Improving Clinician Communication Skills (ICCS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
J. Randall Curtis, University of Washington
ClinicalTrials.gov Identifier:
NCT00687349
First received: May 28, 2008
Last updated: September 13, 2014
Last verified: September 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Patient Outcomes in End-of-Life Care Provided by Physicians and Nurses

Resource links provided by NLM:


Further study details as provided by University of Washington:

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 ]

Enrollment: 6086
Study Start Date: April 2007
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Arm
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.
No Intervention: Control Arm
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687349

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J. Randall Curtis, Professor of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT00687349     History of Changes
Other Study ID Numbers: 31466-G, R01NR009987, R01 NR009987
Study First Received: May 28, 2008
Last Updated: September 13, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
End-of-Life issues
Talking with your doctor
Coping with chronic illness

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Liver Diseases
End Stage Liver Disease
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Digestive System Diseases
Liver Failure
Hepatic Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014