Low mobility during an acute care hospitalization is very frequent, particularly among older patients, and associated with adverse outcomes, such as persistent functional decline, institutionalization and death. However, increasing hospital mobility remains challenging because of the multiple existing barriers. The goal of this clinical trial is to test the effect of a multilevel intervention to increase hospital mobility, which addresses modifiable barriers and facilitators and does not require unavailable additional resources. This study aims to answer whether this intervention can improve mobility and patient-relevant outcomes such as life-space mobility and functional status. The multilevel intervention will target: 1. The patients, who will receive an information booklet, a customizable diary, an exercise booklet and an iPad with access to the videos of the exercise booklet. 2. The healthcare professionals (nursing staff and physicians) who will complete an e-learning, receive an oral presentation on the intervention, and receive a "mobility checklist" that reminds them of what they should assess daily regarding mobility. 3. The hospital environment, where posters will be hung in the wards, including walking itineraries, on topics of interest to older adults. In a first phase, the intervention will be pilot-tested in one ward of each hospital. The intervention will then be adapted based on patient and healthcare professional feedback. In a second phase, the intervention will be tested in a cluster randomized controlled trial, and compared to standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
383
The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment: PATIENTS: * Information booklet on the importance/benefits of mobility, consequences of low mobility, how to be more active (with concrete information). * Customizable diary to document mobility goals, results, difficulties and needs. * Exercise booklet with explanations \& pictures of mobility exercises (supine, sitting, standing). * iPad 10.2'' with videos of the exercises. HCPs (physicians \& nursing staff): * E-learning on the consequences of low mobility, barriers/facilitators to hospital mobility; recommendations, documentation, communication \& interdisciplinary collaboration regarding mobility; implementation. * Oral presentation on the intervention. * Checklist to remind HCPs to address mobility. ENVIRONMENT: * Posters in the wards about mobility and other topics of interest to older adults. * Walking itineraries in the wards.
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland
HFR-Fribourg - hôpital cantonal
Villars-sur-Glâne, Canton of Fribourg, Switzerland
Spital Tiefenau, InselGruppe AG
Bern, Switzerland
Inselspital, Bern University Hospital, InselGruppe AG
Bern, Switzerland
Life-space level
Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (range 0-120, with maximum being a higher score = better outcome). For patients institutionalized, assessment through the Life-Space Assessment in Institutionalized Settings. Both scales can be merged since the scoring is similar. Assessment by telephone interview of the participant/relatives.
Time frame: Day 30 (+/-5) after enrollment
Life-space level
Measured by the University of Alabama at Birmingham Study of Aging Life-Space Assessment (or Life-Space Assessment in Institutionalized Settings for institutionalized patients) by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Activities of Daily Living
Measured by the Barthel Index by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Activities of Daily Living
Measured by the Barthel Index by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Instrumental Activities of Daily Living
Measured by the Lawton Index by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Instrumental Activities of Daily Living
Measured by the Lawton Index by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Quality of life (EQ-5D)
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Quality of life (EQ-5D)
Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Depression
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Depression
Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Pressure ulcer
Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record
Time frame: Discharge (-1 to +2 days after discharge)
Delirium during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Measured by the Confusion Assessment Method
Time frame: Discharge (-1 to +2 days after discharge)
Mobility at discharge
Measured by the de Morton Mobility Index (DEMMI); assessment conducted by the study team
Time frame: Discharge (maximum 1 day before)
Lower-limb muscle strength
Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team
Time frame: Discharge (maximum 1 day before)
Hand-grip muscle strength
Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team
Time frame: Discharge (maximum 1 day before)
Step count during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Measured by a StepWatch ankle accelerometer or a GENEActiv wrist accelerometer (the choice of the device will be defined after the pilot study during which both accelerometers will be tested)
Time frame: Discharge (hospitalization duration expected to be 3 to 20 days on average)
Level of activity during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Measured by GENEActiv wrist accelerometer (only if this accelerometer is chosen after the pilot study)
Time frame: Discharge (hospitalization duration expected to be 3 to 20 days on average)
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time frame: Discharge (-1 to +2 days after discharge)
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Fear of / concerns about falling
Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Fall-risk increasing drugs
Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed through the electronic health record
Time frame: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)
Fall-risk increasing drugs during hospitalization
Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed through the electronic health record
Time frame: Discharge (discharge letter) (hospitalization duration expected to be 3 to 20 days on average)]
Fall-risk increasing drugs
Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed by telephone interview of the participant
Time frame: Day 30 (+/-5) after enrollment
Fall-risk increasing drugs
Including loop diuretic, beta blocker, cardiac glycoside (digitalis, digoxin), statin, antipsychotic (neuroleptic), tricyclic antidepressant, selective serotonin reuptake inhibitor, other antidepressant, benzodiazepine, opioid, antiepileptic. Assessed by telephone interview of the participant
Time frame: Day 180 (+/-5) after enrollment
Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Based on nurse report and electronic health record data
Time frame: Discharge (-1 to +2 days after discharge)
Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)
Based on nurse report and electronic health record data
Time frame: Discharge (-1 to +2 days after discharge)
Number of patients with fall(s) within 30 days after discharge
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time frame: Day 30 (+/-5) after enrollment
Number of falls per patient within 30 days after discharge
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time frame: Day 30 (+/-5) after enrollment
Number of patients with fall(s) within 180 days after discharge
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time frame: Day 180 (+/-5) after enrollment
Number of falls per patient within 180 days after discharge
Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.
Time frame: Day 180 (+/-5) after enrollment
Number of patients with new institutionalization at discharge
According to nurses / electronic health record / self-report by participant/relatives
Time frame: Discharge (-1 to +2 days after discharge)
Number of patients with new institutionalization within 30 days of discharge
Assessed by telephone interview of the participant/relatives
Time frame: Day 30 (+/-5) after enrollment
Number of patients with new institutionalization within 180 days of discharge
Assessed by telephone interview of the participant/relatives
Time frame: Day 180 (+/-5) after enrollment
Number of patients with emergency room visits within 30 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 30 (+/-5) after enrollment
Number of emergency room visits per patient within 30 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 30 (+/-5) after enrollment
Number of patients with emergency room visits within 180 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 180 (+/-5) after enrollment
Number of emergency room visits per patient within 180 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 180 (+/-5) after enrollment
Number of patients with readmission within 30 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 30 (+/-5) after enrollment
Number of readmissions per patient within 30 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 30 (+/-5) after enrollment
Number of patients with readmission within 180 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 180 (+/-5) after enrollment
Number of readmissions per patient within 180 days of discharge
Assessed based on electronic health record and by telephone interview of the participant/relatives, based on the diary the participant/relatives will be asked to complete.
Time frame: Day 180 (+/-5) after enrollment
Experience of the intervention
Assessed through qualitative and quantitative questions by interview of the participants/relatives (on the ward or by telephone). For the intervention group only. Will be done at the end of the assessment to preserve outcome assessor blinding.
Time frame: Discharge (-1 to +2 days after discharge)
Satisfaction with hospitalization
Measured by the satisfaction questionnaire adapted and simplified
Time frame: Discharge (-1 to +2 days after discharge)
Perspectives on hospital mobility
Quantitative questions (Likert-scale answers) based on the Health Action Process Approach (HAPA) model (simplification of a survey used in the preparation phase of this study to assess perspectives of patients and healthcare professionals on hospital mobility).
Time frame: Day 30 (+/-5) after enrollment
Location at follow-up
Assessed by telephone interview of patient/relatives.
Time frame: Day 30 (+/-5) after enrollment
Location at follow-up
Assessed by telephone interview of patient/relatives.
Time frame: Day 180 (+/-5) after enrollment
Discharge destination
Assessed based on electronic health records
Time frame: Discharge (-1 to +2 days after discharge)
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