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Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study.

ABSTRACT: INTRODUCTION:Geriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare. METHODS AND ANALYSIS:Feasibility and exploratory effectiveness of the intervention will be investigated in a monocentric, prospective, non-randomised, controlled trial. The intervention includes systematic information for patients and family about measures to prevent postoperative complications; preoperative screening for frailty, malnutrition, strength and mobility with nutrient supplementation and physical exercise (prehabilitation) as needed. Further components focus on potentially inadequate medication, patient blood-management and carbohydrate loading prior to surgery, retainment of orientation aids in the operating room and a geriatric anaesthesia concept. Data will successively be collected from control, implementation and intervention groups. Patients aged 65+ with impending surgery will be included. A sample size of 240, n=80 per group, is planned. Assessments will take place at inclusion and 2, 30 and 180 days after surgery. Mixed-methods analyses will be performed. Exploratory effectiveness will be assessed using mixed segmented regressions. The primary endpoint is functional status. Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications. Feasibility will be assessed through semi-structured interviews with staff and patients and quantitative analyses of the data quality, focussing on practicability, acceptance, adoption and fidelity to protocol. ETHICS AND DISSEMINATION:The study will be carried out in accordance with the Helsinki Declaration and to principles of good scientific practice. The Ethics Committee of the Medical Association Hamburg, Germany, approved the protocol (study ID: PV5596). Results will be disseminated in scientific journals and healthcare conferences. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT03325413.

SUBMITTER: Olotu C

PROVIDER: S-EPMC6886921 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study.

Olotu Cynthia C Lebherz Lisa L Härter Martin M Mende Anna A Plümer Lili L Goetz Alwin E AE Zöllner Christian C Kriston Levente L Kiefmann Rainer R

BMJ open 20191124 11

<h4>Introduction</h4>Geriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare.<h4>Methods and analys ...[more]

PMID: 31767591

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Project description:ObjectivesPatient involvement in safety improvement is a developing area of research. The aim of this study was to investigate the feasibility of a patient feedback on safety intervention in primary care. Specifically, the intervention acceptability, fidelity, implementation enablers and barriers, scalability, and process of systematically collecting safety data were examined.Design, setting and participantsMixed-methods feasibility trial with six purposively selected Australian primary care practices.InterventionThe intervention comprised an iterative process with a cycle of measurement, learning, feedback, action planning and implementation period of 6 months.Primary and secondary outcomesQualitative and quantitative data relating to feasibility measures (acceptability, fidelity, enablers, barriers, scalability and process of collecting safety data) were collected and analysed.ResultsA total of n=1750 patients provided feedback on safety. There was a statistically significant increase in mean patient safety scores indicating improved safety (4.30-4.37, p=0.002). Staff deemed the intervention acceptable, with minor recommendations for improvement. Intervention fidelity was high and implementation enablers were attributed to the intervention structure and framework, use of intuitive problem-solving approaches, and multidisciplinary team involvement. Practice-based safety interventions resulted in sustainable and measurable changes to systems for safety, such as increased access to care and improved patient information accuracy.ConclusionsThe findings indicate that this innovative patient feedback on safety intervention is feasible for scale-up to a larger effectiveness trial and further spread into policy and practice. This intervention complements existing safety improvement strategies and activities, and integrates into current patient feedback service requirements for Australian primary care. Further research is needed to examine the intervention effects on safety incident reduction.

Project description:BackgroundStress and anxiety are psychophysiological responses commonly experienced by patients during the perioperative process that can increase presurgical and postsurgical complications to a comprehensive and positive recovery. Preventing and intervening in stress and anxiety can help patients achieve positive health and well-being outcomes. Similarly, the provision of education about surgery can be a crucial component and is inversely correlated with preoperative anxiety levels. However, few patients receive stress and anxiety relief support before surgery, and resource constraints make face-to-face education sessions untenable. Digital health interventions can be helpful in empowering patients and enhancing a more positive experience. Digital health interventions have been shown to help patients feel informed about the possible benefits and risks of available treatment options. However, they currently focus only on providing informative content, neglecting the importance of personalization and patient empowerment.ObjectiveThis study aimed to explore the feasibility of a digital health intervention called the Adhera CARINAE Digital Health Program, designed to provide evidence-based, personalized stress- and anxiety-management methods enabled by a comprehensive digital ecosystem that incorporates wearable, mobile, and virtual reality technologies. The intervention program includes the use of advanced data-driven techniques for tailored patient education and lifestyle support.MethodsThe trial will include 5 hospitals across 3 European countries and will use a randomized controlled design including 30 intervention participants and 30 control group participants. The involved surgeries are cardiopulmonary and coronary artery bypass surgeries, cardiac valve replacement, prostate or bladder cancer surgeries, hip and knee replacement, maxillofacial surgery, or scoliosis. The control group will receive standard care, and the intervention group will additionally be exposed to the digital health intervention program.ResultsThe recruitment process started in January 2022 and has been completed. The primary impact analysis is currently ongoing. The expected results will be published in early 2023.ConclusionsThis manuscript details a comprehensive protocol for a study that will provide valuable information about the intervention program, such as the measurement of comparative intervention effects on stress; anxiety and pain management; and usability by patients, caregivers, and health care professionals. This will contribute to the evidence planning process for the future adoption of diverse digital health solutions in the field of surgery.Trial registrationClinicalTrials.gov NCT05184725; https://www.clinicaltrials.gov/ct2/show/NCT05184725.International registered report identifier (irrid)DERR1-10.2196/38536.

Project description:IntroductionSurgical services are increasingly seen to reduce death and disability in Sub-Saharan Africa, where hospital-based mortality remains alarmingly high. This study explores two implementation approaches to improve the quality of perioperative care in a Tanzanian hospital. Effects were compared to a control group of two other hospitals in the region without intervention.MethodsAll hospitals conducted quality assessments with a Hospital Performance Assessment Tool. Changes in immediate outcome indicators after one and two years were compared to final outcome indicators such as Anaesthetic Complication Rate and Surgical Case Fatality Rate.ResultsImmediate outcome indicators for Preoperative Care in the intervention hospital improved (52.5% in 2009; 84.2% in 2011, p<0.001). Postoperative Inpatient Care initially improved to then decline again (63.3% in 2009; 70% in 2010; 58.6% in 2011). In the control group, preoperative care declined from 50.8% (2009) to 32.8% (2011, p <0.001), while postoperative care did not significantly change. Anaesthetic Complication Rate in the intervention hospital declined (1.89% before intervention; 0.96% after intervention, p = 0.006). Surgical Case Fatality Rate in the intervention hospital declined from 5.67% before intervention to 2.93% after intervention (p<0.0010). Surgical Case Fatality Rate in the control group was 4% before intervention and 3.8% after intervention (p = 0.411). Anaesthetic Complication Rate in the control group was not available.DiscussionImmediate outcome indicators initially improved, while at the same time final outcome declined (Surgical Case Fatality, Anaesthetic Complication Rate). Compared to the control group, final outcome improved more in the intervention hospital, although the effect was not significant over the whole study period. Documentation of final outcome indicators seemed inconsistent. Immediate outcome indicators seem more helpful to steer the Continuous Quality Improvement program.ConclusionSpecific interventions as part of Continuous Quality Improvement might lead to sustainable improvement of the quality of care, if embedded in a multi-faceted approach.

Project description:IntroductionBoth regional analgesia and intravenous analgesia are frequently used perioperatively for patients with critical limb ischaemia (CLI). Nevertheless, the comparison of perioperative effect of regional and intravenous analgesia has not yet been thoroughly illustrated. This study will comprehensively compare patient-controlled regional analgesia (PCRA) and patient-controlled intravenous analgesia (PCIA) as two different perioperative analgesia approaches for patients with CLI. It investigates their effects on analgesia, reperfusion and the quality of recovery perioperatively, also aims to provide clinical evidence to those non-surgical patients with non-reconstructable arteries.Methods and analysisThis trial is a randomised, single-centre, open-label, parallel trial with target sample size of 52 in total. Eligible participants will be randomly allocated to the PCRA group (group R) or the PCIA group (group I) after admission. Participants in group R will receive ultrasound-guided subgluteal sciatic catheterisation, followed by continuous PCRA infusion (0.2% ropivacaine 15 mL as loading dose, 8 mL/hour as background with a patient-controlled bolus of 6 mL). Participants in group I will receive PCIA (morphine is given in boluses of 1 mg as needed, background infusion at 1 mg/hour). Data will be collected at baseline (T0), 2 hours before revascularisation treatment (T1) and 2 hours before discharge (T2). The primary outcomes include the Numerical Rating Scale pain score at T1 and T2. The secondary outcomes include the perioperative transcutaneous oxygen pressure, the Tissue Haemoglobin Index, Hospital Anxiety and Depression Scale at T1 and T2; the Patient Global Impression of Change and patient satisfaction at T1 and T2; the perioperative cumulative morphine consumption, the length of postoperative hospital stay and adverse events.Ethics and disseminationThis study received authorisation from the Institutional Review Board of Peking Union Medical College Hospital on 21 March 2017 (approval no. ZS-1289X). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.Trial registration numberChinese Clinical Trial Registry (ChiCTR2000029298).Protocol versionV.4CP.B2 (15 June 2020).

Project description:IntroductionThe Perioperative Quality Improvement Programme (PQIP) is designed to measure complications after major elective surgery and improve these through feedback of data to clinicians. Previous research suggests that despite the significant resources which go into collecting data for national clinical audits, the information they contain is not always used effectively to improve local services.Methods and analysisWe will conduct a formative process evaluation of PQIP comprising a multisited qualitative study to analyse PQIP's programme theory, barriers, facilitators and wider contextual factors that influence implementation. The research will be carried out with the PQIP project team and six National Health Service (NHS) Trusts in England, selected according to geographical location, type of hospital, size and level of engagement with PQIP. We will include one Trust which has not expressed interest in the PQIP for comparison and to explore the role of secular trend in any changes in practice. We will use semi-structured interviews (up to 144 in Trusts and 12 with the project team), non-participant observations (up to 150 ?hours) and documentary analysis. We will track the lifecycle of perioperative data, exploring the transformations it undergoes from creation to use. We will use framework analysis with categories both from our research questions and from themes emerging from the data.Ethics and disseminationEthical approval has been granted from the University College London Research Ethics Committee (ref 10375/001). Permissions to conduct research at NHS Trusts have been granted by local Research and Development offices in coordination with the Health Research Authority. We will follow guidelines for data security, confidentiality and information governance. Findings will be shared at regular time points with the PQIP project team to inform the implementation of the programme, and with participating NHS Trusts to help them reflect on how they currently use data for improvement of perioperative services.

Project description:IntroductionMillions of people survive injuries to the central or peripheral nervous system for which neurorehabilitation is required. In addition to the physical and cognitive impairments, many neurorehabilitation patients experience pain, often not widely recognised and inadequately treated. This is particularly true for multiple sclerosis (MS) patients, for whom pain is one of the most common symptoms. In clinical practice, pain assessment is usually conducted based on a subjective estimate. This approach can lead to inaccurate evaluations due to the influence of numerous factors, including emotional or cognitive aspects. To date, no objective and simple to use clinical methods allow objective quantification of pain and the diagnostic differentiation between the two main types of pain (nociceptive vs neuropathic). Wearable technologies and artificial intelligence (AI) have the potential to bridge this gap by continuously monitoring patients' health parameters and extracting meaningful information from them. Therefore, we propose to develop a new automatic AI-powered tool to assess pain and its characteristics during neurorehabilitation treatments using physiological signals collected by wearable sensors.Methods and analysisWe aim to recruit 15 participants suffering from MS undergoing physiotherapy treatment. During the study, participants will wear a wristband for three consecutive days and be monitored before and after their physiotherapy sessions. Measurement of traditionally used pain assessment questionnaires and scales (ie, painDETECT, Doleur Neuropathique 4 Questions, EuroQoL-5-dimension-3-level) and physiological signals (photoplethysmography, electrodermal activity, skin temperature, accelerometer data) will be collected. Relevant parameters from physiological signals will be identified, and AI algorithms will be used to develop automatic classification methods.Ethics and disseminationThe study has been approved by the local Ethical Committee (285-2022-SPER-AUSLBO). Participants are required to provide written informed consent. The results will be disseminated through contributions to international conferences and scientific journals, and they will also be included in a doctoral dissertation.Trial registration numberNCT05747040.

Project description:IntroductionThe enhanced recovery after surgery (ERAS) protocol provides optimised care guidelines for patients undergoing elective colorectal surgery. To ensure high compliance with active ERAS elements, patients must be educated to actively participate in the perioperative care pathway. Mobile health is a rapidly expanding area of the digital health sector that is effective in educating and engaging patients during follow-up. iColon is a mobile application designed by the Operative Unit of General Surgery of IRCCS Sacro Cuore Don Calabria Hospital of Negrar of Valpolicella, which is specifically targeted at patients undergoing elective colorectal surgery. iColon is organised into ERAS phases, and it provides real-time feedback to surgeons about a patient's adherence to perioperative active ERAS elements.Methods and analysisWe hypothesise that by providing a patient-focused mobile application, compliance with active ERAS elements could be improved.The first coprimary objective is to build patient confidence in using the mobile application, iColon, during perioperative care. The second coprimary objective is to establish patient compliance with active ERAS elements.Secondary objectives include examining: length of stay, 30-day readmission rate, postoperative complications and patient satisfaction of received care.This study is a prospective observational real-world study of patients undergoing elective colorectal surgery who are following the ERAS protocol and using iColon during perioperative periods between September 2020 and December 2022.By educating and engaging patients in the ERAS protocol, the mobile application, iColon, should stimulate patients to be more proactive in managing their healthcare by complying more closely with active ERAS elements.Ethics and disseminationThis study has been approved by the local Ethics Committee with the protocol number 29219 of 25 May 2020. The results will be actively disseminated through peer-reviewed journals, conference presentations and various community engagement activities.

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Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study.

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Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study.

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