Trial record 17 of 33 for:    DEMENTIA, LEWY BODY

Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00294307
First received: February 16, 2006
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

Aim 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, with improvement in patient, caregiver and cost outcomes.

[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.

Aim 2. To compare within each site and over time, health and cost outcomes (identified in Aim 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
Dementia
Dementia, Vascular
Alzheimer Disease
Delirium, Dementia, Amnestic, Cognitive Disorders
Lewy Body Disease
Mild Cognitive Impairment
Behavioral: Augmented Standard Care (ASC)
Behavioral: Resource Nurse Care (RNC)
Behavioral: Advanced Practice Nurse Care (APNC)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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:
  • Patient - Function [ Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge ] [ Designated as safety issue: No ]
    Basic Activities of Daily Living

  • Caregiver - Burden [ Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge ] [ Designated as safety issue: No ]
  • Patient - Health Care Costs [ Time Frame: Through 6 months ] [ Designated as safety issue: No ]
  • Patient - Time to first rehospitalization or death; total rehospitalization days [ Time Frame: From index hospital discharge through 6 months ] [ Designated as safety issue: No ]
    Time calculated from index hospital discharge to first rehospitalization or death. Total days rehospitalized through six months.


Secondary Outcome Measures:
  • Patient - Total rehospitalizations [ Time Frame: From index hospital discharge through 6 months ] [ Designated as safety issue: No ]
  • Patient - Cognitive Function [ Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge ] [ Designated as safety issue: No ]
  • Patient - Care Management [ Time Frame: From enrollment through 6 months ] [ Designated as safety issue: No ]
  • Patient - Symptoms (Physical and depressive symptoms) [ Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge ] [ Designated as safety issue: No ]
  • Patient - Neuropsychiatric Behaviors [ Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge ] [ Designated as safety issue: No ]
  • Patient - Quality of Life [ Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge ] [ Designated as safety issue: No ]
  • Patient/Caregiver - Satisfaction with care [ Time Frame: At 2-weeks and post APNC intervention ] [ Designated as safety issue: No ]
  • Caregiver - Depressive Symptoms [ Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge ] [ Designated as safety issue: No ]

Enrollment: 814
Study Start Date: February 2006
Study Completion Date: August 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Advanced Practice Nurse Care (APNC)
Hospital to Home
Behavioral: Advanced Practice Nurse Care (APNC)
Standard hospital care plus ASC and transitional care starting in the hospital and substituting for standard home care and provided by Advanced Practice Nurses (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].
Augmented Standard Care (ASC)
Hospital only
Behavioral: Augmented Standard Care (ASC)
Standard hospital care and, if referred, home care plus early identification of CI during the patients' hospitalization by trained research assistants with immediate verbal feedback and documentation to patients' primary nurses, attending physicians and discharge planners [low intensity];
Resource Nurse Care (RNC)
Hospital only
Behavioral: Resource Nurse Care (RNC)
Standard hospital and, if referred, home care plus early identification of CI during the patient's hospitalization (ASC) 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];.

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
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized community dwelling older adults with cognitive impairment and a caregiver

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
  • Active untreated substance abuse or psychiatric conditions
  • Primary cancer diagnosis (active treatment)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Mary D Naylor, PhD University of Pennsylvania School of Nursing
  More Information

Publications:
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: September 12, 2012
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:
Dementia
Dementia, Vascular
Delirium, Dementia, Amnestic, Cognitive Disorders
Lewy Body Disease
Alzheimer Disease
Cognition Disorders
Delirium
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 July 24, 2014