Short summary

The implementation of the fast-track programs for surgical patients has reduced the stay in hospital for TKA-patients and the length of stay is now only around 3 days in several Danish surgical centres. Commonly, the patients are discharged to home and referred to physiotherapy in the community settings with only one scheduled follow-up by the surgeon 3 months post-surgery.

The purpose of this project is to investigate the effect of two different types of post-operative treatment after total knee replacement: conventional treatment and telephone follow-up 4 and 14 days after discharge in addition to the conventional treatment. Included patients will be randomized 1:1. The effect is measured 1, 3, 6 and 12 months post-surgery primarily by physical function measured by The Western Ontario and McMaster Universities Arthritis Index (Womac). Secondary outcomes are self-reported health-related quality of life, general self-efficacy and the number of acute visits to the orthopaedic outpatient clinic.

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Rationale

During the early rehabilitation period TKA-patients have experienced several health problems, especially physical ones. In a survey conducted at Gentofte University Hospital in 2011, 96 % out of 86 patients identified 1-7 physical postoperative health problems two-three weeks after undergoing TKA (unpublished observations by the researcher responsible for this trial). The health-related information given during the admission course has been difficult to transfer to the home setting and following discharge, the patients have needed further guidance. Although the problems were apparent, the patients were reluctant to contact health professionals due to a belief that their problems were too insignificant to bother health care providers with. During the rehabilitation period the experience of inadequate preparation for physical symptoms and psychological reactions, as well as unrealistic expectations to activity level have led to anxiety, depression and disappointment to the extent of affecting the patients´ general health.

Self-efficacy is the degree of belief of having adequate action-oriented resources to control events affecting the everyday life successfully. This is positively correlated with physical and mental aspects of health and an important parameter during the rehabilitation period following TKA by influencing physical function and mental health.

Follow-up interventions after discharge of TKA patients have especially focused on the effect of various programs for physiotherapy. Internet based and home-based physiotherapy was assessed to be as effective as outpatient physiotherapy measured by physical function and health-related quality of life, respectively. An intensive outpatient physiotherapy program additional to the home-based exercise program improved physical functional ability and health related quality of life compared to standard care. Postoperative exercise is a highly prioritized part of the TKA treatment, aiming at improving the ability to practice daily activities immediately after surgery and maximizing the long term functional benefit of TKA.

A standardized follow-up program involving an exit video with role models, extra information through newsletters about the rehabilitation process, two telephone calls and weekly telephone hours was evaluated in a randomized clinical trial. The trial included 103 patients undergoing total knee and total hip arthroplasty eligible for a short stay (less than 6 days) in hospital and showed no effect on self-efficacy, social support and pain coping.

The program was not designed to provide individual counselling according to the patients´ personal circumstances and the progress during their rehabilitation period. In contrast, a structured telephone follow-up focusing on individual care in regard to physical, social and mental aspects of the rehabilitation period had a positive effect on physical function, as well as general and mental health in 122 patients aged 65 years or older undergoing total hip arthroplasty. It is assumed that it is possible to retrieve a corresponding positive effect for patients undergoing TKA.

The aim is to evaluate the effect of a structured nurse-managed telephone follow-up in the early rehabilitation period, based on the patient´s individual situation related to physical and psychosocial problems following TKA.

We hypothesize that telephone follow-up as a supplement to conventional treatment will improve health status and self-efficacy and reduce the number of acute clinical outpatient consultations after TKA compared to conventional treatment.

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Description of the cohort

All patients are recruited from Orthopaedic Department, Gentofte University Hospital - a medium sized hospital in the Capital Region of Denmark which performs approximately 600 primary TKA per year.

Inclusion criteria: Primary first-time total knee arthroplasty due to osteoarthritis, age > 18 years, followed conventional course and discharged ? 4 days after surgery, understand and speak Danish, and signed informed consent before randomization.

Exclusion criteria: In terminal phase of another serious illness such as e.g. cancer with expected lifetime less than 6 months and previous total hip arthroplasty

Patients who meet the inclusion criteria, and none of the exclusion criteria, are consecutively enrolled in the trial during admission. Patients are randomized 1:1 to the intervention group or the control group, respectively. The randomization is performed centrally by a web-based randomization program and in blocks unknown to the investigator and other subjects involved in the study. The randomization is executed just before discharge of the patients from hospital.

Data and biological material

Outcome measures are collected at baseline defined by 3 days after discharge from hospital, and 1, 3, 6 and 12 months post-surgery. These data are obtained by self-administered questionnaires mailed to the patients, except for the questionnaire for baseline data, as the first questionnaires are handed to the patients just before discharge. It is recommended to use a disease-specific health status measure supplemented by a generic measure of health-related quality of life to fully assess outcomes after TKA. A combination of the WOMAC Index and SF-36 is the most frequently used combination and will be used in this trial. Self-efficacy will be measured by the General Self-Efficacy Scale.

From the medical records the following data are collected: age, gender, marital status, body mass index, ASA-group (American Society of Anesthesiologist physical status classification), co-morbidities, length of stay, and the code for the surgical intervention.

Furthermore, the following patient-reported data are collected: level of education, occupational status, home care and nursing care at home, and inhibited physical function not caused by the TKA, participation in the rehabilitation program, readmissions, and unscheduled contact with healthcare professionals (general practitioner, readmission and emergency department, doctor on call, the orthopaedic ward or the orthopaedic outpatient clinic).

Collaborating researchers and departments

Research Unit of Nursing, Institute of Clinical Research, University of Southern Denmark

• Associate Professor Birte østergaard, PhD

Department of Orthopedic Surgery, Gentofte Hospital

• Nurse Kirsten Szöts, MSc, PhD-student
• Senior Hospital Physician Søren Solgaard, DMSc

The Research Unit, Gentofte Hospital

• Research Manager Hanne Konradsen, PhD

Publications associated with the project

Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial. / Szöts K, Konradsen H, Solgaard S, Østergaard B. (NCT01771315). B M C Nursing. 2014 maj 21;13(14):14.