Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units

Dementia Clinical Trial

— CARExDEM  

Official title:

Care of Older People With Cognitive Impairment or Dementia Hospitalized in Traumatology Units

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04048980
• Other study ID #: HCB/2017/0499
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Hospital Clinic of Barcelona
• Contact: Claudia Casafont
• Phone: 0034 932275782
• Email: casafont[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Continuity of Patient Care
• Dementia
• Femoral Fractures
• Femur Fracture

Intervention

Behavioral:
• CARExDEM
CARExDEM is an educational program addressed to nurses working in traumatology units and looking after patients with dementia. This intervention pretends to provide strategies to nurses for cognitive impairment management in acute hospital settings, to raise awareness about personalized care in dementia and to improve continuity of care in acute situations in PwD. Training sessions will be held to inform and train nurses about care of PwD and their caregivers by the research team in each hospital.

Locations

Country	Name	City	State
Spain	Hospital Clinic Barcelona	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Complejo Hospitalario de Navarra, Fondo de Investigacion Sanitaria, Hospital Universitario Marqués de Valdecilla, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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Farré M, Haro JM, Kostov B, Alvira C, Risco E, Miguel S, Cabrera E, Zabalegui A. Direct and indirect costs and resource use in dementia care: A cross-sectional study in patients living at home. Int J Nurs Stud. 2016 Mar;55:39-49. doi: 10.1016/j.ijnurstu.2015.10.012. Epub 2015 Nov 19. — View Citation

Foebel AD, Liperoti R, Onder G, Finne-Soveri H, Henrard JC, Lukas A, Denkinger MD, Gambassi G, Bernabei R; SHELTER Study Investigators. Use of antipsychotic drugs among residents with dementia in European long-term care facilities: results from the SHELTER study. J Am Med Dir Assoc. 2014 Dec;15(12):911-7. doi: 10.1016/j.jamda.2014.07.012. Epub 2014 Sep 24. — View Citation

Given CW, Given B, Stommel M, Collins C, King S, Franklin S. The caregiver reaction assessment (CRA) for caregivers to persons with chronic physical and mental impairments. Res Nurs Health. 1992 Aug;15(4):271-83. — View Citation

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KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. — View Citation

Librero J, Peiró S, Ordiñana R. Chronic comorbidity and outcomes of hospital care: length of stay, mortality, and readmission at 30 and 365 days. J Clin Epidemiol. 1999 Mar;52(3):171-9. — View Citation

Mira JJ, Nuño-Solinís R, Guilabert-Mora M, Solas-Gaspar O, Fernández-Cano P, González-Mestre MA, Contel JC, Del Río-Cámara M. Development and Validation of an Instrument for Assessing Patient Experience of Chronic Illness Care. Int J Integr Care. 2016 Aug 31;16(3):13. doi: 10.5334/ijic.2443. — View Citation

Mosk CA, Mus M, Vroemen JP, van der Ploeg T, Vos DI, Elmans LH, van der Laan L. Dementia and delirium, the outcomes in elderly hip fracture patients. Clin Interv Aging. 2017 Mar 10;12:421-430. doi: 10.2147/CIA.S115945. eCollection 2017. — View Citation

Risco E, Zabalegui A, Miguel S, Farré M, Alvira C, Cabrera E. [Application of the Balance of Care model in decision-making regarding the best care for patients with dementia]. Gac Sanit. 2017 Nov - Dec;31(6):518-523. doi: 10.1016/j.gaceta.2016.07.006. Epub 2016 Oct 15. Spanish. — View Citation

Verbeek H, Meyer G, Leino-Kilpi H, Zabalegui A, Hallberg IR, Saks K, Soto ME, Challis D, Sauerland D, Hamers JP; RightTimePlaceCare Consortium. A European study investigating patterns of transition from home care towards institutional dementia care: the protocol of a RightTimePlaceCare study. BMC Public Health. 2012 Jan 23;12:68. doi: 10.1186/1471-2458-12-68. — View Citation

Warden V, Hurley AC, Volicer L. Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. J Am Med Dir Assoc. 2003 Jan-Feb;4(1):9-15. — View Citation

Wimo A, Wetterholm AL, Mastey V, Winblad B. Evaluation of the resource utilization and caregiver time in Anti-dementia drug trials - a quantitative battery. in: Wimo A, Karlsson G, Jönsson B, Winblad B (eds) . The Health Economics of Dementia, 1998. Wiley's, London, UK

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Restraints	Adapted questionnaire from Hammers et al. 8 items (Never - more tan once a day).7 items where each ítem is a type of restraint: Belt, chair or wheelchair with blockages (tables), handrails, adjusts sheets, infrared, sensors,door blockage in room.There is no total scoring, as items will be assessed individually to identify the type of restraint used.	3 months
Primary	Psychotropic medication	Records on chart about use of psychotropic medication. Name of medication administered during hospitalization or at home.	3 months
Primary	Pain assessment in dementia: MPAINAD scale	PAINAD scale (Pain assessment in dementia). 5 items evaluating breathing, negative vocalization, facial expression, body language and consolability. The total score ranges from 0-10 points. A possible interpretation of score is: 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain	3 months
Primary	Falls (number)	Record from proxy if any falls (witnessed/unwitnessed) It is considered a fall when a patient reached the floor from another level. Number of falls recorded	3 months
Primary	Functional capacity	Barthel Index: 10 items evaluating physical impairment; where each item scores 0-15 depending on item (0=dependent, 15 independent). Several authors have proposed guidelines for interpreting Barthel scores. Shah et al. suggested that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency. Total scoring Katz Index: 6 items. Evaluating activities by dependence or Independence. Scoring ranges from 0-6 where 0 is Low (patient very dependent and 6 High, patient very independent)	3 months
Primary	Knowledge of nurses	An "ad hoc" questionnaire was created to know the nurses knowledge of care of patients with dementia. Sociodemographic data as age, level of studies, experience in years at the hospital, and questions about self-assessment abilities,implication with patient care, patient empowerment, evaluation of self training. The questionnaire has 25 questions and applies from (all patients to no patients). It also has open questions about barriers and facilitators regarding patient education in the unit. There is no total scoring, as questions are qualitative mostly and it not considered a scale.	3 months
Primary	Informal Caregiver Costs	RUD (Resource Utilization in Dementia) questionnaire. Evaluates the caregiver's input on resource utilization. Frequency and duration of hospitalization, visits to health care professionals and type of care, medication use, use of social services, caregiver time spent with patient on basic activities and instrumental activities of daily living, caregiver work status and whether informal caregiver substitutes for paid work. Time (in hours) of dedication of informal caregiver for patient. Healthcare services used in the last month (primary care doctor or nurse, physiotherapists, social services...) There is no total scoring as it is not a scale. Costs will be estimated by multiplying the number of units for each relevant factor from the questionnaire with the corresponding unit price vector. Total costs will be measured as average monthly costs in euros.	3 months
Primary	Caregiver burden	CRA (Caregiver reaction assessment) a 24-item instrument designed to measure the reactions of family members to caring for elderly relatives with a variety of illnesses. Items are rated on a 5-point scale (from "strongly agree" to "strongly disagree"). Caregiver's esteem (7 items);Lack of family support (5 items);Impact on finances assesses the adequacy, difficulty, and strain of finances on the caregiver and family (3 items);Impact on schedule (5 items);Impact on health assesses the caregiver's capability to provide care and health in relation to caregiving (4 items).Burden related to disrupted time (range 5-25), financial problems (range 3-15), lack of family support (range 5-25), health problems (range 4-20), and self-esteem (range 7-35). Higher=worse (greater burden)	3 months
Primary	Cognitive status	NPI-Q (Neuro-psychiatric inventory). 12 items evaluating psychopathology in dementia.; Severity; = Mild (noticeable, but not a significant change); = Moderate (significant, but not a dramatic change); = Severe (very marked or prominent; a dramatic change). Scoring for distress: 0 = Not distressing at all Distress; 0 = Not distressing at all; = Minimal (slightly distressing, not a problem to cope with); = Mild (not very distressing, generally easy to cope with); = Moderate (fairly distressing, not always easy to cope with); = Severe (very distressing, difficult to cope with); = Extreme or very severe (extremely distressing, unable to cope with). Total score: After all domains have been scored, adding up the total score out of a possible 144. (Less tan 20=mild problem, 20-50= moderate disturbance, 50+=severe disturbance	3 months
Primary	Comorbidity	Charlson comorbidity index (19 items) evaluating comorbidity. Comorbid diseases were coded as: 0=absent; 1=present. Severity was coded as: 1=not ill; 2=mildly ill; 3=moderately ill; 3=severely ill and 5=moribund. To create a scoring, the method Hutchinson and Thomas combining age and comorbidity.	3 months
Secondary	Psychotropic medication administration	Records on chart about use of psychotropic medication. Dose (mg) during hospitalization or at home.	3 months
Secondary	Frequency on psychotropic medication	Records on chart about use of psychotropic medication. Frequency (calculated in 24h) during hospitalization or at home	3 months
Secondary	Injuries related to falls	Record from proxy if any falls (witnessed/unwitnessed) It is considered a fall when a patient reached the floor from another level. Injuries like bruises, open wounds, luxation or fracture	3 months