RESEARCH PAPER
Efficacy of tele-nursing consultations in rehabilitation after radical prostatectomy: a randomised controlled trial study Bente Thoft Jensen, Susanne Ammitzbøll Kristensen, Sofie Vistoft Christensen and Michael Borre ABSTRACT The dramatic increase in prostate cancer incidence causes higher demands for public health care. To meet these demands, fast track pathways have been introduced in radical prostatectomy. However, the short length of hospital admission leaves less time for patient education. The aim of this study was to investigate whether nurse-led telephone consultations (TCs) could optimize resources and secure rehabilitation and patient satisfaction in the post-operative period. This study is a prospective randomized controlled trial. A random sample of 95 consecutively enrolled patients was randomized to either intervention or standard follow-up. The intervention was an additional TC 3 days post-operatively. The care and patient education offered during hospitalization was similar for all patients. Randomization took place at discharge and was controlled externally. Data were collected from medical records and questionnaires 2 weeks post-operatively. We found no difference in the overall efficacy regarding patient satisfaction, sense of security and post-operative discomfort. Some patients had unmet needs and TCs provided better rehabilitation regarding management of bowel function, pain, catheter and wound care. There was no difference in the need of post-operative contact to other health care affiliates. In general, patients were sufficiently educated in managing early rehabilitation and they expressed high satisfaction and sense of security in the post-operative period after discharge regardless of TC. Therefore, TCs will not be the standard procedure, but the results have increased awareness in daily clinical practice and optimized the clinical pathway in general. The results indicate commitment and high adherence to clinical guidelines among the nursing staff. Key words: Clinical Effectiveness • Evidence-based practice • Nursing research • Prostate cancer • Quality of care • Rehabilitation
INTRODUCTION Prostate cancer is the most common cancer in men in most western countries (Heidenreich et al., 2010). The crude annual incidence in the European Union is 78·9/100 000 men and the mortality rate is 30·6/100 000/year (Heidenreich et al., 2010). Authors: BT Jensen, MPH-PhD.-Stud, Urology Department, Aarhus University Hospital, Aarhus, Denmark; SA Kristensen, RN-MSc-Stud, Urology Department, Aarhus University Hospital, Aarhus, Denmark; SV Christensen, RN, Urology Department, Aarhus University Hospital, Aarhus, Denmark; M Borre, Professor-MD, PhD, Urology Department, Aarhus University Hospital, Aarhus, Denmark Address for correspondence: Bente Thoft Jensen, Urology Department, Aarhus University Hospital Skejby, Aarhus, Denmark E-mail:
[email protected]
In modern surgical care, it is advisable to manage patients within an enhanced recovery protocol (Kehlet, 2011). However, fast track pathways are not very well implemented in urology care except in radical prostatectomy (Kehlet, 2009, 2011; Kehlet and Wilmore, 2010). Radical prostatectomy patients are hospitalized between 24 h when undergoing robot-assisted laparoscopic radical prostatectomy (RALP) and 2–3 days undergoing conventional open retro-pubic radical prostatectomy (RRP) (Tewari et al., 2003). Generally, robot-assisted surgery leads to fewer post-operative complications and thus a reduced length of hospital stay (Menon et al., 2005). Use of the RALP method has spread rapidly across Europe during the past years. The short admission time has put pressure on
© 2011 The Authors. International Journal of Urological Nursing © 2011 BAUN & Blackwell Publishing Ltd International Journal of Urological Nursing 2011 • Vol 5 No 3
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services at ward level. It has caused nursing staff to be concerned if existing rehabilitation programmes sufficiently cover patients’ needs for information and education (Anderson, 2010). Fast track pathways can lead to post-discharge problems. Therefore, patient education is mandatory to provide patients and relatives with skills and knowledge to manage potential post-surgical complications and care in the patient’s own home (Inman et al., 2011). These factors could have a major impact on patient satisfaction and safety (Shaida et al., 2007b). The increased workload from diagnosis and treatment of patients with prostate cancer has given rise to public awareness and discussions among professionals concerning rehabilitation. This places significant demands on health care establishments for improvements in service to maintain quality (Shaida et al., 2007b; Anderson, 2010). In a time with reducing resources, it is of great importance that nursing staff investigate their ongoing practice, understand patient expectations and are motivated for making adjustments. It is crucial to ensure an appropriate follow-up in uro-oncology care because of the relatively short contact time with patients. Different interventions across settings aim to secure and optimize rehabilitation in patient pathways. Studies have indicated that nurseled telephone follow-up is an effective approach to meet needs after discharge and increase patient satisfaction (Booker, 2004; Cox, 2008). Patients are reported to be receptive to nurse-led service and telephone follow-up (Anderson, 2010) and overall patient satisfaction is reported to be high after nurse-led telephone follow-up (Overend et al., 2008). In prostate cancer, patients undergoing radical radiotherapy for example, nurse-led telephone follow up is an acceptable alternative to an out-patient visit and a way to maintain quality and optimize use of specialized nurses (Faithfull et al., 2001). In summary, telephone consultations (TCs) have been shown to be an innovative professional alternative to conventional out-patient visits. Patients report TCs are less stressful, they increase patient satisfaction and provide significant improvements in service delivery. However, a recent Cochrane review of telephone follow-up including more than 33 randomized controlled trials (>5000 patients) assessing the effects of TC initiated by hospital-based health professionals (Mistiaen and Poot, 2006) reported that the effect of TC was low and inconclusive. A comprehensive literature search was performed in this study and later updated and only one study has so far evaluated the efficacy of an early nurse-led telephone intervention to optimize rehabilitation outcome and reduce morbidity in the post-operative period after radical prostatectomy (Inman et al., 2011).
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AIM The aim was to investigate the efficacy of TCs in the immediate post-operative period after fast track radical prostatectomy.
Hypotheses • TCs optimize rehabilitation outcome after radical prostatectomy • TCs ensure subjective patient satisfaction
Endpoints • Subjective patient satisfaction and sense of security • Patient-reported rehabilitation outcome in the domains of catheter-management, post-operative wound care, pain, bowel function and activities of daily living (ADL) after discharge.
MATERIALS AND METHODS Design This study is a prospective randomized controlled trial.
Sample To our knowledge, no previous studies were applicable to the research questions of this study. Therefore, it was not possible to apply previous results and calculate sample size and power.
Study population The study encompassed 142 men with prostate cancer referred for radical prostatectomy in the period from 1 November 2008 to 30 November 2009. The inclusion criteria were men referred for radical prostatectomy by either RRP or RALP. The surgeries were performed by an international recognized surgeon in each field, one for RRP and one for RALP, respectively. The surgeries were all conducted in the same urology centre. All patients were enrolled in a national clinical database on surgical treatment of prostate cancer. Patients discharged later than 4 days post-operatively were excluded.
Patient education Evidence-based standard care programmes are developed nationally (Rigshospitalet, Enhed for Perioperativ Sygepleje, 2011) ensuring that all patients are educated equally before randomization. The education programme provides initial awareness of potential post-surgical problems and the patient must have a clear understanding of how to manage post-surgical issues when discharged. The education programme includes catheter hygiene care, correct catheter
© 2011 The Authors. International Journal of Urological Nursing © 2011 BAUN & Blackwell Publishing Ltd
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function, positioning of penis and management of urine bags. Patients are also introduced to prevention strategies and symptoms of urinary infections. Pain control and administration of analgesics are emphasized in order to reduce surgical stress as one of the cornerstones in fast track methodology. Post-surgical nutritional care and optimizing of bowel function are in focus as well as the importance of physical activity and general restrictions. Moreover, patients are introduced to wound care as well as symptoms of wound infections. At discharge, all patients receive oral and written information of the above issues related to early rehabilitation.
Randomization At discharge patients were randomized to either TC or standard care. The randomization process was controlled by an external data management company. Block randomization was carried out securing the study population reflected the distribution of patients to open versus robot-assisted surgery in daily clinical practice. The intervention group encompassed 46 (15 RRP/31 RALP) patients randomized to TC and a control group of 49 (17 RRP/32 RALP) patients received standard care. In total, 47 patients were excluded because they declined participation or the length of post-operative stay was prolonged (>4 days). In all, 95 patients were included in the study: 32 received RRP and 63 received RALP, respectively (Figure 1).
Start: 142 Patients
47 Patients excluded
Intervention TC was performed 3 days after discharge and managed by two clinical nurse specialists. The duration of TC was standardized to 15 min but prolonged in case of special needs. A manual was used to standardize the TC as a semi-structured interview.
Data collection All patients filled in questionnaires designed for the study. Data were collected 2 weeks post-operatively at the first visit in the out-patient clinic. The questionnaire was divided into sub-sections in accordance with the domains and endpoints of this study. Patient experience was ranked in categories using a Likert format. As an example: ‘Did you experience any problems in managing your urine bag?’ Yes/no. ‘If yes, to which extent?’ To a great extent, to a certain extent or to a less extent. At the end of each subsection, the patient was asked to score the overall degree of discomfort regarding the specific domain and its impact on daily living on a visual analogue scale (VAS). Demographic variables like age, social and marital status were extracted from medical records. Data on length of stay (LOS) and time with catheter were extracted from the public university hospital administration registry.
Pilot study A pilot study was performed including 10 patients testing the semi-structured interview manual and the questionnaire design. To perform an internal validation of the questionnaire, a test–re-test was conducted. Patients were asked twice within 2 weeks to fill in the questionnaire. All patients returned the questionnaire and a high agreement of 80% was found. All patients recommended TC. The study group concluded the face and construct validity was acceptable.
End: 95 Patients
ETHICS 32 open surgery
63 robot assisted surgery
Randomisation
Randomisation
15 + Tele
31 + tele
Figure 1 Flowchart.
17 – tele
32 tele
After obtaining institutional review board approval, the study was approved by the National Ethics Committee and a standard procedure was followed concerning written and oral information and informed consent. The study was approved by the National Data Protection Agency. This study was a quality assurance study and the intervention was considered non-maleficent to the patient as the intervention was an additional service compared to standard procedure. Initially, the intervention was expected to be beneficent for patients by improving rehabilitation in the early post-operative period. According to the study design, the intention was to ensure highest possible veracity and transparency in order to clarify the hypotheses.
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Transport costs in connection with control visits were refunded and sampling of data took place at days where the patient already had an appointment for a control visit at the hospital. As randomization took place at discharge all patients received the same treatment and care during hospitalization. There were no extra costs involved or time the patients had to spend participating in the project except the 15 min phone call in the intervention group. The present standard care offered to these patients post-operatively justified randomization.
ANALYSES AND STATISTICAL METHODS Efficacy was primarily expressed as the difference between the intervention and the control group regarding patient satisfaction and sense of security. Secondly, by the differences in the domains cathetermanagement, post-operative wound care, pain control, bowel function and ADL after discharge. Missing data were only observed in two persons (one in each group) and was not believed to influence the analysis.
Statistics Characteristics like age, LOS, marital status and time with catheter were described. Normally distributed data were described with mean, standard deviation and 95% confidence intervals (CI) and tested with Student’s ttest. Frequencies were compared by Fischer’s exact test. Multivariate analyses were performed with logistic regression with patient satisfaction as the dependent variable. Multivariate model-fit was performed. Associations were reported as odds ratios and 95% CI. P-values
