Improving Communication About Serious Illness

NCT01933789 | Completed Results DMC

• 1 other identifier: 44023
• Study Type: interventional
• Target: 817
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to improve care delivered to patients with serious illness by enhancing communication among patients, families, and clinicians in the outpatient setting. We are testing a new way to help patients share their preferences for talking about end-of-life care with their clinicians and families. To do this we created a simple, short feedback form. The form is designed to help clinicians understand what patients would like to talk about. The goal of this research study is to show that using a feedback form is possible and can be helpful for patients and their families.

Conditions

Critical Illness; Chronic Disease; Terminal Care; Palliative Care; Communication; Advance Care Planning; Neoplasm Metastasis; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Failure; End Stage Liver Disease; Kidney Failure, Chronic

Keywords

Palliative Care; End-of-Life Issues; Patient/Clinician Communication; Patient/Family Communication; Concordance; Treatment Preferences; Anxiety; Depressive Symptoms; Talking with Your Doctor; Coping with Serious Illness; Outpatient Collaboration

Outcome Measures

Primary Outcomes (1)

• Occurrence of Discussion About Goals of Care at Target Visit

  Patient's response to question, "Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?"

  2 weeks after target visit

Secondary Outcomes (29)

• Occurrence of Discussion About Goals of Care at Target Visit

  Target visit

• Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline

  2 weeks after target visit

• Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline

  Target visit

• Goal-Concordant Care

  3 months after target visit

• Goal-Concordant Care Among Patients With Stable Treatment Preference

  3 months after target visit

Other Outcomes (2)

• Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)

  3 months after target visit

• Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care)

  3 months after target visit

Study Arms (2)

Feedback Group

EXPERIMENTAL

Subjects will complete surveys and assessments and will be given the Communication Feedback Form for Patients with Serious Illness to use prior to and during a target outpatient visit.

Behavioral: Communication Feedback Form for Patients with Serious Illness

Comparison/Usual Care Group

NO INTERVENTION

Subjects will only complete surveys and assessments.

Interventions

Communication Feedback Form for Patients with Serious Illness BEHAVIORAL

The intervention, based on self-efficacy theory, identifies patients' preferences for communication about end-of-life care (EOLC) and barriers and facilitators to this communication, and collates these data into a feedback form. The feedback forms are tailored to each recipient (clinician, patient, family) to support the communication tasks which that recipient will address. Feedback forms are sent to participants prior to the target clinic visit. The primary clinician's form suggests referral to palliative care if there are "potentially unmet palliative-care communication needs." All forms include "tips" to help the recipient respond to communication preferences appropriately.

Also known as: "Audit and Feedback"

Feedback Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a "primary role" with eligible patients. A "primary role" denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated
• Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team.
• Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values \<35% predicted or oxygen dependence or restrictive lung disease with a TLC \< 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of \>17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of \< 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD \<250m, restrictive lung disease (IPF, ILD) w/ TLC \<50%, and cystic fibrosis with FEV1 \< 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires.
• Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, "family member" is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires.

Sponsors & Collaborators

• University of Washington: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (6)

Valley Medical Center

Renton, Washington, 98058, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Northwest Hospital and Medical Center

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

UW Neighborhood Clinics

Seattle, Washington, 98195, United States

Location

Related Publications (9)

• Au DH, Udris EM, Engelberg RA, Diehr PH, Bryson CL, Reinke LF, Curtis JR. A randomized trial to improve communication about end-of-life care among patients with COPD. Chest. 2012 Mar;141(3):726-735. doi: 10.1378/chest.11-0362. Epub 2011 Sep 22.

  PMID: 21940765 BACKGROUND

• Knauft E, Nielsen EL, Engelberg RA, Patrick DL, Curtis JR. Barriers and facilitators to end-of-life care communication for patients with COPD. Chest. 2005 Jun;127(6):2188-96. doi: 10.1378/chest.127.6.2188.

  PMID: 15947336 BACKGROUND

• Curtis JR, Patrick DL. Barriers to communication about end-of-life care in AIDS patients. J Gen Intern Med. 1997 Dec;12(12):736-41. doi: 10.1046/j.1525-1497.1997.07158.x.

  PMID: 9436892 BACKGROUND

• Curtis JR, Engelberg RA, Nielsen EL, Au DH, Patrick DL. Patient-physician communication about end-of-life care for patients with severe COPD. Eur Respir J. 2004 Aug;24(2):200-5. doi: 10.1183/09031936.04.00010104.

  PMID: 15332385 BACKGROUND

• Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98. doi: 10.1089/jpm.2006.9.1086.

  PMID: 17040146 BACKGROUND

• Curtis JR, Wenrich MD, Carline JD, Shannon SE, Ambrozy DM, Ramsey PG. Patients' perspectives on physician skill in end-of-life care: differences between patients with COPD, cancer, and AIDS. Chest. 2002 Jul;122(1):356-62. doi: 10.1378/chest.122.1.356.

  PMID: 12114382 BACKGROUND

• Coats H, Downey L, Sharma RK, Curtis JR, Engelberg RA. Quality of Communication and Trust in Patients With Serious Illness: An Exploratory Study of the Relationships of Race/Ethnicity, Socioeconomic Status, and Religiosity. J Pain Symptom Manage. 2018 Oct;56(4):530-540.e6. doi: 10.1016/j.jpainsymman.2018.07.005. Epub 2018 Jul 17.

  PMID: 30025937 DERIVED

• Curtis JR, Downey L, Back AL, Nielsen EL, Paul S, Lahdya AZ, Treece PD, Armstrong P, Peck R, Engelberg RA. Effect of a Patient and Clinician Communication-Priming Intervention on Patient-Reported Goals-of-Care Discussions Between Patients With Serious Illness and Clinicians: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jul 1;178(7):930-940. doi: 10.1001/jamainternmed.2018.2317.

  PMID: 29802770 DERIVED

• Fakhri S, Engelberg RA, Downey L, Nielsen EL, Paul S, Lahdya AZ, Treece PD, Curtis JR. Factors Affecting Patients' Preferences for and Actual Discussions About End-of-Life Care. J Pain Symptom Manage. 2016 Sep;52(3):386-94. doi: 10.1016/j.jpainsymman.2016.03.012. Epub 2016 Jun 3.

  PMID: 27265813 DERIVED

Related Links

• Click here for more information about this study. PCORI Project Summary: Health System Intervention to Improve Communication about End-of-Life Care for Vulnerable Patients
• The End-of-Life Care Research Program at the UW School of Medicine
• The Palliative Care Center of Excellence at the University of Washington

MeSH Terms

Conditions

Critical Illness; Chronic Disease; Communication; Neoplasm Metastasis; Lung Neoplasms; Pulmonary Disease, Chronic Obstructive; Heart Failure; End Stage Liver Disease; Kidney Failure, Chronic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Neoplastic Processes; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Heart Diseases; Cardiovascular Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Mental Disorders; Behavioral Symptoms

Limitations and Caveats

This study took place in one region of the US and may not generalize to other regions. There may be selection bias among those clinicians and patients who were willing to participate.

Results Point of Contact

• Title: Dr. J. Randall Curtis
• Organization: University of Washington

jrc@uw.edu

206-744-3356

Study Officials

• J. Randall Curtis, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine, Division of Pulmonary and Critical Care

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 2, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 20, 2019
• Results First Posted: February 11, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)