Goals of Care Conversations Study

N/AEnrolling By InvitationNCT05001009

VA Office of Research and Development72 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Interventions

Clinician Implementation Strategy Stage 1: low intensity clinician trainingBEHAVIORAL

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.

Clinician Implementation Strategy Stage 2: high intensity clinician trainingBEHAVIORAL

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.

Low patient engagementBEHAVIORAL

Patients will be sent information about goals of care conversations, including the PREPARE website.

High patient engagementBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: CLINICIANS VA primary care advance practice clinicians (MDs, APRNs, PAs) at one of the three study sites able to complete goals of care conversation notes and orders. Advance practice clinicians will be eligible for randomization if they have at least 15 eligible patients without goals of care conversation notes at the start of stage 1 (to allow participating clinicians ample opportunities to write notes) and have written fewer than 4 goals of care conversation notes in the previous 6 months (to select clinicians who need improvement), and can potentially receive the planned implementation strategies, i.e., clinicians who regularly attend the Patient Aligned Care Team (PACT) team meetings. PATIENTS * Veteran enrolled in VHA health care in one of the three study sites who is a current patient of one of the eligible primary care clinicians * Diagnosis of cancer, heart failure, interstitial lung disease, chronic obstructive pulmonary disease, end-stage renal disease, end-stage liver disease, and dementia * Care Assessment Need score of \> or equal to 90 using the one-year combined hospitalization/mortality variable Exclusion Criteria: PATIENTS * Prisoner * Pregnant * under 18 years of age.

Locations (3)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Percent of patients with a goals of care conversation note documented in Stage 2

Amongst patients attributed to a clinician who was randomized in Stage 2, whether or not a goals of care conversation note was written during Stage 2.

Time frame: From the start of stage 2 to 9 months later

Secondary Outcomes

Percent of patients with a goals of care conversation note documented in Stage 1 or 2

Amongst all patients in the study, whether or not a goals of care conversation note was written during the study.

Time frame: From the start of stage 1 to 9 months after the start of stage 2

Percent of patients with a goals of care conversation note documented in Stage 1

Amongst all patients in the study, whether or not a goals of care conversation note was written during stage 1

Time frame: From the start of stage 1 to the beginning of stage 2 (approximately 8 months)