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

Eva van der Meij, Judith Af Huirne, Esther Va Bouwsma, Johanna M van Dongen, Caroline B Terwee, Peter M van de Ven, Chantal M den Bakker, Suzan van der Meij, W Marchien van Baal, Wouter Kg Leclercq, Peggy Maj Geomini, Esther Cj Consten, Steven E Schraffordt Koops, Paul Jm van Kesteren, Hein Bac Stockmann, A Dorien Ten Cate, Paul Hp Davids, Petrus C Scholten, Baukje van den Heuvel, Frederieke G Schaafsma, Wilhelmus Jhj Meijerink, H Jaap Bonjer, Johannes R Anema, Eva van der Meij, Judith Af Huirne, Esther Va Bouwsma, Johanna M van Dongen, Caroline B Terwee, Peter M van de Ven, Chantal M den Bakker, Suzan van der Meij, W Marchien van Baal, Wouter Kg Leclercq, Peggy Maj Geomini, Esther Cj Consten, Steven E Schraffordt Koops, Paul Jm van Kesteren, Hein Bac Stockmann, A Dorien Ten Cate, Paul Hp Davids, Petrus C Scholten, Baukje van den Heuvel, Frederieke G Schaafsma, Wilhelmus Jhj Meijerink, H Jaap Bonjer, Johannes R Anema

Abstract

Background: Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption.

Objective: With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care.

Methods: This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle.

Results: The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted.

Conclusions: We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower.

Clinicaltrial: Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy).

Keywords: adnexal surgery; cholecystectomy; convalescence; cost-effectiveness; eHealth; economic evaluation; inguinal hernia surgery; mHealth; perioperative care; return to normal activities.

Conflict of interest statement

EM, JH, EB, CB, and JA are the developers of the care program under study. JA and JH are setting up a spin-off company concerning the implementation of a mobile application concerning the IKHERSTEL intervention in the Netherlands.

©Eva van der Meij, Judith AF Huirne, Esther VA Bouwsma, Johanna M van Dongen, Caroline B Terwee, Peter M van de Ven, Chantal M den Bakker, Suzan van der Meij, W Marchien van Baal, Wouter KG Leclercq, Peggy MAJ Geomini, Esther CJ Consten, Steven E Schraffordt Koops, Paul JM van Kesteren, Hein BAC Stockmann, A Dorien ten Cate, Paul HP Davids, Petrus C Scholten, Baukje van den Heuvel, Frederieke G Schaafsma, Wilhelmus JHJ Meijerink, H Jaap Bonjer, Johannes R Anema. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.12.2016.

Figures

Figure 1
Figure 1
Text and animations on the website (see Multimedia Appendix 1 for more information).
Figure 2
Figure 2
Personalized convalescence plan (see Multimedia Appendix 1 for more information).
Figure 3
Figure 3
Personalized convalescence plan displayed on a timeline (see Multimedia Appendix 1 for more information).
Figure 4
Figure 4
Recovery monitor (see Multimedia Appendix 1 for more information).
Figure 5
Figure 5
Recovery report (see Multimedia Appendix 1 for more information).
Figure 6
Figure 6
eConsult (see Multimedia Appendix 1 for more information).
Figure 7
Figure 7
Mobile phone app (see Multimedia Appendix 1 for more information).
Figure 8
Figure 8
Activity tracker connected to the mobile phone app (see Multimedia Appendix 1 for more information).

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