Goals of Care Conversations Study

Study Overview
=================
Brief 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 alone, 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.

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

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

Intervention / Treatment
-----------------
* Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training
* Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training
* Behavioral: Low patient engagement
* Behavioral: High patient engagement


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential multiple-assignment randomized clinical trial (SMART)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No then high patient engagement<br>First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training. | Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training<br>* 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.<br>Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training<br>* This includes two components: 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 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.<br>Behavioral: High patient engagement<br>* 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.<br>* Other names: PREPARE information and website and phone call;|
| Active Comparator: No then low patient engagement<br>First stage: No patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training. | Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training<br>* 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.<br>Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training<br>* This includes two components: 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 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.<br>Behavioral: Low patient engagement<br>* Patients will be sent information about goals of care conversations, including the PREPARE website.<br>* Other names: PREPARE information and website;|
| Active Comparator: Low then high patient engagement<br>First stage: Low intensity patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): High patient engagement and high intensity clinician training. | Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training<br>* 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.<br>Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training<br>* This includes two components: 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 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.<br>Behavioral: Low patient engagement<br>* Patients will be sent information about goals of care conversations, including the PREPARE website.<br>* Other names: PREPARE information and website;Behavioral: High patient engagement<br>* 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.<br>* Other names: PREPARE information and website and phone call;|
| Active Comparator: Low then low patient engagement<br>First stage: Low patient engagement. Low intensity clinician training. Second stage (responders only): No patient engagement and high intensity clinician training. Second stage (non-responders only): Low intensity patient engagement and high intensity clinician training. | Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training<br>* 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.<br>Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training<br>* This includes two components: 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 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.<br>Behavioral: Low patient engagement<br>* Patients will be sent information about goals of care conversations, including the PREPARE website.<br>* Other names: PREPARE information and website;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the start of stage 2 to 9 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | From the start of stage 1 to the beginning of stage 2 (approximately 8 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implementation science, primary health care, advance care planning, patient care planning, palliative care, goals of care conversation, serious illness