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

February 1, 2019 updated by: University of Pennsylvania

Hospital to Home: Cognitively Impaired Elders/Caregivers

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. 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, 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

814

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Pennsylvania Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn-Presbyterian Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized community dwelling older adults with cognitive impairment and a caregiver

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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];.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient - Function
Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Basic Activities of Daily Living
At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Caregiver - Burden
Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Health Care Costs
Time Frame: Through 6 months
Through 6 months
Patient - Time to first rehospitalization or death; total rehospitalization days
Time Frame: From index hospital discharge through 6 months
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 Outcome Measures

Outcome Measure
Time Frame
Patient - Total rehospitalizations
Time Frame: From index hospital discharge through 6 months
From index hospital discharge through 6 months
Patient - Cognitive Function
Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Care Management
Time Frame: From enrollment through 6 months
From enrollment through 6 months
Patient - Symptoms (Physical and depressive symptoms)
Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Neuropsychiatric Behaviors
Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient - Quality of Life
Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
Patient/Caregiver - Satisfaction with care
Time Frame: At 2-weeks and post APNC intervention
At 2-weeks and post APNC intervention
Caregiver - Depressive Symptoms
Time Frame: At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge
At hospital admission and at 2-, 6-, 12-, and 26-weeks post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Mary D Naylor, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (ESTIMATE)

February 20, 2006

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AG023116 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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