CommunicationPACIENTENCT02336893
A Semi-structured Interview PACIENTE Improves Communication With Family Members at the Intensive Care Unit
A study testing Training in people with Communication and Quality of Life, run by Fundación Universitaria de Ciencias de la Salud.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication, Quality of Life
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- That consented to participate in the satisfaction survey
- That whom had been in the ICU for 72 h.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Communication, Quality of Life
- Being tested
- Training
- Keywords
- Communication Barriers, Total Communication Methods, Quality Improvement, Quality of Health Care, Critical Care
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Four months
Secondary outcomes (3)
Overall satisfaction with care, measured with the instrument FS-ICU 24.
Measured with the instrument FS-ICU 24.
Measured: Four months
Overall satisfaction with decision-making measured with the instrument FS-ICU 24.
Measured with the instrument FS-ICU 24.
Measured: Four months
Global survey satisfaction measured with the instrument FS-ICU 24.
Measured with the instrument FS-ICU 24.
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria de Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miguel H Coral, MD, Principal investigator, Fundación Universitaria de Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336893
- Sponsor's protocol ID
- DI-I-0734-13
- Acronym
- PACIENTE
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2015
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18725030Bailey 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.
PubMed 20106664Karlsson 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.
PubMed 21199550Curtis 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.
PubMed 12297990Azoulay 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.
PubMed 11208638Brown 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.
PubMed 18403569Auerbach 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.
PubMed 15840894Alexander 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.
PubMed 17065871Lorin 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.
PubMed 16791111Back 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.
PubMed 17353492Sullivan 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.
PubMed 15980082Fineberg 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.
PubMed 16128661Shaw 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.
PubMed 24105452Baile 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.
PubMed 10964998Azoulay 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.
PubMed 12856124
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02336893
- Acronym / sponsor ID
- PACIENTE / DI-I-0734-13
- Conditions
- Communication, Quality of Life
- Keywords
- Communication Barriers, Total Communication Methods, Quality Improvement, Quality of Health Care, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Fundación Universitaria de Ciencias de la SaludUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: TrainingFamily 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- That consented to participate in the satisfaction survey
- That whom had been in the ICU for 72 h.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingThe 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. | Behavioural | Post-intervention |
Primary outcome
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.
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.
3 secondary outcomes
Overall satisfaction with care, measured with the instrument FS-ICU 24.
Time frame: Four months
Overall satisfaction with decision-making measured with the instrument FS-ICU 24.
Time frame: Four months
Global survey satisfaction measured with the instrument FS-ICU 24.
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Results publication: PubMed 18725030Fumis 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.
- Results publication: PubMed 20106664Bailey 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.
- Results publication: PubMed 21199550Karlsson 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.
- Results publication: PubMed 12297990Curtis 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.
- Results publication: PubMed 11208638Azoulay 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.
- Results publication: PubMed 18403569Brown 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.
- Results publication: PubMed 15840894Auerbach 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.
- Results publication: PubMed 17065871Alexander 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.
- Results publication: PubMed 16791111Lorin 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.
- Results publication: PubMed 17353492Back 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.
- Results publication: PubMed 15980082Sullivan 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.
- Results publication: PubMed 16128661Fineberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel H Coral, MD principal investigator
Fundación Universitaria de Ciencias de la Salud
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Communication and Quality of Life, run by Fundación Universitaria de Ciencias de la Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of the information, measured with the instrument FS-ICU 24. Third question, second part. (time frame: Four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336893, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.