In Hospital Care and Welfare Standard (CWSInHosp)

January 21, 2013 updated by: Marcel Olde Rikkert, Radboud University Medical Center

Towards an In Hospital CARE AND WELFARE STANDARD for Frail Elderly

The current organization of hospital care for older patients with complex healthcare needs is of insufficient quality, safety and efficiency. Frail older patients have a higher risk for development of complications and consequently a higher length of hospital stay, a higher risk of functional decline, and higher care needs after discharge. As nearly half of the patients admitted to Dutch hospitals is over 65 years, it is highly necessary to adapt the organization of hospital care to their needs. Besides having introduced the medical specialty geriatrics, hospital management has not started to provide hospital wide healthcare tailored to frail older patients. Therefore, the purpose of this study is to develop and examine the effectiveness of an intervention program for frail older patients admitted to hospital aimed at preventing functional decline and other hospital related negative outcomes.

Study Overview

Detailed Description

The long-term objective of this study is to examine the effectiveness and efficiency of an intervention program for frail older patients admitted to hospital. The specific aims are:

  • To develop a model of integrated hospital care, according to the principle of the Chronic Care Model, focusing both on optimizing care and wellbeing. Feasibility of such a model of care was first evaluated in a pilot study.
  • To conduct a before-after study to evaluate the outcomes associated with the proposed model of hospital care in frail older inpatients. Information on outcome indicators, including autonomy, quality of life, physical and cognitive functioning, and service utilization will be collected and compared before and after implementation of the proposed model of hospital care.

We expect that older patients who participate in the intervention program after one year of implementation, compared to patients who were admitted to hospital before implementation of the intervention program, will:

  • have less functional decline during admission and after three months follow-up compared to two weeks before admission;
  • have a lower incidence, severity and duration of delirium during admission;
  • have less cognitive decline during admission;
  • are more likely to be discharged directly to their own homes;
  • have less weight loss between admission and discharge;
  • experience less falls during admission;
  • experience less readmissions within one month after discharge;
  • have a shorter length of stay;
  • have a significant different pattern of use of health care services after three months follow-up;
  • experience more autonomy during hospital admission and better quality of life after three months follow-up.

Additionally, we expect that the knowledge and attitudes toward care for older patients among nurses and physicians will change positively during implementation of the intervention program.

Study Type

Interventional

Enrollment (Actual)

404

Phase

  • Not Applicable

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

    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Frail patients aged 70 years or older, admitted to one of the participating hospital wards
  • Patients aged <70 years, but living in a nursing home or diagnosed with dementia (and therefore also judged as frail)

Exclusion Criteria:

  • Patients admitted <48 hours
  • Palliative care is main goal of hospital admission
  • Patients admitted and treated by physicians from non-participating wards and specialities
  • Patients who do not speak or understand the Dutch language

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CWS in Hospital
CWS in Hospital in addition to usual care

Every patient aged ≥70 years will be screened for frailty. (For) every frail patient:

  • will have a comprehensive (geriatric) assessment using an adapted version of the EasyCare instrument;
  • a geriatric consultation team will propose/recommend a tailored care and welfare plan, which will be updated at the moment of discharge;
  • will be discussed at least once in a multidisciplinary meeting;
  • a structured medication review will be carried out by a geriatrician;
  • is offered an activation programme by volunteers focusing on improvement of orientation, mobility, social activities or nutrition;
  • may receive a consult of a geriatrician, if judged necessary;
  • will receive extra attention on discharge arrangements.

Hospital staff will be educated, disease-specific guidelines will be adapted to frail older patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient safety
Time Frame: during hospital stay
cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)
during hospital stay

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance or improvement of functional status (patient safety)
Time Frame: 2 weeks before admission, discharge, 3 months after discharge

maintenance or improvement of functional status (Groningen Activity Restriction Scale GARS)):

  • difference between 2 weeks before admission and discharge
  • difference between discharge and 3 months after discharge
  • difference between 2 weeks before admission and 3 months after discharge
2 weeks before admission, discharge, 3 months after discharge
Incidence delirium (patient safety)
Time Frame: during hospital stay
incidence delirium (as judged by an independent physician, structured by daily application of the Confusion Assessment Method (CAM) and Delirium Observation Scale (DOS))
during hospital stay
Autonomy of patient (quality of care)
Time Frame: before implementation and one year after implementation of CWS InHospital
Consumer Quality Indicator CWS In Hospital: to address autonomy of patients, developed by own researchers
before implementation and one year after implementation of CWS InHospital
OPROCS (quality of care)
Time Frame: discharge and 3 months follow-up
OPROCS = cumulative outcome measure functional ability and quality of life etc. as determined by the elderly (Minimum Data Set)
discharge and 3 months follow-up
Validity of delirium diagnoses by the medical specialty involved (quality of care)
Time Frame: before and one year after implementation CWS InHospital
recognition of delirium by medical staff (nurses and doctors) compared to diagnoses by independent physician using CAM and DRS-r-98
before and one year after implementation CWS InHospital
Readmissions (quality of care)
Time Frame: within 1 month after discharge
readmissions within 1 month after discharge (Minimum Data Set, electronic health record)
within 1 month after discharge
Objective burden of care among informal caregivers (quality of care)
Time Frame: from admission to 3 months after discharge patient
objective burden of care among informal caregivers (Minimum Data Set)
from admission to 3 months after discharge patient
Cost-effectiveness
Time Frame: from admission to 3 months after discharge
expressed in incremental cost-effectiveness ratio (length of stay; use of health care services (MDS), quality of life) primary outcomes as nominator, and expressed in costs per quality adjusted life years, all related to total health care costs from a societal perspective, from admission to three months following discharge
from admission to 3 months after discharge

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Marcel GM Olde Rikkert, PhD, Radboud University Medical Center

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.

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

January 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 21, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • Nr. 60-61900-98-272, NPO

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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