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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00294307

Collaborator

National Institute on Aging (NIA) (NIH)

814

Enrollment

Locations

Duration (Months)

271.3

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

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:

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;
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,
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

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 or Disease	Intervention/Treatment	Phase
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)

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.

Study Design

Study Type:

Observational

Actual Enrollment :

814 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Hospital to Home: Cognitively Impaired Elders/Caregivers

Study Start Date :

Feb 1, 2006

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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];.

Arm

Intervention/Treatment

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];.

Outcome Measures

Primary Outcome Measures

Patient - Function [At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge]
Basic Activities of Daily Living
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 [From index hospital discharge through 6 months]
Time calculated from index hospital discharge to first rehospitalization or death. Total days rehospitalized through six months.

Secondary Outcome Measures

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]
Patient - Quality of Life [At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge]
Patient/Caregiver - Satisfaction with care [At 2-weeks and post APNC intervention]
Caregiver - Depressive Symptoms [At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19102
2	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
3	Penn-Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104