AzTrials
AzTrials

Stress Disorders, Post-TraumaticFCRNCT02875912

Prospective Evaluation of Family Care Rituals in the ICU

A study testing Family Care Rituals in people with Stress Disorders, Post-Traumatic and Depression, run by Brown University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate whether or not engaging family members of patients admitted to the ICU in "Family Care Rituals" will reduce stress related symptoms of PTSD, depression and anxiety 90 days after patient death or discharge from the ICU. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Family Care Rituals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
3 sitesin 2 countries
Study dates
Sep 2015to 12 Jun 2017
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Families of patients admitted to the intensive care unit (ICU) with attending physician predicted ICU mortality of greater than 30%.
  • Patients with ICU length of stay greater than 4 days, regardless of mortality, are considered for ENDING-S score

Who cannot join

  • Families of patients with an anticipated ICU length of stay less than 24 hours
  • Families of patients admitted to the ICU for palliative/comfort care only
  • Families of patients with age less than 18
  • Families of patients who are pregnant
  • Families of patients who are incarcerated
  • Family members who are less than 18
  • Family members who are pregnant
  • Family members who are incarcerated

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Brown University

    Providence, Rhode Island, 02903

Other trials in United States

Italy1 site

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

Other trials in Italy

About this study

Official title: PROSPECTIVE EVALUATION OF FAMILY CARE RITUALS IN THE ICU AND VALIDATION OF THE END-of-Life ScorING-System (ENDING-S), a Multicenter, Multinational Trial

This study will evaluate whether or not engaging family members of patients admitted to the ICU in "Family Care Rituals" will reduce stress related symptoms of PTSD, depression and anxiety 90 days after patient death or discharge from the ICU. Family Care Rituals are defined as several domains in which family participation may be of benefit, focusing on the 5 physical senses as well as the personal care of the patient and spirituality of the patient

Read the detailed description

Over the previous century, the location of where people die has shifted from home to either hospitals or nursing homes, with 20% of patients dying in the ICU. Several deficiencies for End-of-Life (EOL) care provided in the ICU have been identified in literature; most of them are related to communication, decision making, sense of control, spirituality, preparation for death, pain and symptom management. Symptoms of stress, anxiety or depression as well as discordance between the perceptions of care by the health care providers (physicians and nurses) and the family members may all be related to these shortcomings. These symptoms are likely from multiple factors in the ICU that strip the family of the ability to provide any direct care or nurturing for their loved one, as families did when people died at home. Moreover, qualitative studies suggest that families want and value a role as a care provider for their loved ones in the ICU. In a pilot study, the investigators identified several domains in which family participation may be of benefit, focusing on the 5 physical senses, personal care of the patient, and spirituality of the patient and family. These areas were incorporated as Family Care Rituals (FCR) in which family members can participate while their loved one is in the ICU

The investigators are conducting a multi-center, multinational prospective evaluation of FCR with the hypothesis that FCR will primarily reduce symptoms of PTSD, as well as anxiety and depression in the surviving family members at 90 days after death or discharge from the ICU. Additionally, the intervention's effect on concordance of care as measured on day of enrollment and ICU day 5 via a questionnaire administered to the family members, the day-time nurse and the attending physician will be evaluated. ICU utilization, family satisfaction, and validation of the END of live scorING System (ENDING-S) are also being evaluated. To understand what care rituals are being performed at the bedside as well as the impact on bedside nursing care, nursing is also completing daily surveys.

The investigators are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the incidence of PTSD in family members is 33%. To reduce the rate of PTSD for family members in the interventional arm to 17%, 114 experimental subjects and 114 control subjects will need to be enrolled to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. An uncorrected chi-squared statistic will be used to evaluate this null hypothesis.

Being tested
Family Care Rituals
Keywords
Family, Care Rituals, End of Life, Discordance of care
Medical subject headings
Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Death

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Care RitualsBehavioural

    Family members being enrolled are given a pamphlet outlining the Family Care Rituals. They are informed of the opportunity to perform these rituals, but that they are in no way obligated to do so.

    Family members are then surveyed at enrollment, and 90 days post ICU discharge for symptoms of PTSD, as well as depression, and anxiety.

    Family members, day-time nursing, and attending physicians are surveyed for concordance of care at enrollment and ICU day 5.

    Demographic information is also collected on the patient and the family members at enrollment Nursing completes surveys while the patient is in the ICU noting what care rituals, if any, are being performed. Additionally, they are asked to complete a survey indicating their opinion of the impact on the care they deliver

Study groups in NCT02875912
Study groupRoleWhat they receive
Usual CareNo interventionFamily members are surveyed at enrollment, day 5 (if patient is still in ICU), and 90 days post ICU discharge for symptoms of PTSD, depression, and anxiety as well as for concordance of care at enrollment and ICU day 5. Nursing completes surveys while the patient is in the ICU noting what care rituals, if any, are being performed to establish baseline data
Family Care Rituals InterventionExperimentalAt enrollment, family members are given a handout/pamphlet outlining the Family Care Rituals. They are informed of the opportunity to perform these rituals, but that they are in no way obligated to do so. The families are then surveyed in the same way as they were during the usual care, with nursing completing the same surveys as well to compare against the baseline data
Receives: Behavioral: Family Care Rituals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptoms of Post-Traumatic Stress Disorder in family members of intensive care patients

    Symptoms of PTSD are measured by the Impact of Events Scale revised (IES-r). This survey is conducted via phone 90 days after patient discharge.

    Measured: 90 days post patient discharge from ICU

Secondary outcomes (8)

  1. Symptoms of depression in family members of intensive care patients

    Symptoms of Depression are measured by the Hospital Anxiety and Depression Screen (HADS). These surveys are conducted via phone 90 days after patient discharge

    Measured: 90 days post patient discharge from ICU

  2. Symptoms of anxiety in family members of intensive care patients

    Symptoms of Anxiety are measured by the Hospital Anxiety and Depression Screen (HADS). These surveys are via phone 90 days after patient discharge

    Measured: 90 days post patient discharge from the ICU

  3. Family satisfaction with ICU care

    Measured by the Family Satisfaction in the ICU- 24 (FS-ICU-24) questionnaire via phone communication at 90 days

    Measured: 90 days post discharge from ICU

  4. Congruency of goals of care

    Enrolled family members, day time nurse and attending physician are surveyed on enrollment day (day 0) and day 5 with a questionnaire designed to evaluate comfort with the care plan and identify why, if uncomfortable, they are uncomfortable with the care plan

    Measured: Evaluated at enrollment and if patient is still in the ICU on hospital day 5 during active enrollment

  5. Validation of the End of Life Scoring System (ENDING-S)

    Multicenter prospective validation of ENDING-S. This score produces a number based on the following calculation: [ENDING-S = (7.25 ∙ Days of Mechanical ventilation/ICU Length of stay) + (10.45 ∙ Days of Vasoactive drugs/ICU length of stay) + (3 ∙ Sepsis) + (0.3 ∙ ICU Length of stay)] where "sepsis" is binary yes/no as to whether or not the patient is septic. Will also include evaluation of the addition of multi-parametric variables (such as functional status, spiritual and communicative variables) to the ENDING-S to generate a final score based on in hospital morbidity combined with prehospital comorbidities

    Measured: Through study completion, anticipated to be 18 months

  6. ICU length of stay

    In an effort to evaluate resources used during study period, ICU length of stay will be collected to ascertain whether or not the intervention reduces length of stay

    Measured: Through study completion, anticipated to be 18 months

  7. Use of palliative/spiritual care during ICU stay

    In an effort to evaluate resources used during study period, data on whether or not a palliative/spiritual care order was placed will be collected to ascertain whether or not the intervention impacts use of these resources

    Measured: Through study completion, anticipated to be 18 months

  8. Location of discharge from ICU

    In an effort to understand type of discharge (death, another hospital floor, nursing home, hospice, etc), charts will be reviewed for location of discharge from the ICU to ascertain whether or not the intervention impacted discharge

    Measured: Through study completion, anticipated to be 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2016 (estimated)
  2. Study startSep 2015
  3. Primary completion12 Mar 2017
  4. Study completion12 Jun 2017

Resources

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
Model description
Prospective before and after intervention evaluation
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02875912
Sponsor's protocol ID
763434-9
Acronym
FCR
Status last verified
Jul 2017
First submitted
4 Aug 2016
Last updated
13 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474.

    PubMed 27380343

  • Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901.

    PubMed 20357283

  • White DB. Strategies to Support Surrogate Decision Makers of Patients With Chronic Critical Illness: The Search Continues. JAMA. 2016 Jul 5;316(1):35-7. doi: 10.1001/jama.2016.8691. No abstract available.

    PubMed 27380340

  • Lautrette 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 17267907

  • Curtis JR, Back AL, Ford DW, Downey L, Shannon SE, Doorenbos AZ, Kross EK, Reinke LF, Feemster LC, Edlund B, Arnold RW, O'Connor K, Engelberg RA. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081.

    PubMed 24302090

  • Curtis JR, Treece PD, Nielsen EL, Gold J, Ciechanowski PS, Shannon SE, Khandelwal N, Young JP, Engelberg RA. Randomized Trial of Communication Facilitators to Reduce Family Distress and Intensity of End-of-Life Care. Am J Respir Crit Care Med. 2016 Jan 15;193(2):154-62. doi: 10.1164/rccm.201505-0900OC.

    PubMed 26378963

  • 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 10966293

  • Heyland DK, Rocker GM, O'Callaghan CJ, Dodek PM, Cook DJ. Dying in the ICU: perspectives of family members. Chest. 2003 Jul;124(1):392-7. doi: 10.1378/chest.124.1.392.

    PubMed 12853551

  • Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.

    PubMed 15090940

  • Reyniers T, Deliens L, Pasman HR, Morin L, Addington-Hall J, Frova L, Cardenas-Turanzas M, Onwuteaka-Philipsen B, Naylor W, Ruiz-Ramos M, Wilson DM, Loucka M, Csikos A, Rhee YJ, Teno J, Cohen J, Houttekier D. International variation in place of death of older people who died from dementia in 14 European and non-European countries. J Am Med Dir Assoc. 2015 Feb;16(2):165-71. doi: 10.1016/j.jamda.2014.11.003. Epub 2014 Dec 18.

    PubMed 25544001

  • Jones C, Skirrow P, Griffiths RD, Humphris G, Ingleby S, Eddleston J, Waldmann C, Gager M. Post-traumatic stress disorder-related symptoms in relatives of patients following intensive care. Intensive Care Med. 2004 Mar;30(3):456-60. doi: 10.1007/s00134-003-2149-5. Epub 2004 Feb 4.

    PubMed 14767589

  • Fumis RR, Ranzani OT, Martins PS, Schettino G. Emotional disorders in pairs of patients and their family members during and after ICU stay. PLoS One. 2015 Jan 23;10(1):e0115332. doi: 10.1371/journal.pone.0115332. eCollection 2015.

    PubMed 25616059

  • Hartog CS, Schwarzkopf D, Riedemann NC, Pfeifer R, Guenther A, Egerland K, Sprung CL, Hoyer H, Gensichen J, Reinhart K. End-of-life care in the intensive care unit: a patient-based questionnaire of intensive care unit staff perception and relatives' psychological response. Palliat Med. 2015 Apr;29(4):336-45. doi: 10.1177/0269216314560007. Epub 2015 Jan 29.

    PubMed 25634628

  • Engstrom A, Soderberg S. The experiences of partners of critically ill persons in an intensive care unit. Intensive Crit Care Nurs. 2004 Oct;20(5):299-308; quiz 309-10. doi: 10.1016/j.iccn.2004.05.009.

    PubMed 15450619

  • McAdam JL, Arai S, Puntillo KA. Unrecognized contributions of families in the intensive care unit. Intensive Care Med. 2008 Jun;34(6):1097-101. doi: 10.1007/s00134-008-1066-z. Epub 2008 Mar 28.

    PubMed 18369593

Questions about this trial

What is this clinical trial studying?

A study testing Family Care Rituals in people with Stress Disorders, Post-Traumatic and Depression, run by Brown University at 3 sites in 2 countries.

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 8 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 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, 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?

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?

Symptoms of Post-Traumatic Stress Disorder in family members of intensive care patients (time frame: 90 days post patient discharge from ICU). 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 NCT02875912, which also lists 28 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 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in