Goals of Care Communication

NCT ID: NCT02466100

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-09-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Goc Intervention

Patient education materials, study nurse phone call, tip sheet, provider tip sheet

Group Type: EXPERIMENTAL

goals of care

Intervention Type: 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.

usual care

care as usual in the community

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

goals of 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Cynthia M. Dougherty

Professor, Biobehavioral Nursing and Health Systems

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27401505 (View on PubMed)

Other Identifiers

44610-ED

Identifier Type: -

Identifier Source: org_study_id