What to consider when implementing a tool for timely recognition of palliative care needs in heart failure: a context-based qualitative study.

BACKGROUND: Needs assessment tools can facilitate healthcare professionals in timely recognition of palliative care needs. Despite the increased attention for implementation of such tools, most studies provide little or no attention to the context of implementation. The aim of this study was to explore factors that contribute positively and negatively to timely screening of palliative care needs in advanced chronic heart failure. METHODS: Qualitative study using individual interviews and focus groups with healthcare professionals. The data were analysed using a deductive approach. The Consolidated Framework for Implementation Research was used to conceptualise the contextual factors. RESULTS: Twenty nine healthcare professionals with different backgrounds and working in heart failure care in the Southern and Eastern parts of the Netherlands participated. Several factors were perceived to play a role, such as perception and knowledge about palliative care, awareness of palliative care needs in advanced chronic heart failure, perceived difficulty when and how to start palliative care, limited acceptance to treatment boundaries in cardiology, limited communication and collaboration between healthcare professionals, and need for education and increased attention for palliative care in advanced chronic heart failure guidelines. CONCLUSIONS: This study clarified critical factors targeting patients, healthcare professionals, organisations to implement a needs assessment tool for timely recognition of palliative care needs in the context of advanced chronic heart failure. A multifaceted implementation strategy is needed which has attention for education, patient empowerment, interdisciplinary collaboration, identification of local champions, chronic heart failure specific guidelines and culture.

Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial.

BACKGROUND: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. METHODS: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. DISCUSSION: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04101773.

The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol.

BACKGROUND: In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0-1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness - including the necessity for re-intervention due to incomplete resection - have not yet been evaluated. METHODS: This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. DISCUSSION: This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. TRIAL REGISTRATION: Dutch trial register, number NTR5357 . Registered 11th of August 2015.

Quality improvement strategies for organizational change: a multiphase observational study to increase insight into nonparticipating organizations.

BACKGROUND: The scope of implementation research is often restricted to the analysis of organizations that participate voluntarily in implementation interventions. The recruitment of participants for a quality improvement collaborative increases awareness of the specific innovation. The objective of this multiphase observational study was to identify differences between organizations that participated in a large-scale implementation project aiming to improve perioperative care, functional recovery, and length of hospital stay after gynecologic surgery and organizations that did not participate. A secondary objective was to explore how perioperative practice changed among nonparticipants. METHODS: Of the seven gynecology departments of nonparticipating Dutch hospitals, five agreed to participate in a retrospective analysis. Baseline data of participating hospitals' (N = 19) characteristics, time to functional recovery, and length of hospital stay were compared. Outcome measures for the subsequent pre-post awareness study in the five nonparticipating hospitals were: (1) overall adherence to predefined evidence-based perioperative elements; and (2) change in functional recovery and length of hospital stay. Multivariable regression models, adjusted for baseline characteristics, were used for analysis. RESULTS: In retrospect, nonparticipating and participating hospitals did not differ in baseline characteristics, functional recovery, and length of hospital stay. In three of the five nonparticipating hospitals, adherence to the selected evidence-based perioperative elements increased significantly after awareness of the trial (overall mean difference 9.7%, 95% CI 6.9 to 12.5%, p <  0.001). Linear regression models revealed no statistically significant or clinically relevant differences in time to functional recovery (mean difference - 0.2 days, 95% CI -0.7 to 0.2, p = 0.319) or length of hospital stay (mean difference - 0.4 days, 95% CI -1.3 to 0.5, p = 0.419) in the nonparticipating hospitals. None of these hospitals managed to reduce time to functional recovery or length of hospital stay significantly. CONCLUSIONS: No differences in perioperative outcomes between the nonparticipating and participating hospitals were identified at baseline. Despite the statistically significant improvement in overall evidence-based perioperative care, the awareness raised by recruitment activities alone was not enough to reduce time to functional recovery and length of hospital stay in nonparticipating hospitals. Insight into the trends of nonparticipants is valuable to existing implementation effectiveness research.

Interdepartmental Spread of Innovations: A Multicentre Study of the Enhanced Recovery After Surgery Programme.

BACKGROUND: Spread of evidence-based innovations beyond pioneering settings is essential to improve quality of care. This study aimed to evaluate the influence of a national project to implement 'Enhanced Recovery After Surgery' (ERAS) among colorectal teams on the spread of this innovation to gynaecological procedures. METHODS: A retrospective observational multicentre study was performed of a consecutive sample of patients who underwent major elective gynaecological surgery in 2012-2013. Ten Dutch hospitals (294 patients) had participated in a colorectal breakthrough project implementing ERAS on a nationwide basis and were assigned to the intervention group. Thirteen hospitals (390 patients) that had not participated in this project acted as controls. Outcome measures were time to functional recovery and total length of postoperative hospital stay. Multilevel models adjusted for clustering and baseline demographics were used for analysis. The uptake of ten selected perioperative care elements was evaluated for each hospital. RESULTS: The estimated mean difference (95% confidence interval) between the intervention and control hospitals was -0.3 (-0.9 to 0.3) days in the time to recovery and 0.2 (-0.8 to 1.3) days in the total length of hospital stay. The mean (± standard deviation) absolute rate of implemented perioperative care elements per hospital was 28.9 ± 14.9% in the control, versus 29.3 ± 11.1% in the intervention group (p = 0.934). CONCLUSION: Initial implementation effects seem to be restricted to the participating teams and do not automatically spread to other surgical teams in the same hospital.

Factors associated with sustainability of 2 quality improvement programs after achieving early implementation success. A qualitative case study.

RATIONALE, AIMS, AND OBJECTIVES: Sustainability of innovations is a relatively new concept in health care research and has become an issue of growing interest. The current study explored factors related to the sustainability of 2 multidisciplinary hospital-based programs 3 to 6 years after achieving early implementation success. METHOD: An exploratory qualitative study was conducted into 2 implementation cases, an Enhanced Recovery After Surgery program for colorectal surgery and a short-stay program for breast cancer surgery. Semistructured interviews were held with key persons involved in the care process in 14 hospitals from both cases minimally 3 years after the implementation, between March 2012 and May 2013. The Consolidated Framework for Implementation Research was used to direct the development of the interview guide, during data collection and during analysis. A directed content analysis was performed. RESULTS: A total of 21 interviews with 26 individuals were held, 18 regarding the Enhanced Recovery After Surgery case and 8 regarding the short-stay program case. Respondents mentioned the following factors associated with sustainability of the programs: modification and adaptability of the program, cost-effectiveness, institutionalization into existing systems, short communication lines within the multidisciplinary team, an innovative culture, benefits for patients, cosmopolitanism, the existence of external policies and incentives, trust and belief in the program, and spread of the program to other settings. Two factors are not covered by the Consolidated Framework for Implementation Research, ie, modification of the program over the years and spread of the program to other contexts. CONCLUSIONS: The factors associated with sustainability put forward in both cases were largely the same. Leadership and the implementation project were not mentioned as having influenced the long-term sustainability of the benefits achieved. Sustainability of the innovations is influenced by determinants stemming from all ecological levels of the health care system and demands continuous effort in the postimplementation phase.

Enhanced recovery pathways in abdominal gynecologic surgery: a systematic review and meta-analysis.

INTRODUCTION: Enhanced recovery pathways have been widely accepted and implemented for different types of surgery. Their overall effect in abdominal gynecologic surgery is still underdetermined. A systematic review and meta-analysis were performed to provide an overview of current evidence and to examine their effect on postoperative outcomes in women undergoing open gynecologic surgery. MATERIAL AND METHODS: Searches were conducted using Embase, Medline, CINAHL, and the Cochrane Library up to 27 June 2014. Reference lists were screened to identify additional studies. Studies were included if at least four individual items of an enhanced recovery pathway were described. Outcomes included length of hospital stay, complication rates, readmissions, and mortality. Quantitative analysis was limited to comparative studies. Effect sizes were presented as relative risks or as mean differences (MD) with 95% confidence intervals (CI). RESULTS: Thirty-one records, involving 16 observational studies, were included. Diversity in reported elements within studies was observed. Preoperative education, early oral intake, and early mobilization were included in all pathways. Five studies, with a high risk of bias, were eligible for quantitative analysis. Enhanced recovery pathways reduced primary (MD -1.57 days, 95% CI CI -2.94 to -0.20) and total (MD -3.05 days, 95% CI -4.87 to -1.23) length of hospital stay compared with traditional perioperative care, without an increase in complications, mortality or readmission rates. CONCLUSION: The available evidence based on a broad range of non-randomized studies at high risk of bias suggests that enhanced recovery pathways may reduce length of postoperative hospital stay in abdominal gynecologic surgery.

Identification of promising strategies to sustain improvements in hospital practice: a qualitative case study.

BACKGROUND: A quality improvement collaborative is an intensive project involving a combination of implementation strategies applied in a limited "breakthrough" time window. After an implementation project, it is generally difficult to sustain its success. In the current study, sustainability was described as maintaining an implemented innovation and its benefits over a longer period of time after the implementation project has ended. The aim of the study was to explore potentially promising strategies for sustaining the Enhanced Recovery After Surgery (ERAS) programme in colonic surgery as perceived by professionals, three to six years after the hospital had successfully finished a quality improvement collaborative. METHODS: A qualitative case study was performed to identify promising strategies to sustain key outcome variables related to the ERAS programme in terms of adherence, time needed for functional recovery and hospital length of stay (LOS), as achieved immediately after implementation. Ten hospitals were selected which had successfully implemented the ERAS programme in colonic surgery (2006-2009), with success defined as a median LOS of 6 days or less and protocol adherence rates above 70%. Fourteen semi-structured interviews were held with eighteen key participants of the care process three to six years after implementation, starting with the project leader in every hospital. The interviews started by confronting them with the level of sustained implementation results. A direct content analysis with an inductive coding approach was used to identify promising strategies. The mean duration of the interviews was 37 minutes (min 26 minutes - max 51 minutes). RESULTS: The current study revealed strategies targeting professionals and the organisation. They comprised internal audit and feedback on outcomes, small-scale educational booster meetings, reminders, changing the physical structure of the organisation, changing the care process, making work agreements and delegating responsibility, and involving a coordinator. A multifaceted self-driven promising strategy was applied in most hospitals, and in most hospitals promising strategies were suggested to sustain the ERAS programme. CONCLUSIONS: Joining a quality improvement collaborative may not be enough to achieve long-term normalisation of transformed care, and additional investments may be needed. The findings suggest that certain post-implementation strategies are valuable in sustaining implementation successes achieved after joining a quality improvement collaborative.

Diffusion of Enhanced Recovery principles in gynecologic oncology surgery: is active implementation still necessary?

OBJECTIVE: Spontaneous diffusion of the evidence-based Enhanced Recovery After Surgery (ERAS) program from an early adopter department (colorectal surgery) to other closely related departments (gynecologic surgery) within the same hospital could be expected. Given this diffusion hypothesis, this quality improvement study examines the value of active implementation of ERAS in addition to spontaneous diffusion. METHODS: A nonrandomized, pre-post intervention study was conducted at a tertiary referral hospital. Prospective data of consecutive patients who underwent abdominal surgery between March, 2010 and March, 2011 for gynecologic malignancies were collected and compared with those of a historical cohort of patients treated before the structured implementation of ERAS by an expert team. Outcomes were length of hospital stay, length of functional recovery, and compliance to protocol care elements. RESULTS: Seventy-seven patients treated after structured implementation of ERAS were compared with 38 patients included in the historical cohort. Most women had surgery for ovarian or endometrial cancer (48% and 37% respectively). Postoperative care mostly lacked ERAS elements and needed to be actively implemented. With structured implementation, a reduced time to functional recovery (median 3 versus 6 days, p<0.001) and a shorter length of hospital stay (5 versus 7 days, p<0.001) were achieved. CONCLUSIONS: After several years of practicing ERAS in colorectal surgery, spontaneous spread of ERAS principles to gynecologic oncology surgery occurred partially. The results of this study underscore the need for a structured and supported pro-active process to implement the ERAS program in a complete and successful way.

Structured synchronous implementation of an enhanced recovery program in elective colonic surgery in 33 hospitals in The Netherlands.

BACKGROUND: It has been clearly shown that after elective colorectal surgery patients benefit from multimodal perioperative care programs. The Dutch Institute for Health Care Improvement started a breakthrough project to implement a multimodal perioperative care program of enhanced recovery after surgery (ERAS). This pre/post noncontrolled study evaluated the success of large-scale implementation of the ERAS program for elective colonic surgery using the breakthrough series. METHODS: A total of 33 hospitals participated in this breakthrough project during 2005-2009. Each hospital performed a retrospective chart review to gather information on traditionally treated patients (pre-ERAS group, n = 1,451). During the subsequent year patients were treated according to the ERAS program (ERAS group, n = 1 034). Outcomes were length of stay (LOS), functional recovery, adherence to the protocol, and determinants of reduced LOS. RESULTS: Median LOS decreased significantly from 9 to 6 days (p < 0.001). In the ERAS group, functional recovery was reached within 3 days. Adherence to the protocol elements was high during the preoperative and perioperative phases but slightly lower during the postoperative phase. Younger age, female sex, American Society of Anesthesiologists grades I/II, and laparoscopic surgery were associated with decreased LOS. Care elements that positively influenced LOS were cessation of intravenous fluids and mobilization on postoperative day 1 and administration of laxatives postoperatively. CONCLUSIONS: The ERAS program was successfully implemented in one-third of all Dutch hospitals using the breakthrough series. Participating hospitals reduced the LOS by a median 3 days and were able to improve their standard of care in elective colonic surgery.

Sustainability of healthcare innovations (SUSHI): long term effects of two implemented surgical care programmes (protocol).

BACKGROUND: Two healthcare innovations were successfully implemented using different implementation strategies. First, a Short Stay Programme for breast cancer surgery (MaDO) was implemented in four early adopter hospitals, using a hospital-tailored implementation strategy. Second, the Enhanced Recovery After Surgery (ERAS) programme for colonic surgery was implemented in 33 Dutch hospitals, using a generic breakthrough implementation strategy. Both strategies resulted in a shorter hospital length of stay without a decrease in quality of care. Currently, it is unclear to what extent these innovative programmes and their results have been sustained three to five years following implementation. The aim of the sustainability of healthcare innovations (SUSHI) study is to analyse sustainability and its determinants using two implementation cases. METHODS: This observational study uses a mixed methods approach. The study will be performed in 14 hospitals in the Netherlands, from November 2010. For both implementation cases, the programme aspects and the effects will be evaluated by means of a follow-up measurement in 160 patients who underwent breast cancer surgery and 300 patients who underwent colonic surgery. A policy cost-effectiveness analysis from a societal perspective will be performed prospectively for the Short Stay Programme for breast cancer surgery in 160 patients. To study determinants of sustainability key professionals in the multidisciplinary care processes and implementation change agents will be interviewed using semi-structured interviews. DISCUSSION: The concept of sustainability is not commonly studied in implementation science. The SUSHI study will provide insight in to what extent the short-term implementation benefits have been maintained and in the determinants of long-term continuation of programme activities.