Facilitating Communication Study

NCT03721952 | Completed Results DMC

• 1 other identifier: STUDY00005369
• Study Type: interventional
• Target: 977
• Locations: 1 country
• Sites: 3

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

Chronic Disease; Neoplasm Metastasis; Lung Neoplasm; Pulmonary Disease, Chronic Obstructive; Heart Failure, Congestive; Liver Cirrhosis; Kidney Failure, Chronic; Multiple Organ Failure; Health Care Quality, Access, and Evaluation; Intensive Care Units; Palliative Care, Health Services; Palliative Care, Patient Care; Lung Diseases; Cerebrovascular Disorders; Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Depression Symptoms, Family (HADS-D)

  Family member symptoms of depression and anxiety assessed with the Hospital Anxiety and Depression Scale (HADS). 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. For each of three follow-up points (1-month, 3-month, and 6-month), the response variable was the sum of 7 items measuring depression, weighted for the number of items with valid responses. The sum could range from 0 to 21, with higher values indicating greater depression (i.e., worse outcome),

  1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value

Secondary Outcomes (15)

• Anxiety Symptoms, Family (HADS-A)

  1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value

• Quality of Family Experience - Relationship With Healthcare Providers (QUAL-E Fam)

  1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value

• Quality of Family Experience - Sense of Completion (QUAL-E Fam)

  1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value

• Quality of Family Experience - Preparation Issues (QUAL-E Fam)

  1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value

• Goal-Concordant Care, Family Assessment

  1-month, 3-month, and 6-month values for the outcome, using a linear mixed-effects model that evaluates the effects of the intervention, time point, and the intervention-time interaction on the outcome after adjustment for the baseline value

Other Outcomes (6)

• Perceived Competence Scale (PCS), 1 Month - Family

  Assessed on 1-month questionnaires

• Perceived Competence Scale (PCS), 3 Months - Family

  Assessed on 3-month questionnaires

• Perceived Competence Scale (PCS), 6 Months - Family

  Assessed on 6-month questionnaires

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 or by telephone 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 5 days per week. 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:

• PATIENTS. Eligible patients 18 years of age or older, English-speaking, with a chronic life-limiting illness suggesting a median survival of approximately 2 years or a severe acute illness with a risk of hospital mortality of at least 15%. Chronic life-limiting illnesses include: cancer with a poor prognosis (e.g. metastatic cancer); chronic pulmonary disease (e.g. COPD, restrictive lung disease); coronary artery disease (CAD); congestive heart failure (CHF); peripheral vascular disease (PVD); severe liver disease (e.g. cirrhosis); diabetes with end-organ damage; renal failure (e.g. ESRD); and dementia. Acute illness criteria include a SOFA, APACHE or trauma severity score predicting a 15% or greater risk of hospital mortality. Acute illnesses and conditions also include: age \>=80 years; acute respiratory distress syndrome (ARDS) with P/F ratio \<=300; subarachnoid hemorrhage (SAH) Fisher grade 3/4 with Glasgow coma score (GCS) \<=12; spontaneous hemorrhage (ICH, IPH, EDH, SDH) with GCS \<=12; stroke or cardiovascular accident (CVA) with GCS \<=12; decompressive/crash craniotomy (bone flap) with GCS \<=12; traumatic brain injury (TBI) or diffuse axonal injury (DAI) based on MRI \~day 10; or anoxic brain injury due to cardiac arrest \>48 hours. All potential participants screened for facility with English and absence of significant cognitive impairment (prior to their current hospitalization) that would limit their ability to complete survey instruments.
• FAMILY. Eligible family subjects18 years of age or older, English-speaking, and identified as someone involved in patient's medical care or decision-making. Eligible family may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends.
• CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. Eligible clinicians and administrators 18 years of age or older, English-speaking, employed at a participating hospital and have a familiarity with the study and the intervention.

You may not qualify if:

• PATIENTS. We will exclude patients with an anticipated ICU stay of less than 2 days, as assessed by the critical care attending physician or his/her designee. We will exclude patients who have been in the ICU for more than 14 days.
• CLINICIAN AND ADMINISTRATOR INTERVIEW SUBJECTS. n/a

Sponsors & Collaborators

• University of Washington: lead

Study Sites (3)

UW Medicine - Harborview Medical Center

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center - Northwest

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Chronic Disease; Neoplasm Metastasis; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Failure; Liver Cirrhosis; Kidney Failure, Chronic; Multiple Organ Failure; Lung Diseases; Cerebrovascular Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Lung Diseases, Obstructive; Heart Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Shock; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

This study took place in one region of the US and may not generalize to other regions. There may be selection bias among those family members and patients who were willing to participate.

Results Point of Contact

• Title: Dr. Ruth Engelberg
• Organization: University of Washington

rengel@uw.edu

206-744-9523

Study Officials

• Ruth A Engelberg, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 26, 2018
• Study Start: April 17, 2019
• Primary Completion: October 26, 2023
• Study Completion: June 30, 2024
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)