Evaluating Effectiveness of a Communication Facilitator : A Randomized Trial

NCT04133753 | Unknown DMC

• 1 other identifier: APHP180586
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, model, and teach communication strategies that enable patients and their families to secure care in line with patients' goals of care over an illness trajectory, beginning in the ICU and continuing to care in the community.

Conditions

Intensive Care Unit; Life Stress; Family Members; Facilitation, Social

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale (HADS) - family

  Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS), which has become standard for ICU and post-ICU studies. The HADS is a reliable and valid 14-item, 2-domain (anxiety and depression) tool used to assess symptoms of psychological distress. Seven items evaluate anxiety and seven evaluate depression. Each item is scored on a 4-point scale (ranging from 0-3) with scores for each subscale (anxiety and depression) ranging from 0-21. HADS has been used in over 700 studies with evidence of reliability, validity and responsiveness among critically ill patients and their family.

  6 months after randomization

Secondary Outcomes (15)

• Hospital Anxiety and Depression Scale (HADS) - family 1, 3

  1- and 3- months after randomization

• Hospital Anxiety and Depression Scale (HADS) - patient 1, 3, 6

  1-, 3-, and 6-months after randomization

• Hospital Anxiety and Depression Scale - Anxiety subscale - family 1, 3, 6

  1-, 3-, and 6-months after randomization

• Hospital Anxiety and Depression Scale - Anxiety subscale - patient 1, 3, 6

  1-, 3-, and 6-months after randomization

• Goal-concordant care (SUPPORT items) - patient and family

  1-, 3-, and 6-months after randomization

Other Outcomes (4)

• Qualitative interviews

  6-months after randomization

• return to work - family

  6-months after randomization

• return to work - patient

  6-months after randomization

Study Arms (2)

Facilitator-Based Intervention

EXPERIMENTAL

The 'Facilitator-Based Intervention' includes patient and family member subjects.

Behavioral: Facilitator-Based Intervention

Usual Care

NO INTERVENTION

The 'Usual Care' arm includes patient and family member subjects.

Interventions

Facilitator-Based Intervention BEHAVIORAL

Facilitators interact in person with patients, family, and clinicians both during and following the patient's ICU stay for 3 months. In-person contacts include visits to patients' homes and/or care facilities; phone contacts include calls to patients, families and clinicians. Patients and families have access to facilitators through phone and email. Facilitators may attend clinic visits with patients. In addition to checking directly with patients/families during regular contacts, facilitators also access the electronic health record to ensure they have accurate information about appointments and treatment plans and to document key points for the clinical team. Facilitators encourage referral to inpatient or outpatient palliative care services when needs are identified.

Also known as: Communication Facilitator

Facilitator-Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient:
• Age \>=18 years
• Admitted to the ICU with an expected length of stay of at least 2 days
• A chronic life-limiting illness suggesting a median survival of approximately 2 years or a risk of hospital mortality of \>15% using either SOFA score, APACHE score or Injury Severity Score (with any one or more score predicting hospital mortality \>15%)
• Patient informed consent or relative or trusted person of patient consent (when lacking patient decisional capacity)
• Patient with visiting relatives
• Family member:
• Age \>=18 years
• Family will be identified by the patient. If the patient does not have decisional capacity, family will be identified by a legal surrogate decision-maker. We will not limit the number of family members who can participate but anticipate 1-3 family members per patient (average 1.5 based on prior studies).
• Family informed consent

You may not qualify if:

• Patient:
• Non-French speaking patient or relative
• Pregnant or breastfeeding patient
• No social security coverage Family Member
• Non-French speaking

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint-Louis Hospital

Paris, 75010, France

Location

Related Publications (2)

• Renet A, Azoulay E, Reignier J, Cariou A, Renault A, Huet O, Pochard F, Engelberg RA, Kentish-Barnes N. "It's all about setting the stage." The nurse facilitator trial: perceived outcomes and implementation issues. A qualitative study among ICU clinicians and nurse facilitators. Intensive Care Med. 2024 Oct;50(10):1657-1667. doi: 10.1007/s00134-024-07589-z. Epub 2024 Aug 19.

  PMID: 39158706 DERIVED

• Kentish-Barnes N, Azoulay E, Reignier J, Cariou A, Lafarge A, Huet O, Gargadennec T, Renault A, Souppart V, Clavier P, Dilosquer F, Leroux L, Lege S, Renet A, Brumback LC, Engelberg RA, Pochard F, Resche-Rigon M, Curtis JR. A randomised controlled trial of a nurse facilitator to promote communication for family members of critically ill patients. Intensive Care Med. 2024 May;50(5):712-724. doi: 10.1007/s00134-024-07390-y. Epub 2024 Apr 4.

  PMID: 38573403 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Social Facilitation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Social Behavior

Central Study Contacts

Nancy KENTISH-BARNES, PhD

CONTACT

142499995; nancy.kentish@aphp.fr

Matthieu RESCHE-RIGON, MD PhD

CONTACT

142499742; matthieu.resche-rigon@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 21, 2019
• Study Start: January 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 21, 2019

Record last verified: 2019-10

Locations

FR (1)