Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

UC Health Care Planning Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04012749
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
University of California, San Francisco
University of California, Irvine
Information provided by (Responsible Party):
Neil Wenger, MD, MPH, University of California, Los Angeles

Brief Summary:
Using a cluster randomized design at the clinic level, this project will implement and test three real-world, scalable advance care planning interventions among primary care clinics across three University of California health systems. Seriously ill patients identified using data from the electronic health record will receive (1) an advance directive with targeted messaging, (2) intervention 1 plus prompting to engage with the Prepare For Your Care website, or (3) intervention 2 plus engagement from a clinic-based facilitator. A Research cohort of patients will provide complete surveys at baseline, 12 and 24 months. The main outcomes are advance directive completion among the population cohort and goal concordant care among the Research cohort at 12 months.

Condition or disease Intervention/treatment Phase
Advance Care Planning Advance Directives Advanced Cancer Behavioral: Advance directive Behavioral: Prepare Behavioral: Facilitator Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomized trial at the primary care clinic level
Masking: Single (Outcomes Assessor)
Masking Description: Statistician blinded to study arm
Primary Purpose: Supportive Care
Official Title: Population-based Comparison of Evidence-based, Patient-centered Advance Care Planning Interventions on Advance Directive Completion, Goal Concordant Care and Caregiver Outcomes for Patients With Advanced Illness
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Advance directive
Messaging and advance directive distribution. All arms receive physician advance care planning education at the clinic level.
Behavioral: Advance directive
Patient receives a health system-specific advance directive along with a message crafted with input from a broad group of stakeholders at the clinical sites and external advisors. Messaging introduces advance care planning, the purpose of the advance directive and contains instructions for completing it and turning it in, as well as a prompt to discuss the document with the patient's primary care physician.

Active Comparator: Advance directive and Prepare
Messaging and advance directive distribution plus introduction to the Prepare For Your Care website. All arms receive physician advance care planning education at the clinic level.
Behavioral: Advance directive
Patient receives a health system-specific advance directive along with a message crafted with input from a broad group of stakeholders at the clinical sites and external advisors. Messaging introduces advance care planning, the purpose of the advance directive and contains instructions for completing it and turning it in, as well as a prompt to discuss the document with the patient's primary care physician.

Behavioral: Prepare
Patient invited to use the Prepare For Your Care website (www.prepareforyourcare.org) that will introduce and facilitate advance care planning and guide completion of an advance directive.

Active Comparator: Advance directive, Prepare and Facilitator
Messaging and advance directive distribution, introduction to the Prepare For Your Care website, plus patient engagement from a trained facilitator who also can interact with the primary care physician. All arms receive physician advance care planning education at the clinic level.
Behavioral: Advance directive
Patient receives a health system-specific advance directive along with a message crafted with input from a broad group of stakeholders at the clinical sites and external advisors. Messaging introduces advance care planning, the purpose of the advance directive and contains instructions for completing it and turning it in, as well as a prompt to discuss the document with the patient's primary care physician.

Behavioral: Prepare
Patient invited to use the Prepare For Your Care website (www.prepareforyourcare.org) that will introduce and facilitate advance care planning and guide completion of an advance directive.

Behavioral: Facilitator
Facilitator engages patient to activate advance care planning and to carry out navigation and facilitation aspects of advance care planning. Facilitator can tee up advance care planning activities with the primary care physician.




Primary Outcome Measures :
  1. Advance directive completion, 12 months [ Time Frame: 12 months or death ]
    Proportion of patients that have advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) at 12 months (or death) compared to baseline. Baseline date defined as the clinic intervention start date. Intention to treat analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

  2. Research cohort: Goal concordant care, cross-sectional survey, 12 months [ Time Frame: 12 months or death ]
    Goal concordant care measured by patient/caregiver reports of receipt of preference concordant care based on questions from SUPPORT (Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical Care Inconsistent with Patients' Treatment Goals: Association with 1-Year Medicare Resource Use and Survival. J Am Geriatr Soc. 2002;50(3):496-500. doi:10.1046/j.1532-5415.2002.50116.)


Secondary Outcome Measures :
  1. New advance directive completion, 12 months [ Time Frame: 12 months or death ]
    Advance care planning documentation (enduring advance directive, POLST or out-of-hospital DNR form in the electronic health record) among patients with no advance care planning documentation in the past three years. Baseline date defined as receipt of intervention. "As treated" analysis will use logistic regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

  2. Research cohort: Report of end of life care [ Time Frame: 24 months ]
    Caregiver report of quality of end of life care among decedents based on the modified Bereaved Family Survey

  3. Advance directive completion, 24 months [ Time Frame: 24 months or death ]
    Proportion of patients that have advance care planning documentation

  4. New advance directive completion, 24 months [ Time Frame: 24 months or death ]
    Advance care planning documentation

  5. Research cohort: Goal concordant care, cross-sectional survey, 24 months [ Time Frame: 24 months or death ]
    Goal concordant care measured by patient/caregiver reports of receipt of preference concordant care based on questions from SUPPORT (Teno JM, Fisher ES, Hamel MB, Coppola K, Dawson NV. Medical Care Inconsistent with Patients' Treatment Goals: Association with 1-Year Medicare Resource Use and Survival. J Am Geriatr Soc. 2002;50(3):496-500. doi:10.1046/j.1532-5415.2002.50116.)

  6. Research cohort: Goal concordant care, comparison of care to preferences [ Time Frame: 24 months or death ]
    Goal concordant care measured as match of care receipt to future care preference based on survey

  7. Research cohort: Goal concordant care, post-mortem survey [ Time Frame: 24 months or death ]
    Goal concordant care measured as caregiver post-mortem report goal concordant care (Teno JM, Freedman VA, Kasper JD, Gozalo P, Mor V. Is care for the dying improving in the United States? J Palliat Med. 2015;18(8):662-6).


Other Outcome Measures:
  1. Healthcare utilization among decedents [ Time Frame: 24 months ]
    Hospitalization, ICU care and ER visits within 30 days of death will be compared among decedents of the three study arms using regression models to account for patients clustered within clinics including covariates of patient age, gender, race/ethnicity, serious illness category, clinic baseline advance directive completion rate, study site, time, study arm, and study arm-time interaction.

  2. Research cohort: advance care planning process, 12 months [ Time Frame: 12 months ]
    Advance care planning level of engagement and conversations based on survey (Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465).

  3. Research cohort: advance care planning process, 24 months [ Time Frame: 24 months ]
    Advance care planning level of engagement and conversations based on validated survey (Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Population cohort

Inclusion Criteria

  • At least 2 visits to a primary care clinic in the health system in the past 12 months
  • Serious illness according to an algorithm using electronic health record data including patients with: advanced cancer, advanced heart failure, advanced chronic obstructive pulmonary disease, decompensated liver disease, end stage renal disease, amyotrophic lateral sclerosis, or was a vulnerable elder with a serious illness

Exclusion Criteria: None.

Research cohort: Derived from the population cohort plus:

Inclusion Criteria

  • Speak English or Spanish
  • Provide informed consent

Exclusion Criteria

  • Too cognitively impaired to provide informed consent
  • Primary care physician identifies that survey may be harmful

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012749


Contacts
Layout table for location contacts
Contact: Neil Wenger, MD 310-794-2288 nwenger@mednet.ucla.edu
Contact: Anne Walling, MD, PhD 310-794-0741 awalling@mednet.ucla.edu

Locations
Layout table for location information
United States, California
University of California, Irvine Active, not recruiting
Irvine, California, United States, 92868
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Neil S Wenger, MD    310-794-2288    nwenger@mednet.ucla.edu   
Contact: Katherine Santos    310-794-3656    KMSantos@mednet.ucla.edu   
University of California at San Francisco Active, not recruiting
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, Los Angeles
University of California, San Francisco
University of California, Irvine
Investigators
Layout table for investigator information
Principal Investigator: Neil S Wenger, MD University of California, Los Angeles
Publications:
Layout table for additonal information
Responsible Party: Neil Wenger, MD, MPH, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04012749    
Other Study ID Numbers: 18-001612
PLC-1609-36291 ( Other Grant/Funding Number: PCORI )
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neil Wenger, MD, MPH, University of California, Los Angeles:
serious illness
POLST
population health
primary care