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Clinical Trials/NCT04078334
NCT04078334
Recruiting
Not Applicable

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

Université du Québec a Montréal1 site in 1 country720 target enrollmentOctober 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Université du Québec a Montréal
Enrollment
720
Locations
1
Primary Endpoint
Changes in muscle strength after intervention (upper muscle strength : handgrip strength, lower limb strength: sit to stand-30sec)
Status
Recruiting
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
October 2, 2020
End Date
October 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Université du Québec a Montréal
Responsible Party
Principal Investigator
Principal Investigator

Mylène Aubertin-Leheudre

Principale Investigator-Researcher

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in muscle strength after intervention (upper muscle strength : handgrip strength, lower limb strength: sit to stand-30sec)

Time Frame: Up to 36 weeks

Handgrip strengh, sit to stand test (30sec)

Changes in walking after intervention (Walking speed :4 m habitual gait speed and walking parameter : 3 meter timed up and go)

Time Frame: Up to 36 weeks

4 m habitual gait speed test and 3 m timed up and go test

Changes in short physical performance battery (SPPB) after intervention

Time Frame: Up to 36 weeks

SPPB is comprised of 3 tasks: a standing balance test (side by side, semi-tandem and tandem), 4-m habitual gait speed and 5 sit to stand from a chair. Each task is scored (based on time) from 0-4 points.

Secondary Outcomes

  • Usability of the clinical tools : MATCH, PATH, PATH 2.0(Up to 24 months)
  • Changes in the quality of life after intervention (SF-12)(Up to 36 weeks)
  • Changes in caregiver burden after intervention(Up to 36 weeks)
  • Feasibility of the clinical tools : MATCH, PATH, PATH 2.0(Up to 24 months)
  • Estimate the benefits-cost ratio on the use of post-hospitalization health services(Up to 36 weeks)
  • Use of health resources(Up to 2 years)
  • Acceptability of the clinical tools: MATCH, PATH, PATH 2.0(Up to 24 months)
  • Changes in the length of stay after intervention(up to 3 months)
  • Impact of healthcare area(Up to 24 months)
  • Impact of pandemic period(Up to 24 months)

Study Sites (1)

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