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Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP-PEACE)

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: NCT03609177
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
Boston Medical Center
Northwell Health
Mayo Clinic
Duke University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
James A. Tulsky, Dana-Farber Cancer Institute

Brief Summary:

In this research study, the investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may improve health care delivery.

- It is expected that about 12,000 people will take part in this research study, 11,550 of these patients, the vast majority, will be included only for medical record review.


Condition or disease Intervention/treatment Phase
Other Cancer Other: Clinician Communication Skills Training Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids Other: Video Declarations (ViDec) Not Applicable

Detailed Description:

The purpose of this study is to improve the quality of care provided to millions of older Americans with cancer. The investigators are working to help oncologists better serve patients by delivering more patient-centered, goal-concordant care that may dramatically improve health care delivery.

This is pragmatic stepped wedge cluster randomized trial (SW-CRT) of a Comprehensive ACP (Advance Care Planning) Program among older oncology patients. The ACP Program will include training clinicians in communication skills and using video decision aids for participants.

- This study will involve medical record review of 11,550 people age 65 or older with advanced cancer.

We will also recruit 450 eligible patients (150 patients from each of our three sites broken down into 75 patients during the control phase and 75 patients during the intervention phase) to conduct an in-person survey for our secondary patient-centered outcomes (confidence, satisfaction with physician communication, patient decisional satisfaction and regret). From among this sub-group we will engage 240 participants (80 from each of our three sites broken down into 40 patients during the control phase and 40 patients during the intervention phase) in an activity to film video declarations of their preferences.

During the first year, three pilot sites (one at each health care system) will trial the intervention. The subjects recruited at these pilot sites will not be included in the final analysis. Thus, the main trial will begin during year 2 and continue through year 5 with recruitment of 11,550 subjects for the primary outcome at 36 oncology clinics. The first year pilot will serve to inform the larger roll-out and the intervention may change during the first year based on pilot-clinic experience.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Advance Care Planning in Oncology: A Pragmatic, Cluster-Randomized Trial Integrating Patient Videos and Clinician Communication Training
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Arm Intervention/treatment
Experimental: Advance Care Planning

-In Person Survey:

  • A group of older patients with advanced cancer (N=450) will have an in-person survey over the course of the 36 months of recruitment.
  • Participants will be provided written copies of the questions to follow along during the in-person interviews
Other: Clinician Communication Skills Training
Communication skills training
Other Name: Vital Talk Communication Skills Training

Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids

Experimental: Advance Care Planning-Video Declaration

Video Declaration:

  • From among this group of 450 participants, the video declaration of preferences activity will be conducted with 240 patients.
  • For those participants that agree to the video declaration, they will proceed with recording of their video declarations
  • The RA will begin by reading a standardized introduction to aid the subject do the video
Other: Clinician Communication Skills Training
Communication skills training
Other Name: Vital Talk Communication Skills Training

Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids

Other: Video Declarations (ViDec)
Recording of patient advance care planning videos

Comprehensive Record Review of ACP
  • A review of Medical orders for resuscitation preferences in the electronic health record
  • A review of Medical orders for Palliative care consultations preferences in the electronic health record
  • A review of Medical orders for Hospice use preferences in the electronic health record
Other: Clinician Communication Skills Training
Communication skills training
Other Name: Vital Talk Communication Skills Training

Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids

Other: Video Declarations (ViDec)
Recording of patient advance care planning videos

Experimental: Main Study Arm
Patients with cancer being seen at the 36 oncology clinics will be exposed to clinicians who have had communication skills training (Vital Talk) and who are using video decision aids (ACP Decisions). Our main outcome is advance care planning documentation.
Other: Clinician Communication Skills Training
Communication skills training
Other Name: Vital Talk Communication Skills Training

Other: Advance Care Planning (ACP) Decisions Videos Decisions Aids
ACP Decisions video decision aids

Other: Video Declarations (ViDec)
Recording of patient advance care planning videos




Primary Outcome Measures :
  1. Advance Care Planning Documentation [ Time Frame: 4 years ]
    Any advance directive (e.g., living will, POLST, etc.) and changes of resuscitation orders or any indication in the EHR of a goals-of-care or advance care planning conversation


Secondary Outcome Measures :
  1. Rate of Preferences for Resuscitation [ Time Frame: 4 years ]
    Documented choices regarding CPR and mechanical ventilation in the EHR

  2. Rate of Palliative Care Consultation [ Time Frame: 4 years ]
    Use of palliative care services (consults, outpatient visits) in the EHR

  3. Rate of Hospice Use [ Time Frame: 4 years ]
    Use of hospice documented in the EHR

  4. Confidence in Future Care [ Time Frame: 4 years ]
    (in person survey) patient confidence that they will receive the right care at the right time by their health system

  5. Communication and Decisional Satisfaction [ Time Frame: 4 years ]
    (In person survey) patient satisfaction with communication and decision making

  6. Decisional Regret [ Time Frame: 4 years ]
    (In person survey) patient regret regarding decision making



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.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for clinics:

Clinic eligibility criteria include:

  • More than one oncologist
  • Serve a patient population that is at least 30% aged 65 or older
  • Disease-based oncology clinic

Subject Eligibility: (for the in-person surveys):

- Any patient affiliated with one of the study clinics who speaks English and is aged 65 or older with advanced cancer is eligible for participation. Advanced cancer is defined as metastatic disease for solid tumors and recurrent or refractory disease for hematological malignancies. There are no exclusions based on gender, race, or ethnicity.

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

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): NCT03609177


Contacts
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Contact: James A. Tulsky, MD 617-582-9201 JamesA_Tulsky@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: James A. Tulsky, MD    617-582-9201    JamesA_Tulsky@dfci.harvard.edu   
Principal Investigator: James A. Tulsky, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jon Tilburt, MD    507-284-2269    Tilburt.jon@mayo.edu   
Principal Investigator: Jon Tilburt, MD         
United States, New York
Northwell Health Recruiting
New Hyde Park, New York, United States, 11040
Contact: Diana Martins-Welch, MD    516-708-2520    Dmartins1@northwell.edu   
Principal Investigator: Diana Martins-Welch, MD         
United States, North Carolina
Duke Health Recruiting
Durham, North Carolina, United States, 27710
Contact: Kathryn Pollak, MD    919-681-4757    Kathryn.pollak@duke.edu   
Principal Investigator: Kathryn Pollak, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Boston Medical Center
Northwell Health
Mayo Clinic
Duke University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: James A. Tulsky, MD Dana-Farber Cancer Institute
  Study Documents (Full-Text)

Documents provided by James A. Tulsky, Dana-Farber Cancer Institute:
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Responsible Party: James A. Tulsky, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03609177    
Other Study ID Numbers: 18-276
UG3AG060626 ( U.S. NIH Grant/Contract )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James A. Tulsky, Dana-Farber Cancer Institute:
Cancer Care