Clinical trial NCT04048980: Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units
Official title: Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Femur Fracture
Continuity of Patient Care
Keywords: intervention
elderly
nursing care
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Puerta de Hierro University Hospital
name: Hospital Universitario Marqués de Valdecilla
name: Complejo Hospitalario de Navarra
name: Fondo de Investigacion Sanitaria
First posted: 2019-08-07
Enrollment: 432
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 65

   * Hospitalized for surgery
   * Informal caregiver able to understand the recommendations of health professionals
   * Score of 5 or less in the Short Portable Mental Status Questionnaire (SPMSQ) test
   * Signed informed consent form.
2. Informal caregivers:

   * Living with the PwD or visiting at least three times per week at home or nursing home
   * Signed informed consent form.

Exclusion Criteria:

* Patients younger than 65
* Psychiatric symptoms or Korsakov syndrome
* No signed consent form.

Primary outcomes:
measure: Use of Restraints
timeFrame: 3 months
measure: Psychotropic medication
timeFrame: 3 months
measure: Pain assessment in dementia: MPAINAD scale
timeFrame: 3 months
measure: Falls (number)
timeFrame: 3 months
measure: Functional capacity
timeFrame: 3 months
measure: Knowledge of nurses
timeFrame: 3 months
measure: Informal Caregiver Costs
timeFrame: 3 months
measure: Caregiver burden
timeFrame: 3 months
measure: Cognitive status
timeFrame: 3 months
measure: Comorbidity
timeFrame: 3 months
Secondary outcomes:
measure: Psychotropic medication administration
timeFrame: 3 months
measure: Frequency on psychotropic medication
timeFrame: 3 months
measure: Injuries related to falls
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
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