NCT02336893

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

January 8, 2015

Last Update Submit

January 12, 2015

Conditions

CommunicationQuality of Life

Keywords

Communication BarriersTotal Communication MethodsQuality ImprovementQuality of Health CareCritical Care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (3)

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

    Four months

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

    Four months

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

    Four months

Study Arms (2)

Pre-intervention

NO 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.

Post-intervention

EXPERIMENTAL

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

Interventions

TrainingBEHAVIORAL

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.

Post-intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • That consented to participate in the satisfaction survey
  • That whom had been in the ICU for 72 h.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (17)

  • 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.

    PMID: 18725030RESULT

  • 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.2009.12.006. Epub 2010 Jan 27.

    PMID: 20106664RESULT

  • Karlsson C, Tisell A, Engstrom 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.

    PMID: 21199550RESULT

  • 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. 2002 Sep;17(3):147-60. doi: 10.1053/jcrc.2002.35929.

    PMID: 12297990RESULT

  • 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. doi: 10.1164/ajrccm.163.1.2005117.

    PMID: 11208638RESULT

  • 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.

    PMID: 18403569RESULT

  • Auerbach SM, Kiesler DJ, Wartella J, Rausch S, Ward KR, Ivatury R. Optimism, satisfaction with needs met, interpersonal perceptions of the healthcare team, and emotional distress in patients' family members during critical care hospitalization. Am J Crit Care. 2005 May;14(3):202-10.

    PMID: 15840894RESULT

  • Alexander SC, Keitz SA, Sloane R, Tulsky JA. A controlled trial of a short course to improve residents' communication with patients at the end of life. Acad Med. 2006 Nov;81(11):1008-12. doi: 10.1097/01.ACM.0000242580.83851.ad.

    PMID: 17065871RESULT

  • 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. doi: 10.1097/01.CCM.0000230239.04781.BD.

    PMID: 16791111RESULT

  • 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. doi: 10.1001/archinte.167.5.453.

    PMID: 17353492RESULT

  • Sullivan AM, Lakoma MD, Billings JA, Peters AS, Block SD; PCEP Core Faculty. Teaching and learning end-of-life care: evaluation of a faculty development program in palliative care. Acad Med. 2005 Jul;80(7):657-68. doi: 10.1097/00001888-200507000-00008.

    PMID: 15980082RESULT

  • Fineberg IC. Preparing professionals for family conferences in palliative care: evaluation results of an interdisciplinary approach. J Palliat Med. 2005 Aug;8(4):857-66. doi: 10.1089/jpm.2005.8.857.

    PMID: 16128661RESULT

  • 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.

    PMID: 24105452RESULT

  • 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. doi: 10.1634/theoncologist.5-4-302.

    PMID: 10964998RESULT

  • Azoulay E, Pochard F, Chevret S, Arich C, Brivet F, Brun F, Charles PE, Desmettre T, Dubois D, Galliot R, Garrouste-Orgeas M, Goldgran-Toledano D, Herbecq P, Joly LM, Jourdain M, Kaidomar M, Lepape A, Letellier N, Marie O, Page B, Parrot A, Rodie-Talbere PA, Sermet A, Tenaillon A, Thuong M, Tulasne P, Le Gall JR, Schlemmer B; French Famirea Group. Family participation in care to the critically ill: opinions of families and staff. Intensive Care Med. 2003 Sep;29(9):1498-504. doi: 10.1007/s00134-003-1904-y. Epub 2003 Jul 10.

    PMID: 12856124RESULT

  • 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. doi: 10.1097/01.CCM.0000251122.15053.50.

    PMID: 17133189RESULT

  • 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. doi: 10.1053/jcrc.2001.30163.

    PMID: 11815899RESULT

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Miguel H Coral, MD

    Fundación Universitaria de Ciencias de la Salud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 13, 2015

Record last verified: 2015-01