NCT00294307

Brief Summary

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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
814

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4.4 years

First QC Date

February 16, 2006

Last Update Submit

February 1, 2019

Conditions

Keywords

Nursing Models of CareCollaborative CareCare ManagementTransitional CareAdvanced Practice Nurse Care InterventionsCognitive ImpairmentDementiaDelirium

Outcome Measures

Primary Outcomes (4)

  • Patient - Function

    Basic Activities of Daily Living

    At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge

  • Caregiver - Burden

    At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge

  • Patient - Health Care Costs

    Through 6 months

  • Patient - Time to first rehospitalization or death; total rehospitalization days

    Time calculated from index hospital discharge to first rehospitalization or death. Total days rehospitalized through six months.

    From index hospital discharge through 6 months

Secondary Outcomes (8)

  • Patient - Total rehospitalizations

    From index hospital discharge through 6 months

  • Patient - Cognitive Function

    At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge

  • Patient - Care Management

    From enrollment through 6 months

  • Patient - Symptoms (Physical and depressive symptoms)

    At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge

  • Patient - Neuropsychiatric Behaviors

    At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge

  • +3 more secondary outcomes

Study Arms (3)

Advanced Practice Nurse Care (APNC)

Hospital to Home

Behavioral: Advanced Practice Nurse Care (APNC)

Augmented Standard Care (ASC)

Hospital only

Behavioral: Augmented Standard Care (ASC)

Resource Nurse Care (RNC)

Hospital only

Behavioral: Resource Nurse Care (RNC)

Interventions

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 \[low intensity\];

Augmented Standard Care (ASC)

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 \[medium intensity\];.

Resource Nurse Care (RNC)

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 \[high intensity\].

Advanced Practice Nurse Care (APNC)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized community dwelling older adults with cognitive impairment and a caregiver

You may qualify if:

  • 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.

You may not qualify if:

  • End Stage Disease
  • Active untreated substance abuse or psychiatric conditions
  • Primary cancer diagnosis (active treatment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19102, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn-Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (9)

  • Naylor MD, Hirschman KB, Bowles KH, Bixby MB, Konick-McMahan J, Stephens C. Care coordination for cognitively impaired older adults and their caregivers. Home Health Care Serv Q. 2007;26(4):57-78. doi: 10.1300/j027v26n04_05.

    PMID: 18032200BACKGROUND
  • Naylor MD, Stephens C, Bowles KH, Bixby MB. Cognitively impaired older adults: from hospital to home. Am J Nurs. 2005 Feb;105(2):52-61; quiz 61-2. doi: 10.1097/00000446-200502000-00028. No abstract available.

    PMID: 15674058BACKGROUND
  • McCauley K, Bradway C, Hirschman KB, Naylor MD. Studying nursing interventions in acutely ill, cognitively impaired older adults. Am J Nurs. 2014 Oct;114(10):44-52. doi: 10.1097/01.NAJ.0000454851.22018.5d.

    PMID: 25251126BACKGROUND
  • Shankar KN, Hirschman KB, Hanlon AL, Naylor MD. Burden in caregivers of cognitively impaired elderly adults at time of hospitalization: a cross-sectional analysis. J Am Geriatr Soc. 2014 Feb;62(2):276-84. doi: 10.1111/jgs.12657. Epub 2014 Feb 6.

    PMID: 24502827BACKGROUND
  • Hirschman KB, Paik HH, Pines JM, McCusker CM, Naylor MD, Hollander JE. Cognitive Impairment among Older Adults in the Emergency Department. West J Emerg Med. 2011 Feb;12(1):56-62.

    PMID: 21691473BACKGROUND
  • Bradway C, Trotta R, Bixby MB, McPartland E, Wollman MC, Kapustka H, McCauley K, Naylor MD. A qualitative analysis of an advanced practice nurse-directed transitional care model intervention. Gerontologist. 2012 Jun;52(3):394-407. doi: 10.1093/geront/gnr078. Epub 2011 Sep 9.

  • Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Comparison of evidence-based interventions on outcomes of hospitalized, cognitively impaired older adults. J Comp Eff Res. 2014 May;3(3):245-57. doi: 10.2217/cer.14.14.

  • Naylor MD, Hirschman KB, Hanlon AL, Bowles KH, Bradway C, McCauley KM, Pauly MV. Effects of alternative interventions among hospitalized, cognitively impaired older adults. J Comp Eff Res. 2016 May;5(3):259-72. doi: 10.2217/cer-2015-0009. Epub 2016 May 5.

  • Pauly MV, Hirschman KB, Hanlon AL, Huang L, Bowles KH, Bradway C, McCauley K, Naylor MD. Cost impact of the transitional care model for hospitalized cognitively impaired older adults. J Comp Eff Res. 2018 Sep;7(9):913-922. doi: 10.2217/cer-2018-0040. Epub 2018 Sep 11.

MeSH Terms

Conditions

DementiaDementia, VascularAlzheimer DiseaseNeurocognitive DisordersLewy Body DiseaseCognitive DysfunctionDelirium

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesMental DisordersCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesTauopathiesNeurodegenerative DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesCognition DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary D Naylor, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2006

First Posted

February 20, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2010

Study Completion

August 1, 2012

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations