In Hospital Care and Welfare Standard (CWSInHosp)

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Marcel Olde Rikkert, Radboud University
ClinicalTrials.gov Identifier:
NCT01273116
First received: December 28, 2010
Last updated: January 21, 2013
Last verified: January 2013

December 28, 2010
January 21, 2013
January 2011
July 2012   (final data collection date for primary outcome measure)
Patient safety [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
cumulative incidence in delirium, falls, functional decline (GARS), and loss of cognition (MMSE)
  • incidence delirium [ Time Frame: during hospital admission ] [ Designated as safety issue: No ]
    incidence delirium (Confusion Assessment Method (CAM) and Delirium Rating Scale - Revised 98 (DRS-R-98))
  • maintenance or improvement of functional status [ Time Frame: moment of 2 weeks before admission and day of discharge ] [ Designated as safety issue: No ]
    maintenance or improvement of functional status between 2 weeks before admission and discharge (Groningen Activity Restriction Scale (GARS))
Complete list of historical versions of study NCT01273116 on ClinicalTrials.gov Archive Site
  • Maintenance or improvement of functional status (patient safety) [ Time Frame: 2 weeks before admission, discharge, 3 months after discharge ] [ Designated as safety issue: No ]

    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
  • Incidence delirium (patient safety) [ Time Frame: during hospital stay ] [ Designated as safety issue: No ]
    incidence delirium (as judged by an independent physician, structured by daily application of the Confusion Assessment Method (CAM) and Delirium Observation Scale (DOS))
  • Autonomy of patient (quality of care) [ Time Frame: before implementation and one year after implementation of CWS InHospital ] [ Designated as safety issue: No ]
    Consumer Quality Indicator CWS In Hospital: to address autonomy of patients, developed by own researchers
  • OPROCS (quality of care) [ Time Frame: discharge and 3 months follow-up ] [ Designated as safety issue: No ]
    OPROCS = cumulative outcome measure functional ability and quality of life etc. as determined by the elderly (Minimum Data Set)
  • Validity of delirium diagnoses by the medical specialty involved (quality of care) [ Time Frame: before and one year after implementation CWS InHospital ] [ Designated as safety issue: No ]
    recognition of delirium by medical staff (nurses and doctors) compared to diagnoses by independent physician using CAM and DRS-r-98
  • Readmissions (quality of care) [ Time Frame: within 1 month after discharge ] [ Designated as safety issue: No ]
    readmissions within 1 month after discharge (Minimum Data Set, electronic health record)
  • Objective burden of care among informal caregivers (quality of care) [ Time Frame: from admission to 3 months after discharge patient ] [ Designated as safety issue: No ]
    objective burden of care among informal caregivers (Minimum Data Set)
  • Cost-effectiveness [ Time Frame: from admission to 3 months after discharge ] [ Designated as safety issue: No ]
    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
  • quality of life [ Time Frame: day of discharge, and 3 months after discharge ] [ Designated as safety issue: No ]

    quality of life (EuroQol 5 dimensions (EQ5D))

    • difference between group in baseline measurement and group after implementation at the moment of discharge
    • difference between discharge and 3 months after discharge
  • severity and duration of delirium episodes [ Time Frame: during hospital admission ] [ Designated as safety issue: No ]
    severity and duration of delirium episodes (DRS-R-98)
  • recognition of delirium [ Time Frame: before implementation and one year after implementation of CWS InHospital ] [ Designated as safety issue: No ]
    recognition of delirium by medical staff (nurses and doctors) compared to diagnoses by independent physician using CAM and DRS-r-98.
  • cognitive functioning [ Time Frame: day of admission, day of discharge ] [ Designated as safety issue: No ]
    cognitive functioning (Mini Mental State Examination (MMSE))
  • discharge destination [ Time Frame: day of discharge ] [ Designated as safety issue: No ]
    discharge destination (Minimum Data Set, electronic health record) whether or not a patient is discharged to his/her own home
  • weight change [ Time Frame: day of admission, day of discharge ] [ Designated as safety issue: No ]
    weight change during admission (scale, kg)
  • fall incidence, fall rate [ Time Frame: after discharge ] [ Designated as safety issue: No ]
    fall incidence and fall rate during hospital admission (decentral incident registration system (DIM))
  • readmissions [ Time Frame: within 1 month after discharge ] [ Designated as safety issue: No ]
    readmissions within 1 month after discharge (Minimum Data Set, electronic health record)
  • length of stay [ Time Frame: day of admission to day of discharge ] [ Designated as safety issue: No ]
    length of stay (electronic health record)
  • use of health care services [ Time Frame: from admission to 3 months after discharge ] [ Designated as safety issue: No ]
    use of health care services (Minimum Data Set)
  • cost-effectiveness [ Time Frame: from admission to 3 months after discharge ] [ Designated as safety issue: No ]
    cost-effectiveness (expressed in incremental cost-effectiveness ratio (with abovementioned 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)
  • objective burden of care among informal caregivers [ Time Frame: from admission to 3 months after discharge patient ] [ Designated as safety issue: No ]
    objective burden of care among informal caregivers (Minimum Data Set)
  • maintenance or improvement of functional status [ Time Frame: 2 weeks before admission to 3 months after discharge ] [ Designated as safety issue: No ]

    physical functioning (Groningen Activity Restriction Scale (GARS))

    • difference between discharge and 3 months after discharge
    • difference between 2 weeks before admission and 3 months after discharge
  • Consumer Quality Indicator CWS InHospital [ Time Frame: before implementation and one year after implementation of CWS InHospital ] [ Designated as safety issue: No ]
    CQI to address autonomy of patients, developed by own researchers
Not Provided
Not Provided
 
In Hospital Care and Welfare Standard
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Functional Decline and Complications of Frail Older Patients Admitted to Hospital
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.

Experimental: CWS in Hospital
CWS in Hospital in addition to usual care
Intervention: Other: CWS in Hospital
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
404
January 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01273116
Nr. 60-61900-98-272, NPO
No
Marcel Olde Rikkert, Radboud University
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Marcel GM Olde Rikkert, PhD Radboud University
Radboud University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP