Telephone follow-up by nurse following total knee arthroplasty – protocol for a randomized clinical trial (NCT 01771315)

BACKGROUND: Due 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/DESIGN: The 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov: NCT01771315