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Goals of Care Conversations Study (LSTDI)

Primary Purpose

Seriously Ill Patients, Cancer, Heart Failure

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clinician Implementation Strategy Stage 1

Clinician Implementation Strategy Stage 2

Low patient engagement

High patient engagement

About this trial

This is an interventional health services research trial for Seriously Ill Patients focused on measuring implementation science, primary health care, advance care planning, patient care planning, palliative care, goals of care conversation, serious illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

VA Palo Alto Health Care System, Palo Alto, CA
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Rocky Mountain Regional VA Medical Center, Aurora, CO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Arm Label

No then high patient engagement

No then low patient engagement

No then no patient engagement

Low then high patient engagement

Low then low patient engagement

Low then no patient engagement

Arm Description

First stage: No patient engagement Second stage: High patient engagement

First stage: No patient engagement Second stage: Low patient engagement

First stage: No patient engagement Second stage: No patient engagement

First stage: Low patient engagement Second stage: High patient engagement

First stage: Low patient engagement Second stage: Low patient engagement

First stage: Low patient engagement Second stage: No patient engagement

Outcomes

Primary Outcome Measures

Number of goals of care conversation notes completed among clinicians

Number of goals of care conversation notes completed among clinicians in both stages of the SMART.

Secondary Outcome Measures

Percent of eligible patients sent a letter

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

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

Percent of eligible patients spoken to by telephone during stage 2 of the SMART.

Full Information

NCT ID

NCT05001009

First Posted

August 2, 2021

Last Updated

October 6, 2022

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT05001009

Brief Title

Goals of Care Conversations Study

Acronym

LSTDI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

September 13, 2022 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

implementation science, primary health care, advance care planning, patient care planning, palliative care, goals of care conversation, serious illness

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Sequential multiple-assignment randomized clinical trial (SMART)

Masking

Investigator

Masking Description

The primary outcome of goals of care conversation notes is determined by whether notes are entered into the electronic health record. The data manager queries the VA corporate data warehouse to determine if these notes are completed. Because the data manager can see who wrote the notes, she is not blinded. However, we do not expect her to judge whether the notes were completed.

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

No then high patient engagement

Arm Type

Active Comparator

Arm Description

First stage: No patient engagement Second stage: High patient engagement

Arm Title

No then low patient engagement

Arm Type

Active Comparator

Arm Description

First stage: No patient engagement Second stage: Low patient engagement

Arm Title

No then no patient engagement

Arm Type

Active Comparator

Arm Description

First stage: No patient engagement Second stage: No patient engagement

Arm Title

Low then high patient engagement

Arm Type

Active Comparator

Arm Description

First stage: Low patient engagement Second stage: High patient engagement

Arm Title

Low then low patient engagement

Arm Type

Active Comparator

Arm Description

First stage: Low patient engagement Second stage: Low patient engagement

Arm Title

Low then no patient engagement

Arm Type

Active Comparator

Arm Description

First stage: Low patient engagement Second stage: No patient engagement

Intervention Type

Behavioral

Intervention Name(s)

Clinician Implementation Strategy Stage 1

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Clinician Implementation Strategy Stage 2

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Low patient engagement

Other Intervention Name(s)

PREPARE information and website

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

High patient engagement

Other Intervention Name(s)

PREPARE information and website and phone call

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of goals of care conversation notes completed among clinicians

Description

Number of goals of care conversation notes completed among clinicians in both stages of the SMART.

Time Frame

6 months in Stage 1, 9 months in Stage 2

Secondary Outcome Measure Information:

Title

Percent of eligible patients sent a letter

Description

Percent of eligible patients sent a letter about goals of care conversations in both stages of the SMART.

Time Frame

3 months

Title

Percent of eligible patients that view the PREPARE website

Description

Percent of eligible patients that view the PREPARE website in both stages of the SMART.

Time Frame

6 months in Stage 1, 9 months in Stage 2

Title

Percent of eligible patients spoken to by telephone during stage 2 of the SMART

Description

Percent of eligible patients spoken to by telephone during stage 2 of the SMART.

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Bekelman, MD MPH

Organizational Affiliation

Rocky Mountain Regional VA Medical Center, Aurora, CO

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anne M Walling, MD PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Palo Alto Health Care System, Palo Alto, CA

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304-1290

Country

United States

Facility Name

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

City

West Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

Rocky Mountain Regional VA Medical Center, Aurora, CO

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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