Dementia Clinical Trial
Official title:
Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units
This is a quasi-experimental design with repeated observations, taken at baseline, post-intervention, and at one and three months post-intervention. Participants will be patients hospitalized with cognitive disorders o dementia and a femur fracture. The study will be developed in four general hospitals in Spain and will include 430 patients with dementia (PwD) and their informal caregivers (IC). The study sample will be assigned to the control group (n=215) from each hospital involved and will receive the standard treatment. After completing the recruitment for the control group, the investigators will start to recruit patients until experimental patient group is complete (n=215) from each hospital to whom the CARExDEM intervention will be implemented.
The high vulnerability of PwD hospitalized generates the need to confront this challenge from
a global and continuous perspective along with the clear lack of intervention studies with
PwD hospitalized at a national and international level.
The aim of this study is to design, implement and evaluate the effectiveness of an
intervention program for nurses looking after hospitalized patients with proximal femur
fracture and dementia or cognitive impairment, in acute hospitals and its impact in quality
of care, morbidity reduction, improvement of continuity of care and reduction in costs.
The study will be conducted in four traumatology units of high technology public hospitals
across Spain: the autonomous communities included are Catalonia (Hospital Clinic Barcelona),
Madrid (Hospital Puerta de Hierro Madrid), Cantabria (Hospital Marqués de Valdecilla) and
Navarra (Complejo hospitalario de Navarra). The study will be held in a 3 year frame time.
Participants will be patients with dementia and their caregiver elected consecutively
(n=432), and healthcare professionals working in the traumatology unit. All questionnaires
selected are valid and reliable and widely used among studies with PwD. All questionnaires
were translated already to Spanish and we have permission of the authors for using them. They
are structured in Likert scaling. The whole questionnaire can be completed in 45 minutes (for
patient questions) and 15 minutes (for informal caregivers).
Data will be collected by trained interviewers at hospital admission (within 24 hours),
discharge, 1 moth follow up at the outpatient traumatology visit and 3 months follow up
(phone call). Questionnaires have been customized in one document according to the collection
phase. Questions will be responded according to patient and caregiver data.
Procedure
The study will be conducted in 3 phases:
1. Pre-intervention stage: Program design Design of the intervention CARExDEM: It will be
developed from the results obtained from the European study RightTimePlaceCare. They
evaluated care of PwD and their caregivers in Europe using the Balance of Care
methodology. This method implies expert healthcare professionals (nurses, physicians,
physiotherapists, social workers and care assistants) in care of patients with dementia
or cognitive impairment and traumatology. The experts will reach a consensus about the
best care needed under these circumstances, constituting the educational intervention
CARExDEM.
CARExDEM is an educational program aimed for nurses and other health professionals
looking after PwD and a femur fracture. Information and dynamic educational sessions
will be adapted from clinical guidelines and best practices. This intervention pretends
to provide nurses with strategies in the management of PwD in acute care and to raise
awareness about the importance on individualized care in these patients to improve
continuity of care in exacerbated situations on PwD.
Educational training will be held, approved by unit managers and the research team, and
all hospitals will follow the same protocol. The investigators will train nurses about
the care guide including aspects such as use of physical restraints, psychotropic
medication, falls, functional capacity and pain.
2. Implementation of the intervention CARExDEM A pilot test will be monitored prior to
implementation in each hospital. The investigators will consider opinions of experts and
informal caregivers related to its applicability, follow up, population participation
and time cost/savings. Once the intervention is implemented, the investigators will
follow closely in case of doubts or barriers. Weekly meetings will be held to review the
nurses training.
3. Follow up and evaluation of the CARExDEM implementation related to costs Data will be
introduced in a database and results will be evaluated by an expert statistician. The
research team will discuss the results and outcomes will be presented in Congresses and
articles.
Intervention The intervention will be designed following the Balance of Care (BoC)
methodology. This methodology implies multidisciplinary experts (nurses, physicians,
physiotherapists, social workers and care assistants) evaluating resources and activities
needed for an optimum care of PwD admitted to traumatology units.
CARExDEM is an educational program addressed to nurses working in traumatology units and
looking after patients with dementia. The intervention will be complemented with a checklist
guide that will enhance implication and raise awareness when implementing it. Information and
dynamics of training sessions will be adapted according to clinical guidelines and best
practice.
Statistical Analysis Descriptive analysis will be used for baseline data. Categorical
variables will be represented with absolute frequencies and percentages. For continuous
variables, mean values, standard deviation or medians will be calculated. To study the effect
of the intervention, analysis of co-variance will be approached (ANCOVA), also Student's
t-test in continuous variables and McNemar test in categorical variables. Sensibility will be
analyzed to compare basal data of participants finishing the study and those who will not
finish it. Outcomes measured will evaluate longitudinal changes from all the collection
phases; baseline (admission), discharge, 1 month and 3 months follow up. Data from the four
hospitals participating in the study also will be compared according to own resources.
Confidence intervals of 95% will be calculated. Values of p< 0,05 will be considered
significant. Confidence interval of 95% will be calculated. Statistical analysis will be done
with R program, 3.2.3. Version for Windows. The research team will reflect about the analyzed
data and will issue a final report including the CARExDEM program with the required
modifications identified following the implementation evaluation. This will ease the
implementation of the program in other hospitals subsequently.
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