(Cost-)effectiveness of a personalized multidisciplinary eHealth intervention for knee arthroplasty patients to enhance return to activities of daily life, work and sports - rationale and protocol of the multicentre ACTIVE randomized controlled trial

• Published in: BMC musculoskeletal disorders 2023-03, Vol.24 (1), p.162-15, Article 162
• Main Authors: Straat, A Carlien, Maarleveld, Jantine M, Smit, Denise J M, Visch, Lara, Hulsegge, Gerben, Huirne, Judith A F, van Dongen, J M, van Geenen, Rutger C, Kerkhoffs, Gino M M J, Anema, Johannes R, Coenen, Pieter, Kuijer, P Paul F M
• Format: Article
• Language: English
• Subjects: Aged; Aging; Arthritis; Arthroplasty; Arthroplasty (knee); Arthroplasty, Replacement, Knee; Care and treatment; Clinical outcomes; Clinical trials; Cost–benefit analysis; Data collection; Ethnicity; Health care; Humans; Industrialized nations; Informed consent; Integrated delivery systems; Intervention; Joint replacement surgery; Knee; Methods; Multicenter Studies as Topic; Musculoskeletal diseases; Orthopedics; Osteoarthritis; Participation; Patient outcomes; Patients; Perioperative care; Quality of Life; Questionnaires; Randomized Controlled Trials as Topic; Rehabilitation; Replacement; Return to work; Study Protocol; Surgeons; Surgery; Telemedicine
• ISSN: 1471-2474; 1471-2474
• DOI: 10.1186/s12891-023-06236-w

With the worldwide rising obesity epidemic and the aging population, it is essential to deliver (cost-)effective care that results in enhanced societal participation among knee arthroplasty patients. The purpose of this study is to describe the development, content, and protocol of our (cost-)effectiveness study that assesses a perioperative integrated care program, including a personalized eHealth app, for knee arthroplasty patients aimed to enhance societal participation post-surgery compared to care as usual. The intervention will be tested in a multicentre randomized controlled trial with eleven participating Dutch medical centers (i.e., hospitals and clinics). Working patients on the waiting-list for a total- or unicompartmental knee arthroplasty with the intention to return to work after surgery will be included. After pre-stratification on medical centre with or without eHealth as usual care, operation procedure (total- or unicompartmental knee arthroplasty) and recovery expectations regarding return to work, randomization will take place at the patient-level. A minimum of 138 patients will be included in both the intervention and control group, 276 in total. The control group will receive usual care. On top of care as usual, patients in the intervention group will receive an intervention consisting of three components: 1) a personalized eHealth intervention called ikHerstel ('I Recover') including an activity tracker, 2) goal setting using goal attainment scaling to improve rehabilitation and 3) a referral to a case-manager. Our main outcome is quality of life, based on patient-reported physical functioning (using PROMIS-PF). (Cost-)effectiveness will be assessed from a healthcare and societal perspective. Data collection has been started in 2020 and is expected to finish in 2024. Improving societal participation for knee arthroplasty is relevant for patients, health care providers, employers and society. This multicentre randomized controlled trial will evaluate the (cost-)effectiveness of a personalized integrated care program for knee arthroplasty patients, consisting of effective intervention components based on previous studies, compared to care as usual. Trialsearch.who.int; reference no. NL8525, reference date version 1: 14-04-2020.