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Completed

NCT Number: NCT00294307

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

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Key information

Conditions

Dementia Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Confusion Delirium Delirium, Dementia, Amnestic, Cognitive Disorders Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Lewy Body Disease Mental Disorders Mild Cognitive Impairment Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tauopathies Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Augmented Standard Care (ASC)

Behavioral

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)

Behavioral

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];.

Advanced Practice Nurse Care (APNC)

Behavioral

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].

Primary outcomes

  1. Patient - Function

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

    Basic Activities of Daily Living

  2. Caregiver - Burden

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

  3. Patient - Health Care Costs

    Time frame: Through 6 months

  4. 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.

Secondary outcomes

  1. Patient - Total rehospitalizations

    Time frame: From index hospital discharge through 6 months

  2. Patient - Cognitive Function

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

  3. Patient - Care Management

    Time frame: From enrollment through 6 months

  4. Patient - Symptoms (Physical and depressive symptoms)

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

  5. Patient - Neuropsychiatric Behaviors

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

  6. Patient - Quality of Life

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

  7. Patient/Caregiver - Satisfaction with care

    Time frame: At 2-weeks and post APNC intervention

  8. Caregiver - Depressive Symptoms

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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Hospital to Home: Cognitively Impaired Elders/Caregivers

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Feb 20, 2006
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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