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CompletedNCT01273116CWSInHospUpdated Jan 23, 2013

In Hospital Care and Welfare Standard

An interventional study of CWS in Hospital in Functional Decline and Complications of Frail Older Patients Admitted to Hospital, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2013-01-23.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
404
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Functional Decline and Complications of Frail Older Patients Admitted to Hospital

Keywords

  • frailty
  • integrated care
  • hospital
  • geriatrics
  • hospital-wide intervention
03

In context

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
404 participants (actual)

Study arms

  • Experimental
    CWS in Hospital

    CWS in Hospital in addition to usual care

    Other: CWS in Hospital

Interventions

  • OtherCWS 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.

06

What researchers measure

Primary outcomes

  1. Patient safety

    cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)

    Time frame: during hospital stay

Secondary outcomes

  1. Maintenance or improvement of functional status (patient safety)

    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

    Time frame: 2 weeks before admission, discharge, 3 months after discharge

  2. Incidence delirium (patient safety)

    incidence delirium (as judged by an independent physician, structured by daily application of the Confusion Assessment Method (CAM) and Delirium Observation Scale (DOS))

    Time frame: during hospital stay

  3. Autonomy of patient (quality of care)

    Consumer Quality Indicator CWS In Hospital: to address autonomy of patients, developed by own researchers

    Time frame: before implementation and one year after implementation of CWS InHospital

  4. OPROCS (quality of care)

    OPROCS = cumulative outcome measure functional ability and quality of life etc. as determined by the elderly (Minimum Data Set)

    Time frame: discharge and 3 months follow-up

  5. Validity of delirium diagnoses by the medical specialty involved (quality of care)

    recognition of delirium by medical staff (nurses and doctors) compared to diagnoses by independent physician using CAM and DRS-r-98

    Time frame: before and one year after implementation CWS InHospital

  6. Readmissions (quality of care)

    readmissions within 1 month after discharge (Minimum Data Set, electronic health record)

    Time frame: within 1 month after discharge

  7. Objective burden of care among informal caregivers (quality of care)

    objective burden of care among informal caregivers (Minimum Data Set)

    Time frame: from admission to 3 months after discharge patient

  8. Cost-effectiveness

    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

    Time frame: from admission to 3 months after discharge

07

Study locations

1 site
  • Radboud University Nijmegen Medical Centre
    Nijmegen, Gelderland 6500 HB, Netherlands
08

References and documents

Publications

  • Bakker FC, Persoon A, Bredie SJH, van Haren-Willems J, Leferink VJ, Noyez L, Schoon Y, Olde Rikkert MGM. The CareWell in Hospital program to improve the quality of care for frail elderly inpatients: results of a before-after study with focus on surgical patients. Am J Surg. 2014 Nov;208(5):735-746. doi: 10.1016/j.amjsurg.2014.04.009. Epub 2014 Jun 27. PubMed 25085385 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01273116
Lead sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Responsible party
Marcel Olde Rikkert (prof dr, Radboud University Medical Center) — Principal investigator
First posted
Jan 10, 2011
Start date
Jan 2011
Primary completion
Jul 2012
Completion
Jan 2013
Last update
Jan 23, 2013

Study contacts

Marcel GM Olde Rikkert, PhD
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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