Goals of Care Conversations Study

NCT05001009 | Enrolling By Invitation

• 2 other identifiers: IIR 19-018HX002935
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percent of patients with a goals of care conversation note documented in Stage 1 or 2

  From the start of stage 1 to 9 months after the start of stage 2

• Percent of patients with a goals of care conversation note documented in Stage 1

  From the start of stage 1 to the beginning of stage 2 (approximately 8 months)

Study Arms (4)

No then high patient engagement

ACTIVE COMPARATOR

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.

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

No then low patient engagement

ACTIVE COMPARATOR

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.

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

Low then high patient engagement

ACTIVE COMPARATOR

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.

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

Low then low patient engagement

ACTIVE COMPARATOR

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.

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

Interventions

Clinician Implementation Strategy Stage 1: low intensity clinician training 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.

Low then high patient engagement; Low then low patient engagement; No then high patient engagement; No then low patient engagement

Clinician Implementation Strategy Stage 2: high intensity clinician training 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 then high patient engagement; Low then low patient engagement; No then high patient engagement; No then low patient engagement

Low patient engagement BEHAVIORAL

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

Also known as: PREPARE information and website

Low then high patient engagement; Low then low patient engagement; No then low patient engagement

High patient engagement 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.

Also known as: PREPARE information and website and phone call

Low then high patient engagement; No then high patient engagement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• PATIENTS
• Prisoner
• Pregnant
• under 18 years of age.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

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

West Los Angeles, California, 90073-1003, United States

Location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Related Publications (3)

• 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.

  PMID: 34981344 BACKGROUND

• 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.

  PMID: 39254148 BACKGROUND

• 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.

  PMID: 39074531 RESULT

MeSH Terms

Conditions

Neoplasms; Heart Failure; Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive; Kidney Failure, Chronic; End Stage Liver Disease; Dementia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Sequential multiple-assignment randomized clinical trial (SMART)

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 11, 2021
• Study Start: September 13, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)