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Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers
This study is currently recruiting participants.
Verified by University of Pennsylvania, August 2009
First Received: February 16, 2006   Last Updated: August 11, 2009   History of Changes
Sponsor: University of Pennsylvania
Collaborator: National Institute on Aging (NIA)
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00294307
  Purpose
  1. 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.

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

Resource links provided by NLM:


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].

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

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

Locations
United States, Pennsylvania
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Karen Hirschman, PhD     215-573-3755     karen.hirschman@uphs.upenn.edu    
Principal Investigator: Mary D Naylor, PhD            
Penn-Presbyterian Medical Center Recruiting
Philadelphia, 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            
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Mary D Naylor, PhD University of Pennsylvania School of Nursing
  More Information

Publications:
Responsible Party: University of Pennsylvania School of Nursing ( Mary D. Naylor, PhD RN FAAN; Principal Investigator )
Study ID Numbers: R01-AG023116
Study First Received: February 16, 2006
Last Updated: August 11, 2009
ClinicalTrials.gov Identifier: NCT00294307     History of Changes
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:
Basal Ganglia Diseases
Arteriosclerosis
Neurodegenerative Diseases
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Signs and Symptoms
Intracranial Arteriosclerosis
Movement Disorders
Mental Disorders
Dementia, Vascular
Cardiovascular Diseases
Dementia
Neurobehavioral Manifestations
Delirium
Arterial Occlusive Diseases
Nervous System Diseases
Alzheimer Disease
Vascular Diseases
Central Nervous System Diseases
Confusion
Lewy Body Disease
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Neurologic Manifestations
Parkinsonian Disorders
Tauopathies

ClinicalTrials.gov processed this record on November 09, 2009