Clinical trial NCT04078334: Personalized Exercises Program Prescription to Prevent Functional Decline Throughout Older Adults Hospitalization
Official title: Prevention of the Functional Decline Throughout Hospitalization Among Older Adults by Using a Systematic Process for Prescribing Personalized, Evidence-based Exercises Via the Implementation of the Tool PATH 2.0
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Hospitalization
Keywords: Frail older adults
Physical activity
exercise
Hospitalization
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 720
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bed rest related to hospitalization contributes to the physical decline in capacities of the elderly, the loss of autonomy accelerated in post-hospitalization and the prevalence of the iatrogenic functional decline is about 20 to 50% for the elderly after an hospitalization.

Mobilization through physical activity (PA) programs is strongly suggested to counter this phenomenon, but it is not part of the routine clinical hospital practices.The consequences are the functional incapacities, the mobility loss, the re-hospitalization falls and the important use of the health care and health services. In this regard, the Ministry of Health and Social Services adopted in 2011 a framework making mandatory the set up of interventions to prevent the functional decline of hospitalized elderly in every hospital centres in Quebec. The Geriatric Units (GU) admit elderly around 80 years old that present complex health problems. The scientific literature presents effective mobilisation programs to ensure the maintenance of functional capacities and the mobility of frail elderly. However, even with this knowledge, the prescription of physical exercises by the GU does not seem to be integrated in a natural and systematic way by in the professional practices.

Our research team would like to implant the clinical tools : MATCH, PATH and PATH 2.0 that is a unique process of systematic prescriptions of physical activity during hospitalization (MATCH), at discharge (PATH) and during hospitalization and at discharge (PATH 2.0) in the GU, adapted to the profile of these patients.

The objective of this project is to evaluate the implementation of the clinical tools MATCH, PATH and PATH 2.0 in different GU and to evaluate the tools efficiency and estimate the benefits-cost ratio on the use of post-hospitalization health services. Finally, the conclusions would help us refine the procedures to use in the short and medium term which clinical tool is likely a standard practice our GU and to improve the health continuum of elderly.

Detailed description: The aging of the population and the increase in longevity are associated with societal issues, both in terms of costs, and the health resources needed to meet the needs of seniors. Moreover, it is recognized that frail elderly people (defined as at risk of developing or aggravating functional limitations or disabilities) are the largest users of health care services. In Canada, as in other industrialized countries, more than a third of hospitalizations annually are among people aged 65 and over, even though they account for only 18% of the population .

However, hospitalizations exacerbate the deterioration of fitness, muscle weakness, loss of balance, and physical inactivity that typically occur during aging and are precursors to functional decline and frailty. One explanation for this deterioration in the health of elderly people during hospital stays is bed rest and general immobility. Thus, the prevention of immobilization syndrome in elderly people in hospitals being a priority issue for both national and international health networks, a project was carried out between 2014 and 2016 within the geriatric unit (GU) of a Canadian university-affiliated geriatric hospital (IUGM). This project aimed to implement in a pragmatic way (adjusted to the human and material resources in place) a physical activity (PA) program for hospitalization according to the functional capacities of the hospitalized patients. This project showed that the implementation of this program was feasible (at least 1 session of PA / day) and acceptable by health professionals, patients and their caregivers.

At the same time, it is recognized that, following hospitalization, 22 to 50% of older people will experience a functional decline that will decrease their ability to perform activities of daily living and, consequently, their quality. of life. These tangible losses lead to a vicious circle as they contribute to readmission for 33% of those affected and additional use of health services in the majority of cases. Prescription of PA is one of the recognized solutions to prevent or reduce these deteriorations. PA, whether practiced in the community or at home, improves the mobility and functional level of pre-frail and frail seniors to moderate effect sizes (mobility).

The post-hospitalization prescription of an PA program, however, does not appear to be integrated into standard care delivery practices, unlike the management of medications or assistance with the performance of activities of daily living, and this, despite the priorities established in this regard by governments and the World Health Organization (WHO). On average, 35% of GU patients at discharge receive a prescription to maintain or improve the strength and balance (internal data of the Regroupement des Unités de courte durée gériatrique et des services hospitaliers de gériatrie-RUSHGQ), even if these communities have rehabilitation services. As part of a project (2016-2018), the research team has created an easy-to-implement decisional tree that can be used to prescribe appropriate programs for GU at discharge, while inducing beneficial effects for patients.

However, these two innovative projects, which aim to prevent functional decline through hospitalization and which meet the policy of the Ministry of Health and Social Services, are the"Adapted Health Care Approach for Older Adults in Quebec Hospital Centres" through systematic, specific and specialized interventions, have not been implemented in a combined and complementary way. However, the implementation of a proactive and adapted approach to prescribing PA per and post-hospitalization, through a simple tool based on the clinical measures available in practice settings, represents a real organizational innovation and should add value to current practices. Thus, the study of the cost-benefit of implementing such a practice is important to validate the scope of such a tool on the use of post-hospital health care services compared to an isolated intervention of PA per or post-hospitalization or usual care. In this sense, a study showed a savings of 22,000 $ / person in health services costs for seniors who improved their mobility via PA in post-hospitalization. Thus, the investigators can sense that preventing the loss of muscle function and mobility as well as falls, the quality of life of patients and their caregivers. In addition, from a collective point of view, this should lead to savings because of the reduction in the costs of care related to injuries caused by a fall or fall after hospitalization that may result in re-hospitalization or even a death.

Considering 1) the importance of the negative impacts of sedentarity / immobilization on seniors, particularly per and post-hospitalization, as well as its potential economic and societal impact; 2) the recognized importance of PA prescription in the prevention of the functional decline of seniors per and post-hospitalization and 3) the absence of organizational processes favoring the implementation of systematic prescribing of PA per and post-hospitalization, The implementation of a systematic process of prescribing adapted, validated and integrated physical exercises in the usual per and or post-hospitalization practices appears crucial to the preservation of the autonomy and quality of life of the elderly.

In the present study, an interventional pragmatic study design with randomization by cluster was selected.

INTERVENTIONS :

MATCH : PA program per hospitalization PATH : PA program post hospitalization PATH 2.0 : Combination of the PA program Per (MATCH) and Post hospitalization (PATH).

Control : usual care by clinical teams

Eligibility criteria: There is no eligibility criteria but the doctor will have to consider these criteria :

* be aged 65 and over,
* planned discharge to home
* Presence of self-criticism
* No PA contraindication
* And ability to speak and understand French and/or English

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in short physical performance battery (SPPB) after intervention
timeFrame: Up to 36 weeks
measure: Changes in muscle strength after intervention (upper muscle strength : handgrip strength, lower limb strength: sit to stand-30sec)
timeFrame: Up to 36 weeks
measure: Changes in walking after intervention (Walking speed :4 m habitual gait speed and walking parameter : 3 meter timed up and go)
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Feasibility of the clinical tools : MATCH, PATH, PATH 2.0
timeFrame: Up to 24 months
measure: Usability of the clinical tools : MATCH, PATH, PATH 2.0
timeFrame: Up to 24 months
measure: Acceptability of the clinical tools: MATCH, PATH, PATH 2.0
timeFrame: Up to 24 months
measure: Estimate the benefits-cost ratio on the use of post-hospitalization health services
timeFrame: Up to 36 weeks
measure: Changes in the length of stay after intervention
timeFrame: up to 3 months
measure: Changes in the quality of life after intervention (SF-12)
timeFrame: Up to 36 weeks
measure: Use of health resources
timeFrame: Up to 2 years
measure: Changes in caregiver burden after intervention
timeFrame: Up to 36 weeks
measure: Impact of pandemic period
timeFrame: Up to 24 months
measure: Impact of healthcare area
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Geriatric Units
state: Quebec
Study officials:
affiliation: Université du Québec a Montréal
name: Mylene Aubertin-Leheudre, Ph. D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de recherche de l'institut Universitaire de Gériatrie de Montreal
name: Marie-Jeanne Kergoat, M.D., FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Université du Québec a Montréal
name: Fonseca Raquel, Ph. D
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Veillette Nathalie, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: