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Completed

NCT Number: NCT02466100

Goals of Care Communication

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

goals of care

Behavioral

. 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 outcomes

  1. quality of communication

    Time frame: 1 month after intervention completed

    qoc questionnaire

Secondary outcomes

  1. HF qol

    Time frame: 1 month after intervention completed

    KCCQ questionnaire

  2. anxiety

    Time frame: 1 month after intervention completed

    GAD-7 questionnaire

  3. depression

    Time frame: 1 month after intervention completed

    phq-9 questionnaire

  4. advanced directives

    Time frame: 1 month after intervention completed

    completion of adv directive or 5 wishes

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Goals of Care Communication in Advanced Heart Failure

Acronym: GoC

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2015
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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