Abstract
BackgroundDue to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage. The objective of this trial is to study the effects of two treatment schemes following total knee arthroplasty: conventional treatment following discharge from hospital and early follow-up by telephone consultations in addition to conventional treatment following discharge from hospital. The ultimate aim is to increase the effectiveness of the treatment by improving patients' health status, promote self-efficacy, and reduce the number of acute visits to the orthopaedic outpatient clinic during the rehabilitation period.Method/designThe design is a randomized un-blinded parallel group clinical trial conducted at the Department of Orthopaedic Surgery, Gentofte Hospital, the Capital Region of Denmark. In total, 116 patients will be allocated by an external randomization program to 2 groups: an intervention group following usual treatment after discharge supplemented by a nurse managed structured follow-up consultation conducted by telephone 4 and 14 days after discharge from hospital and a control group following treatment as usual. The consultations are structured by key subjects relevant to assess the health status according to the VIPS-model (the Swedish acronym for the concepts Well-being, Integrity, Prevention and Safety). The content of the consultations can vary according to the patients´ individual situations and needs. All consultations are conducted by the researcher responsible for the trial.The effect is measured 1, 3, 6 and 12 months post-surgery. The primary outcome is self-reported physical function measured by The Western Ontario and McMaster Universities Arthritis Index. Secondary outcomes are self-reported health-related quality of life, general self-efficacy and the number of acute visits to the orthopaedic outpatient clinic.DiscussionThe result of this trial is expected to provide new knowledge to support the development of targeted and effective follow-up after total knee arthroplasty in order to improve the patients´ health-related knowledge and skills of being able to take actively part in their illness and improve their health status.Trial registrationClinicalTrials.gov: NCT01771315
Highlights
Due to shorter hospitalization, patients have to take responsibility for their rehabilitation period at a very early stage
Secondary outcomes Secondary analysis will assess the effect of telephone follow-up in the intervention group compared to the control group by change in pain and stiffness scores in WOMAC LK 3.1 Index, change in health-related quality of life measured by the Medical Outcomes Study Short Form (SF-36) [27], change in the General Self-Efficacy Scale score [28], and the number of acute visits to the orthopaedic outpatient clinic
WOMAC Index LK 3.1 WOMAC is developed and recommended for evaluation of treatment effect of total knee arthroplasty (TKA) [26,32]
Summary
Telephone follow-up is considered an inexpensive and organized intervention, and a good way to exchange information, provide health education and advice, manage symptoms and early recognition of complication, reassurance and quality aftercare [43]. The drop-out rate can be expected to increase during the 12 months follow-up period and rapid response to unreturned questionnaires is executed by telephone calls to minimize the drop-out rate All interventions in this trial are conducted by the first author, reflecting the practice of that specific nurse and representing a positive attitude to the intervention, which could influence the outcome positively. The sample in this trial will only represent the group of patients with a short stay in hospital, which minimizes the time for health-related counselling and information, and increases the possibility of a positive outcome of the study. All authors have revised the manuscript critically and given their final approval of the version to be published
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