This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
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.
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.
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.
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.
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.
Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy)
Between 1993 and 2013 the number of surgical procedures per year at community hospitals in the United States increased by 16.5% to more than 26 million per year [
Therefore, improving the quality of perioperative care may contribute to accelerated recovery and health care efficiency, which in turn may reduce health care costs. eHealth seems to be an effective tool in this process for several reasons. First, electronic devices are widely available and are increasingly popular. This means that patients can be easily reached using this medium. Second, there is an increasing demand for self-management in society; eHealth has the potential to motivate people and turn them into more active and effective managers of their own health [
Patients will be included from the surgical and gynecological departments of 7 teaching hospitals in the Netherlands. The trial was conducted in accordance with the Standard Protocol Items: Recommendations for Interventional Trials and reported in accordance with the Consolidated Standards of Reporting Trials [
Eligible patients for this study are adults from 18 to 75 years old who are on the waiting list for one of the following commonly applied minor surgical procedures: laparoscopic cholecystectomy, open or laparoscopic inguinal hernia surgery, or laparoscopic adnexal surgery. Participants meeting any of the exclusion criteria will not be considered (
Exclusion criteria:
Surgery without a curative intention or with additional radio- or chemotherapy
Deep infiltrating endometriosis
Ectopic pregnancy
Adnexal surgery because of pelvic inflammatory disease or tubal ovarian abscess
Combination of several surgical procedures
Severe comorbidity which might complicate the postoperative course
Patient who are unable to understand the information from the study
Insufficient understanding or ability to complete questionnaires in Dutch
Patients allocated to the control group will receive usual care and access to the nonintervention part of the website (www.ikherstel.nl). On this part of the website, the patient information brochure about the surgical procedure from the hospital where the patient will have surgery is presented. This is the same brochure as the one patients often receive in various hospitals when they are scheduled for surgery. The only reason to give patients access to this website is to minimize the bias in estimation of the intervention effect. Furthermore, pre- and postoperative care will be given according to the local protocol of the hospital. In the Netherlands, patients do not receive structural and detailed instructions about the resumption of normal activities including work. Usually, after the patient is discharged from the hospital, an outpatient postoperative consultation is scheduled 4 to 8 weeks following surgery.
Patients in the intervention group will receive access to the intervention part of the website, a mobile application, and an activity tracker.
Components of the intervention.
Component | Target population | Content | Aim |
Website | All patients of the intervention group | Information by text and animationsa | Enhancing patient involvement and recovery expectations and reducing anxiety |
Making a personalized convalescence plana | Creating recovery expectations and improving recovery | ||
Recovery monitor and recovery reporta | Reducing uncertainties and fear related to the recovery process and improving monitoring of postoperative care | ||
eConsult | Increasing access to care, reducing patient uncertainties and fear related to the recovery process, and reducing costs and workload (by replacing the appointment in the outpatient clinic) | ||
App | All patients of the intervention group with a smartphone | Information by texta | Enhancing patient involvement and recovery expectations and reducing anxiety |
Insight in the convalescence plana | Creating recovery expectations and improving recovery | ||
Recovery monitor and recovery reporta | Reducing uncertainties and fear related to the recovery process and improving monitoring and transition of postoperative care | ||
Creating a packing list | Helpful tool | ||
Section to make notes | Helpful tool | ||
Activity tracker | All patients of the intervention group with a smartphone which can be linked to an activity tracker | Monitoring and giving feedback on recoverya | Reducing uncertainties and fear related to the recovery process, which may improve recovery |
aContent is based on the intervention mapping study of Vonk Noordegraaf et al [
The website aims to prepare patients in the best possible manner for their surgery and to offer guidance during their recovery process until full recovery and resumption of all daily activities are achieved. The following tools on the website will support this.
On the website, information will be tailored to the patient, which offers the opportunity to enhance patient involvement (
Text and animations on the website (see
The most important tool on the website is the option to generate a personalized and tailored convalescence plan, including advice about resumption of daily (work) activities (
Personalized convalescence plan (see
Personalized convalescence plan displayed on a timeline (see
The recovery monitor and report are tools to identify recovery problems and give patients feedback on their recovery progress. Patients are asked to indicate by a recovery monitor to what extent they have resumed their activities (
Recovery monitor (see
Recovery report (see
At discharge, patients from the intervention group will not receive a standard appointment at the outpatient clinic. Instead, they are offered continuous guidance via the website (information, feedback on recovery) and the possibility to ask questions on the website to a health care professional from their own hospital by means of an eConsult in case of recovery problems (
eConsult (see
All information which is available on the website is also available on the mobile phone app (Ikherstel app), which will be synchronized with the website. This mHealth app has been developed because of the increasing use of mobile phone apps and in order to make the intervention more accessible. This means that the convalescence plan that is created by the patient on the website will also be displayed on the app. In addition, the app will offer some extra features, such as a section to make notes and the option to compose a list of what to pack when being admitted to hospital (
Mobile phone app (see
Activity tracker connected to the mobile phone app (see
The primary outcome measure of the study will be time to return to normal activities (RNA). The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Functioning item bank version 1.2 will be used to measure limitations in daily activities. This item response theory (IRT)–based item bank has been developed and validated in the United States and translated into Dutch-Flemish [
As secondary outcomes we will use the time until the first activity can be resumed and the moment that 75% of the activities are resumed. Scores of the physical functioning short forms will also be calculated by summarizing for each patient the scores of the 8 activities and transforming them into a T-score on the PROMIS physical functioning metric, where 50 represents the average score of the US population with an SD of 10. The following outcomes will also be measured:
Social participation: assessed with the PROMIS Ability to Participate in Social Roles and Activities version 2.0 short form 8a [
Self-rated health: measured by the 3-level EuroQol-5D (EQ-5D-3L) [
Durations of return to work (RTW) (only for the working population): the time until the first day on which work will be resumed and the time until full resumption of work activities will be assessed
Physical activity: assessed by the International Physical Activity Questionnaire (IPAQ) short form [
Length of recovery: measured by the recovery specific quality of life questionnaire (RI-5) short form [
Pain intensity: measured by the Von Korff questionnaire visual analog scale (VAS) [
Patient satisfaction: measured with a self-developed patient satisfaction questionnaire focused on satisfaction with perioperative care, the care program (both groups), the website (both groups), the app (intervention group only), and the activity tracker (intervention group only).
Outcome measures, measurement instruments, and time points.
Enrollment | Surgery | Post-allocation | ||||||||||
Time Pointa | ||||||||||||
Eligibility screen | X | |||||||||||
Informed consent | X | |||||||||||
Allocation | X | |||||||||||
Intervention part of the website | XXXXXXXXXXXXXXXXXXXXXXXXXXXXX | |||||||||||
Mobile phone app | XXXXXXXXXXXXXXXXXXXXXXXXXXXXX | |||||||||||
Activity tracker | XXXXXXXXXXXXXXXXXXXXXXXXXXXXX | |||||||||||
Nonintervention part of the website | XXXXXXXXXXXXXXXXXXXXXXXXXXXXX | |||||||||||
Return to normal activities (PROMISb physical functioning item bank) | X | X | X | X | X | X | ||||||
Participation (PROMIS short form Social Roles) | X | X | X | X | X | |||||||
Self-rated health (EuroQol-5D-3L) | X | X | X | X | X | |||||||
Return to work (Return to work questionnaire) | X | X | X | X | X | |||||||
Physical activity (IPAQc) | X | X | X | X | ||||||||
Recovery (RI-5d) | X | X | X | X | ||||||||
Pain intensity (VASe) | X | X | X | |||||||||
Patient satisfaction (Satisfaction questionnaire) | X | |||||||||||
Sociodemographic data (Sociodemographic questionnaire) | X | |||||||||||
Complications during surgery (Surgical report) | Xf | |||||||||||
Postoperative complications (Postoperative medical notes) | Xf | |||||||||||
Protocol adherence (Adherence questionnaire) | X | |||||||||||
Care program (Bottom-up approach) | Xf | |||||||||||
Health care utilization (Cost questionnaire) | X | X | ||||||||||
Informal care (Cost questionnaire) | X | X | ||||||||||
Presenteeism: iPCQg and WHO-HPQh | X | X | X | X | X | X | ||||||
Absenteeism: iPCQ | X | X | X | X | X | X | ||||||
Unpaid productivity: Cost questionnaire | X | X |
aT0: 1 month before surgery; T1: 1 week after surgery; T2: 3 weeks after surgery; T3: 6 weeks after surgery; T4: 3 months after surgery; T5: 6 months after surgery.
bPROMIS: Patient-Reported Outcomes Measurement Information System.
cIPAQ: International Physical Activity Questionnaire.
dRI-5: recovery specific quality of life questionnaire short form.
eVAS: visual analog scale.
fMeasured by the research team.
giPCQ: Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire.
hWHO-HPQ: World Health Organization—Health and Work Performance Questionnaire.
Before surgery (T0), various sociodemographic data will be assessed (sex, age, level of education, living conditions, working conditions) and questions asked regarding expectations about the length of recovery. Also the T-scores of the PROMIS physical functioning short forms conducted by the patient will be calculated.
Major complications during surgery (eg, conversion to an open procedure), major complications in the postoperative course (eg, leading to a prolonged hospital stay of more than 2 nights after surgery), and readmission to the hospital in the 30 days after surgery or repeated surgery in the 30 days after surgery are considered as potential confounders. The complications will be assessed by reviewing the surgical reports and postoperative notes.
A process evaluation of the intervention will be carried out in accordance with the Linnan and Steckler method [
Process evaluation.
Website | App | eConsult | Telephone consult after 2 weeks | Activity tracker | |||
Reach: |
Patients who met the inclusion criteria, signed informed consent, and are randomized to the intervention or control groupa | ||||||
Dose delivered: |
Proportion of the patients of the intervention group who received an account for the web portal and appa | Proportion of the patients of the intervention group who received a telephonic appointment at dischargeb | Proportion of the patients of the intervention group who received an activity trackera | ||||
Dose received: |
Proportion of the patients of the intervention group that made a convalescence planc | Proportion of the patients of the intervention group that used the appd | Proportion of the patients of the intervention group that asked one or more questions on the web portalc | Proportion of the patients of the intervention group that received their telephonic appointmentb | Proportion of the patients of the intervention group that connected the activity tracker to their phonec | ||
Fidelty: |
Proportion of the convalescence plans that are electronically approved by the specialistc | X | Proportion of the questions that were answeredc | Proportion of the patients of the intervention group that came back at the outpatient office in addition to their telephonic consultb | Proportion of the patients of the intervention group that used the activity tracker in the first 3 weeks after surgery (minimum 3 days per week) and in the sixth week after surgery (minimum 3 days)c | ||
Participant attitudes: |
Assessment of the website by the intervention group and reasons for not using the websited | Assessment of the app and reasons for not using the appd | X | X | Assessment of the activity tracker and reasons for not using the activity trackerd |
aData collection method: logistic database.
bData collection method: notes in the medical record.
cData collection method: web log.
dData collection method: adherence and satisfaction questionnaire.
Costs will be measured from a societal and a health care perspective. Societal costs will consist of costs of the intervention (ie, the substitution of perioperative care by eHealth), other health care use, informal care, absenteeism (ie, absence from work), presenteeism (ie, reduced productivity while at work), and unpaid productivity (ie, inability to perform educational activities, chores, volunteer work). When the health care perspective is applied, only costs accruing to the formal health care sector will be included (ie, costs of the intervention and other health care use).
Intervention costs will include all costs related to the development and implementation of the intervention and will be measured using a bottom-up microcosting approach (ie, detailed data will be collected regarding the quantity of resources consumed during the development and implementation of the intervention as well as their unit prices). All other cost categories will be measured using Web-based questionnaires administered at baseline and after 1 week, 3 weeks, 6 weeks, 3 months, and 6 months of follow-up (
Previous studies evaluating this type of intervention on RNA are lacking. We based our sample size calculation on the outcomes on RTW after gynecological surgery of our previous study [
All patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or adnexal surgery in one of the participating hospitals who meet the inclusion criteria will receive a letter of information about the study on behalf of their doctor. After 1 week, contact will be made by phone to evaluate their willingness to participate and to access eligibility. If the patient wants to and is eligible to participate, informed consent will be signed. Participants will not receive any financial or nonfinancial incentives.
After inclusion, patients will be asked to complete the first online questionnaire (T0) within the month before surgery. After patients have completed the questionnaire, randomization will take place by means of a computer-based randomization list stratified regarding hospital, sex, and surgical procedure using permuted blocks, size 2. Patients are randomized to the intervention or the control group in a 1:1 ratio. The researcher performing randomization is independent from the recruitment or data analyses.
Patients are blinded to the intervention as they do not know which program is developed as a nonintervention or intervention care program. After allocation, patients will receive an email containing a link to the care program to which they are allocated. Both care programs can be accessed through the website, but after signing in, patients will receive access only to the part of the website to which they are randomized. The researchers involved in the analyses will be blinded to the allocation throughout the analyses. Health care providers cannot be blinded to the intervention because it is highly likely that they will be notified of the allocation either by the patient or the patient’s medical file.
Data will be collected by means of self-reported electronic questionnaires at standard moments. Data will be collected in the month before surgery (T0) and 1 week (T1), 3 weeks (T2), 6 weeks (T3), 3 months (T4) and 6 months (T5) after surgery (
All analyses will be performed in SPSS (IBM Corp). Baseline characteristics will be summarized using descriptive statistics and compared between the intervention and control group using
The economic evaluation will be performed from a societal and health care perspective. The time horizon of the economic evaluation is 6 months, thus discounting of costs and effects is not necessary. Both cost-effectiveness and cost-utility analyses will be performed. The cost-effectiveness analysis will be performed with the primary effect measure (ie, RNA). The cost-utility analysis will be performed with quality-adjusted life-years (QALYs). The patients’ EQ-5D-3L health states will be converted into utilities using the Dutch tariff, and QALYs will be calculated using linear interpolation between measurement points [
The inclusion process started in September 2015. The expected end date is August 2016. The data collection process will last until February 2017 since the follow-up duration is 6 months. The results are expected in 2018. Data cleaning or analyses have not begun as of this article’s submission.
In this RCT we will evaluate the effect of eHealth on RNA after abdominal surgery.
In the earlier studies performed by our research group, the effect of the eHealth intervention was evaluated in terms of duration until RTW [
To our knowledge, there are 13 other studies which have evaluated an educational or supportive eHealth intervention in perioperative care [
Improving the quality of perioperative care is required because postoperative care is limited due to the reduction in the length of hospital stay. In addition, because of the increasing demand for health care due to the aging population and personnel shortages in health care, it is necessary to deliver more efficient and cost effective perioperative care. This study will evaluate whether eHealth can be used to suit this purpose. It will both give insight for health care professionals by determining the best form of perioperative care and facilitate policy makers in deciding whether eHealth can be used to substitute usual care against lower costs. The generalizability of this study is high because the eHealth intervention will be evaluated in various types of surgical procedures and will only require minor adaptions in order to be applied to other types of procedures.
Further information on screenshots.
Selection of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2.
Peer review report 1.
Peer review report 2.
Peer review report 3.
computer-adaptive testing
electronic health
EuroQol-5D (3 level)
hazard ratio
incremental cost-effectiveness ratio
International Physical Activity Questionnaire
Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire
item response theory
mobile health
Patient-Reported Outcomes Measurement Information System
quality-adjusted life-years
randomized controlled trial
recovery specific quality of life questionnaire short form
return to normal activities
return to work
visual analog scale
World Health Organization Health and Work Performance Questionnaire
This study is carried out with funding of the Netherlands Organisation for Health Research and Development (project number 837002409).
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.