A Supportive Care Approach for Patients Late in Life - Full Text View

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:

MedlinePlus related topics: Caregivers Dementia Heart Failure Hospice Care

U.S. FDA Resources

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 June 13, 2013