Improving Clinician Communication Skills (ICCS)

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT00687349

Collaborator

National Institute of Nursing Research (NINR) (NIH)

6,086

Enrollment

Locations

Arms

Duration (Months)

1521.5

Patients Per Site

21.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer Chronic Obstructive Pulmonary Disease (COPD) Restrictive Lung Disease Congestive Heart Failure End Stage Liver Disease	Behavioral: Training Program Intervention	Phase 3

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:

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6086 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Patient and family ratings on the "End-of-Life domain" of the Quality of Communication Questionaire (QOC) [4/1/2007-3/31/2012]

Secondary Outcome Measures

Patient symptoms of depression as assessed by the PHQ-8 (Memorial Symptom Assessment scale) [4/01/2007-3/31/2012]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425
2	University of Washington; Harborview Medical Center	Seattle	Washington	United States	98104
3	Veteran's Affairs Puget Sound HCS	Seattle	Washington	United States	98108
4	University of Washington; UW Medical Center	Seattle	Washington	United States	98195