Improving Clinician Communication Skills (ICCS)

NCT ID: NCT00687349

Last Updated: 2014-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6086 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2013-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Training Program Intervention

Intervention Type: BEHAVIORAL

Resident or NP Student receives the educational intervention during 8 half-day sessions.

Control Arm

Resident or NP student is assigned to usual education.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training Program Intervention

Resident or NP Student receives the educational intervention during 8 half-day sessions.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

J. Randall Curtis

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Randall Curtis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington, Div. of Pulmonary and Critical Care Medicine

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

University of Washington; Harborview Medical Center

Seattle, Washington, United States

Veteran's Affairs Puget Sound HCS

Seattle, Washington, United States

University of Washington; UW Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24302090 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24649963 (View on PubMed)

Other Identifiers

R01NR009987

Identifier Type: NIH

Identifier Source: secondary_id

View Link

31466-G

Identifier Type: -

Identifier Source: org_study_id