Clinical trial NCT02466100: Goals of Care Communication
Official title: Goals of Care Communication in Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. Diagnosis of HF from either systolic or diastolic dysfunction, with an ejection fraction of ≤ 40%
2. Completion of an outpatient HF visit within the past 6 months
3. Ability to read, write, and speak in English

Exclusion criteria:

1. Short BLESSED cognitive score \> 10 to rule out significant cognitive impairment;82
2. Diagnosis of any additional terminal illness with life expectancy of ≤ 1 year not related to heart disease
3. Psychiatric illness that required hospitalization in the past year; and (4) age less than 18 years

Primary outcomes:
measure: quality of communication
timeFrame: 1 month after intervention completed
Secondary outcomes:
measure: HF qol
timeFrame: 1 month after intervention completed
measure: anxiety
timeFrame: 1 month after intervention completed
measure: depression
timeFrame: 1 month after intervention completed
measure: advanced directives
timeFrame: 1 month after intervention completed
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
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.