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Sponsors and Collaborators: |
University of Pennsylvania National Institute on Aging (NIA) |
Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00294307 |
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 |
Procedure: Augmented Standard Care Procedure: Resource Nurse Care Procedure: Advanced Practice Nurse Care |
Phase I Phase II |
Genetics Home Reference related topics: | Alzheimer disease familial paroxysmal nonkinesigenic dyskinesia |
MedlinePlus related topics: | Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia Lewy Body Disease |
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.
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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].
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2: Experimental
All three sites receive the same high intensity intervention.
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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].
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Show Detailed Description |
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
- End Stage Disease
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, 19104 | |||||
Contact: Margaret Crowley, MSN 215-829-8716 crowleym@uphs.upenn.edu | |||||
Principal Investigator: Mary D Naylor, PhD | |||||
Penn-Presbyterian Medical Center | Recruiting | ||||
Phila, 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 |
University of Pennsylvania |
National Institute on Aging (NIA) |
Principal Investigator: | Mary D Naylor, PhD | University of Pennsylvania School of Nursing |
Responsible Party: | University of Pennsylvania School of Nursing ( Mary D. Naylor, PhD RN FAAN; Principal Investigator ) |
Study ID Numbers: | R01-AG-023116-01A1 |
First Received: | February 16, 2006 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00294307 |
Health Authority: | United States: Institutional Review Board |
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