LifeCourse: A Supportive Care Approach for Patients Late in Life

Not Applicable

Completed

• Conditions: Ongoing or Significant Medical Condition
• Interventions: Other: Care team

• Registration Number: NCT01746446
• Lead Sponsor: Allina Health System

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-11
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 903

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care team	Care team	Patients are offered the support and services of the care team.

Primary Outcome Measures

Name	Time	Method
Caregiver care experience	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	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	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	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.

Trial Locations

Locations (3)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Augustana Health Care Center; 🇺🇸 Minneapolis, Minnesota, United States

Walker Methodist Health Center; 🇺🇸 Minneapolis, Minnesota, United States