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Goals of Care Conversations Study

NCT ID: NCT05001009

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Sequential multiple-assignment randomized clinical trial (SMART)
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
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, the data manager is not blinded. However, the investigators do not expect the data manager to judge whether the notes were completed.

Study Groups

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No then high patient engagement

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.

Group Type ACTIVE_COMPARATOR

Clinician Implementation Strategy Stage 1: low intensity clinician training

Intervention Type BEHAVIORAL

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 training

Intervention Type BEHAVIORAL

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.

High patient engagement

Intervention Type BEHAVIORAL

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.

No then low patient engagement

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.

Group Type ACTIVE_COMPARATOR

Clinician Implementation Strategy Stage 1: low intensity clinician training

Intervention Type BEHAVIORAL

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 training

Intervention Type BEHAVIORAL

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 engagement

Intervention Type BEHAVIORAL

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

Low then high patient engagement

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.

Group Type ACTIVE_COMPARATOR

Clinician Implementation Strategy Stage 1: low intensity clinician training

Intervention Type BEHAVIORAL

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 training

Intervention Type BEHAVIORAL

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 engagement

Intervention Type BEHAVIORAL

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

High patient engagement

Intervention Type BEHAVIORAL

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.

Low then low patient engagement

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.

Group Type ACTIVE_COMPARATOR

Clinician Implementation Strategy Stage 1: low intensity clinician training

Intervention Type BEHAVIORAL

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 training

Intervention Type BEHAVIORAL

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 engagement

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Low patient engagement

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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PREPARE information and website PREPARE information and website and phone call

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Bekelman, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Anne M Walling, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Site Status

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

West Los Angeles, California, United States

Site Status

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Ha DM, Deng LR, Lange AV, Swigris JJ, Bekelman DB. Reliability, Validity, and Responsiveness of the DEG, a Three-Item Dyspnea Measure. J Gen Intern Med. 2022 Aug;37(10):2541-2547. doi: 10.1007/s11606-021-07307-1. Epub 2022 Jan 3.

Reference Type BACKGROUND
PMID: 34981344 (View on PubMed)

Haverfield MC, Ma J, Walling A, Bekelman DB, Brown-Johnson C, Lo N, Lorenz KA, Giannitrapani KF. Communication processes in an advance care planning initiative: A socio-ecological perspective for service evaluation. Palliat Med. 2024 Dec;38(10):1134-1143. doi: 10.1177/02692163241277394. Epub 2024 Sep 10.

Reference Type BACKGROUND
PMID: 39254148 (View on PubMed)

Bekelman DB, Giannitrapani K, Linn KA, Langner P, Sudore RL, Rabin B, Lorenz KA, Foglia M, Glickman A, Pawlikowski S, Sloan M, Gamboa RC, McCaa MD, Hines A, Walling AM. Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial. Contemp Clin Trials. 2024 Oct;145:107643. doi: 10.1016/j.cct.2024.107643. Epub 2024 Jul 27.

Reference Type RESULT
PMID: 39074531 (View on PubMed)

Other Identifiers

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HX002935

Identifier Type: OTHER

Identifier Source: secondary_id

IIR 19-018

Identifier Type: -

Identifier Source: org_study_id