Prosthetist screening for comorbidity during routine care visits: a randomised controlled clinical trial evaluating benefits, acceptability and feasibility

OBJECTIVES: Comorbidity among adults with lower-limb amputation exceeds that in the general population and contributes to poor outcomes. The primary objectives of this clinical trial were to explore benefits, acceptability and feasibility of comorbidity screening by prosthetists during routine follow-up visits. Our primary hypothesis was that when compared with standard-of-care (SOC) follow-up visits, standard-of-care + comorbidity screening (SOC+) would result in greater patient satisfaction and reduced prosthetic care minutes. DESIGN: Randomised controlled clinical trial with mixed-methods approach. SETTINGS: Prosthetic clinical practices. PARTICIPANTS: 70 adults with unilateral lower-limb amputation. INTERVENTIONS: Participants were randomly assigned to receive SOC or SOC+, which included assessment for depressive symptoms, suicidal ideation, moderate-to-high risk low back pain, lack of pedal pulses suggestive of peripheral arterial disease and lack of protective sensation suggestive of peripheral neuropathy. Screening results were reviewed with participants and faxed to primary care with telephone follow-ups when indicated. Prosthetists participated in a focus group. Healthcare utilisation over the subsequent 3 months was tracked. PRIMARY AND SECONDARY OUTCOME MEASURES: Patient satisfaction surveys and care utilisation. RESULTS: Few adverse events and protocol deviations occurred; intervention fidelity was >95%. There were no significant between-group differences in overall patient satisfaction, prosthetic care utilisation over the subsequent 3 months, nor initial prosthetic care visit length (p>0.050). Item-by-item analysis found participants rated prosthetist responsiveness to concerns higher with SOC+ (p=0.046, r=0.251). Prosthetists identified benefits from screening. Screening prompted positive healthcare seeking behaviours in this vulnerable population. CONCLUSIONS: Comorbidity screening by prosthetists appears feasible and acceptable. TRIAL REGISTRATION NUMBER: NCT05410548.