Clinical trial NCT01273116: In Hospital Care and Welfare Standard
Official title: Towards an In Hospital CARE AND WELFARE STANDARD for Frail Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Decline and Complications of Frail Older Patients Admitted to Hospital
Keywords: frailty
integrated care
hospital
geriatrics
hospital-wide intervention
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2011-01-10
Enrollment: 404
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient safety
timeFrame: during hospital stay
Secondary outcomes:
measure: Maintenance or improvement of functional status (patient safety)
timeFrame: 2 weeks before admission, discharge, 3 months after discharge
measure: Incidence delirium (patient safety)
timeFrame: during hospital stay
measure: Autonomy of patient (quality of care)
timeFrame: before implementation and one year after implementation of CWS InHospital
measure: OPROCS (quality of care)
timeFrame: discharge and 3 months follow-up
measure: Validity of delirium diagnoses by the medical specialty involved (quality of care)
timeFrame: before and one year after implementation CWS InHospital
measure: Readmissions (quality of care)
timeFrame: within 1 month after discharge
measure: Objective burden of care among informal caregivers (quality of care)
timeFrame: from admission to 3 months after discharge patient
measure: Cost-effectiveness
timeFrame: from admission to 3 months after discharge
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Marcel GM Olde Rikkert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.