LSTDI: Goals of Care Conversations Study

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT05001009

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seriously Ill Patients Cancer Heart Failure Interstitial Lung Disease Chronic Obstructive Pulmonary Disease End-stage Renal Disease End-stage Liver Disease Dementia	Behavioral: Clinician Implementation Strategy Stage 1 Behavioral: Clinician Implementation Strategy Stage 2 Behavioral: Low patient engagement Behavioral: High patient engagement	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Sequential multiple-assignment randomized clinical trial (SMART)Sequential multiple-assignment randomized clinical trial (SMART)

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: No then high patient engagement First stage: No patient engagement Second stage: High patient engagement	Behavioral: Clinician Implementation Strategy Stage 1 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 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. 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. Other Names: PREPARE information and website and phone call
Active Comparator: No then low patient engagement First stage: No patient engagement Second stage: Low patient engagement	Behavioral: Clinician Implementation Strategy Stage 1 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 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. Behavioral: Low patient engagement Patients will be sent information about goals of care conversations, including the PREPARE website. Other Names: PREPARE information and website
Active Comparator: No then no patient engagement First stage: No patient engagement Second stage: No patient engagement	Behavioral: Clinician Implementation Strategy Stage 1 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 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.
Active Comparator: Low then high patient engagement First stage: Low patient engagement Second stage: High patient engagement	Behavioral: Clinician Implementation Strategy Stage 1 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 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. Behavioral: Low patient engagement Patients will be sent information about goals of care conversations, including the PREPARE website. Other Names: PREPARE information and 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. Other Names: PREPARE information and website and phone call
Active Comparator: Low then low patient engagement First stage: Low patient engagement Second stage: Low patient engagement	Behavioral: Clinician Implementation Strategy Stage 1 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 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. Behavioral: Low patient engagement Patients will be sent information about goals of care conversations, including the PREPARE website. Other Names: PREPARE information and website
Active Comparator: Low then no patient engagement First stage: Low patient engagement Second stage: No patient engagement	Behavioral: Clinician Implementation Strategy Stage 1 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 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. Behavioral: Low patient engagement Patients will be sent information about goals of care conversations, including the PREPARE website. Other Names: PREPARE information and website

Outcome Measures

Primary Outcome Measures

Number of goals of care conversation (LST) notes completed among clinicians [6 months]
Number of goals of care conversation (LST) notes completed among clinicians in both stages of the SMART.

Secondary Outcome Measures

Percent of eligible patients sent a letter [6 months]
Percent of eligible patients sent a letter about goals of care conversations in both stages of the SMART.
Percent of eligible patients that view the PREPARE website [6 months]
Percent of eligible patients that view the PREPARE website in both stages of the SMART.
Percent of eligible patients spoken to by telephone during stage 2 of the SMART [6 months]
Percent of eligible patients spoken to by telephone during stage 2 of the SMART.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

CLINICIANS VA primary care advance practice clinicians (MDs, APRNs) at one of the three study sites able to complete LST notes and orders. Advance practice clinicians will be eligible for randomization if they have at least 15 eligible patients without LST notes at the start of stage 1 (to allow participating clinicians ample opportunities to write notes) and have written fewer than 4 LST notes in the previous year (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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California	United States	94304-1290
2	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California	United States	90073
3	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado	United States	80045

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO
Principal Investigator: Anne M Walling, MD PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA