NCT05001009

Goals of Care Conversations Study

Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The long term goal is to improve quality of care in Veterans with serious illnesses by aligning medical care with Veterans' goals and values. The objective of this study is to use a sequentially randomized trial to determine what implementation strategies are effective to increase early, outpatient goals of care conversations. The study will use interviews with and surveys of medical providers, patients, and caregivers, along with medical record data. This work is significant because it tests ways Veterans can express their goals and preferences for life sustaining treatments and have them honored.

Detailed description

The aims of this study are as follows: Aim 1. Use a clinician-level SMART in three VA health systems to determine the effectiveness of clinician and patient implementation strategies to improve the occurrence of documented goals of care conversations in Veterans with serious medical illness. Hypothesis 1 (first stage of the SMART): Compared to a low intensity clinician strategy alone, a low intensity clinician and patient strategy will lead to increased documentation of goals of care conversations. Hypothesis 2. Among those who do not respond to low intensity strategies, compared to a high intensity clinician strategy paired with a low intensity patient strategy, a high intensity clinician and patient strategy will lead to increased documentation of goals of care conversations. Aim 2a. Identify the sequence of implementation strategies that leads to the overall greatest increase in documentation of goals of care conversations. Aim 2b (exploratory). Identify patient and clinician characteristics that modify the effect of sequences of implementation strategies on documentation of goals of care conversations. Aim 3. Understand clinician and patient implementation strategy success or failure using a mixed method evaluation involving clinicians, leaders, patients, and caregivers.

Conditions

• Seriously Ill Patients
• Cancer
• Heart Failure
• Interstitial Lung Disease
• Chronic Obstructive Pulmonary Disease
• End-stage Renal Disease
• End-stage Liver Disease
• Dementia

Interventions

Type	Name	Description
BEHAVIORAL	Clinician Implementation Strategy Stage 1: low intensity clinician training	A "booster" of the established LSTDI implementation strategy. Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study. Online training options and when and how to complete goals of care conversations and documentation will be highlighted.
BEHAVIORAL	Clinician Implementation Strategy Stage 2: high intensity clinician training	This includes two components: 1. Team facilitation to help the primary care team (advance practice provider, nurse, social worker) work together to create roles and responsibilities for accomplishing goals of care conversations with patients 2. A patient list "trigger" of patients potentially eligible for goals of care conversations (the patient study population) will be sent to the primary care clinicians.
BEHAVIORAL	Low patient engagement	Patients will be sent information about goals of care conversations, including the PREPARE website.
BEHAVIORAL	High patient engagement	Patients will be sent information about goals of care conversations, including the PREPARE website. Follow-up phone calls to discuss goals of care conversations and the PREPARE website will be made.

Timeline

• Start date: 2022-09-13
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2021-08-11
• Last updated: 2024-12-27

Locations

3 sites across 1 country: United States