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      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

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          Abstract

          Background

          The 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.

          Objective

          The 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.

          Methods

          The 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.

          Results

          The 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.

          Conclusions

          We 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 Registration

          Netherlands Trial Register: NTR2933; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2933 (Archived by WebCite at http://www.webcitation.org/6Q7exPG84).

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          Most cited references63

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          Grading the severity of chronic pain.

          Michael Von Korff, Johan Ormel, Francis Keefe … (1992)
          This research develops and evaluates a simple method of grading the severity of chronic pain for use in general population surveys and studies of primary care pain patients. Measures of pain intensity, disability, persistence and recency of onset were tested for their ability to grade chronic pain severity in a longitudinal study of primary care back pain (n = 1213), headache (n = 779) and temporomandibular disorder pain (n = 397) patients. A Guttman scale analysis showed that pain intensity and disability measures formed a reliable hierarchical scale. Pain intensity measures appeared to scale the lower range of global severity while disability measures appeared to scale the upper range of global severity. Recency of onset and days in pain in the prior 6 months did not scale with pain intensity or disability. Using simple scoring rules, pain severity was graded into 4 hierarchical classes: Grade I, low disability--low intensity; Grade II, low disability--high intensity; Grade III, high disability--moderately limiting; and Grade IV, high disability--severely limiting. For each pain site, Chronic Pain Grade measured at baseline showed a highly statistically significant and monotonically increasing relationship with unemployment rate, pain-related functional limitations, depression, fair to poor self-rated health, frequent use of opioid analgesics, and frequent pain-related doctor visits both at baseline and at 1-year follow-up. Days in Pain was related to these variables, but not as strongly as Chronic Pain Grade. Recent onset cases (first onset within the prior 3 months) did not show differences in psychological and behavioral dysfunction when compared to persons with less recent onset. Using longitudinal data from a population-based study (n = 803), Chronic Pain Grade at baseline predicted the presence of pain in the prior 2 weeks. Chronic Pain Grade and pain-related functional limitations at 3-year follow-up. Grading chronic pain as a function of pain intensity and pain-related disability may be useful when a brief ordinal measure of global pain severity is required. Pain persistence, measured by days in pain in a fixed time period, provides useful additional information.
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            Consort 2010 statement: extension to cluster randomised trials.

            , K. Campbell, Doug G. Altman … (2011)
            Article 0 comments Cited 273 times – based on 0 reviews     Review now
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              Multimodal strategies to improve surgical outcome.

              Henrik Kehlet, Douglas Wilmore (2002)
              To evaluate the effect of modifying perioperative care in noncardiac surgical patients on morbidity, mortality, and other outcome measures. New approaches in pain control, introduction of techniques that reduce the perioperative stress response, and the more frequent use of minimal invasive surgical access have been introduced over the past decade. The impact of these interventions, either alone or in combination, on perioperative outcome was evaluated. We searched Medline for the period of 1980 to the present using the key terms fast track surgery, accelerated care programs, postoperative complications and preoperative patient preparation; and we examined and discussed the articles that were identified to include in this review. This information was supplemented with our own research on the mediators of the stress response in surgical patients, the use of epidural anesthesia in elective operations, and pilot studies of fast track surgical procedures using the multimodality approach. The introduction of newer approaches to perioperative care has reduced both morbidity and mortality in surgical patients. In the future, most elective operations will become day surgical procedures or require only 1 to 2 days of postoperative hospitalization. Reorganization of the perioperative team (anesthesiologists, surgeons, nurses, and physical therapists) will be essential to achieve successful fast track surgical programs. Understanding perioperative pathophysiology and implementation of care regimes to reduce the stress of an operation, will continue to accelerate rehabilitation associated with decreased hospitalization and increased satisfaction and safety after discharge. Developments and improvements of multimodal interventions within the context of "fast track" surgery programs represents the major challenge for the medical professionals working to achieve a "pain and risk free" perioperative course.
              Article 0 comments Cited 204 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Judith AF Huirne:
                Department of Obstetrics and GynecologyVU University Medical CenterDe Boelelaan 1117Amsterdam, Netherlands31 20444 482731 204444811j.huirne@vumc.nl
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications Inc. (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: Apr-Jun 2014
                Publication date (Electronic): 18 June 2014
                Volume: 3
                Issue: 2
                Electronic Location Identifier: e30
                Affiliations
                [01] 1Department of Obstetrics and Gynecology VU University Medical Center AmsterdamNetherlands
                [02] 2Department of Public and Occupational Health VU University Medical Center AmsterdamNetherlands
                [03] 3EMGO Institute for Health and Care Research AmsterdamNetherlands
                [04] 4Department of Epidemiology and Statistics VU University Medical Center AmsterdamNetherlands
                [05] 5Department of Health Sciences Faculty of Earth and Life Sciences VU University AmsterdamNetherlands
                [06] 6Department of Obstetrics and Gynecology Meander Medical Center AmersfoortNetherlands
                [07] 7Department of Obstetrics and Gynecology Onze Lieve Vrouwe Gasthuis AmsterdamNetherlands
                [08] 8Department of Obstetrics and Gynecology Flevo Hospital AlmereNetherlands
                [09] 9Department of Obstetrics and Gynecology Kennemer Gasthuis HaarlemNetherlands
                [10] 10Department of Obstetrics and Gynaecology Spaarne Hospital HoofddorpNetherlands
                [11] 11Department of Obstetrics and Gynaecology Diakonessenhuis UtrechtNetherlands
                [12] 12Department of Obstetrics and Gynecology Amstelland Hospital AmstelveenNetherlands
                [13] 13Department of Obstetrics and Gynecology Medical Center Alkmaar AlkmaarNetherlands
                Author notes
                Corresponding Author: Judith AF Huirne j.huirne@ 123456vumc.nl
                Article
                Publisher ID: v3i2e30
                DOI: 10.2196/resprot.3236
                PMC ID: 4090379
                PubMed ID: 24943277
                SO-VID: a4410af1-cf42-436a-a6af-8eb50d990cb9
                Copyright © ©Esther VA Bouwsma, Johannes R Anema, Antonie Vonk Noordegraaf, Dirk L Knol, Judith E Bosmans, Steven E Schraffordt Koops, Paul JM van Kesteren, W Marchien van Baal, Jos P Lips, Mark H Emanuel, Petrus C Scholten, Alexander Mozes, Albert H Adriaanse, Hans AM Brölmann, Judith AF Huirne. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.06.2014.
                License:

                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.

                History
                Date received : 01 April 2014
                Date revision requested : 22 April 2014
                Date accepted : 21 May 2014
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: gynecology,internet,telemedicine,convalescence,return to work,economic evaluation
                Data availability:
                Keywords: gynecology, internet, telemedicine, convalescence, return to work, economic evaluation

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