Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients (iCMP)

October 9, 2019 updated by: Bernacki, Rachelle E.,M.D., Brigham and Women's Hospital
The hypothesis of the Serious Illness Care Program (SICP) is that adherence to the Serious Illness Conversation Guide (SICG) portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the Serious Illness Care Program (SICP) is to provide clinicians with an evidence-based structure for eliciting and documenting vital information about preferences for patient driven care of their serious illness. It is designed to help open the door for patients, families, and clinicians to talk and reflect on end-of-life issues in an ongoing way. The hypothesis of the Serious Illness Care Program is that adherence to the conversation guide portion, the SIGC, will enhance patient understanding and allow control over their own decisions, relieve burdens of decision-making on family members, and help patients achieve a state of peace as they approach the end of life. For this protocol specifically, the investigators are testing a pilot intervention of a quality improvement project; the investigators plan to train clinicians and assess the feasibility and impact of the Serious Illness Care Program, which includes patient identification, clinician training, "triggering" of clinicians to conduct the SICG conversation, and documentation, in the iCMP at the Brigham and Women's Hospital.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Clinician Inclusion Criteria:

  1. Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham & Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner
  2. Care for patients enrolled in Brigham and Women's Hospital integrated Care Management Program (iCMP)

Clinician Exclusion Criteria:

  1. Resident in Training
  2. Non-English Speaking Clinic (e.g. Spanish Clinic)

Patient Inclusion Criteria:

  1. Over 18 years of age
  2. English Speaker
  3. Patient at Brigham and Women's Hospital or Newton Wellesley Primary Care Clinician at one of the following practices: The Phyllis Jen Center for Primary Care, Faulkner Community Physicians, Brigham and Women's Physician Group, Brigham & Women's Primary Care Associates of Brookline, Brigham Circle Medical Associates, Faulkner
  4. Enrolled in Brigham and Women's Hospital integrated Care Management Program

Patient Exclusion Criteria:

1. Patient at Dana-Farber Cancer Institute

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Trained Clinicians
Training in Serious Illness Communication Guide
Behavioral: Training
  1. Clinician training
  2. System for patient selection
  3. System of "triggering" and tracking conversations
  4. Training on how to use the Serious Illness Care Guide, a guide for patients about initiating conversations with family members about end-of-life goals and values
  5. Longitudinal Medical Record (LMR) documentation module to serve as a "Single source of truth" about advance care preferences in the LMR.
NO_INTERVENTION: Untrained Clinicians
No training in Serious Illness Communication Guide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of eligible patients with documented goals of care conversations
Time Frame: from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months
For patients whose death falls during the study period, the percentage of goals of care conversations completed and documented in the electronic medical record by clinicians in the intervention group and the control group. A completed conversation is defined by key elements being documented regarding goals of care in the patient's medical record.
from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median number of days before death of first documented goals of care conversation
Time Frame: from date of determination of eligibility to date of death during the study period, assessed for up to 18 months
For all patients whose death falls during the study period, the median number of days from the date of the first documented goals of care conversation to date of death in both the intervention and the control group.
from date of determination of eligibility to date of death during the study period, assessed for up to 18 months
Percentage of eligible patients with more comprehensive documentation of goals of care before death
Time Frame: from date of determination of eligibility to date of death during study period, assessed for up to 18 months
For all patients whose death falls during the study period, the percentage of patients with more comprehensive goals of care documentation before death in both the intervention group and the control group. More comprehensive is defined as documentation of a goals of care conversation that addresses more than code status only and will be evaluated for completeness in containing more key elements of a Serious Illness Care Guide conversation.
from date of determination of eligibility to date of death during study period, assessed for up to 18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Completion of eligible conversations
Time Frame: from date of clinician training study start to study end date, assessed for up to 18 months
Median percentage of eligible patients with completed conversations (will report for all intervention clinicians as a whole and also on individual clinician level)
from date of clinician training study start to study end date, assessed for up to 18 months
Length of conversation
Time Frame: from date of clinician training study start to study end date, assessed for up to 18 months
Median length of time per conversation in the intervention group as reported by clinician survey
from date of clinician training study start to study end date, assessed for up to 18 months
Clinician Confidence
Time Frame: at initial clinician training and end of study (an average of 18 months)
Clinicians who are trained to use the Guide will have improved confidence in carrying out end-of-life conversations, compared to untrained clinicians. Confidence will be evaluated before training and at end of study and measured using a 22-question survey asking clinicians to quantify their confidence on a scale of 1-7. This survey was designed by study investigators based on national surveys used to evaluate a sample of medical students, residents, and attending physicians' attitudes about end-of-life care, as well as the Harvard Medical School Center for Palliative Care's national faculty development program.
at initial clinician training and end of study (an average of 18 months)
Clinician Attitudes
Time Frame: at clinician training and end of study (an average of 18 months)
Clinicians who are trained to use the Guide will have improved attitudes in carrying out end-of-life conversations, compared to untrained clinicians. Confidence will be evaluated before training and at end of study and measured using an 11-question survey asking clinicians to quantify their confidence on a scale of 1-5. This survey was designed by study investigators based on national surveys used to evaluate a sample of medical students, residents, and attending physicians' attitudes about end-of-life care, as well as the Harvard Medical School Center for Palliative Care's national faculty development program.
at clinician training and end of study (an average of 18 months)
Utilization
Time Frame: at end of study (an average of 18 months)
Patients of clinicians who are trained to use the Guide will have higher rates of hospice usage, less health care utilization, and lower expenses near the end of life. We will measure utilization outcomes for those patients for whom we have claims data through risk contracts and the accountable care organization and will compare usage and trends between intervention and comparison patients.
at end of study (an average of 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Partners HealthCare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachelle E Bernacki, MD, Dana-Farber Cancer Institute
  • Principal Investigator: Susan D Block, MD, Dana-Farber Cancer Institute
  • Principal Investigator: Rebecca Cunningham, MD, Brigham and Women's Hospital
  • Principal Investigator: Joshua R Lakin, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014P000211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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