This study proposal hypothesizes that huge health efficiency gains can be achieved by substitution and improvement of usualperi operative care by Ehealth and ICT. The main research question is: Is perioperative E-health & ICT costeffective…
ID
Source
Brief title
Condition
- Lifestyle issues
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.Quality-of-life (Rand 36 or EQ-5D)
2.Return-to-normal activities including work (RNA/RTW) according to WHO
definition of social participation (ICF, 40)
Secondary outcome
- Return to physical activities
- Return to work
- Length of recovery
- Empowerment
- Pain intensity
- Patients satisfaction
- Protocol adherence
- Quality improvement
Background summary
In the last decade the number of surgeries increased with 30% in the
Netherlands (1.3 M/year in 2009). To reduce costs,
in-hospital perioperative care is increasingly reduced due to one day
hospitalisations (>50%) and transferred to primary care.
Guidance & monitoring on recovery and resumption of (work)activities are mostly
not provided in secondary and primary care.
The increase of surgeries leads to rising hospital care costs, increasing with
more than 33% between 2000-2009[1] In addition,
studies showed that due to the poor quality of usual perioperative care,
return-to-normal-activities/work after surgery is
hampered, leading to high productivity loss costs .
Our placebo controlled RCT showed that webportal significantly improved
quality-of-life, return-to-(work)activities (9 days
difference), pain intensity, and patient satisfaction compared to placebo. We
hypothesize based on these results that the
webportal substituting usual postoperative care can reduce 68ME/yr healthcare
costs & 1355ME/yr productivity loss.
Study objective
This study proposal hypothesizes that huge health efficiency gains can be
achieved by substitution and improvement of usual
peri operative care by Ehealth and ICT. The main research question is: Is
perioperative E-health & ICT costeffective compared
to usual perioperative care?
Study design
Randomized controlled trial; 661 patients with abdominal surgery in 11
participating hospitals;
A cost-effectiveness, cost-utility analysis & budget impact analyses of the
intervention will be performed from a societal &
healthcare level.
Intervention
Patients in the intervention group will receive a special perioperative care
program. This care program consists of:
1. E-health intervention (webportal and accelerometer)
1.1 Personalized convalescence plan
The most important tool of the webportal is the possibility to generate a
tailored convalescence plan, including advice about resumption of (work)
activities. Using a modified delphi method, specific convalescence
recommendations are developed for the above mentioned types of abdominal
surgery.It aims to improve recovery, return to normal activities/work and
quality of life. The convalescence plan is approved electronically by the
surgeon who performed to surgery on the first post-operative day, resulting in
a definitive convalescence plan.
1.2 Feedback on recovery
a. Recovery monitor and report
This is a tool to identify recovery problems and to give patients feedback on
their recovery progress. Inventory of the resumption of activities takes place
at several moments after surgery and is graphically displayed in a recovery
report allowing to track progress. In case patients fall behind, an alerting
system advises them to contact a specific health care professional, depending
on the underlying problem. It also aims to improve monitoring & transition of
postoperative care: After the patient has given consent, the webportal can be
accessed to all involved healthcare providers in secondary and primary care to
monitor patient*s recovery and to improve transition of secondary to primary
care.
b. Accelerometer
The accelerometer will be used as an aid for patients and their physician to
monitor and give feedback on recovery. Patients have to wear the accelerometer
from the seventh day before surgery until a few weeks after surgery. In a
separate pilot study we will determine the time period that patients have to
wear the accelerometer after surgery. In the seven-day period before surgery,
the accelerometer will be blinded in both groups (intervention and control
group). After surgery the display will be visible in the intervention group,
but remains blinded in the control group. Preoperative activity is defined as
the average activity score of the 7 days before surgery. Postoperative activity
will be expressed each day as a percentage of the preoperative value.
1.3 E-consult
In case patients fall behind, an alerting system advises them to contact a
specific health care professional by e-mail (e-consultation).
In case of a successful convalescence period, patients are offered the
opportunity for e-consultation. This aims to substitute standard postoperative
consultation in outpatient clinics to reduce costs and workload and to meet
patient preferences of care during out of office hours. This will only be
available for patients in subgroup 1.
2. Interventions at cluster level
2.1 Guidelines with convalescence recommendations
Guidelines (developed in the above mentioned modified Delphi method) will be
distributed among clinical staff of the 11 participating hospitals in order to
stimulate evidence-based discharge instructions. All health professionals
involved in clinical care, receive a pocket card on which these recommendations
are summarized for quick reference. Residents involved in discharge
communication are instructed to explain the convalescence recommendations to
their patients before discharge. Giving structural discharge instructions based
on evidence-based guidelines aims to prevent feelings of uncertainty,
irrational beliefs and postoperative fear among patients, which may hamper
recovery.
2.2 Early postoperative check in the outpatient department
Following an open procedure patients will get an appointment for a
postoperative consultation in the outpatient clinic, four weeks after surgery.
After a laparoscopic procedure this appointment will take place two weeks after
surgery. As described before, patients will be offered an e-consultation, in
case of a uncomplicated postoperative recovery period (only for patients in
subgroup 1).
Study burden and risks
The webportal www.ikherstel.nl is an ICT and e health intervention. It aims to
improve recovery by personalized perioperative recovery recommendations. In the
event of severe complications, the gynecologist can choose not to approve the
convalescence plan and patients then receive a message that the convalescence
plan is not valid anymore and that they should follow up with the specific
instructions given at discharge. With consent of the patient, the approved
convalescence plan is also disclosed to the general practitioner and/or
occupational physician of the patient. An accelerometer will be used as an
objective outcome measure to monitor recovery.
In subgroup 1, data will be collected in both groups (intervetion and control
group) by means of self-reported electronic questionnaires before surgery and 2
weeks (T1), 6 weeks (T2), 12 weeks (T3) and 26 weeks (T4) after surgery.
In subgroup 2, data will be collected before surgery and 2 week (T1), 4 weeks
(T2), 6 weeks (T3), 12 weeks (T4), 26 weeks (T5), 40 weeks (T6) and 52 weeks
(T7).
van der Boechorstraat 7
Amsterdam 1081 BT
NL
van der Boechorstraat 7
Amsterdam 1081 BT
NL
Age
Inclusion criteria
All patients aged from 18 to 70 years old who are on the waiting list for a laparoscopic cholecystectomy, an open or laparoscopic colectomy, an open or laparoscopic appendectomy, open or laparoscopic inguinal hernia surgery, an abdominal or laparoscopic hysterectomy or laparoscopic adnexal surgery. Due to differences in surgical procedures we identify two subgroups in the study population:
Subgroup 1: Patients who are on the waiting list for a laparoscopic cholecystectomy, an open or laparoscopic appendectomy, open or laparoscopic inguinal hernia surgery or laparoscopic adnexal surgery.
Subgroup 2: Patients who are on the waiting list for an open or laparoscopic colectomy, or an abdominal or laparoscopic hysterectomy.
Exclusion criteria
• Surgery without a curative intention or with additional radio- or chemotherapy
• Colectomy because of crohn*s disease or ulcerative colitis
• Deep infiltrating endometriosis
• Perforated appendicitis
• Adnexal surgery because of pelvic inflammatory disease/ tubal ovarian abces
• Combination of surgery with other surgical procedures
• Concomitant health problems affecting daily activities
• Severe comorbidity which might complicate the postoperative course
• Patients who are unable to understand the information belonging the research
• Insufficient understanding or ability to fill in (Dutch) questionnaires
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL49248.029.14 |