NCT01746446

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
903

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

4.5 years

First QC Date

November 27, 2012

Last Update Submit

June 7, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Patient Quality of Life

    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

    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

    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

    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.

Study Arms (2)

Care team

EXPERIMENTAL

Patients are offered the support and services of the care team.

Other: Care team

Usual Care

NO INTERVENTION

Patients receive usual care.

Interventions

Provides additional support to patients, family, and friends.

Care team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Augustana Health Care Center

Minneapolis, Minnesota, 55404, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Walker Methodist Health Center

Minneapolis, Minnesota, 55409, United States

Location

Related Publications (9)

  • Schellinger S, Cain CL, Shibrowski K, Elumba D, Rosenberg E. Building New Teams for Late Life Care: Lessons From LifeCourse. Am J Hosp Palliat Care. 2016 Jul;33(6):561-7. doi: 10.1177/1049909115574692. Epub 2015 Mar 5.

    PMID: 25747670BACKGROUND
  • Fernstrom KM, Shippee ND, Jones AL, Britt HR. Development and validation of a new patient experience tool in patients with serious illness. BMC Palliat Care. 2016 Dec 30;15(1):99. doi: 10.1186/s12904-016-0172-x.

    PMID: 28038669BACKGROUND
  • Anderson EW, Frazer MS, Schellinger SE. Expanding the Palliative Care Domains to Meet the Needs of a Community-Based Supportive Care Model. Am J Hosp Palliat Care. 2018 Feb;35(2):258-265. doi: 10.1177/1049909117705061. Epub 2017 Apr 20.

    PMID: 28423918BACKGROUND
  • Anderson EW, White KM. "It Has Changed My Life": An Exploration of Caregiver Experiences in Serious Illness. Am J Hosp Palliat Care. 2018 Feb;35(2):266-274. doi: 10.1177/1049909117701895. Epub 2017 Apr 16.

    PMID: 28413927BACKGROUND
  • Schellinger SE, Anderson EW, Frazer MS, Cain CL. Patient Self-Defined Goals: Essentials of Person-Centered Care for Serious Illness. Am J Hosp Palliat Care. 2018 Jan;35(1):159-165. doi: 10.1177/1049909117699600. Epub 2017 Mar 23.

    PMID: 28330379BACKGROUND
  • Shippee ND, Shippee TP, Mobley PD, Fernstrom KM, Britt HR. Effect of a Whole-Person Model of Care on Patient Experience in Patients With Complex Chronic Illness in Late Life. Am J Hosp Palliat Care. 2018 Jan;35(1):104-109. doi: 10.1177/1049909117690710. Epub 2017 Jan 29.

    PMID: 28133973BACKGROUND
  • Cain CL, Taborda-Whitt C, Frazer M, Schellinger S, White KM, Kaasovic J, Nelson B, Chant A. A mixed methods study of emotional exhaustion: Energizing and depleting work within an innovative healthcare team. J Interprof Care. 2017 Nov;31(6):714-724. doi: 10.1080/13561820.2017.1356809. Epub 2017 Sep 18.

    PMID: 28922038BACKGROUND
  • Anderson EW, White KM. "This Is What Family Does": The Family Experience of Caring for Serious Illness. Am J Hosp Palliat Care. 2018 Feb;35(2):348-354. doi: 10.1177/1049909117709251. Epub 2017 Jun 30.

    PMID: 28662594BACKGROUND
  • Britt HR, JaKa MM, Fernstrom KM, Bingham PE, Betzner AE, Taghon JR, Shippee ND, Shippee TP, Schellinger SE, Anderson EW. Quasi-Experimental Evaluation of LifeCourse on Utilization and Patient and Caregiver Quality of Life and Experience. Am J Hosp Palliat Care. 2019 May;36(5):408-416. doi: 10.1177/1049909118817740. Epub 2018 Dec 13.

Study Officials

  • Eric W Anderson, MD

    Allina Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 11, 2012

Study Start

October 1, 2012

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations