Back to resultsPalliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients (iCMP)
Primary Purpose
Failure to Thrive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training
Sponsored by
About this trial
This is an interventional health services research trial for Failure to Thrive focused on measuring Care management, end of life, advanced care planning, palliative care
Eligibility Criteria
Clinician Inclusion Criteria:
- 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
- Care for patients enrolled in Brigham and Women's Hospital integrated Care Management Program (iCMP)
Clinician Exclusion Criteria:
- Resident in Training
- Non-English Speaking Clinic (e.g. Spanish Clinic)
Patient Inclusion Criteria:
- Over 18 years of age
- English Speaker
- 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
- Enrolled in Brigham and Women's Hospital integrated Care Management Program
Patient Exclusion Criteria:
1. Patient at Dana-Farber Cancer Institute
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Trained Clinicians
Untrained Clinicians
Arm Description
Training in Serious Illness Communication Guide
No training in Serious Illness Communication Guide
Outcomes
Primary Outcome Measures
Percentage of eligible patients with documented goals of care conversations
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.
Secondary Outcome Measures
Median number of days before death of first documented goals of care conversation
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.
Percentage of eligible patients with more comprehensive documentation of goals of care before death
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.
Full Information
NCT ID
NCT02879357
First Posted
May 7, 2015
Last Updated
October 9, 2019
Sponsor
Brigham and Women's Hospital
Collaborators
Partners HealthCare
1. Study Identification
Unique Protocol Identification Number
NCT02879357
Brief Title
Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients
Acronym
iCMP
Official Title
Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Partners HealthCare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Thrive
Keywords
Care management, end of life, advanced care planning, palliative care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trained Clinicians
Arm Type
Experimental
Arm Description
Training in Serious Illness Communication Guide
Arm Title
Untrained Clinicians
Arm Type
No Intervention
Arm Description
No training in Serious Illness Communication Guide
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
Clinician training
System for patient selection
System of "triggering" and tracking conversations
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
Longitudinal Medical Record (LMR) documentation module to serve as a "Single source of truth" about advance care preferences in the LMR.
Primary Outcome Measure Information:
Title
Percentage of eligible patients with documented goals of care conversations
Description
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.
Time Frame
from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months
Secondary Outcome Measure Information:
Title
Median number of days before death of first documented goals of care conversation
Description
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.
Time Frame
from date of determination of eligibility to date of death during the study period, assessed for up to 18 months
Title
Percentage of eligible patients with more comprehensive documentation of goals of care before death
Description
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.
Time Frame
from date of determination of eligibility to date of death during study period, assessed for up to 18 months
Other Pre-specified Outcome Measures:
Title
Completion of eligible conversations
Description
Median percentage of eligible patients with completed conversations (will report for all intervention clinicians as a whole and also on individual clinician level)
Time Frame
from date of clinician training study start to study end date, assessed for up to 18 months
Title
Length of conversation
Description
Median length of time per conversation in the intervention group as reported by clinician survey
Time Frame
from date of clinician training study start to study end date, assessed for up to 18 months
Title
Clinician Confidence
Description
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.
Time Frame
at initial clinician training and end of study (an average of 18 months)
Title
Clinician Attitudes
Description
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.
Time Frame
at clinician training and end of study (an average of 18 months)
Title
Utilization
Description
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.
Time Frame
at end of study (an average of 18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Clinician Inclusion Criteria:
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
Care for patients enrolled in Brigham and Women's Hospital integrated Care Management Program (iCMP)
Clinician Exclusion Criteria:
Resident in Training
Non-English Speaking Clinic (e.g. Spanish Clinic)
Patient Inclusion Criteria:
Over 18 years of age
English Speaker
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
Enrolled in Brigham and Women's Hospital integrated Care Management Program
Patient Exclusion Criteria:
1. Patient at Dana-Farber Cancer Institute
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachelle E Bernacki, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan D Block, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rebecca Cunningham, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua R Lakin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Palliative Care Population Management Project for Integrated Care Management Program for High-Risk Patients
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