Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Improving Clinician Communication Skills (ICCS)
This study is currently recruiting participants.
Verified by National Institute of Nursing Research (NINR), May 2008
Sponsored by: National Institute of Nursing Research (NINR)
Information provided by: National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT00687349
  Purpose

This research study is a randomized trial to evaluate a training program that is designed to improve the communication skills of clinicians. The training program focuses on care for patients with serious illnesses and their family members, and assesses effectiveness using patient and family outcomes. The long term goal of this research is to improve communication skills of doctors and nurses, thereby improving patient and family outcomes.


Condition Intervention Phase
Advanced Cancer
Chronic Obstructive Pulmonary Disease (COPD)
Restrictive Lung Disease
Congestive Heart Failure
End Stage Liver Disease
Behavioral: Training Program Intervention
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Heart Failure Hospice Care Liver Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Parallel Assignment
Official Title: Improving Patient Outcomes in End-of-Life Care Provided by Physicians and Nurses

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Patient and family ratings on the "End-of-Life domain" of the Quality of Communication Questionaire (QOC) [ Time Frame: 4/1/2007-3/31/2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient symptoms of depression as assessed by the PHQ-8 (Memorial Symptom Assessment scale) [ Time Frame: 4/01/2007-3/31/2012 ] [ Designated as safety issue: No ]
  • Patient-, family-, and nurse-assessed ratings of the quality of end-of-life care provided by study clinicians using Quality of End-of-Life Care questionaire [ Time Frame: 4/01/2007-3/31/2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 14550
Study Start Date: April 2007
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention Arm: Experimental
The training program will assign resident or NP student to a rotation. They will be receiving the educational intervention during 8 half-day sessions.
Behavioral: Training Program Intervention
Resident or NP Student receives the educational intervention during 8 half-day sessions.
Control Arm: No Intervention
Resident or NP student is assigned to usual education.

Detailed Description:

Three decades of research on end-of-life care in the United States indicates that people who are dying often spend their final days with a significant burden of pain and other symptoms and receive care they would not choose. Patient-clinician communication about end-of-life care is an important focus for improving patient-centered end-of-life care for three reasons: 1) it is an integral component of clinician skill that affects all other aspects of end-of-life care; 2) physicians and nurses in practice do not demonstrate adequate skills for communicating about end-of-life care; and 3) current training in end-of-life communication is inadequate. Studies have shown that clinicians can improve their communication skills with experiential training, but no studies to date have shown that an intervention to improve clinician communication skill improves patient outcomes. Furthermore, despite widespread knowledge that end-of-life care is best delivered in an interdisciplinary context, most studies do not incorporate interdisciplinary training that includes physicians and nurses.

This is a randomized trial of a communication skills workshop for internal medicine residents and nurse practitioner (NP) students. A total of 373 residents and 128 NP students from two large training programs (UW and MUSC) will be randomized to either the intervention or usual education. The study's primary outcome measure will be the QOC scores on the "communication about end-of-life care" domain. The QOC will be assessed by patients, family members, and nurses before and after the intervention time period for all trainees. Secondary outcome measures are patient symptoms and patient-, family - and nurse-assessed QEOLC scores. Outcome measures will be collected for 5 patients and family members per trainee before the intervention period and 5 patients and family members per trainee after the intervention period. Process measures for both residents and NP students will include pre- and post-intervention assessment of knowledge, attitudes, and behavior regarding communication using standardized patient assessment as well as self-assessment and faculty assessment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Physician:

  • all internal medicine residents at either University of Washington (UW)or the Medical University of South Carolina
  • who have a clinical rotation allowing implementation of the intervention.

NP Student:

  • All NP Students at UW or MUSC
  • in programs that train them to work with the following patient types:
  • Adult patents with Cancer or other chronic, life-limiting illnesses
  • Older Adults
  • Adults Primary Care Patients

Patient:

One or more of the following diagnostic criteria:

  • Advanced Cancer;
  • Chronic obstructive pulmonary disease (COPD) with FEV1 values < 35% predicted and/or oxygen dependent;
  • Restrictive lung disease with a TLC < 50% predicted;
  • Congestive heart failure with an ejection fraction <30% or functional deficits matching New York Heart Association Class III or IV heart failure;
  • End stage liver disease including Child's Class C cirrhosis, MELD score ≥ 18, a variceal bleed, refractory ascites, or spontaneous bacterial peritonitis (SBP);
  • a Charlson Comorbidity Score point value ≥6;
  • in-patients with a University HealthSystem Consortium (UHC) Risk of Mortality score of major or extreme;
  • OR hospitalized patients ≥ 80 years.

Family:

  • The ability to speak English well enough to be able to complete the study procedures
  • AND no significant dementia or delirium that would limit the family member's ability to complete instruments.

Nurse-evaluators:

  • are working in the hospital or clinic with the resident or NP student enrolled in the study.

Exclusion Criteria:

  • less than 18 years,
  • significant dementia, delirium, or psychosis;
  • the inability to speak English well enough to be able to complete the study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687349

Contacts
Contact: J. Randall Curtis, MD, MPH 206-744-3356 jrc@u.washington.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
United States, Washington
University of Washington; Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
University of Washington; UW Medical Center Recruiting
Seattle, Washington, United States, 98195
Veteran's Affairs Puget Sound HCS Recruiting
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Principal Investigator: J. Randall Curtis, MD, MPH University of Washington, Div. of Pulmonary and Critical Care Medicine
  More Information

Responsible Party: University of Washington, Division of Pulmonary and Critical Care Medicine ( Dr. J. Randall Curtis )
Study ID Numbers: R01NR009987, R01 NR009987
Study First Received: May 28, 2008
Last Updated: May 30, 2008
ClinicalTrials.gov Identifier: NCT00687349  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):
End-of-Life issues
Talking with your doctor
Coping with chronic illness

Study placed in the following topic categories:
Heart Failure
Lung Diseases, Obstructive
Liver Diseases
Digestive System Diseases
Heart Diseases
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009