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

NCT02879357 | Completed

• 1 other identifier: 2014P000211
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Failure to Thrive

Keywords

Care management; end of life; advanced care planning; palliative care

Outcome Measures

Primary Outcomes (1)

• 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.

  from date of determination of eligibility to date of death death during the study period, assessed for up to 18 months

Secondary Outcomes (2)

• Median number of days before death of first documented goals of care conversation

  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

  from date of determination of eligibility to date of death during study period, assessed for up to 18 months

Other Outcomes (5)

• Completion of eligible conversations

  from date of clinician training study start to study end date, assessed for up to 18 months

• Length of conversation

  from date of clinician training study start to study end date, assessed for up to 18 months

• Clinician Confidence

  at initial clinician training and end of study (an average of 18 months)

Study Arms (2)

Trained Clinicians

EXPERIMENTAL

Training in Serious Illness Communication Guide

Behavioral: Training

Untrained Clinicians

NO INTERVENTION

No training in Serious Illness Communication Guide

Interventions

Training BEHAVIORAL

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.

Trained Clinicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Resident in Training
• Non-English Speaking Clinic (e.g. Spanish Clinic)
• 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 at Dana-Farber Cancer Institute

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Partners HealthCare: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Failure to Thrive; Death

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rachelle Bernacki, M.D., M.S.

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: August 25, 2016
• Study Start: March 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)