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In Hospital Care and Welfare Standard (CWSInHosp)

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ClinicalTrials.gov Identifier: NCT01273116
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : January 23, 2013
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Marcel Olde Rikkert, Radboud University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Functional Decline and Complications of Frail Older Patients Admitted to Hospital Other: CWS in Hospital Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Towards an In Hospital CARE AND WELFARE STANDARD for Frail Elderly
Study Start Date : January 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: CWS in Hospital
CWS in Hospital in addition to usual care
Other: CWS in Hospital

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.

Primary Outcome Measures :
  1. Patient safety [ Time Frame: during hospital stay ]
    cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)

Secondary Outcome Measures :
  1. 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. 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))

  3. 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

  4. 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)

  5. 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

  6. Readmissions (quality of care) [ Time Frame: within 1 month after discharge ]
    readmissions within 1 month after discharge (Minimum Data Set, electronic health record)

  7. 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)

  8. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273116

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Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
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Principal Investigator: Marcel GM Olde Rikkert, PhD Radboud University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcel Olde Rikkert, prof dr, Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT01273116    
Other Study ID Numbers: Nr. 60-61900-98-272, NPO
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013
Keywords provided by Marcel Olde Rikkert, Radboud University Medical Center:
integrated care
hospital-wide intervention