Goals of Care Communication (GoC)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
goals of care
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion criteria:
- Diagnosis of HF from either systolic or diastolic dysfunction, with an ejection fraction of ≤ 40%
- Completion of an outpatient HF visit within the past 6 months
- Ability to read, write, and speak in English
Exclusion criteria:
- Short BLESSED cognitive score > 10 to rule out significant cognitive impairment;82
- Diagnosis of any additional terminal illness with life expectancy of ≤ 1 year not related to heart disease
- Psychiatric illness that required hospitalization in the past year; and (4) age less than 18 years
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Goc Intervention
usual care
Arm Description
Patient education materials, study nurse phone call, tip sheet, provider tip sheet
care as usual in the community
Outcomes
Primary Outcome Measures
quality of communication
qoc questionnaire
Secondary Outcome Measures
HF qol
KCCQ questionnaire
anxiety
GAD-7 questionnaire
depression
phq-9 questionnaire
advanced directives
completion of adv directive or 5 wishes
Full Information
NCT ID
NCT02466100
First Posted
November 7, 2014
Last Updated
October 24, 2016
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02466100
Brief Title
Goals of Care Communication
Acronym
GoC
Official Title
Goals of Care Communication in Advanced Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study proposes to evaluate, among adults with advanced heart failure (HF) and their health care providers, the effects of a communication intervention designed to improve patient-provider communication about goals of care (GoC). Patient activated GoC conversations can result in providers' better understanding their patients' preferences for end-of-life care. GoC conversations that occur over time may allow patients and providers to consider a wider range of options earlier in the HF illness trajectory. Preliminary data suggests that the proposed GoC intervention increases the occurrence and quality of patient-provider communication about end-of-life care for advanced COPD. The proposed study will test the effects of the GoC intervention compared to usual care, using a randomized, 2-group (N = 80, n = 40/arm), repeated-measures design. Measures will be taken at a patient's baseline study entry and after the next scheduled clinic visit. Specific Aim 1 is to evaluate change in number of GoC conversations between patient and provider between the two groups. Specific Aim 2 is to examine whether the intervention increases patient quality of life, referrals to palliative care, advance care planning, decreases depression and anxiety. Specific Aim 3 is to describe the feasibility, acceptability, perceived benefits, burden, and implementation success of the intervention in the heart failure clinic setting. Patients will be randomized to the GoC intervention or to receive usual care. Patients in the GoC intervention group, telephone coaching by a research nurse to help patients role-play talking with their HF providers. Both patients and their providers, will be provided with summaries of individualized, patient-centered information about patient preferences for communicating about end-of-life care and patient self-identified barriers to and facilitators of communication about end-of-life care with tips on how to initiate goals of care discussions. Providers of patients in the intervention group will also be provided with patient-specific prognostic information based on the Seattle Heart Failure Model. The GoC intervention will be tested in a real-world clinic setting. This intervention is expected to be relatively cost-effective and easily translated into general cardiology practice in the future. The study is expected to make significant contributions to provision of earlier access to palliative care in the advanced HF disease trajectory.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Goc Intervention
Arm Type
Experimental
Arm Description
Patient education materials, study nurse phone call, tip sheet, provider tip sheet
Arm Title
usual care
Arm Type
No Intervention
Arm Description
care as usual in the community
Intervention Type
Behavioral
Intervention Name(s)
goals of care
Intervention Description
. Patients in the GoC intervention group, telephone coaching by a research nurse to help patients role-play talking with their HF providers. Both patients and their providers, will be provided with summaries of individualized, patient-centered information about patient preferences for communicating about end-of-life care and patient self-identified barriers to and facilitators of communication about end-of-life care with tips on how to initiate goals of care discussions. Providers of patients in the intervention group will also be provided with patient-specific prognostic information based on the Seattle Heart Failure Model.
Primary Outcome Measure Information:
Title
quality of communication
Description
qoc questionnaire
Time Frame
1 month after intervention completed
Secondary Outcome Measure Information:
Title
HF qol
Description
KCCQ questionnaire
Time Frame
1 month after intervention completed
Title
anxiety
Description
GAD-7 questionnaire
Time Frame
1 month after intervention completed
Title
depression
Description
phq-9 questionnaire
Time Frame
1 month after intervention completed
Title
advanced directives
Description
completion of adv directive or 5 wishes
Time Frame
1 month after intervention completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Diagnosis of HF from either systolic or diastolic dysfunction, with an ejection fraction of ≤ 40%
Completion of an outpatient HF visit within the past 6 months
Ability to read, write, and speak in English
Exclusion criteria:
Short BLESSED cognitive score > 10 to rule out significant cognitive impairment;82
Diagnosis of any additional terminal illness with life expectancy of ≤ 1 year not related to heart disease
Psychiatric illness that required hospitalization in the past year; and (4) age less than 18 years
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27401505
Citation
Doorenbos AZ, Levy WC, Curtis JR, Dougherty CM. An Intervention to Enhance Goals-of-Care Communication Between Heart Failure Patients and Heart Failure Providers. J Pain Symptom Manage. 2016 Sep;52(3):353-60. doi: 10.1016/j.jpainsymman.2016.03.018. Epub 2016 Jul 9.
Results Reference
derived
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