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Goals of Care Communication (GoC)

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University of Washington

Status and phase

Completed
Phase 2
Phase 1

Conditions

Heart Failure

Treatments

Behavioral: goals of care

Study type

Interventional

Funder types

Other

Identifiers

NCT02466100
44610-ED

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Goc Intervention
Experimental group
Description:
Patient education materials, study nurse phone call, tip sheet, provider tip sheet
Treatment:
Behavioral: goals of care
usual care
No Intervention group
Description:
care as usual in the community

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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