LifeCourse: A Supportive Care Approach… | Clinical Trial

Key information

Conditions

Ongoing or Significant Medical Condition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Northwestern Hospital, Minneapolis, Minnesota, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Care team

Other

Provides additional support to patients, family, and friends.

Primary outcomes

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 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.
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.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Collaborators

Robina Foundation

Registry information

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Dec 11, 2012
Registry last updated: Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.