured with the instrument FS-ICU 24.	Measured with the instrument FS-ICU 24.	Four months	No