Goals of Care Conversations Study (LSTDI)

VA Office of Research and Development

Status: Invitation-only

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

Treatments: Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training; Behavioral: Low patient engagement; Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training; Behavioral: High patient engagement

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05001009

HX002935 (Other Identifier)

IIR 19-018

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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72 participants in 4 patient groups

No then high patient engagement

Active Comparator group

Description:

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.

Treatment:

Behavioral: High patient engagement

Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training

Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training

No then low patient engagement

Active Comparator group

Description:

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.

Treatment:

Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training

Behavioral: Low patient engagement

Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training

Low then high patient engagement

Active Comparator group

Description:

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.

Treatment:

Behavioral: High patient engagement

Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training

Behavioral: Low patient engagement

Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training

Low then low patient engagement

Active Comparator group

Description:

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.

Treatment:

Behavioral: Clinician Implementation Strategy Stage 1: low intensity clinician training

Behavioral: Low patient engagement

Behavioral: Clinician Implementation Strategy Stage 2: high intensity clinician training