Learn about Research & Clinical Trials

Goals of Care Conversations Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

CLINICIANS VA primary care advance practice clinicians (MDs, APRNs) at one of the three study sites able to complete LST notes and orders. Advance practice clinicians will be eligible for randomization if they have at least 15 eligible patients without LST notes at the start of stage 1 (to allow participating clinicians ample opportunities to write notes) and have written fewer than 4 LST notes in the previous year (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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05001009
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VA Office of Research and Development
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Bekelman, MD MPHAnne M Walling, MD PhD
Principal Investigator Affiliation Rocky Mountain Regional VA Medical Center, Aurora, COVA Greater Los Angeles Healthcare System, West Los Angeles, CA
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

U.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

Active Comparator: No then high patient engagement

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

Active Comparator: No then low patient engagement

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

Active Comparator: No then no patient engagement

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

Active Comparator: Low then high patient engagement

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

Active Comparator: Low then low patient engagement

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

Active Comparator: Low then no patient engagement

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

Interventions

Behavioral: - Clinician Implementation Strategy Stage 1

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.

Behavioral: - Clinician Implementation Strategy Stage 2

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.

Behavioral: - Low patient engagement

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Palo Alto, California

Status

Address

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290

Site Contact

Karleen F Giannitrapani, MPH MA PhD

karleen.giannitrapani@va.gov

650-493-5000 #26959

West Los Angeles, California

Status

Address

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

West Los Angeles, California, 90073

Site Contact

Mark T Canning, BA

mark.canning@va.gov

818-891-7711 #36008

Aurora, Colorado

Status

Address

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045

Site Contact

Marilyn Sloan, BS

marilyn.sloan@va.gov

507-250-2429