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Advanced CancerPhase 3ICCSNCT00687349

Improving Clinician Communication Skills (ICCS)

A Phase 3 study testing Training Program Intervention in people with Advanced Cancer and Chronic Obstructive Pulmonary Disease (COPD), run by University of Washington at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Training Program Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,086 participants
Where
4 sitesUnited States
Study dates
Apr 2007to Mar 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 24Show fewer
  • 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.

Who cannot join

  • less than 18 years,
  • significant dementia, delirium, or psychosis;
  • the inability to speak English well enough to be able to complete the study procedures.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Washington; Harborview Medical Center

    Seattle, Washington, 98104

  • Veteran's Affairs Puget Sound HCS

    Seattle, Washington, 98108

  • University of Washington; UW Medical Center

    Seattle, Washington, 98195

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Training Program Intervention
Keywords
End-of-Life issues, Talking with your doctor, Coping with chronic illness
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Heart Failure, End Stage Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training Program InterventionBehavioural

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

Study groups in NCT00687349
Study groupRoleWhat they receive
Intervention ArmExperimentalThe training program will assign resident or NP student to a rotation. They will be receiving the educational intervention during 8 half-day sessions.
Receives: Behavioral: Training Program Intervention
Control ArmNo interventionResident or NP student is assigned to usual education.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4/1/2007-3/31/2012

Secondary outcomes (2)

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

    Measured: 4/01/2007-3/31/2012

  2. 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

    Measured: 4/01/2007-3/31/2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2008 (estimated)
  2. Study startApr 2007
  3. Primary completionFeb 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,086 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00687349
Sponsor's protocol ID
31466-G
Other IDs
R01NR009987
Acronym
ICCS
Status last verified
Sep 2014
First submitted
28 May 2008
Last updated
16 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24302090

  • 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.

    PubMed 24649963

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Training Program Intervention in people with Advanced Cancer and Chronic Obstructive Pulmonary Disease (COPD), run by University of Washington at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00687349, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.

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