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Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers
This study is currently recruiting participants.
Study NCT00294307   Information provided by University of Pennsylvania
First Received: February 16, 2006   Last Updated: August 11, 2009   History of Changes

February 16, 2006
August 11, 2009
February 2006
March 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Instrumental Activities of Daily Living at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
  • Caregiver Burden
  • Time to subsequent rehospitalizations at 6 months after initial hospital discharge
  • Time till death at 6 months after initial hospital discharge and yearly thereafter.
  • Health Care costs at six months after initial hospitalization
  • Activities of Daily Living at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
Complete list of historical versions of study NCT00294307 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Rate of rehospitalization at 6 months after initial hospital discharge
  • Cognitive Function at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
  • Beneficial Clinical Events at discharge and at 6months
  • Adverse Clinical events at discharge and at 6 months
  • Neuropsychiatric Inventory at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
  • Behaviors at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
  • Depression at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
  • Symptom Status at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
  • Quality of Life at hospital admission,and at 2, 6, 12, and 24 weeks post-discharge
  • Caregiver satisfaction with care at 6 months
 
Enhancing Care Coordination: Hospital to Home for Cognitively Impaired Older Adults and Their Caregivers
Hospital to Home: Cognitively Impaired Elders/Caregivers
  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.

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.

Phase I, Phase II
Interventional
Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • 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
  • Experimental: Three different nursing interventions of varying intensity, one offered at one of three sites.
  • Experimental: All three sites receive the same high intensity intervention.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
420
August 2010
March 2010   (final data collection date for primary outcome measure)

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

Both
65 Years and older
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
 
NCT00294307
Mary D. Naylor, PhD RN FAAN; Principal Investigator, University of Pennsylvania School of Nursing
R01-AG023116
University of Pennsylvania
National Institute on Aging (NIA)
Principal Investigator: Mary D Naylor, PhD University of Pennsylvania School of Nursing
University of Pennsylvania
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP