The Cost Effectiveness of a Tailored, Web-Based Care Program to Enhance Postoperative Recovery in Gynecologic Patients in Comparison With Usual Care: Protocol of a Stepped Wedge Cluster Randomized Controlled Trial

Abstract

BackgroundThe length of recovery after benign gynecological surgery and return to work frequently exceeds the period that is recommended or expected by specialists. A prolonged recovery is associated with a poorer quality of life. In addition, costs due to prolonged sick leave following gynecological surgery cause a significant financial burden on society.ObjectiveThe objective of our study was to present the protocol of a stepped wedge cluster randomized controlled trial to evaluate the cost effectiveness of a new care program for patients undergoing hysterectomy and/or adnexal surgery for benign disease, compared to the usual care.MethodsThe care program under study, designed to improve convalescence and to prevent delayed return to work, targets two levels. At the hospital level, guidelines will be distributed among clinical staff in order to stimulate evidence-based patient education. At the patient level, additional perioperative guidance is provided by means of an eHealth intervention, equipping patients with tailored convalescence advice, and an occupational intervention is available for those patients at risk of prolonged sick leave. Due to the stepped wedge design of the trial, the care program will be sequentially rolled out among the 9 participating hospitals, from which the patients are recruited. Eligible for this study are employed women, 18-65 years of age, who are scheduled for hysterectomy and/or laparoscopic adnexal surgery. The primary outcome is full sustainable return to work. The secondary outcomes include general recovery, quality of life, self-efficacy, coping, and pain. The data will be collected by means of self-reported electronic questionnaires before surgery and at 2, 6, 12, 26, and 52 weeks after surgery. Sick leave and cost data are measured by monthly sick leave calendars, and cost diaries during the 12 month follow-up period. The economic evaluation will be performed from the societal perspective. All statistical analyses will be conducted according to the intention-to-treat principle.ResultsThe enrollment of the patients started October 2011. The follow-up period will be completed in August 2014. Data cleaning or analysis has not begun as of this article’s submission.ConclusionsWe hypothesize the care program to be effective by means of improving convalescence and reducing costs associated with productivity losses following gynecological surgery. The results of this study will enable health care policy makers to decide about future implementation of this care program on a broad scale.Trial RegistrationNetherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84).

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial

“…Only 1 study aimed to evaluate eHealth as (partial) substitution of usual care; however, this study had no report of a power calculation and included patients undergoing orthopedic surgery. The most comparable study to ours is that of Bouwsma et al [46], which evaluated the cost-effectiveness of an eHealth intervention in patients undergoing gynecological surgery (results not yet published). The main differences with our study are the primary outcome measure (RNA vs RTW), the aim of the eHealth intervention (substitution of care vs additional care), and the patient population (working and nonworking men and women vs working women).…”

“…In the earlier studies performed by our research group, the effect of the eHealth intervention was evaluated in terms of duration until RTW [16,46]. The reason the primary outcome measure in this study is changed to duration until RNA is that in the earlier studies only employed patients could participate; we believe that unemployed patients can also benefit from this eHealth care program to facilitate recovery.…”

“…To our knowledge, there are 13 other studies which have evaluated an educational or supportive eHealth intervention in perioperative care [16,46,50-61]. Most of these studies were relatively small or did not perform a power calculation.…”

Electronic Health Program to Empower Patients in Returning to Normal Activities After General Surgical and Gynecological Procedures: Intervention Mapping as a Useful Method for Further Development (Preprint)

“…Patients undergoing these surgical procedures are chosen as part of the target population, next to those patients undergoing gynecological procedures including hysterectomy and adnexal surgery as the other part of the target population. This way, a broad patient population of general surgical and gynecological patients can be achieved [18][19][23][24]. The study population is divided in 1) the minor abdominal general surgical and gynecological procedures group which consists of laparoscopic cholecystectomy and adnexal surgery;…”

“…In addition, most RCTs regarding enhancing the postoperative course are performed in cardiac surgery whereas there is a lack of RCTs evaluating postoperative recovery after general surgical and gynecological procedures [73][74][75][76][77][78][79][80]. The studies of Vonk et al and Bouwsma et al are most comparable [18,23]. However our study will be the only RCT which will be performed in patients undergoing major abdominal surgery focusing on RNA which also includes procedures performed due to a malignant indication [81].…”