Staying Active with Multimorbidity In Acute hospital (StAMInA) Trial: a randomised controlled trial investigating the feasibility of allied health assistant delivered mobility rehabilitation for patients with multimorbidity in an acute hospital setting

INTERVENTION: Name of intervention: Allied health assistant provision of routine acute mobility rehabilitation Who will deliver the intervention and what is their training: The intervention will be delivered by a senior allied health assistant (grade 3). The allied health assistant will have a certificate IV allied health assistant qualification. A mid‐level (grade 2) physiotherapist will supervise the senior allied health assistant as per health network clinical supervision guidelines. This supervision will include monthly meetings to discuss professional and clinical skill development in the management of people with multimorbidity. It will also involve direct supervision/observation of the senior allied health assistant’s management of patients with multimorbidity. Note that this is the only difference between the exposure and comparator groups; all other procedures/protocols are the same. Mode of delivery: Individual, face‐to‐face Dose: Daily therapy provided on weekdays (i.e. daily therapy 5 Xper week) until discharge from acute hospital. Initial physiotherapy assessment may occur on a Saturday. The duration of each session will vary dependent on patient needs but will typically range from 10 to 40 minutes. Location/Timing: All therapy will be provided to patients with multimorbidity on the acute general medical ward at Frankston Hospital. Therapy will be provided by the allied health assistant following an initial physiotherapy assessment of the patient. The allied health assistant will be delegated provision of routine acute mobility rehabilitation if the patient is transferred to sitting out of bed during the physiotherapy assessment and appropriate for mobilisation (i.e. transfers and walking). This process will involve the physiotherapist completing an initial CONDITION: Multimorbidity; ; Multimorbidity Physical Medicine / Rehabilitation ‐ Physiotherapy Public Health ‐ Health service research PRIMARY OUTCOME: Feasibility: Demand Domain (Primary Outcome). Demand domain will be evaluated by measuring the recruitment rate (comparing the number of people recruited to the number of eligible participants). This data will be collected prospectively during recruitment by a research assistant who will monitor and record the number of patients who 1) meet the eligibility criteria and 2) participate in the trial. [Time of discharge from acute hospital.] Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the amount of time that allied health assistant spends providing therapy to the patient. This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records. It will be recorded as either 1) direct contact activities (e.g. providing therapy) or 2) indirect contact activities (e.g. typing notes). Direct contact activities and indirect contact activities will be measured as a composite outcome.[Time of discharge from acute hospital] Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the amount of time that the physiotherapist spends providing therapy to the patient. This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records. It will be recorded as either 1) direct contact activities (e.g. providing therapy) or 2) indirect contact activities (e.g. typing notes). Direct contact activities and indirect contact activities will be measured as a composite outcome.[Time of discharge from acute hospital] SECONDARY OUTCOME: 30‐day hospital re‐admission (Secondary Outcome). 30‐day hospital readmission includes any unplanned readmission within 30 days of discharge from the health service (i.e., readmission from private residence) and will be collected from patient medical records.[30‐days following discharge from health service.] Cost of Sub‐Acute Patient Care (Secondary Outcome). Cost of sub‐acute patient care will be calculated using hospital admission cost data from the health service.[Time of discharge from sub‐acute hospital.] Cost of Sub‐Acute Physiotherapy Service (Secondary Outcome). Cost of physiotherapy service will be calculated using the time spent treating and managing patients with multimorbidity and pay rates for physiotherapists and allied health assistants. The time physiotherapists and allied health assistants spend treating patients will be collected from the hospital network electronic medical record system. Pay rates will be obtained from the Victorian Government award rates for physiotherapists and allied health assistants. Costs will include 25% on‐costs.[Time of discharge from sub‐acute hospital.] Daily mobilisation (Secondary Outcome). Daily mobilisation will be measured as the number of days that the patient mobilises (e.g. sits out of bed, walks) during their acute hospital stay and will be audited from patient medical records.[Time of discharge from acute hospital.] Daily steps (Secondary Outcome). Daily steps will be measured using a tri‐axial accelerometer‐based activity monitor (ActivPAL).[First 7 days after the commencement of rehabilitation from either the allied health assistant or physiotherapist, or until discharge from acute hospital if discharged within 7 days after commencement.] Daily time spent sitting or lying (i.e. sedentary behaviour) (Secondary Outcome). Daily time in minutes spent sitting or lying will be measured using a tri‐axial accelerometer‐based activity monitor (ActivPAL).[First 7 days after the commencement of rehabilitation from either the allied health assistant or physiotherapist, or until discharge from acute hospital if discharged within 7 days after commencement.] Daily time spent walking (Secondary Outcome). Daily time in minutes spent walking will be measured using a tri‐axial accelerometer‐based activity monitor (ActivPAL).[First 7 days after the commencement of rehabilitation from either the allied health assistant or physiotherapist, or until discharge from acute hospital if discharged within 7 days after commencement.] Discharge Destination from Acute Hospital (Secondary Outcome). Discharge destination will be selected from the following list of possible destinations: (i) home; (ii) relative/friend’s home; (iii) residential care; (iv) inpatient transition care program, (v) sub‐acute rehab/geriatric evaluation management unit. Discharge destination will be collected from patient medical records.[Time of discharge from acute hospital.] Discharge Destination From Sub‐Acute Hospital (Secondary Outcome). Discharge destination will be selected from the following list of possible destinations: (i) home; (ii) relative/friend’s home; (iii) residential care. Discharge destination will be collected from patient medical records.[Time of discharge from sub‐acute hospital.] Falls (Secondary Outcome). The incidence of inpatient falls will be recorded as a composite outcome, where a fall is defined as ‘unintentionally coming to rest on the ground, floor, or other lower level’. Falls will be further classified to reflect the degree of harm; falls that result in either the permanent or temporary loss of function will be classified as an injurious fall, while falls that result in no loss of function will be classified as a non‐injurious fall. This data will be collected from patient medical records.[Time of discharge from acute hospital.] Feasibility: Acceptability Domain (Primary Outcome). Acceptability domain will be evaluated by conducting in‐depth semi‐structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi‐structured interviews will be conducted one‐to‐one using an interview guide, and audio‐recorded. The interviews will explore their experience with this model of care. [Following cessation of patient participant recruitment and outcome assessment.] Feasibility: Acceptability Domain (Primary Outcome). Acceptability domain will be evaluated by measuring patient satisfaction with physiotherapy care. Patient satisfaction with physiotherapy care will be measured using a modified version of a questionnaire for hospital inpatients receiving inpatient physiotherapy care, whether supervised by a physiotherapist or allied health assistant. The original version of the questionnaire has been validated for use in an inpatient population by Ampiah and colleagues (2019). The patient rates their agreement with each statement on a 5‐point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). For the purpose of this study we will use a modified version with si Xof the items removed. The items related to financial cost of physiotherapy care, diagnosis, time from physiotherapy referral to assessment, equipment available to the physiotherapist/assistant and compliance with physiotherapy will be removed from the questionnaire.[Time of discharge from acute hospital.] Feasibility: Demand Domain (Primary Outcome). Demand domain will be evaluated by conducting in‐depth semi‐structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi‐structured interviews will be conducted one‐to‐one using an interview guide, and audio‐recorded. The interviews will explore their experience with this model of care. [Following cessation of patient participant recruitment and outcome assessment.] Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by conducting in‐depth semi‐structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi‐structured interviews will be conducted one‐to‐one using an interview guide, and audio‐recorded. The interviews will explore their experience with this model of care. [Following cessation of patient participant recruitment and outcome assessment.] Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the number of allied health assistant occasions of service provided to the patient. An occasion of service involves only direct patient activities (i.e. providing therapy). This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records.[Time of discharge from acute hospital.] Feasibility: Implementation Domain (Primary Outcome). Implementation domain will be evaluated by measuring the number of physiotherapist occasions of service provided to the patient. An occasion of service involves only direct patient activities (i.e. providing therapy). This information will be collected using the hospital network electronic medical record system. This information is routinely collected by the system and is recorded in patient medical records.[Time of discharge from acute hospital.] Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by conducting in‐depth semi‐structured interviews with physiotherapists and the allied health assistant who are involved in the implementation of this model of care. The semi‐structured interviews will be conducted one‐to‐one using an interview guide, and audio‐recorded. The interviews will explore their experience with this model of care. [Following cessation of patient participant recruitment and outcome assessment.] Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by measuring adverse events. Adverse events will include any incident of patient harm that is recorded in the patient medical record. Possible examples of patient harm events include falls and unconscious collapse/vasovagal. Patient harm events will be further classified as ‘not related to the study’, ‘probably not related to the study’, ‘unlikely but possibly related’ or ‘probably related to the study’ by an independent, medical academic. Harm events will also be classified as ‘serious’ or ‘non‐serious’.[Time of discharge from acute hospital.] Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by measuring the cost of acute patient care. Cost of acute patient care will be calculated using hospital admission cost data from the health service.[Time of discharge from acute hospital.] Feasibility: Practicality Domain (Primary Outcome). Practicality domain will be evaluated by measuring the cost of acute physiotherapy service. Cost of physiotherapy service will be calculated using the time spent treating and managing patients with multimorbidity and pay rates for physiotherapists and allied health assistants. The time physiotherapists and allied health assistants spend treating patients will be collected from the hospital network electronic medical record system. Pay rates will be obtained from the Victorian Government award rates for physiotherapists and allied health assistants. Costs will include 25% on‐costs.[Time of discharge from acute hospital.] Length of Acute Hospital Stay (Secondary Outcome). Patient length of acute hospital stay will be measured as the number of days from patient admission to acute hospital to discharge from acute hospital. Length of stay will be collected from patient medical records.[Time of discharge from acute hospital.] Length of Sub‐Acute Hospital Stay (Secondary Outcome). Patient length of sub‐acute hospital stay will be measured as the number of days from patient admission to sub‐acute hospital to discharge from sub‐acute hospital. Length of stay will be collected from patient medical records.[Time of discharge from sub‐acute hospital.] Patient Functional Activity ‐ Level of Assistance (Secondary Outcome): Patients’ functional activity at discharge will be measured using the Modified Iowa Level of Assistance Scale (mILOA). The mILOA consists of si Xitems and measures the assistance required to achieve functional tasks, including moving from lying to sitting on the edge of the bed; moving from sitting to standing; walking; and negotiating one step. It also measures walking distance and the use of an assistive device.[Time of commencement of rehabilitation from either the allied health assistant or physiotherapist (i.e. baseline) and time of discharge from acute hospital.] Reasons for Not Mobilising (Secondary Outcome). Documented reasons for patients not mobilising will be audited from patient medical records. Days on which mobilisation is medically contraindicated will be recorded, ensuring rates of mobilisation reflect only days on which patients were deemed medically suitable for mobilisation. Patients will be contraindicated on any day if one or more of the following complications are experienced: ; • Severe pain that restricts mobilisation ; • Nausea or vomiting with or without antiemetic ; • Vitally unstable: postural blood pressure drop, febrile, bradycardia <40bpm or abnormal heart rhythm ; • Disorientated, heavily sedated or difficult to rouse ; [Time of discharge from acute hospital.] INCLUSION CRITERIA: Eligible participants will be patients with multimorbidity who have been admitted to the general medical ward at the participating acute hospital site. Participants must meet the following eligibility criteria: • Coexistence of two or more chronic conditions, such as cardiovascular disease, diabetes, arthritis, osteoporosis, back pain, respiratory disease (e.g. asthma, chronic obstructive pulmonary disease), arthritis, kidney disease, liver disease, cancer, obesity, and mental health conditions as recorded on the medical record. • Walked independently prior to admission with or without the use of a walking aid • Referred to physiotherapy; and on initial assessment physiotherapist prescribes mobility rehabilitation • Willingness and ability, as determined by initial physiotherapy assessment, to participate in mobility rehabilitation • Aged 18 years or older • Able to provide written, informed consent • Able to communicate in conversational