LSTDI: Goals of Care Conversations Study

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05001009
Collaborator
(none)
72
Enrollment
3
Locations
6
Arms
54
Anticipated Duration (Months)
24
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of the research team 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 study's significance is that it ensures that Veterans can express their goals and preferences for life sustaining treatments and have them honored.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Clinician Implementation Strategy Stage 1
  • Behavioral: Clinician Implementation Strategy Stage 2
  • Behavioral: Low patient engagement
  • Behavioral: High patient engagement
N/A

Detailed 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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Sequential multiple-assignment randomized clinical trial (SMART)Sequential multiple-assignment randomized clinical trial (SMART)
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving Implementation of Outpatient Goals of Care Conversations for Veterans With Serious Illness
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: No then high patient engagement

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

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: 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.
Other Names:
  • PREPARE information and website and phone call
  • Active Comparator: No then low patient engagement

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

    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.
    Other Names:
  • PREPARE information and website
  • Active Comparator: No then no patient engagement

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

    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.

    Active Comparator: Low then high patient engagement

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

    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.
    Other Names:
  • PREPARE information and 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.
    Other Names:
  • PREPARE information and website and phone call
  • Active Comparator: Low then low patient engagement

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

    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.
    Other Names:
  • PREPARE information and website
  • Active Comparator: Low then no patient engagement

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

    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.
    Other Names:
  • PREPARE information and website
  • Outcome Measures

    Primary Outcome Measures

    1. Number of goals of care conversation (LST) notes completed among clinicians [6 months]

      Number of goals of care conversation (LST) notes completed among clinicians in both stages of the SMART.

    Secondary Outcome Measures

    1. Percent of eligible patients sent a letter [6 months]

      Percent of eligible patients sent a letter about goals of care conversations in both stages of the SMART.

    2. Percent of eligible patients that view the PREPARE website [6 months]

      Percent of eligible patients that view the PREPARE website in both stages of the SMART.

    3. Percent of eligible patients spoken to by telephone during stage 2 of the SMART [6 months]

      Percent of eligible patients spoken to by telephone during stage 2 of the SMART.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Needs score of > or equal to 90 using the one-year combined hospitalization/mortality variable

    Exclusion Criteria:

    PATIENTS

    • Prisoner

    • Pregnant

    • under 18 years of age.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCaliforniaUnited States94304-1290
    2VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCaliforniaUnited States90073
    3Rocky Mountain Regional VA Medical Center, Aurora, COAuroraColoradoUnited States80045

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: David Bekelman, MD MPH, Rocky Mountain Regional VA Medical Center, Aurora, CO

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05001009
    Other Study ID Numbers:
    • IIR 19-018
    • HX002935
    First Posted:
    Aug 11, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021