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| Sponsor: | University of Pennsylvania |
|---|---|
| Collaborator: |
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:
[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.
[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 |
| 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
|
|
2: Experimental
All three sites receive the same high intensity intervention.
|
Procedure: Advanced Practice Nurse Care
|
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 |
Inclusion Criteria:
Exclusion Criteria:
- End Stage Disease
Contacts and Locations| 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, 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 | |
| Principal Investigator: | Mary D Naylor, PhD | University of Pennsylvania School of Nursing |
More Information
| 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 |
|
Nursing Models of Care Collaborative Care Care Management Transitional Care |
Advanced Practice Nurse Care Interventions Cognitive Impairment Dementia Delirium |
|
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 |