Goals of Care Conversations Study

Cancer Clinical Trial

— LSTDI  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05001009
• Other study ID #: IIR 19-018
• Secondary ID: HX002935
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Chronic Obstructive Pulmonary Disease
• Dementia
• End Stage Liver Disease
• End-stage Liver Disease
• End-stage Renal Disease
• Heart Failure
• Interstitial Lung Disease
• Kidney Failure, Chronic
• Liver Diseases
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• 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.
• Clinician Implementation Strategy Stage 2: high intensity clinician training
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.
• Low patient engagement
Patients will be sent information about goals of care conversations, including the PREPARE website.
• 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.

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)