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Improving Clinician Communication Skills (ICCS) (ICCS)

Primary Purpose

Advanced Cancer, Chronic Obstructive Pulmonary Disease (COPD), Restrictive Lung Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Training Program Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advanced Cancer focused on measuring End-of-Life issues, Talking with your doctor, Coping with chronic illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina
  • University of Washington; Harborview Medical Center
  • Veteran's Affairs Puget Sound HCS
  • University of Washington; UW Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

The training program will assign resident or NP student to a rotation. They will be receiving the educational intervention during 8 half-day sessions.

Resident or NP student is assigned to usual education.

Outcomes

Primary Outcome Measures

Patient and family ratings on the "End-of-Life domain" of the Quality of Communication Questionaire (QOC)

Secondary Outcome Measures

Patient symptoms of depression as assessed by the PHQ-8 (Memorial Symptom Assessment scale)
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

Full Information

First Posted
May 28, 2008
Last Updated
September 13, 2014
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00687349
Brief Title
Improving Clinician Communication Skills (ICCS)
Acronym
ICCS
Official Title
Improving Patient Outcomes in End-of-Life Care Provided by Physicians and Nurses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer, Chronic Obstructive Pulmonary Disease (COPD), Restrictive Lung Disease, Congestive Heart Failure, End Stage Liver Disease
Keywords
End-of-Life issues, Talking with your doctor, Coping with chronic illness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6086 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
The training program will assign resident or NP student to a rotation. They will be receiving the educational intervention during 8 half-day sessions.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Resident or NP student is assigned to usual education.
Intervention Type
Behavioral
Intervention Name(s)
Training Program Intervention
Intervention Description
Resident or NP Student receives the educational intervention during 8 half-day sessions.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Patient symptoms of depression as assessed by the PHQ-8 (Memorial Symptom Assessment scale)
Time Frame
4/01/2007-3/31/2012
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Randall Curtis, MD, MPH
Organizational Affiliation
University of Washington, Div. of Pulmonary and Critical Care Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Washington; Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Veteran's Affairs Puget Sound HCS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
University of Washington; UW Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24302090
Citation
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 with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081. Erratum In: JAMA. 2014 Apr 2;311(13):1360.
Results Reference
result
PubMed Identifier
24649963
Citation
Ford DW, Downey L, Engelberg R, Back AL, Curtis JR. Association between Physician Trainee Self-Assessments in Discussing Religion and Spirituality and Their Patients' Reports. J Palliat Med. 2014 Apr;17(4):453-62. doi: 10.1089/jpm.2013.0388. Epub 2014 Mar 20.
Results Reference
derived

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Improving Clinician Communication Skills (ICCS)

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