An INtervention TO Improve MOBility of Older Hospitalized Patients (INTOMOB)

Impact of an INtervention TO Increase MOBility in Older Hospitalized Medical Patients (INTOMOB): a Cluster Randomized Controlled Trial

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: 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. 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. 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.

Hospital Mobility, Mobility Limitation, Life-Space, Functional Status, Hospital-Acquired Condition, Muscle Atrophy or Weakness, Sarcopenia, Iatrogenic Disease

Hospital mobility, Life-Space, Functional status, Hospital-Acquired disability, Exercise, Movement, Ambulation

In a first phase, the intervention will be pilot-tested in one ward of each hospital (no comparison group). In a second phase, it will be tested in a parallel design (cluster randomized controlled trial).

Complete blinding is difficult due to the nature of the intervention and the design (cluster randomization). To preserve blinding as much as possible, several strategies have been set. At the cluster level (healthcare professional intervention): Since rotation across wards happens at the physician level, but is rare at the level of the nursing staff, the healthcare professional intervention targets mostly nurses. The healthcare professionals will be informed to avoid speaking about the intervention with colleagues of other wards. At the patient level, differential information for candidates for the intervention or for the control group (the randomization group is known when first approaching candidates for participation because of the cluster design) will be provided. Candidates for the control group will receive only partial information without explaining the intervention. They will be informed orally at the end of the study about all aspects of the study.

The intervention will be multilevel, targeting the patients, healthcare professionals (HCPs) and environment, as described under "Intervention description".

Control procedure in the randomized trial: Patients will receive standard of care, including physiotherapy if prescribed by the hospital physician and usual mobility recommendations and support by the HCPs. HCPs will neither complete the e-learning, nor receive the checklist and the oral presentation. The environment will not be modified in regards to mobility. Already existing information on this topic (e.g., small posters hanging in patient rooms) will not be removed, since it corresponds to current standard of care in some hospitals. In the pilot study, there will be no control procedure, since the objective is to assess experience and feasibility of the intervention, not its effects.

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.

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.

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

Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives

Measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire by telephone interview of the participant/relatives

Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives

Measured by the Patient Health Questionnaire (PHQ)-2 by telephone interview of the participant/relatives

Evaluated according to the NPUAP/EPUAP classification, based on nurse report and electronic health record

Measured by lower-limb manual testing according to the method by Hislop and Montgomery; assessment conducted by the study team

Measured by JAMAR (for the pilot study) and SAEHAN (for the RCT) hand dynamometer; assessment conducted by the study team

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)

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)

Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

Measured by the Falls Efficacy Scale - International by telephone interview of the participant/relatives

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

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

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

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

Number of patients with fall(s) during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

Number of falls per patient during hospitalization (hospitalization duration expected to be 3 to 20 days on average)

Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

Assessed by telephone interview of the participant/relatives, based on a diary the participants/relatives will be asked to complete.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

Inclusion criteria: Admission to a general internal medicine (GIM) ward of a participating hospital Age ≥60 years Being ambulatory during the 2 weeks before admission (self-report) Living in the community (not in a nursing home or another institution) for at least the last 30 days prior to admission Ability to understand French or German Planned length of stay at least 3 days after enrollment For the pilot-study only: Possibility to start the study within 48 hours after admission to the GIM ward Exclusion criteria: Medical contraindication to walk (e.g., wound not allowing loading weight) Wheelchair-bound End-of-life Severe psychiatric disorder (severe depression, schizophrenia, psychosis) Delirium (according to the Confusion Assessment Method [CAM]) Additional exclusion criterion for the pilot-study only: - Dementia (defined as Mini-Cog <3) Additional exclusion criteria for the RCT only: Cognitive impairment making impossible to use study material (=implement the intervention) and to understand and sign informed consent, based on clinical judgement, except if a proxy can be actively involved in the study and provides consent Severe visual impairment

Study protocol, statistical analysis plan, informed consent form will be published. Other data will be made available upon reasonable request.