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

Sponsor:	University of Pennsylvania
Collaborator:	National Institute on Aging (NIA)
Information provided by (Responsible Party):	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 Mild Cognitive Impairment	Procedure: Augmented Standard Care Procedure: Resource Nurse Care Procedure: Advanced Practice Nurse Care	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Hospital to Home: Cognitively Impaired Elders/Caregivers

Resource links provided by NLM:

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

MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Delirium Dementia Lewy Body Disease Mild Cognitive Impairment

U.S. FDA Resources

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 2012
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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].
Experimental: 2 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

Experimental: 1

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].

Experimental: 2

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].

Detailed Description:

Cognitive impairment (CI) is a major health problem complicating the care of increasing numbers of older adults hospitalized for an acute medical or surgical condition. Dementia and delirium, the most common causes of CI among these elders, is associated with higher mortality rates, increased morbidity and higher health care costs. A growing body of science suggests that these patients and their caregivers are particularly vulnerable to systems of care that either do not recognize or ignore their needs. The consequences are devastating for the patients and their caregivers and add tremendous burden to hospital staffs coping with a severe shortage of nurses. For these reasons, the Institute of Medicine identified improved care management of this patient group as a national priority for action. Unfortunately, little evidence is available to guide optimal care of this patient group or to address the unique needs of their caregivers. Collectively, available evidence suggests that these patients may benefit from interventions aimed at improving management of CI, comorbid conditions or both but the exact nature and intensity of intervention needed to effectively and efficiently improve their outcomes and those of their caregivers is not known. Thus, the timing is excellent for rigorous research aimed at identifying care management strategies that will result in high quality, cost-effective outcomes for this challenging patient group and their caregivers.

Eligibility

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

Criteria

Inclusion Criteria:

Age >= 65 and older
Speaks English
Resides within 30 miles of admitting hospital site
Admitted from home to one of three hospital sites
a documented history of pre-existing dementia in their medical records or pre-screen positive for cognitive impairment using our Pre-Screen Process.
a primary caregiver (knowledgeable informant), defined as the spouse, family member, partner or friend, who will provide support following discharge to home and is reachable by telephone.

Exclusion Criteria:

- End Stage Disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294307

Locations

United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19102
Penn-Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

National Institute on Aging (NIA)

Investigators

Principal Investigator:

Mary D Naylor, PhD

University of Pennsylvania School of Nursing

More Information

Publications:

Naylor MD, Hirschman KB, Bowles KH, Bixby MB, Konick-McMahan J, Stephens C. Care coordination for cognitively impaired older adults and their caregivers. Home Health Care Serv Q. 2007;26(4):57-78.

Naylor MD, Stephens C, Bowles KH, Bixby MB. Cognitively impaired older adults: from hospital to home. Am J Nurs. 2005 Feb;105(2):52-61; quiz 61-2. No abstract available.

Alzheimer's Association. 2009 Alzheimer's disease facts and figures. Alzheimers Dement. 2009 May;5(3):234-70.

Responsible Party:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00294307 History of Changes
Other Study ID Numbers:	R01-AG023116
Study First Received:	February 16, 2006
Last Updated:	December 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Nursing Models of Care
Collaborative Care
Care Management
Transitional Care

Advanced Practice Nurse Care Interventions
Cognitive Impairment
Dementia
Delirium

Additional relevant MeSH terms:

Alzheimer Disease
Cognition Disorders
Delirium
Dementia
Dementia, Vascular
Delirium, Dementia, Amnestic, Cognitive Disorders
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Confusion

Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders

ClinicalTrials.gov processed this record on February 12, 2012