Dataset Information

Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation.

ABSTRACT: OBJECTIVE:To evaluate the implementation and effectiveness of an internet-based perioperative care programme for patients following gynaecological surgery for benign disease. DESIGN:Stepped-wedge cluster randomised controlled trial. SETTING:Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS:433 employed women aged 18-65 years scheduled for hysterectomy and/or laparoscopic adnexal surgery. INTERVENTIONS:An internet-based care programme was sequentially rolled out using a multifaceted implementation strategy. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or the care programme (n=227). The care programme included an e-health intervention equipping patients with tailored personalised convalescence advice. MAIN OUTCOME MEASURES:The primary outcome was duration until full sustainable return to work (RTW). The degree of implementation of the care programme was evaluated at the level of the patient, healthcare provider and organisation by indicators measuring internet-based actions by patients and providers. RESULTS:Median time until RTW was 49 days (IQR 27-76) in the intervention group and 62 days (42-85) in the control group. A piecewise Cox model was fitted to take into account non-proportionality of hazards. In the first 85 days after surgery, patients receiving the intervention returned to work faster than patients in the control group (HR 2.66, 95%?CI 1.88 to 3.77), but this effect was reversed in the small group of patients that did not reach RTW within this period (0.28, 0.17 to 0.46). Indicators showed that the implementation of the care programme was most successful at the level of the patient (82.8%) and professional (81.7%). CONCLUSIONS:Implementation of an internet-based care programme has a large potential to lead to accelerated recovery and improved RTW rates following different types of gynaecological surgeries. TRIAL REGISTRATION NUMBER:NTR2933; Results.

SUBMITTER: Bouwsma EVA

PROVIDER: S-EPMC5829654 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation.

Bouwsma Esther V A EVA Huirne Judith A F JAF van de Ven Peter M PM Vonk Noordegraaf Antonie A Schaafsma Frederieke G FG Schraffordt Koops Steven E SE van Kesteren Paul J M PJM Brölmann Hans A M HAM Anema Johannes R JR

BMJ open 20180130 1

<h4>Objective</h4>To evaluate the implementation and effectiveness of an internet-based perioperative care programme for patients following gynaecological surgery for benign disease.<h4>Design</h4>Stepped-wedge cluster randomised controlled trial.<h4>Setting</h4>Secondary care, nine hospitals in the Netherlands, 2011-2014.<h4>Participants</h4>433 employed women aged 18-65 years scheduled for hysterectomy and/or laparoscopic adnexal surgery.<h4>Interventions</h4>An internet-based care programme w ...[more]

PMID: 29382673

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Project description:OBJECTIVES:To evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients. DESIGN:Economic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up. SETTING:Secondary care, nine hospitals in the Netherlands, 2011-2014. PARTICIPANTS:433 employed women aged 18-65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery. INTERVENTION:The intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227). MAIN OUTCOME MEASURES:The primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery. RESULTS:At 12 months, there were no statistically significant differences in total societal costs (€-647; 95% CI €-2116 to €753) and duration until RTW (-4.1; 95% CI -10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs. CONCLUSIONS:Considering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery. TRIAL REGISTRATION NUMBER:NTR2933; Results.

Project description:BackgroundPerioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery.MethodsThe multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network's five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.DiscussionThe study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts.Trial registrationClinicalTrials.gov NCT04060303 . Registered on 07 August 2019.

Project description:BackgroundElectronic health (eHealth) interventions have proven effective, but implementation in clinical practice is difficult. More research focusing on the implementation process of eHealth interventions is necessary.ObjectiveThe objective of this study was to describe the process evaluation of a perioperative eHealth intervention, aiming to enhance recovery after laparoscopic abdominal surgery.MethodsA process evaluation was carried out alongside a multicenter randomized controlled trial. Patients aged between 18 and 75 years who were scheduled for a laparoscopic cholecystectomy, hernia inguinal surgery, or laparoscopic adnexal surgery were included. The eHealth intervention comprised a website and mobile phone app with the possibility to develop a personalized convalescence plan, a section with information about the surgical procedure and the recovery period, the possibility to ask questions via an electronic consultation (eConsult), and an activity tracker. The process evaluation was carried out using the model of Linnan and Steckler, measuring components such as reach, dose delivered, dose received, fidelity, and participants' attitudes. Implementation scores were calculated based on the average of the four components. Quantitative data were collected by means of an electronic questionnaire, a logistic database, a weblog, and medical files. Qualitative data were collected by conducting interviews with a subsample of the study participants.ResultsA total of 344 of the 863 eligible patients were included in the study, which accounted for a reach of 39.9%, and 173 participants were randomized to the intervention group. The implementation scores of the different functions of the intervention ranged between 60% and 65%. The website, mobile phone app, and activity tracker were rated 7.3 to 7.6 on a scale of 1 to 10. Almost all participants who were interviewed about the eConsult function rated it as being of additional value if combined with the usual care but not as a replacement for usual care.ConclusionsAlthough participants were overall satisfied with the intervention, the implementation scores of the different functions of the intervention were fair. More research is needed to evaluate the barriers and facilitators for implementation of this perioperative eHealth intervention in normal practice outside study setting.Trial registrationNetherlands Trial Registry NTR4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6vr02V4KK).

Project description:BACKGROUND:Controlled implementation trials often randomize the intervention at the site level, enrolling relatively few sites (e.g., 6-20) compared to trials that randomize by subject. Trials with few sites carry a substantial risk of an imbalance between intervened (cases) and non-intervened (control) sites in important site characteristics, thereby threatening the internal validity of the primary comparison. A stepped wedge design (SWD) staggers the intervention at sites over a sequence of times or time waves until all sites eventually receive the intervention. We propose a new randomization method, sequential balance, to control time trend in site allocation by minimizing sequential imbalance across multiple characteristics. We illustrate the new method by applying it to a SWD implementation trial. METHODS:The trial investigated the impact of blended internal-external facilitation on the establishment of evidence-based teams in general mental health clinics in nine US Department of Veterans Affairs medical centers. Prior to randomization to start time, an expert panel of implementation researchers and health system program leaders identified by consensus a series of eight facility-level characteristics judged relevant to the success of implementation. We characterized each of the nine sites according to these consensus features. Using a weighted sum of these characteristics, we calculated imbalance scores for each of 1680 possible site assignments to identify the most sequentially balanced assignment schemes. RESULTS:From 1680 possible site assignments, we identified 34 assignments with minimal imbalance scores, and then randomly selected one assignment by which to randomize start time. Initially, the mean imbalance score was 3.10, but restricted to the 34 assignments, it declined to 0.99. CONCLUSIONS:Sequential balancing of site characteristics across groups of sites in the time waves of a SWD strengthens the internal validity of study conclusions by minimizing potential confounding. TRIAL REGISTRATION:Registered at ClinicalTrials.gov as clinical trials # NCT02543840 ; entered 9/4/2015.

Project description:BackgroundStepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs.MethodsBased on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals.ResultsSite recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3 months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6-8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled).ConclusionsFuture studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a "ramp-up" period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out.Trial registrationClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.

Project description:BACKGROUND:Internet-based Cognitive Behavioural Therapy (iCBT) is found effective in treating common mental disorders. However, the use of these interventions in routine care is limited. The international ImpleMentAll study is funded by the European Union's Horizon 2020 programme. It is concerned with studying and improving methods for implementing evidence-based iCBT services for common mental disorders in routine mental health care. A digitally accessible implementation toolkit (ItFits-toolkit) will be introduced to mental health care organizations with the aim to facilitate the ongoing implementation of iCBT services within local contexts. This study investigates the effectiveness of the ItFits-toolkit by comparing it to implementation-as-usual activities. METHODS:A stepped wedge cluster randomized controlled trial (SWT) design will be applied. Over a trial period of 30?months, the ItFits-toolkit will be introduced sequentially in twelve routine mental health care organizations in primary and specialist care across nine countries in Europe and Australia. Repeated measures are applied to assess change over time in the outcome variables. The effectiveness of the ItFits-toolkit will be assessed in terms of the degree of normalization of the use of the iCBT services. Several exploratory outcomes including uptake of the iCBT services will be measured to feed the interpretation of the primary outcome. Data will be collected via a centralized data collection system and analysed using generalized linear mixed modelling. A qualitative process evaluation of routine implementation activities and the use of the ItFits-toolkit will be conducted within this study. DISCUSSION:The ImpleMentAll study is a large-scale international research project designed to study the effectiveness of tailored implementation. Using a SWT design that allows to examine change over time, this study will investigate the effect of tailored implementation on the normalization of the use of iCBT services and their uptake. It will provide a better understanding of the process and methods of tailoring implementation strategies. If found effective, the ItFits-toolkit will be made accessible for mental health care service providers, to help them overcome their context-specific implementation challenges. TRIAL REGISTRATION:ClinicalTrials.gov NCT03652883 . Retrospectively registered on 29 August 2018.

Project description:ImportanceInfections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.ObjectiveTo study the effectiveness of a program to strengthen compliance with perioperative standards and reduce postoperative complications following cesarean delivery.Design, setting, and participantsThis stepped-wedge cluster randomized clinical trial included patients undergoing cesarean delivery from August 24, 2021, to January 31, 2023, at 9 hospitals organized into 5 clusters in Ethiopia.InterventionClean Cut, a multimodal surgical quality improvement program that includes process-mapping 6 perioperative standards and creating site-specific, systems-level improvements. The control period was the period before implementation of the intervention.Main outcomes and measuresThe primary end point was surgical site infection rate, and secondary end points were maternal mortality and perinatal mortality and a composite outcome of infections and both mortality outcomes. All were assessed at 30 days postoperatively in the intervention and control groups, adjusting for clustering and demographics. Compliance with standards and the relationship between compliance and outcomes were also compared between the 2 arms.ResultsAmong 9755 women undergoing cesarean delivery, 5099 deliveries (52.3%) occurred during the control period (2722 emergency cases [53.4%]) and 4656 (47.7%) during the intervention period (2346 emergency cases [50.4%]). Mean (SD) patient age was 27.04 (0.05) years. Thirty-day follow-up was completed for 5153 patients (52.8%). No significant reduction in infection rates was detected after the intervention (OR, 0.84; 95% CI, 0.55-1.27; P = .40). Intraoperative infection prevention standards improved significantly in the intervention arm vs control arm for compliance with at least 5 of the 6 standards (odds ratio [OR], 2.95; 95% CI, 2.40-3.62; P < .001). Regardless of trial arm, high compliance was associated with reduced odds of maternal (OR, 0.32; 95% CI, 0.11-0.93; P = .04) and perinatal (OR, 0.64; 95% CI, 0.47-0.89; P = .008) mortality.Conclusions and relevanceIn this stepped-wedge cluster randomized clinical trial of patients undergoing cesarean delivery, no significant reductions in surgical site infections were observed. However, compliance with perioperative standards improved following the intervention.Trial registrationClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402.

Dataset Information

Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation.

Publications

Effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: cluster controlled trial with randomised stepped-wedge implementation.

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