Improving Outcomes of Hospitalized Elders and Caregivers

June 13, 2012 updated by: Bethel Powers, University of Rochester

In this study, an intervention is tested that is designed to improve the outcomes of hospitalized elders and family caregivers.

Study design:

  • randomized, controlled study
  • participants: 280 family caregivers aged 21 or above
  • length of follow-up: 2 weeks and 2 months after hospitalization

Study hypothesis: In this randomized clinical trial, the following hypotheses will be tested:

  1. Hospitalized elders whose family CGs receive the CARE program versus those who receive a comparison program will have better outcomes during and after hospitalization as measured by: (1) fewer incidents of dysfunctional syndrome; (2) shorter hospital stays; (3) lower readmission rates; (4) less depressive symptoms; (5) higher cognitive level; (6) less functional decline perceived by family CG; and (7) a closer relationship with their family CGs.
  2. Family CGs of hospitalized elders who receive the CARE program will report: (1) More positive beliefs about their loved one's responses to hospitalization and their role in the hospital setting; (2) more positive emotional outcomes (less worry, anxiety, and depressive symptoms) during and after hospitalization; (3) More participation in their loved one's care during hospitalization; and (4) More positive role outcomes (more role reward, less role strain, more prepared for their loved one's care, and a closer relationship with their elderly relatives, both during and after hospitalization).
  3. The proposed model to explain the effects of the CARE program on the process and outcomes of family CG coping and elderly patient outcomes will be supported for CGs and elderly patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

More than 12 million elderly people are hospitalized each year in the United Status, frequently resulting in functional decline. Family care of hospitalized elders is important given the increasing numbers of hospitalized elders, needs for elder care in the home after hospital discharge, and responsibilities of family caregivers for providing this care. Involving family caregivers in the hospital care of their loved one may result in positive outcomes for both the elderly patients and their family caregivers. However, there is a paucity of empirical studies that have been conducted to evaluate the effectiveness of interventions to enhance family participation in caring for hospitalized elders. In the proposed study, we will build upon our prior work that has demonstrated the positive effects of theoretically-driven interventions with families of hospitalized patients and older adults at home. Among the unique contributions of this study include: (a) a randomized controlled design, (b) testing of a theoretically-driven, reproducible intervention that can be easily translated into clinical practice and widely disseminated; (c) the testing of an explanatory model to explain the effects of the intervention, (d) a prospective cost-effectiveness analysis; and (e) an intervention that begins early in the hospital stay, and (f) measurement of both short- and more long-term outcomes, up to 2 months following hospital discharge.

The primary aim of this study is to evaluate the effects of a theoretically-driven, reproducible intervention (CARE: Creating Avenues for Relative Empowerment) on the process and outcomes of hospitalized elders and their family caregivers. The secondary aims are to: (a) explore what factors moderate the effects of the intervention program (e.g., social economic status and family preferences for care participation); and (b) determine the cost-effectiveness of the CARE program. A two-group experiment will be used with 280 family caregivers of hospitalized elders. Measures of both process and outcome variables will be included, such as family caregiver beliefs, anxiety, worry, depression, role outcomes, as well as elderly patients outcomes during hospitalization and after hospital discharge. Findings from a recent pilot study with 49 family caregiver-elders dyads support undertaking this full-scale clinical trial in that family caregivers who received the CARE program, versus those who received a comparison program, had more positive coping and role outcomes and their hospitalized elderly relatives had positive outcomes during and after hospitalization.

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 2

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
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester School of Nursing

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:Family CGs

  • age of 21 years or above;
  • have an elderly relative (65 years or above) admitted to the three study units within the past 24-48 hours; (c) are related to the patient by blood, marriage, adoption, or affinity as a significant other (e.g., life partner, close friend);
  • are primary CGs;
  • can read and speak English; and
  • live within a 1-hour drive of the facility (60 miles).

Exclusion Criteria: Family CGS

  • paid care providers;
  • unable to complete the questionnaires or provide care because of their own mental or physical impairment;

Patient:

  • dies during the hospital stay or within 2 months after discharge;
  • is transferred from the Intensive Care Unit (ICU) and stayed in the ICU for more than 2 nights;
  • is diagnosed with dementia;
  • is admitted from a long-term care facility; and
  • is hospitalized for longer than 30 days
  • is staying longer than 6 weeks in a nursing home immediately after hospitalization.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Treatment group
Behavioral: Care Project for Hospitalized Elders & Family Caregivers

Phase 1 in-hospital contact: Family caregivers complete baseline data, listen to a tape about helping the elderly relative cope with hospitalization, and work on a mutual agreement/identification of goals for participation in family member's hospital care (i.e., selection of two complications to focus on based on patient's illness condition)

Phase 2 pre-hospital discharge: Family caregivers listen to a second tape about coping with the hospital experience, participating in their family member's in-hospital care, and preparing for hospital discharge/transition to home
Active Comparator: 2
Comparison Group
Behavioral: Comparison Group

Phase 1 in-hospital contact: Family caregivers complete baseline data and listen to an informational tape about hospital policies.

Phase 2 pre-hospital discharge: Family caregivers listen to a second informational tape about the hospital and medical center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients' outcomes: rates of dysfunctional syndrome, readmission rate, and depression.
Time Frame: At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
Family Caregiver: emotional coping (worry, anxiety and depression); functional coping (participation in patient's care); and role outcomes(role reward, role strain)
Time Frame: 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost analysis.
Time Frame: At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge
At intake, 1-3 days pre-hospital discharge, at 2 weeks and at 2 months post hospital discharge

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Hong Li, Ph.D., RN, University of Rochester School of Nursing
  • Principal Investigator: Bethel A Powers, RN, PhD, University of Rochester School of Nursing

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

April 1, 2003

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01NR008455-01 (U.S. NIH Grant/Contract)
  • R01NR008455 (U.S. NIH Grant/Contract)

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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