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Table 3 Feasibility outcome measures

From: Implementing digital devices to increase mobility training for people receiving inpatient rehabilitation: protocol for a feasibility hybrid type II randomized controlled trial

Feasibility outcome measures

Details

Feasibility criteria

1. Processes

 a. Recruitment rate

Number of participants recruited into the study per week (a PRIMARY outcome)

Nil

 b. Eligibility criteria

Proportion of patients screened who were eligible and ineligible, and reasons why patients were ineligible

Nil

 b. Refusal rate

Proportion of people screened who were eligible who declined taking part in the study and the reasons why they declined

Nil

 d. Retention rate

Number of participants who have a 3-week assessment (primary outcome timepoint) completed prior to discharge between 2 and 4 weeks post-randomization)

 ≥ 85% completed for all outcome measures except activity monitor (≥ 80%)

2. Resource use

 a. Equipment

•Number and cost of devices + consumables/support equipment (e.g., data cards)

•Number lost/broken devices needing replacement

Nil

 b. IT

How many times devices did not work, time needed to fix, how and who it was fixed by and cost of fixing it

 ≥ 75% devices work for at least 75% of trial time

 c. Staff

•Total FTE staff within the physiotherapy rehabilitation team that are participating in the trial

•Number of physiotherapists needed training over course of project and number of hours spent training them in using digital devices

•Number of physiotherapy students who required training (total blocks and total students) over course of project and number of hours spent training them in using digital devices

•Number of training sessions missed by staff and students and reasons why

•Number of staff trained and conducting screening, recruitment and outcome assessments

Nil

 d. Training physiotherapists to embed digital devices

•Time and hours spent by clinical champion and study investigators in staff training

•Number of workshops/journal clubs/clinical reasoning/audit and feedback activities performed

Nil

3.Management

 a. Dosage

•Percentage of exercise practice sheets reflecting usual care and digital device that are complete and legible with repetitions recorded (a PRIMARY outcome)

•Number of devices that dosage data were successfully retrieved from

•Who collected and how were dosage data collected for technology use?

•Exercise practice sheets complete for ≥ 85% of all participants

4. Patient- and implementation outcome measures

 a. Safety

•Number and type of minor and serious adverse events (e.g., falls) and circumstances of event when using digital devices during supervised/semi-supervised/out of therapy practice collected from hospital incidence reporting system

Nil

 b. Estimation of effectiveness

•Between group difference and 95% CI for each patient-level outcome measure at 3 weeks post-randomization (these are outlined in Table 4)

Nil

 c. Success of implementation

•Fidelity: average total active time in minutes per day using digital devices for mobility tasks (a PRIMARY outcome)

•Number of days over 3-week intervention technology not used by participants and reasons why (e.g., patient refusal, technology not working, staff shortages)

•Device use: percentage of participants each device was used with; average number of different devices used per participant; percentage of devices used per participant where it was progressed (e.g., game level, repetitions, sets, time)

•Type of practice: percentage of participants each mobility limitation was trained with devices; average number of different mobility limitations trained per participant

•Percentage of staff trained that participated in prescribing and delivering rehabilitation using digital devices

Average of ≥ 30 min per day for > 50% intervention participants; 0 min per day for > 90% control participants (to confirm no contamination)

 d. Determinants of implementation success

•Change in physiotherapists’ capability, opportunity and motivation to prescribing and delivering rehabilitation using digital devices, measured using study specific questionnaire (see Additional file 4), developed based upon the COM-B self-evaluation questionnaire [27]

Nil