LifeCourse: A Supportive Care Approach for Patients Late in Life

June 7, 2022 updated by: Allina Health System
The purpose of the study is to test a new model of care for patients with an ongoing or significant medical condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

LifeCourse is a late life care approach that promotes whole person care through a structured approach built upon an expanded set of palliative care domains and chronic illness care practices. It includes a trained lay healthcare worker as the primary contact who follows the patient across care settings and over time. The care guide asks patients and caregivers to articulate individualized goals and take part in decision making, and uses a family-oriented approach to understand needs, leverage strengths, and empower families to effectively support the individual living with serious illness.

Study Type

Interventional

Enrollment (Actual)

903

Phase

  • 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
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55404
        • Augustana Health Care Center
      • Minneapolis, Minnesota, United States, 55409
        • Walker Methodist Health Center

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Patient has an Allina Health primary or specialty provider
  • Patient's medical chart indicates an on-going or significant medical condition
  • LifeCourse will invite vulnerable patients to enroll, including:
  • Critically ill patients
  • Cognitively impaired patients
  • Elderly patients, some of whom may have cognitive impairment and/or be institutionalized

Exclusion Criteria

  • Patient resides in a zip code which does not lie partially within a 45 mile radius from the Allina Health Commons in Minneapolis, Minnesota.
  • Patient has not visited an Allina facility, affiliate, or community partner within the last year.
  • Patient is eligible for hospice.
  • Patient is actively dying.
  • Patient is abusive or is discharged against medical advice (AMA).

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Care team
Patients are offered the support and services of the care team.
Other: Care team
Provides additional support to patients, family, and friends.
No Intervention: Usual Care
Patients receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Quality of Life
Time Frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Patient QOL was measured using the Functional Assessment of Chronic Illness Therapy-Palliative v4 (FACIT-Pal) survey, a general measure of health-related QOL in 4 domains: physical, social, emotional, and functional, plus a measure of end-of-life experiences. Items were reverse scored according to scoring guidelines and domain scores were calculated via prorated scores when there were <50% missing items for a given domain and <20% missing domains for a total score.
Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Patient Care Experience
Time Frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Patient care experience was collected via a previously validated survey tool focused on the patient's experience with their care team in the last 30 days. Three domains were scored: care team, goals, and communication with prorated scores when there were <50% missing items for a given domain and <20% missing domains for a total score.
Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Caregiver care experience
Time Frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Caregiver care experience was measured by a developed tool, addressing various aspects of care experience. An overall score was calculated by summing answers to all items. Scores were also calculated in 3 domains: care team, communication, and support.
Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
Caregiver Quality of Life
Time Frame: Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.
aregiver QOL was assessed via the patient-reported outcomes measurement information system (PROMIS) which asks caregivers to report their QOL in 8 domains. The PROMIS-29 scores were calculated by summing answers to all items within each domain.
Change from baseline survey responses at 3 month intervals until subject withdrawal or date of death from any cause, whichever comes first, up to six years.

Collaborators and Investigators

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

Sponsor

Allina Health System

Collaborators

Robina Foundation

Investigators

  • Principal Investigator: Eric W Anderson, MD, Allina Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 1, 2012

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

November 27, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 11, 2012

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 38632

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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