Improving Clinician Communication Skills (ICCS)

Advanced Cancer Clinical Trial

— ICCS  

Official title:

Improving Patient Outcomes in End-of-Life Care Provided by Physicians and Nurses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687349
• Other study ID #: 31466-G
• Secondary ID: R01NR009987
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2008
• Last updated: September 13, 2014
• Start date: April 2007
• Est. completion date: March 2013

Study information

• Verified date: September 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6086
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Advanced Cancer
• Chronic Obstructive Pulmonary Disease (COPD)
• Congestive Heart Failure
• End Stage Liver Disease
• Heart Failure
• Liver Diseases
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Restrictive Lung Disease

Intervention

Behavioral:
• Training Program Intervention
Resident or NP Student receives the educational intervention during 8 half-day sessions.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Washington; Harborview Medical Center	Seattle	Washington
United States	University of Washington; UW Medical Center	Seattle	Washington
United States	Veteran's Affairs Puget Sound HCS	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and family ratings on the "End-of-Life domain" of the Quality of Communication Questionaire (QOC)		4/1/2007-3/31/2012	No
Secondary	Patient symptoms of depression as assessed by the PHQ-8 (Memorial Symptom Assessment scale)		4/01/2007-3/31/2012	No
Secondary	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		4/01/2007-3/31/2012	No