Table 3 Trial outcomes and success criteria
Aim 1: Intervention feasibility and acceptability | ||
Objective | Method of assessment | Success criteria |
Objective 1.1: To determine the feasibility and acceptability of the complex and multicomponent behaviour change intervention to participants and treating physiotherapists (P) | • Participants: Semi-structured interviews •Physiotherapists: Focus group | Continue without modifications: Thematic analysis identifies that trial participants and treating physiotherapists found the intervention satisfactory (i.e. it was feasible and acceptable) in semi-structured interviews and focus groups respectively Stop: Thematic analysis suggests that trial participants and treating physiotherapists did not find the intervention satisfactory (i.e. it was unfeasible and/or unacceptable) |
Objective 1.2: To determine the acceptability of the bespoke Empowering Coaching training programme (Empowering Physio) to treating physiotherapists (P) | • Focus group | Continue without modifications: Thematic analysis identifies that intervention physiotherapists perceived that the EC training programme developed their understanding and enactment of how to create an empowering treatment climate Stop: Thematic analysis suggests that intervention physiotherapists perceived that the EC training programme was insufficient to develop their understanding or enactment of how to create an empowering treatment climate |
Objective 1.3: To evaluate fidelity of intervention delivery by treating physiotherapists (S) | • Two members of the research team will assess transcripts of one intervention session from the adoption, routine formation and maintenance phases from first and third participants for the following: 1) Intervention content by coding of BCTs 2) Treatment climate using the ISPACOT [39] | • Essential pre-specified BCTs are delivered with at least mean ‘moderate’ levels of fidelity (≥ 50%) [40] • Mean score of ≥ 4/7 on Likert scale when using ISPACOT to evaluate treatment climate [41] |
Aim 2: Trial feasibility and acceptability | ||
Objective | Method of assessment | Success criteria |
Objective 2.1: To measure the recruitment rates of participants (P) | • Recording number (n) of participants who were sent a participant information sheet, number who agreed to participate and number recruited per month | Continue without modification • Target of n = 35 participants recruited in 9 months (approx. 4/month) • Conversion rate of ≥ 30% (number sent PIS/ number who agreed to participate) Stop • Target of n = 35 participants recruited takes > 12 months (less than 3/month) • Conversion rate of ≤ 15% (number sent PIS/ number who agreed to participate) |
Objective 2.2: To measure the completeness of data collection of performance-based and patient-reported outcome measures at baseline, 3- and 6-month post-baseline (P) | • Record number of PROMs returned to trial team and number of participants who completed performance-based outcomes during virtual outcome assessments at each timepoint | Continue without modification •  ≤ 80% PROM and performance-based data collected at 3-month post-baseline •  ≤ 70% PROM and performance-based data collected at 6-month post-baseline Stop •  ≤ 50% PROM and performance-based data collected at 3-month post-baseline •  ≤ 50% PROM and performance-based data collected at 6-month post-baseline |
Objective 2.3: To determine the feasibility and acceptability of trial-related procedures (recruitment, outcome assessment) to participants and ROH research staff ((P) | • Participants: Semi-structured interviews • ROH research staff: Focus groups | Continue with modification • Thematic analysis identifies that trial participants and ROH research staff are satisfied (i.e. feasible and acceptable) with trial procedures (e.g. recruitment, outcome assessment) in semi-structured interviews and focus groups respectively Stop • Thematic analysis identifies that trial participants and ROH research staff are not satisfied (i.e. they do not perceive it is feasible and/or acceptable) with trial procedures (e.g. recruitment, outcome assessment) in semi-structured interviews and focus groups respectively |
Objective 2.4: To determine the feasibility and acceptability of utilising an accelerometer as the primary outcome in a definitive randomised controlled trial (S) | • % of accelerometers returned to research staff with valid data • Semi-structured interviews | •  ≤ 70% of accelerometer data collected at 6-month post-baseline • Accelerometer data will be considered valid if it has been recorded for ≥ 10 h [42, 43] for ≥ 4/7 days, with at least one falling on a weekend [44,45,46] • Participants state that they believe that accelerometer is feasible and acceptable to use as the primary outcome measure in future definitive trial |
Objective 2.5: To determine the acceptability of the patient-reported and performance-based outcome measures to participants ((S) | • Semi-structured interviews | • Participants report that they found the patient-reported and performance-based outcomes feasible and acceptable, and the time taken to complete was satisfactory for use in a definitive randomised controlled trial |