LifeCourse: A Supportive Care Approach for Patients Late in Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Allina Health System
Sponsor:
Information provided by (Responsible Party):
Allina Health System
ClinicalTrials.gov Identifier:
NCT01746446
First received: November 27, 2012
Last updated: September 29, 2015
Last verified: September 2015
  Purpose
The purpose of the study is to test a new model of care for patients with an ongoing or significant medical condition.

Condition Intervention
Ongoing or Significant Medical Condition
Other: Care team

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: LifeCourse: A Supportive Care Approach for Patients Late in Life

Further study details as provided by Allina Health System:

Primary Outcome Measures:
  • Patient goals [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
  • Number of patients enrolled in hospice [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
  • Number of inpatient hospital days [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient quality of life [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Patient experience [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Caregiver quality of life [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Caregiver experience [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Total cost of care [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care team
Patients are offered the support and services of the care team.
Other: Care team

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746446

Contacts
Contact: Eric W Anderson, MD 612-262-1448 Eric.Worden.Anderson@allina.com

Locations
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States
Augustana Health Care Center Recruiting
Minneapolis, Minnesota, United States
Walker Methodist Health Center Recruiting
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Allina Health System
Investigators
Principal Investigator: Eric W Anderson, MD Allina Health
  More Information

Publications:
Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT01746446     History of Changes
Other Study ID Numbers: 38632 
Study First Received: November 27, 2012
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on February 11, 2016