Critical IllnessIntensiva2NCT03438175
Intensiva 2.0: Improve the Communication Towards Families of Critically Ill Patients
A study testing Enhanced communication by brochure, website and posters in people with Critical Illness and Stress Disorders, Traumatic, Acute, run by University of Milan at 1 site in Italy.
Trial summary
The admission of a loved one in an ICU is a hard experience for family members. They frequently feel fear and grief, develop anxiety and depression symptoms, or even show some behaviors as this event was a real traumatic one, like hyper-arousal, avoidance and intrusion in the daily life.To improve the communication… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic
- What is being tested?
- Enhanced communication by brochure, website and posters
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 31 Dec 2020
- 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
- age ≥ 18 years
- family member of ICU patient
- patient with mechanical ventilation length expected at admission > 48 hours;
Who cannot join
- refusal to participate;
- inability to understand Italian language;
- any previously diagnosed and not compensated psychiatric condition;
- absence of visiting relatives in the first 4 ICU days.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AO San Paolo - Polo Universitario
Milan, 20142
Giovanni Mistraletti, MD, +39.339.8245014, giovanni.mistraletti@unimi.it
About this study
Official title: Randomized, Multicenter, Before-after Study for a Large-scale Evaluation of the Effectiveness of a Multitasking Intervention to Improve the Communication Towards Families of Critically Ill Patients
The admission of a loved one in an ICU is a hard experience for family members. They frequently feel fear and grief, develop anxiety and depression symptoms, or even show some behaviors as this event was a real traumatic one, like hyper-arousal, avoidance and intrusion in the daily life.To improve the communication between them and the ICU staff members, and to meet their needs in terms of medical comprehension and emotional legitimization, a specific website was built, and a brochure was printed to make them welcomed in the ICU; moreover, a series of poster was prepared for the family waiting room outside the ICU. These instruments appeared able to improve the correctness of prognosis comprehension and to decrease the post-traumatic stress symptoms in a multicenter study involving Italian ICUs. The proposal of the present study is to verify on a larger scale if these instruments can really ameliorate the empathic communication among staff members, without increase in workload, and to make less traumatic, for the family members, their experience during and after the ICU stay.
Read the detailed description
Many recent studies described the comprehension, the satisfaction, and the psychological consequences due to the experience of an ICU admission of a loved one. Even if satisfaction about meetings and clinical information is about 90%, from 50 to 70% of family members reported an incomplete medical comprehension, and 70% showed symptoms of anxiety and depression. Many interventions may considerably improve their ICU experience, regarding both the comprehension and the emotions. For example, the family members of ICU patients that receive clear and reassuring information can deal better with the stress associated with their loved one illness, or may participate in the clinical decisional processes with awareness and lighter emotional distress.
Literature shows that relationship with families of ICU patients presents these problems:
- comprehension of care essentials (diagnosis, prognosis about illness severity, interventions undertaken);
- trust on ICU staff members;
- management of their emotions (anxiety, fear, depression);
- post-traumatic stress symptoms due to the concerns about life-threatening diseases of their loved one.
To ameliorate the relationship and the communication in the harsh ICU environment, and to meet the problems aforementioned, in 2012 some instruments for families were created (website, brochure, posters). They present in non-technical language the activities and the environment of ICU, with the aim to increase their comprehension and - at the same time - to make them feel not alone and powerless.
To evaluate the effectiveness of these information instruments, a before-and-after study was done in 2012 in 12 Italian ICUs. These instruments were demonstrated able to improve the correctness of communication about outcome and treatment (not about the illness and the organ dysfunctions, that is responsibility of local staff), and to decrease the post-traumatic symptoms. Anxiety and depression symptoms were showed non-significantly decreased. The physicians also reported an improvement in the quality of communication with families. (Intensive Care Med. 2017 Jan;43(1):69-79). The main study limitations were: low prevalence of internet browsing among families; few participating centers; lacking of complete diagnosis of PTSD, made after 6 months from traumatic event; lacking of characteristics of staff members who participated on the family meetings. The present larger, randomized and controlled trial was then designed, to replicate and verify the preliminary results, overcoming the limits and finding new strategies of communication.
- Being tested
- Enhanced communication by brochure, website and posters
- Keywords
- Post-traumatic Stress Disorder, Web-site, Communication, Intensive Care Unit, Comprehension
- Medical subject headings
- Critical Illness, Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced communication by brochure, website and postersBehavioural
Several instruments to improve communication toward ICU patients' families were prepared for this study: a brochure of 12 pages, a website with 80 webpages, 8 posters for the waiting room, 1 sign for the ICU door. All these instruments are made to have more correct comprehension and to legitimize emotions of ICU patients' families.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Families of Critically Ill will be informed about patients'clinical status only by oral communication during daily family meeting |
| Intervention | Experimental | Families of critically ill patients will receive during the first ICU day of their loved one a brochure presenting the ICU and inviting them to visit a website specifically created for this project: www.intensiva.it Moreover, in the waiting room of the ICU will be placed 8 posters to improve comprehension and to legitimize emotions. Receives: Behavioral: Enhanced communication by brochure, website and posters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correctness of comprehension
Improvement in correctness of comprehension during the family meetings about medical information (main outcome: prognosis quo ad vitam), and about medical treatment and not diagnosis regarding organ dysfunction (comprehension assessment interview, CAI, minimum = 0, maximum = 16)
Measured: 7 days
Secondary outcomes (6)
Anxiety
Evaluation of anxiety on families after an ICU admission of a loved one (Hospital Anxiety and Depression Scale, HADS, for anxiety: minimum = 0, maximum = 21)
Measured: 7 days
Depression
Evaluation of depression on families after an ICU admission of a loved one (Hospital Anxiety and Depression Scale, HADS, for depression: minimum = 0, maximum = 21)
Measured: 7 days
Acute traumatic stress
Evaluation of traumatic experience (ICU admission of a loved one) influence on families in the early term of the first ICU week (short screening scale for symptoms of post-traumatic stress disorder, minimum = 0, maximum = 7)
Measured: 7 days
Post-traumatic stress disorder
Evaluation of traumatic experience (ICU admission of a loved one) influence on families in the long term of 6 months after ICU discharge (PTSD check list for DSM V - civilian version, PCL-5, minimum = 0, maximum = 80)
Measured: 6 months
Empathy
Evaluation of project effects on ICU staff involvement (Jefferson Scale for Physician Empathy, JSPE, minimum = 20, maximum = 140).
Measured: 2 months
Burnout
Evaluation of project effects on work satisfaction in ICU staff members (Maslach burnout inventory, MBI, minimum = 0, maximum = 132).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva, Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED), Ass. Anestesisti Rianimatori Ospedalieri Italiani - Em. Area Crit. (AAROI-EMAC), Associazione Nazionale Infermieri di Area Critica (ANIARTI)
- Responsible party
- Principal investigator, Giovanni Mistraletti, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438175
- Sponsor's protocol ID
- 35410/2017
- Acronym
- Intensiva2
- Status last verified
- May 2018
- First submitted
- 2 Feb 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
PubMed 10966293Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med. 2001 Oct;29(10):1893-7. doi: 10.1097/00003246-200110000-00007.
PubMed 11588447Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
PubMed 17267907Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Gunther A, Witte OW, Reinhart K, Hartog CS. Family satisfaction in the intensive care unit: a quantitative and qualitative analysis. Intensive Care Med. 2013 Jun;39(6):1071-9. doi: 10.1007/s00134-013-2862-7. Epub 2013 Feb 16.
PubMed 23417207Mistraletti G, Umbrello M, Mantovani ES, Moroni B, Formenti P, Spanu P, Anania S, Andrighi E, Di Carlo A, Martinetti F, Vecchi I, Palo A, Pinna C, Russo R, Francesconi S, Valdambrini F, Ferretti E, Radeschi G, Bosco E, Malacarne P, Iapichino G; http://www.intensiva.it Investigators. A family information brochure and dedicated website to improve the ICU experience for patients' relatives: an Italian multicenter before-and-after study. Intensive Care Med. 2017 Jan;43(1):69-79. doi: 10.1007/s00134-016-4592-0. Epub 2016 Nov 9.
PubMed 27830281Mistraletti G, Mezzetti A, Anania S, Ionescu Maddalena A, Del Negro S, Giusti GD, Gili A, Iacobone E, Pulitano SM, Conti G, Bocci MG. Improving communication toward ICU families to facilitate understanding and reduce stress. Protocol for a multicenter randomized and controlled Italian study. Contemp Clin Trials. 2019 Nov;86:105847. doi: 10.1016/j.cct.2019.105847. Epub 2019 Sep 13.
PubMed 31525488
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multicenter, Before-after Study for a Large-scale Evaluation of the Effectiveness of a Multitasking Intervention to Improve the Communication Towards Families of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03438175
- Acronym / sponsor ID
- Intensiva2 / 35410/2017
- Keywords
- Post-traumatic Stress Disorder, Web-site, Communication, Intensive Care Unit, Comprehension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva, Società Italiana di Anestesia, Rianimazione, Emergenza e Dolore (SIARED), Ass. Anestesisti Rianimatori Ospedalieri Italiani - Em. Area Crit. (AAROI-EMAC), Associazione Nazionale Infermieri di Area Critica (ANIARTI)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Feb 2018 (actual)
- 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 admission of a loved one in an ICU is a hard experience for family members. They frequently feel fear and grief, develop anxiety and depression symptoms, or even show some behaviors as this event was a real traumatic one, like hyper-arousal, avoidance and intrusion in the daily life.To improve the communication between them and the ICU staff members, and to meet their needs in terms of medical comprehension and emotional legitimization, a specific website was built, and a brochure was printed to make them welcomed in the ICU; moreover, a series of poster was prepared for the family waiting room outside the ICU. These instruments appeared able to improve the correctness of prognosis comprehension and to decrease the post-traumatic stress symptoms in a multicenter study involving Italian ICUs. The proposal of the present study is to verify on a larger scale if these instruments can really ameliorate the empathic communication among staff members, without increase in workload, and to make less traumatic, for the family members, their experience during and after the ICU stay.
Detailed description
Many recent studies described the comprehension, the satisfaction, and the psychological consequences due to the experience of an ICU admission of a loved one. Even if satisfaction about meetings and clinical information is about 90%, from 50 to 70% of family members reported an incomplete medical comprehension, and 70% showed symptoms of anxiety and depression. Many interventions may considerably improve their ICU experience, regarding both the comprehension and the emotions. For example, the family members of ICU patients that receive clear and reassuring information can deal better with the stress associated with their loved one illness, or may participate in the clinical decisional processes with awareness and lighter emotional distress.
Literature shows that relationship with families of ICU patients presents these problems:
- comprehension of care essentials (diagnosis, prognosis about illness severity, interventions undertaken);
- trust on ICU staff members;
- management of their emotions (anxiety, fear, depression);
- post-traumatic stress symptoms due to the concerns about life-threatening diseases of their loved one.
To ameliorate the relationship and the communication in the harsh ICU environment, and to meet the problems aforementioned, in 2012 some instruments for families were created (website, brochure, posters). They present in non-technical language the activities and the environment of ICU, with the aim to increase their comprehension and - at the same time - to make them feel not alone and powerless.
To evaluate the effectiveness of these information instruments, a before-and-after study was done in 2012 in 12 Italian ICUs. These instruments were demonstrated able to improve the correctness of communication about outcome and treatment (not about the illness and the organ dysfunctions, that is responsibility of local staff), and to decrease the post-traumatic symptoms. Anxiety and depression symptoms were showed non-significantly decreased. The physicians also reported an improvement in the quality of communication with families. (Intensive Care Med. 2017 Jan;43(1):69-79). The main study limitations were: low prevalence of internet browsing among families; few participating centers; lacking of complete diagnosis of PTSD, made after 6 months from traumatic event; lacking of characteristics of staff members who participated on the family meetings. The present larger, randomized and controlled trial was then designed, to replicate and verify the preliminary results, overcoming the limits and finding new strategies of communication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Families of Critically Ill will be informed about patients'clinical status only by oral communication during daily family meeting |
| Intervention | Experimental | Behavioral: Enhanced communication by brochure, website and postersFamilies of critically ill patients will receive during the first ICU day of their loved one a brochure presenting the ICU and inviting them to visit a website specifically created for this project: www.intensiva.it Moreover, in the waiting room of the ICU will be placed 8 posters to improve comprehension and to legitimize emotions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 18 years
- family member of ICU patient
- patient with mechanical ventilation length expected at admission > 48 hours;
Key exclusion criteria (4 listed)
- refusal to participate;
- inability to understand Italian language;
- any previously diagnosed and not compensated psychiatric condition;
- absence of visiting relatives in the first 4 ICU days.
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 |
|---|---|---|
| Enhanced communication by brochure, website and postersSeveral instruments to improve communication toward ICU patients' families were prepared for this study: a brochure of 12 pages, a website with 80 webpages, 8 posters for the waiting room, 1 sign for the ICU door. All these instruments are made to have more correct comprehension and to legitimize emotions of ICU patients' families. | Behavioural | Intervention |
Primary outcome
Correctness of comprehension
Time frame: 7 days
Improvement in correctness of comprehension during the family meetings about medical information (main outcome: prognosis quo ad vitam), and about medical treatment and not diagnosis regarding organ dysfunction (comprehension assessment interview, CAI, minimum = 0, maximum = 16)
6 secondary outcomes
Anxiety
Time frame: 7 days
Depression
Time frame: 7 days
Acute traumatic stress
Time frame: 7 days
Post-traumatic stress disorder
Time frame: 6 months
Empathy
Time frame: 2 months
Burnout
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Results publication: PubMed 10966293Azoulay E, Chevret S, Leleu G, Pochard F, Barboteu M, Adrie C, Canoui P, Le Gall JR, Schlemmer B. Half the families of intensive care unit patients experience inadequate communication with physicians. Crit Care Med. 2000 Aug;28(8):3044-9. doi: 10.1097/00003246-200008000-00061.
- Results publication: PubMed 11588447Pochard F, Azoulay E, Chevret S, Lemaire F, Hubert P, Canoui P, Grassin M, Zittoun R, le Gall JR, Dhainaut JF, Schlemmer B; French FAMIREA Group. Symptoms of anxiety and depression in family members of intensive care unit patients: ethical hypothesis regarding decision-making capacity. Crit Care Med. 2001 Oct;29(10):1893-7. doi: 10.1097/00003246-200110000-00007.
- Results publication: PubMed 17267907Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446.
- Results publication: PubMed 23417207Schwarzkopf D, Behrend S, Skupin H, Westermann I, Riedemann NC, Pfeifer R, Gunther A, Witte OW, Reinhart K, Hartog CS. Family satisfaction in the intensive care unit: a quantitative and qualitative analysis. Intensive Care Med. 2013 Jun;39(6):1071-9. doi: 10.1007/s00134-013-2862-7. Epub 2013 Feb 16.
- Results publication: PubMed 27830281Mistraletti G, Umbrello M, Mantovani ES, Moroni B, Formenti P, Spanu P, Anania S, Andrighi E, Di Carlo A, Martinetti F, Vecchi I, Palo A, Pinna C, Russo R, Francesconi S, Valdambrini F, Ferretti E, Radeschi G, Bosco E, Malacarne P, Iapichino G; http://www.intensiva.it Investigators. A family information brochure and dedicated website to improve the ICU experience for patients' relatives: an Italian multicenter before-and-after study. Intensive Care Med. 2017 Jan;43(1):69-79. doi: 10.1007/s00134-016-4592-0. Epub 2016 Nov 9.
- Derived from this study: PubMed 31525488Mistraletti G, Mezzetti A, Anania S, Ionescu Maddalena A, Del Negro S, Giusti GD, Gili A, Iacobone E, Pulitano SM, Conti G, Bocci MG. Improving communication toward ICU families to facilitate understanding and reduce stress. Protocol for a multicenter randomized and controlled Italian study. Contemp Clin Trials. 2019 Nov;86:105847. doi: 10.1016/j.cct.2019.105847. Epub 2019 Sep 13.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced communication by brochure, website and posters in people with Critical Illness and Stress Disorders, Traumatic, Acute, run by University of Milan at 1 site in Italy.
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 3 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: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Mistraletti (+39.339.8245014, giovanni.mistraletti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correctness of comprehension (time frame: 7 days). 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 NCT03438175, which also lists 6 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 22 May 2018.