Process evaluation of a breastfeeding support intervention to promote exclusive breastfeeding and reduce social inequity: a mixed-methods study in a cluster-randomised trial.

BACKGROUND: Breastfeeding is a powerful public health intervention that produces long-term health benefits. However, in high-income countries such as Denmark, breastfeeding rates are suboptimal and unequally distributed across socio-economic positions. The 'Breastfeeding - a good start together' intervention, to promote longer duration of exclusive breastfeeding and reduce social inequity, was implemented in a cluster-randomised trial during 2022-2023 across 21 municipalities in two Danish regions. A process evaluation was conducted to assess the implementation, mechanisms of impact, and possible contextual factors affecting the intervention. METHODS: The study was guided by the Medical Research Council's guidance for conducting process evaluations and employed a mixed-methods approach in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8). RESULTS: Overall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors responded positively to the intervention, noting that it fitted well within their usual practice and enhanced families' chances of breastfeeding. Mothers expressed having received the intervention with few exceptions, and reacted positively to the intervention. Although health visitors were concerned about the potential stigmatisation of mothers receiving the intensified intervention, none of the interviewed mothers felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms included staff and management turnover, project infrastructure and mothers' context, such as resources, social networks and previous experiences. The overall fidelity of the intervention delivery was high. CONCLUSIONS: Health visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in alignment with support provided in other sectors of the health care system, may increase breastfeeding rates and reduce social inequity in breastfeeding, even in international contexts. TRIAL REGISTRATION: Clinical Trials: NCT05311631. First posted April 5, 2022.

Strengthening health visitors' breastfeeding support: Results from a cluster randomised study.

AIMS: To assess the effect of the education programme on three constructs of health visitors' breastfeeding support: knowledge, self-efficacy and action competence. Furthermore, the study aimed to confirm the factor structure of these three constructs. BACKGROUND: Health professionals are key in supporting breastfeeding women but studies report gaps in health professionals' breastfeeding support knowledge and competences. The present intervention study aimed to strengthen the breastfeeding support of families to improve breastfeeding rates. Health visitors received an interactive education programme to enhance their breastfeeding support knowledge, self-efficacy and action competence, including e-learning and a two-day course of lectures, role plays and discussions. DESIGN: A pre- and post-test study was applied in a cluster randomised trial METHODS: Cluster units were Danish municipal health visiting programmes, randomised by stratifying for region and annual births per cluster. Health visitors from 21 clusters (11 intervention, 10 control) participated. The knowledge, self-efficacy and action competence were assessed in self-reported questionnaires before and after education (n=368; intervention n=176, control n=196). To analyse the effects, the intention-to-treat principle and linear mixed models were applied. Confirmatory Factor Analysis was used to confirm the factor structures of the hypothesised knowledge, self-efficacy and action competence constructs. RESULTS: 158 health visitors in the control arm and 157 in the intervention arm completed the baseline questionnaire and were analysed in intention-to-treat analyses. 125 and 116, respectively, completed the follow-up questionnaire and were analysed in sensitivity analyses. Health visitors in both trial arms had high levels of self-efficacy and action competence at baseline. Mean treatment effect of the education programme was 0.5 points (CI95 % 0.1-0.8) for knowledge, 2.4 points (CI95 % 1.6-3.3) for self-efficacy and 1.4 points (CI95 % 0.7-2.0) for action competence. The factor structure of the items used to measure knowledge, self-efficacy and action competence were confirmed. CONCLUSIONS: The education programme improved the self-reported breastfeeding support knowledge, self-efficacy and action competence of health visitors. The factor structures of the instruments used to measure effects were confirmed by confirmatory factor analysis. TRIAL REGISTRATION: Clinical Trials: NCT05311631. First posted April 5, 2022.

Barriers and facilitators to cancer rehabilitation for patients with head and neck or lung cancer-a scoping review mapping structural and healthcare professionals' perspectives.

PURPOSE: Rehabilitation can positively affect quality of life, functional status, and physiological status for patients with head and neck or lung cancer. However, barriers and facilitators regarding access, referral, and participation in rehabilitation have not been outlined in the literature either from a healthcare professional or from a structural perspective. Therefore, the objective of this paper was to identify and map barriers and facilitators from structural and healthcare professionals' perspectives in relation to access, referral, and participation in rehabilitation for patients with head and neck or lung cancer. MATERIALS AND METHODS: Two systematic searches were conducted in five databases mapping peer-reviewed research literature. RESULTS: In total, 17 studies of 3918 potential sources were included. Seven themes were identified. Four themes concerned access: Understanding Patients' Resources; Collaboration Determining Access; Education, Knowledge, and Evidence Impact Access to Rehabilitation; and Resources Affecting Availability to Rehabilitation Services. Two themes concerned referral: Referral Criteria; and Elements Affecting Referral Pathway. One theme concerned participation: Factors Influencing Participation. CONCLUSION: From structural and healthcare professionals' perspectives, barriers and facilitators impact access, referral and participation in rehabilitation. However, the findings on facilitators were limited; only one theme addressed participation and two findings concerned patients with low socioeconomic status.IMPLICATIONS FOR REHABILITATIONHealthcare professionals should be mindful that a diverse array of barriers and facilitators may impact the rehabilitation pathway for patients with head, neck, and lung cancer.Engagement by healthcare professionals and structural initiatives are needed to ensure comprehensive access to information concerning rehabilitation options.Local guidelines should be developed to prescribe methods for informing and guiding patients towards suitable rehabilitation options.It is important that healthcare professionals take the individual patient's resources into account when navigating aspects of access, referral, and participation in rehabilitation.

Effectiveness of a community-based support programme to reduce social inequality in exclusive breastfeeding: study protocol for a cluster-randomised trial.

BACKGROUND: Breastmilk is the ideal nutrition for infants, and breastfeeding protects infants and mothers from a range of adverse health outcomes. In Denmark, most mothers initiate breastfeeding but many cease within the first months resulting in just 14% reaching the World Health Organization recommendation of six months of exclusive breastfeeding. Furthermore, the low breastfeeding proportion at six months is characterised by a marked social inequality. A previous intervention tested in a hospital setting succeeded in increasing the proportion of mothers breastfeeding exclusively at six months. However, most breastfeeding support is provided within the Danish municipality-based health visiting programme. Therefore, the intervention was adapted to fit the health visiting programme and implemented in 21 Danish municipalities. This article reports the study protocol, which will be used to evaluate the adapted intervention. METHODS: The intervention is tested in a cluster-randomised trial at the municipal level. A comprehensive evaluation approach is taken. The effectiveness of the intervention will be evaluated using survey and register data. Primary outcomes are the proportion of women who breastfeed exclusively at four months postpartum and duration of exclusive breastfeeding measured as a continuous outcome. A process evaluation will be completed to evaluate the implementation of the intervention; a realist evaluation will provide an understanding of the mechanisms of change characterising the intervention. Finally, a health economic evaluation will assess the cost-effectiveness and cost-utility of this complex intervention. DISCUSSION: This study protocol reports on the design and evaluation of the Breastfeeding Trial - a cluster-randomised trial implemented within the Danish Municipal Health Visiting Programme from April 2022 to October 2023. The purpose of the programme is to streamline breastfeeding support provided across healthcare sectors. The evaluation approach is comprehensive using a multitude of data to analyse the effect of the intervention and inform future efforts to improve breastfeeding for all. TRIAL REGISTRATION: Prospectively registered with Clinical Trials NCT05311631 https://clinicaltrials.gov/ct2/show/NCT05311631.

Cancer rehabilitation and palliative care for socially vulnerable patients in Denmark: an exploration of practices and conceptualisations.

Background: Despite a tax-funded, needs-based organisation of the Danish health system, social inequality in cancer rehabilitation and palliative care (PC) has been noted repeatedly. Little is known about how best to improve access and participation in cancer rehabilitation and PC for socio-economically disadvantaged and socially vulnerable patients. Aim: To gather, synthesise and describe practice-orientated development studies presented in Danish-language publications and examine the underpinning conceptualisations of social inequality and vulnerability; explore related views of stakeholders working in the field. Methods: The study comprised a narrative review of Danish-language literature on practice-orientated development studies which address social inequality and vulnerability in cancer rehabilitation and PC and an online stakeholder consultation workshop with Danish professionals and academics working in the field. Results: Two themes characterise the included publications (n = 8): types of interventions; conceptualisations of social inequality and vulnerability; three themes were identified in the workshop data: focus and type of interventions; organisation of cancer care; and vulnerability of the healthcare system. The publications and the workshop participants (n = 12) favoured approaches which provide additional individualised resources throughout the cancer trajectory for this patient group. The terms social inequality and social vulnerability are largely used interchangeably, and associated with low income and no or little education yet qualified with multiple descriptors, which reflect the diverse socio-economic situations professionals encounter in cancer patients and their psychosocial needs. Conclusion: Addressing social inequality and vulnerability in cancer rehabilitation and PC in Denmark entails practical and conceptual challenges. Of importance is individualised support and the integration of rehabilitation and PC into standardised care pathways. To conceive of social vulnerability as a layered, dynamic, relational and contextual concept reflects current practice in identifying the diversity of cancer patients who may benefit from additional support in accessing and participating in rehabilitation and PC.

Breastfeeding trajectories of young and short-term educated mothers and their partners; experiences of a journey facing tailwind and headwind.

OBJECTIVE: To explore needs, experiences and socio-cultural context of young and short-term educated mothers and their partners affecting breastfeeding duration and self-efficacy during pregnancy and the first months following birth. DESIGN: A qualitative study was conducted using Malterud's method of Systematic Text Condensation. SETTING: Data collection took place in two rural regions in Denmark between October and December 2020. PARTICIPANTS: Thirteen interviews (eight mothers and five fathers), four focus group interviews (24 health visitors) and seven observations of home visits by health visitors were performed. The mothers were below 25 years and had short-term education. FINDINGS: Four themes formed the narrative "Setting off and carrying through a breastfeeding journey": 1) Bringing your unique story of life into the breastfeeding journey, 2) Looking forward to a natural breastfeeding, 3) Facing breastfeeding and the intrusive needs of the baby, and 4) Adaptation to breastfeeding or bottle feeding. Each of these describing barriers and facilitators regarding breastfeeding and breastfeeding self-efficacy. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Becoming familiar with breastfeeding and developing a relationship with the baby posed common challenges for the young and short-term educated mothers and their partners. However, the process was embedded in the parents' unique and often fragile socio-cultural everyday life influencing breastfeeding and breastfeeding self-efficacy. The relationship with the health visitor was essential for the parents' benefit of breastfeeding support, which underscores the importance of viewing adequate breastfeeding support as a relational phenomenon including socio-cultural, parent-baby, and health visitor-parent perspectives in young and short-term educated parents.

Implementation of systematic screening for anxiety and depression in cardiac rehabilitation: Real world lessons from a longitudinal study.

AIMS: Systematic screening for anxiety and depression is widely recommended as a core component of cardiac rehabilitation in ischemic heart disease, however, recommendation-practice gaps are common and limited knowledge exists about factors hindering and supporting implementation. The study aimed to assess adherence to national clinical guideline recommendations and to gain a greater understanding of the implementation of screening in real-world practice. METHODS: An observational, longitudinal mixed-methods design including hospitals and municipalities in Denmark. We retrieved nationwide survey data from 2013, 2015, 2018 and 2021 to assess adherence to screening on programme level, and clinical quality registry data from 2016 to 2020 to assess proportion of patients screened. Data were analysed descriptively. Semi-structured interviews with healthcare professionals were conducted in 2015 (n = 11) and 2020 (n = 11) to explore how screening was conducted and factors supporting implementation. Normalization Process Theory guided interviews and content analysis. RESULTS: Screening on programme level increased from 61% to 88% in hospitals and 20% to 89% in municipalities. The individual proportion of patients screened remained relatively stable in both hospitals and municipalities overall, however with considerable inter-site differences. Screening practices became more aligned to guidelines, pushed by formal recommendations and monitoring, and pulled by activities strengthening the knowledge and motivation among staff. CONCLUSION: Screening for anxiety and depression improved considerably over the seven-year period, from a scattered practice driven by individuals to a movement where healthcare professionals had a feeling of going with the flow. Nationwide implementation of screening requires national and local supporting activities and a continuous effort.

Daily living and rehabilitation needs in patients and caregivers affected by myeloproliferative neoplasms (MPN): A qualitative study.

AIMS AND OBJECTIVES: To explore experiences of daily living and identify rehabilitation needs in patients and caregivers living with myeloproliferative neoplasms. BACKGROUND: Myeloproliferative neoplasms are chronic haematological cancers. Studies report a high symptom burden but little is known about supportive care and rehabilitation for this patient group. DESIGN: Qualitative study with a phenomenological approach using focus group interviews to gather knowledge about the participants' lived experiences. METHODS: Forty-eight patients and seven caregivers attending a 5-day rehabilitation course were interviewed in 12 focus groups. Systematic Text Condensation was used to analyse the interviews. Reporting adhered to COREQ. RESULTS: Two main themes for patients were found: The loss of choice and identity due to the need to prioritise energy and The schism of being a person but also a patient. Patients described how living with myeloproliferative neoplasms meant having to prioritise energy and, therefore, losing freedom to choose activities. This changed their identity and impaired their quality of life. Patients of working age seemed to struggle the most in balancing the disease, family, social relationships and work. One main theme was found for caregivers: Influence of the disease. Caregivers reported how the disease limited their social lives, that the disease brought psychological strain, extra work, and that communication between couples was impaired. When both patients and caregivers participated in rehabilitation courses, they reported better understanding between couples and more open conversations. Rehabilitation needs identified were mainly in relation to psychosocial support and patient education, although needs varied across patients and caregivers. CONCLUSIONS: Patients and caregivers expressed difficulties in adjusting to the lives the disease enforced upon them. Our findings indicate that myeloproliferative neoplasms patients and their caregivers would benefit from a combined model of psychosocial support, patient education, peer support and rehabilitation interventions based on an individual needs assessment. RELEVANCE TO CLINICAL PRACTICE: Nurses can be responsible for individual needs assessments and refer patients and caregivers to suitable supportive care and rehabilitation interventions. TRIAL REGISTRATION DETAILS: The study was approved by the Danish Data Protection agency (J.nr. 2008-58-0035).

Communication about Complementary and Alternative Medicine in Danish Oncological Settings: An Intervention Study.

PURPOSE: Communication about complementary and alternative medicine (CAM) between cancer patients and health professionals rarely takes place. This article reports on an intervention study that aimed to support communication about the use and effects of CAM between cancer patients and care providers. METHODS: The intervention consisted of the use of evidence-based information material (website; leaflet) about the effects of CAM for cancer. Focus groups with cancer patients, relatives, nurses and doctors (n = 50) determined the preferred content and format of materials and evaluated the intervention. The information material was informed by a related systematic metareview of literature. A survey identified patient participants' CAM use, information sources, and the extent of communication about CAM before and after the intervention. RESULTS: No significant impact of the intervention on communication about CAM for cancer patients, patients' CAM use or sources of information was identified. Health professionals disseminated the leaflet only in response to patients raising the topic; the website was not accessed during consultations. The intervention and information materials were well received. CONCLUSION: Cancer patients and care providers wish to improve communication about CAM. Nevertheless, patients and professionals wait for the other to broach the subject of CAM. This reflects a "culture of waiting."

Effect of Home-Based Cardiac Rehabilitation in a Lower-Middle Income Country: RESULTS FROM A CONTROLLED TRIAL.

PURPOSE: Cardiovascular disease is the leading cause of mortality and morbidity in lower-middle income countries (LMICs), including Bangladesh. Cardiac rehabilitation (CR) as part of secondary prevention of cardiovascular disease has been shown to reduce mortality and morbidity and improve quality of life and exercise capacity. However, to date, very few controlled trials of CR have been conducted in LMICs. METHODS: A quasi-randomized controlled trial comparing home-based CR plus usual care with usual care alone was undertaken with patients following coronary artery bypass graft surgery. Participants in the CR group received an in-hospital CR class and were introduced to a locally developed educational booklet with details of a home-based exercise program and then received monthly telephone calls for 12 mo. Primary outcomes were coronary heart disease (CHD) risk factors, health-related quality of life (HRQOL), and mental well-being. Maximal oxygen uptake as a measure of exercise capacity was a secondary outcome. RESULTS: In total, 142 of 148 eligible participants took part in the trial (96%); 71 in each group. At 12-mo follow-up, 61 patients (86%) in the CR group and 40 (56%) in the usual care group provided complete outcome data. Greater reductions in CHD risk factors and improvements in HRQOL, mental well-being, and exercise capacity were seen for the CR group compared with the usual care group. CONCLUSIONS: In the context of a single-center LMIC setting, this study demonstrated the feasibility of home-based CR programs and offers a model of service delivery that could be replicated on a larger scale.

Implementation of a politically initiated national clinical guideline for cardiac rehabilitation in hospitals and municipalities in Denmark.

A politically initiated national clinical guideline was launched in Denmark in 2013 to improve quality and equality of cardiac rehabilitation (CR) services. The guideline is to be implemented in both hospital and community (municipality) settings due to shared responsibility for provision of CR services. Little is known about implementation outcomes of a guideline in these two settings. We aimed to study this by determining the extent to which Danish CR services in hospitals and municipalities adhered to national recommendations following the launch of the guideline. The study employed an observational, longitudinal design. Data were gathered by a questionnaire survey to compare CR services at baseline, measured in 2013 immediately before the guideline was launched, with CR services at a two-year follow up in 2015. All Danish hospital departments offering CR services (N = 36) and all municipalities (N = 98) were included. Data were analysed using inferential statistics. Hospitals reported improvement of both content and quality of CR services. Municipalities reported no change in content of services, and lower level of fulfilment of one quality aspect. The results suggest that the guideline had different impact in hospitals and municipalities and that the differences in content and quality of services between the two settings increased in the study period, thus contradicting the guideline´s aim of uniform, evidence-based content of CR services across settings.

Dietary interventions in cardiac rehabilitation - The gap between guidelines and clinical practice.

BACKGROUND & AIMS: An unhealthy diet is a risk factor for ischemic heart disease (IHD) and therefore cardiac rehabilitation (CR) should include dietary interventions. In 2007, CR became a shared responsibility between Danish hospitals and municipalities. Later, a national clinical guideline including recommendations on dietary interventions was developed to facilitate implementation of CR. The aim of the present study is: 1) To describe provision of dietary interventions in CR for IHD patients in Denmark in 2013 and 2015 emphasizing differences between hospitals and municipalities, and 2) To evaluate the implementation of the national clinical guideline in clinical practice. METHODS: A repeated nationwide cross-sectional electronic survey was carried out in 2013 and 2015. Participation was mandatory for all Danish hospital departments offering CR (n = 36), but voluntary for municipalities (n = 98) reaching response rates of 82% and 89% in 2013 and 2015, respectively. The electronic survey covered the core components of dietary interventions in CR as described in the national clinical guideline. RESULTS: In 2015, 72% of municipalities provided dietary interventions. This proportion was significantly higher in hospitals (94%, p = 0.007). 26% and 38% of hospitals screened systematically for dietary intervention needs in 2013 and 2015, respectively. Corresponding results from municipalities were 26% and 29%. No significant differences were seen in clinical practice over time. CONCLUSIONS: The results of this study identified a major gap between recommendations in the national clinical guideline and actual clinical practice on dietary interventions in CR in Danish hospitals and municipalities. The study confirmed that implementation of guidelines in clinical practice takes time and requires an intensive effort.

The Danish Cardiac Rehabilitation Database.

AIM OF DATABASE: The Danish Cardiac Rehabilitation Database (DHRD) aims to improve the quality of cardiac rehabilitation (CR) to the benefit of patients with coronary heart disease (CHD). STUDY POPULATION: Hospitalized patients with CHD with stenosis on coronary angiography treated with percutaneous coronary intervention, coronary artery bypass grafting, or medication alone. Reporting is mandatory for all hospitals in Denmark delivering CR. The database was initially implemented in 2013 and was fully running from August 14, 2015, thus comprising data at a patient level from the latter date onward. MAIN VARIABLES: Patient-level data are registered by clinicians at the time of entry to CR directly into an online system with simultaneous linkage to other central patient registers. Follow-up data are entered after 6 months. The main variables collected are related to key outcome and performance indicators of CR: referral and adherence, lifestyle, patient-related outcome measures, risk factor control, and medication. Program-level online data are collected every third year. DESCRIPTIVE DATA: Based on administrative data, approximately 14,000 patients with CHD are hospitalized at 35 hospitals annually, with 75% receiving one or more outpatient rehabilitation services by 2015. The database has not yet been running for a full year, which explains the use of approximations. CONCLUSION: The DHRD is an online, national quality improvement database on CR, aimed at patients with CHD. Mandatory registration of data at both patient level as well as program level is done on the database. DHRD aims to systematically monitor the quality of CR over time, in order to improve the quality of CR throughout Denmark to benefit patients.