A Supportive Care Approach for Patients Late in Life

This study is currently recruiting participants.
Verified December 2012 by Allina Health System
Sponsor:
Information provided by (Responsible Party):
Allina Health System
ClinicalTrials.gov Identifier:
NCT01746446
First received: November 27, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

The purpose of the study it so to determine whether a new model of care for patients late in life will enable patients and families to receive care that aligns with their goals and wishes.


Condition Intervention
Heart Failure
Dementia
Cancer
Other: Care team

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Supportive Care Approach for Patients Late in Life: Creating a Sustainable Model of Systematic Care to Improve the Experience of Patients, Their Families, and Caregivers.

Resource links provided by NLM:


Further study details as provided by Allina Health System:

Primary Outcome Measures:
  • Patient goals and wishes honored [ 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 ]
  • Total cost of care [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
  • Number of days enrolled in hospice [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: No ]
  • Number of hospice referrals [ 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 ]
  • Patient access and coordination [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Primary caregiver quality of life [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Primary caregiver experience [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Primary caregiver access and coordination [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Primary caregiver's perspective of patient's quality of life (living) [ Time Frame: Date of enrollment and every 3 months for up to 26 months ] [ Designated as safety issue: No ]
  • Primary caregiver's perception of patient's quality of life (deceased) [ Time Frame: After death of participant ] [ Designated as safety issue: No ]
  • Secondary caregiver quality of life [ Time Frame: Date of enrollment and every 6 months for up to 26 months ] [ Designated as safety issue: No ]
  • Care team well-being [ Time Frame: Beginning of role on research project and every 3 months for up to 26 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care team Other: Care team

Detailed Description:

The care model includes a non-clinical care guide who establishes an ongoing, personal relationship to hear the patient's life story and understand their goals of living. The other team members include a social worker, marriage and family therapist, registered nurse, chaplain, and pharmacist. The team maintains a focus on the whole person so that non-medical as well as medical goals are established. The care guide partners with patients and caregivers to get the right support from within Allina, from their community, and from the family's own strengths and assets. As a result, patients and caregivers should feel honored and supported in the process.

  Eligibility

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

Inclusion Criteria:

  • Potential patient has a signed consent for use of medical records in research
  • Patient has a primary diagnosis of advanced cancer (stage 3 or 4), advanced heart failure, or advanced dementia
  • Patient and family are willing to participate in extensive pre-pilot procedures

Exclusion Criteria:

  • Patient is actively dying or terminally ill
  • Hospice eligible patients
  • Non Allina network primary care provider
  • Patient does not speak or read English
  • Patient discharged against medical advice
  • Patient carries major mental health issues as defined by Minimum Data Set standards
  • Patient has active major chemical dependency
  • Patient resides outside of a 25 mile radius of the Allina Commons
  Contacts and Locations
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
Walker Methodist Health Center Recruiting
Minneapolis, Minnesota, United States
Augustana Health Care Center Recruiting
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Allina Health System
Investigators
Principal Investigator: Eric W Anderson, MD Allina Health
  More Information

No publications provided

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: December 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dementia
Heart Failure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014