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Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

ABSTRACT: INTRODUCTION:Following cardiac surgery, patients currently attend an outpatient review 6?weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8?weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier. METHODS AND ANALYSES:This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial. ETHICS AND DISSEMINATION:Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders. TRIAL REGISTRATION NUMBER:ISRCTN80441309.

SUBMITTER: Ngaage D

PROVIDER: S-EPMC6937080 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

Ngaage Dumbor D Mitchell Natasha N Dean Alexandra A Hirst Claire C Akowuah Enoch E Doherty Patrick Joseph PJ Fairhurst Caroline C Flemming Kate K Hewitt Catherine C Hinde Sebastian S Mitchell Alex A Nichols Simon S Watson Judith J

BMJ open 20191229 12

<h4>Introduction</h4>Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increa ...[more]

PMID: 31888947

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Project description:BackgroundIncreasing numbers of elderly patients experience prolonged decreased functional capacity and impaired quality of life after seemingly successful cardiac surgery. After discharge from hospital, these patients experience a substantial gap in care until centre-based cardiac rehabilitation commences. They may benefit from immediate coaching by means of mobile health technology to overcome psychological and physiological barriers to physical activity. The aim of this study was to explore the usability, acceptability, and relevance of a mobile health application designed to support remote exercise-based cardiac rehabilitation of elderly patients early after cardiac surgery from the perspective of patients, their relatives, and physiotherapists.MethodsWe adapted a home-based mobile health application for use by elderly patients early after cardiac surgery. Semi-structured dyadic interviews were conducted with a purposive sample of patients (n = 9), their spouses (n = 5), and physiotherapists (n = 2) following two weeks of the intervention. The transcribed interviews were analysed thematically.ResultsThree themes were identified: 1) creating an individual fit by tailoring the intervention; 2) prioritizing communication and collaboration; and 3) interacting with the mobile health application. Overall, the findings indicate that the mobile health intervention has the potential to promote engagement, responsibility, and motivation among elderly patients to exercise early after surgery. However, the intervention can also be a burden on patients and their relatives when roles and responsibilities are unclear.ConclusionThe mobile health intervention showed potential to bridge the intervention gap after cardiac surgery, as well as in fostering engagement, responsibility, and motivation for physical activity among elderly individuals. Nevertheless, our findings emphasize the necessity of tailoring the intervention to accommodate individual vulnerabilities and capabilities. The intervention may be improved by addressing a number of organizational and communicational issues. Adaptions should be made according to the barriers and facilitators identified in this study prior to testing the effectiveness of the intervention on a larger scale. Future research should focus on the implementation of a hybrid design that supplements or complements face-to-face and centre-based cardiac rehabilitation.Trial registrationDanish Data Protection Agency, Central Denmark Region (1-16-02-193-22, 11 August 2022).

Project description:ObjectiveTo determine the acceptability and feasibility of delivering early outpatient review following cardiac surgery and early cardiac rehabilitation (CR), compared to standard practice to establish if a future large-scale trial is achievable.MethodsA randomised controlled, feasibility trial with embedded health economic evaluation and qualitative interviews, recruited patients aged 18-80 years from two UK cardiac centres who had undergone elective or urgent cardiac surgery via a median sternotomy. Eligible, consenting participants were randomised 1:1 by a remote, centralised randomisation service to postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control), or postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention). The primary outcome measures related to trial feasibility including recruitment, retention, CR adherence, and acceptability to participants/staff. Secondary outcome measures included health-rated quality of life using EQ-5D-5L, NHS resource-use, Incremental Shuttle Walk Test (ISWT) distance, 30- and 90-day mortality, surgical site complications and hospital readmission rates.ResultsFifty participants were randomised (25 per group) and 92% declared fit for CR. Participant retention at final follow-up was 74%; completion rates for outcome data time points ranged from 28 to 92% for ISWT and 68 to 94% for follow-up questionnaires. At each time point, the mean ISWT distance walked was greater in the intervention group compared to the control. Mean utility scores increased from baseline to final follow-up by 0.202 for the intervention (0.188 control). Total costs were £1519 for the intervention (£2043 control). Fifteen participants and a research nurse were interviewed. Many control participants felt their outpatient review and CR could have happened sooner; intervention participants felt the timing was right. The research nurse found obtaining consent for willing patients challenging due to discharge timings.ConclusionRecruitment and retention rates showed that it would be feasible to undertake a full-scale trial subject to some modifications to maximise recruitment. Lower than expected recruitment and issues with one of the clinical tests were limitations of the study. Most study procedures proved feasible and acceptable to participants, and professionals delivering early CR.Trial registrationISRCTN80441309 (prospectively registered on 24/01/2019).

Project description:ObjectiveTo assess the impact of the closure of group-based cardiac rehabilitation (CR) training during the first COVID-19 lockdown in spring 2020 on patients' physical activity, cardiorespiratory fitness, and cardiovascular risk, and to describe the patient experience of lockdown and home-based exercise training during lockdown.DesignMixed methods study. Prospectively collected post-lockdown measurements were compared to pre-lockdown medical record data. Quantitative measurements were supplemented with qualitative interviews about the patient experience during lockdown.SettingOutpatient CR centre in Salzburg, Austria.ParticipantsTwenty-seven patients [six female, mean (SD) age 69 (7.4) years] who attended weekly CR training sessions until the first COVID-19 lockdown in March 2020.Outcome measuresQuantitative: exercise capacity (maximal ergometer test, submaximal ergometer training), cardiovascular risk (Framingham risk score, blood pressure, body mass index, lipids). Qualitative: individual semi-structured interviews.ResultsExercise capacity had significantly reduced from pre- to post-lockdown: mean (SD) power (W) in maximal ergometry 165 (70) vs. 151 (70), p < 0.001; submaximal ergometer training 99 (40) vs. 97 (40), p = 0.038. There was no significant difference in Framingham risk score and other cardiovascular risk factors. Qualitative data showed that almost all patients had kept physically active during lockdown, but 17 (63%) said they had been unable to maintain their exercise levels, and 15 (56%) felt their cardiorespiratory fitness had deteriorated. Many patients missed the weekly CR training and the motivation and sense of community from training together with others. Several patients stated that without professional supervision they had felt less confident to carry out home-based exercise training at high intensity.ConclusionThis study highlights the importance of group-based supervised exercise training for patients who engage well in such a setting, and the detrimental impact of disruption to this type of CR service on physical activity levels and exercise capacity. Additionally, learning from the COVID-19 pandemic may inform the development and implementation of remote CR modalities going forward.

Project description:BackgroundBreast cancer surgery results in numerous acute and long-term adverse outcomes; the degree to which these can be mitigated or prevented through prehabilitation is unknown.MethodsWe conducted a longitudinal, single-arm, mixed-methods study to examine the feasibility of prehabilitation in 22 women undergoing breast cancer surgery. All participants received an individualized exercise prescription including upper quadrant-specific resistance and mobility training and aerobic exercise for the duration of their surgical wait time. Feasibility was assessed by recruitment, adherence, attrition, and intervention-related adverse event rates. An exploratory investigation of intervention efficacy was conducted via a 6-min walk test, upper-quadrant strength and range of motion, volumetric chances associated with lymphedema, and participant-reported quality of life, fatigue, pain, and disability. Outcome assessments were conducted at baseline, prior to surgery, and at six and 12 weeks after surgery. Semi-structured interviews with a subset of participants (n = 5) and health-care providers (H; n = 2) were conducted to provide further insights about intervention feasibility. Qualitative data were analyzed using a hybrid inductive and deductive thematic analysis approach.ResultsRecruitment and attrition rates were 62 and 36%, respectively. Average prehabilitation duration was 31 days (range = 7-69 days). Seventy six percent of participants complied with at least 70% of their prehabilitation prescription. There was a clinically significant increase in the 6-min walk distance from baseline to the preoperative assessment (57 m, 95% CI = -7.52, 121.7). The interviews revealed that the intervention was favorably received by participants and HCPs and included suggestions that prehabilitation (i) should be offered to all surgical candidates, (ii) is an avenue to regain control in the preoperative period, (iii) is a facilitator of postoperative recovery, and (iv) is an opportunity to provide education regarding postoperative rehabilitation protocols. A preference for multimodal prehabilitation (including dietetic and psychological counseling) was also highlighted.ConclusionOur findings suggest that surgical prehabilitation in women with breast cancer is feasible. Data are hampered by study sample size and lack of a control group. Thus, randomized controlled trials to examine prehabilitation efficacy in people with breast cancer, especially interventions employing a multimodal strategy, are warranted.

Project description:BackgroundThere is limited evidence of Aboriginal and Torres Strait Islander people attending cardiac rehabilitation (CR) programs despite high levels of heart disease. One key enabler for CR attendance is a culturally safe program. This study evaluates improving access for Aboriginal and Torres Strait Islander women to attend a CR program in a non-Indigenous health service, alongside improving health workforce cultural safety.MethodsAn 18-week mixed-methods feasibility study was conducted, with weekly flexible CR sessions delivered by a multidisciplinary team and an Aboriginal and/or Torres Strait Islander Health Worker (AHW) at a university health centre. Aboriginal and Torres Strait Islander women who were at risk of, or had experienced, a cardiac event were recruited. Data was collected from participants at baseline, and at every sixth-session attended, including measures of disease risk, quality-of-life, exercise capacity and anxiety and depression. Cultural awareness training was provided for health professionals before the program commenced. Assessment of health professionals' cultural awareness pre- and post-program was evaluated using a questionnaire (n = 18). Qualitative data from participants (n = 3), the AHW, health professionals (n = 4) and referrers (n = 4) was collected at the end of the program using yarning methodology and analysed thematically using Charmaz's constant comparative approach.ResultsEight referrals were received for the CR program and four Aboriginal women attended the program, aged from 24 to 68 years. Adherence to the weekly sessions ranged from 65 to 100%. At the program's conclusion, there was a significant change in health professionals' perception of social policies implemented to 'improve' Aboriginal people, and self-reported changes in health professionals' behaviours and skills. Themes were identified for recruitment, participants, health professionals and program delivery, with cultural safety enveloping all areas. Trust was a major theme for recruitment and adherence of participants. The AHW was a key enabler of cultural authenticity, and the flexibility of the program contributed greatly to participant perceptions of cultural safety. Barriers for attendance were not unique to this population.ConclusionThe flexible CR program in a non-Indigenous service provided a culturally safe environment for Aboriginal women but referrals were low. Importantly, the combination of cultural awareness training and participation in the program delivery improved health professionals' confidence in working with Aboriginal people.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) 12618000581268, http://www.ANZCTR.org.au/ACTRN12618000581268.aspx , registered 16 April 2018.

Project description:IntroductionPhysiotherapy assistants/support workers are an important part of the physiotherapy workforce in the UK. Many of them work in National Health Service (NHS) physiotherapy outpatient services treating patients with musculoskeletal (MSK) conditions. In many services, they take responsibility, under professional supervision, for types of clinical work traditionally undertaken by physiotherapists such as leading exercise classes and treating individual patients. Nevertheless, their role(s) are relatively undefined and as such, there is considerable variation in the duties and tasks they undertake. This study aims to design a framework of 'best practice' in delegation to guide the work of clinicians in NHS physiotherapy MSK services and facilitate standardisation of practice to ensure that patients receive safe and effective treatment by the most appropriate person.Methods and analysisThis mixed-methods study will be conducted in four stages. In stage 1, a focused ethnography in two MSK outpatient physiotherapy services will explore how the current use of delegation is informed by the culture within the clinical setting as well as views, attitudes about, and experiences of, delegation among clinicians, managers and patients. In stage 2a, nominal group technique will be used with three separate groups (physiotherapists/physiotherapy assistants/support workers, managers) to reach a consensus about what components should be included in a best practice framework of delegation. In stage 2b, a discrete choice experiment will elicit patients' preferences between care from physiotherapists and physiotherapy assistants/support workers within MSK physiotherapy services. In the final stage, the results of all previous stages will be triangulated to inform the development of a best practice delegation framework for future testing and use within NHS MSK outpatient physiotherapy services.Ethics and disseminationEthical approval has been granted by the South West-Frenchay Research Ethics Committee. The findings will be disseminated in peer-reviewed journals, conference presentations, the lay press and social media.

Project description:ObjectivesGiven the current excellent early mortality rates for paediatric cardiac surgery, stakeholders believe that this important safety outcome should be supplemented by a wider range of measures. Our objectives were to prospectively measure the incidence of morbidities following paediatric cardiac surgery and to evaluate their clinical and health-economic impact over 6 months.DesignThe design was a prospective, multicentre, multidisciplinary mixed methods study.SettingThe setting was 5 of the 10 paediatric cardiac surgery centres in the UK with 21 months recruitment.ParticipantsIncluded were 3090 paediatric cardiac surgeries, of which 666 patients were recruited to an impact substudy.ResultsFamilies and clinicians prioritised:Acute neurological event, unplanned re-intervention, feeding problems, renal replacement therapy, major adverse events, extracorporeal life support, necrotising enterocolitis, postsurgical infection and prolonged pleural effusion or chylothorax.Among 3090 consecutive surgeries, there were 675 (21.8%) with at least one of these morbidities. Independent risk factors for morbidity included neonatal age, complex heart disease and prolonged cardiopulmonary bypass (p<0.001). Among patients with morbidity, 6-month survival was 88.2% (95% CI 85.4 to 90.6) compared with 99.3% (95% CI 98.9 to 99.6) with none of the morbidities (p<0.001). The impact substudy in 340 children with morbidity and 326 control children with no morbidity indicated that morbidity-related impairment in quality of life improved between 6 weeks and 6 months. When compared with children with no morbidities, those with morbidity experienced a median of 13 (95% CI 10.2 to 15.8, p<0.001) fewer days at home by 6 months, and an adjusted incremental cost of £21 292 (95% CI £17 694 to £32 423, p<0.001).ConclusionsEvaluation of postoperative morbidity is more complicated than measuring early mortality. However, tracking morbidity after paediatric cardiac surgery over 6 months offers stakeholders important data that are of value to parents and will be useful in driving future quality improvement.

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Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

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Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.

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