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Clinical Trials/NCT01746446
NCT01746446
Completed
Not Applicable

LifeCourse: A Supportive Care Approach for Patients Late in Life

Allina Health System3 sites in 1 country903 target enrollmentOctober 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ongoing or Significant Medical Condition
Sponsor
Allina Health System
Enrollment
903
Locations
3
Primary Endpoint
Caregiver care experience
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of the study is to test a new model of care for patients with an ongoing or significant medical condition.

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.

Registry
clinicaltrials.gov
Start Date
October 2012
End Date
March 31, 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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.

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.

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.

Study Sites (3)

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