Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers - Full Text View

Sponsors and Collaborators:	University of Pennsylvania National Institute on Aging (NIA)
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00294307

Sponsors and Collaborators:

University of Pennsylvania
National Institute on Aging (NIA)

Information provided by:

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT00294307

Purpose

To compare across three hospital sites the effects on health and cost outcomes observed by the following three interventions, each designed to enhance adaptation and improve outcomes of hospitalized cognitively impaired elders and their caregivers:
1. augmented standard care (ASC) - standard hospital and, if referred, home care plus early identification of CI during the patients' hospitalization by trained registered nurses (RNs) with immediate feedback to patients' primary nurses, attending physicians and discharge planners;
2. resource nurse care (RNC) - standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization by trained RNs and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home; or,
3. advanced practice nurse care (APNC) - standard hospital care plus transitional (hospital to home) care substituting for standard home care and provided by APNs with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers.
[H1] We hypothesize that health and cost outcomes with APNC, a comprehensive intervention designed to meet the unique needs of cognitively impaired older adults hospitalized for an acute medical or surgical event and their caregivers will be associated, relative to health and cost outcomes with ASC and RNC.

[H2] We hypothesize that improvements in patient, caregiver and cost outcomes observed for the RNC group will be greater than those observed for the ASC group.
To compare within each site and over time, health and cost outcomes (identified in 1) from patients treated with either ASC or RNC, both relatively lower intensity interventions, with the outcomes of patients at the same site observed after switching to APNC, a high intensity intervention.

[H3] We hypothesize that compared to patients receiving the ASC or the RNC interventions, patients at the same site will have improved patient, caregiver and cost outcomes after the site switches to APNC.

[H4] We hypothesize that patient, caregiver and cost outcomes achieved by the groups receiving APNC interventions at T1 and T2 will be similar.

Condition	Intervention	Phase
Dementia Dementia, Vascular Alzheimer Disease Delirium, Dementia, Amnestic, Cognitive Disorders Lewy Body Disease	Procedure: Augmented Standard Care Procedure: Resource Nurse Care Procedure: Advanced Practice Nurse Care	Phase I Phase II

Genetics Home Reference related topics: Alzheimer disease familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia Lewy Body Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Hospital to Home: Cognitively Impaired Elders/Caregivers

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

Instrumental Activities of Daily Living [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Caregiver Burden [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Time to subsequent rehospitalizations [ Time Frame: anytime to 24 weeks post-discharge from initial hospitalization ] [ Designated as safety issue: No ]
Time till death [ Time Frame: anytime to 24 weeks post-discharge from initial hospitalization ] [ Designated as safety issue: No ]
Health Care costs [ Time Frame: 24 weeks post-discharge from initial hospitalization ] [ Designated as safety issue: No ]
Activities of Daily Living [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of rehospitalization [ Time Frame: at 24 weeks after initial hospital discharge ] [ Designated as safety issue: No ]
Cognitive Function [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Beneficial Clinical Events [ Time Frame: at discharge and 24 weeks ] [ Designated as safety issue: No ]
Adverse Clinical events [ Time Frame: at discharge and 24 weeks ] [ Designated as safety issue: No ]
Neuropsychiatric Inventory [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Behaviors [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Depression [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Symptom Status [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge ] [ Designated as safety issue: No ]
Caregiver satisfaction with care [ Time Frame: by 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	420
Study Start Date:	February 2006
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Three different nursing interventions of varying intensity, one offered at one of three sites.	Procedure: Augmented Standard Care - standard hospital and, if referred, home care plus early identification of CI during the patients' hospitalization by trained registered nurses (RNs) with immediate feedback to patients' primary nurses, attending physicians and discharge planners [low intensity]; Procedure: Resource Nurse Care - standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization by trained RNs and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home [medium intensity];. Procedure: Advanced Practice Nurse Care - standard hospital care plus transitional (hospital to home) care substituting for standard home care and provided by APNs with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers [high intensity].
2: Experimental All three sites receive the same high intensity intervention.	Procedure: Advanced Practice Nurse Care - standard hospital care plus transitional (hospital to home) care substituting for standard home care and provided by APNs with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers [high intensity].

Arms

Assigned Interventions

1: Experimental

Three different nursing interventions of varying intensity, one offered at one of three sites.

Procedure: Augmented Standard Care

- standard hospital and, if referred, home care plus early identification of CI during the patients' hospitalization by trained registered nurses (RNs) with immediate feedback to patients' primary nurses, attending physicians and discharge planners [low intensity];

Procedure: Resource Nurse Care

- standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization by trained RNs and hospital care by RNs trained in the use of expert clinical guidelines developed to enhance the care management of hospitalized cognitively impaired elders and to facilitate their transition from hospital to home [medium intensity];.

Procedure: Advanced Practice Nurse Care

- standard hospital care plus transitional (hospital to home) care substituting for standard home care and provided by APNs with advanced training in the management of CI patients using an evidence-based protocol designed specifically for this patient group and their caregivers [high intensity].

2: Experimental

All three sites receive the same high intensity intervention.

Procedure: Advanced Practice Nurse Care

Show Detailed Description

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Contact: Mary D Naylor, PhD	(215) 898-6088	naylor@nursing.upenn.edu
Contact: Karen B Hirschman, PhD	(215) 573-3755	hirschk@nursing.upenn.edu

United States, Pennsylvania
Pennsylvania Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Margaret Crowley, MSN 215-829-8716 crowleym@uphs.upenn.edu
Principal Investigator: Mary D Naylor, PhD
Penn-Presbyterian Medical Center	Recruiting
Phila, Pennsylvania, United States, 19104
Contact: Kathy Witta, MSN 215-662-8796 Kathy.Witta@uphs.upenn.edu
Principal Investigator: Mary D. Naylor, PhD.
Hospital of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michelle Feil, MSN 215-615-3800 feilm@uphs.upenn.edu
Principal Investigator: Mary D. Naylor, PhD

Responsible Party:	University of Pennsylvania School of Nursing ( Mary D. Naylor, PhD RN FAAN; Principal Investigator )
Study ID Numbers:	R01-AG-023116-01A1
Study First Received:	February 16, 2006
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00294307
Health Authority:	United States: Institutional Review Board