Multicentre Mixed-methods Study Research Articles

P123: Cognitive Disorders and Impact on Caregivers: The COGCARE Study protocol

Introduction and objectives:Dementia is associated with a high burden of disease, impacting patients, families and society. Nevertheless, related epidemiological data is becoming outdated, given the difficulties of implementing costly and laborious fieldwork surveys. Data is also difficult to retrieve from health and social services’ information systems. Overall, we must improve the feasibility and validity of case definition regarding dementia and the assessment of caregivers’ consequences. The 10/66 Dementia Research Group diagnostic algorithm is a cross-culturally valid method(1). A ‘short 10/66’ was also validated(2), but not in Portugal. We intend to assess its feasibility and validity in Portuguese samples, using REDcap (a browser-based, metadata-driven software) in mobile devices. Additionally, we aim to assess dementia family caregivers’ subjective burden and psychological distress, contrasting primary care and hospital outpatient settings.Methods:A multicentre mixed-methods study will be conducted on fifty dyads of older people with dementia and their caregivers, plus 150 dyads of ‘controls’ and their close family members, as informants. The ‘short 10/66’ will be administered. Dementia caregivers’ assessments include the Zarit Burden Interview and Self-report Questionnaire. Quantitative analyses will estimate the sensitivity and specificity of the ‘short 10/66’ dementia case definition. Semi-structured qualitative interviews will be conducted with participants and research assistants, exploring their experiences with the assessment process; thematic analysis will then be used.Implications:We expect this study to facilitate the diagnosis of dementia and data collection in health/social services on a routine basis, which will potentially improve the feasibility and decrease the costs of epidemiological surveys and allow for prevalence monitoring in Portugal.

Developing a supportive and palliative care intervention for patients with allogeneic stem cell transplantation: protocol of a multicentre mixed-methods study (allo-PaS)

IntroductionAlthough allogeneic stem cell transplantation (allo-SCT) is a curative treatment for many haematological malignancies, it is often associated with a high morbidity and mortality. Yet, little is known about the...

Effects of care of multimorbid patients in general practices by advanced practice nurses (FAMOUS): study protocol for a nonrandomized controlled trial

BackgroundMultimorbidity is a common phenomenon among patients treated in general practices. Key challenges within this group include functional difficulties, polypharmacy, treatment burden, fragmentation of care, reduced quality of life and increased health care utilization. These problems cannot be solved in the short consultation time of a general practitioner (GP) since there is an increasing shortage of GPs. In many countries, advanced practice nurses (APNs) are successfully integrated into primary health care for multimorbid patients.The objective of this study is to examine whether the integration of APNs in the primary care of multimorbid patients in Germany leads to optimized care of the target group and to a reduction in the workload of the GPs.MethodsThe intervention includes the integration of APNs into the care for multimorbid patients in general practice for twelve months. Qualifications for APNs include a master's level academic degree and 500 hours of project-specific training. Their tasks include in-depth assessment, preparation, implementation, monitoring and evaluation of a person-centred and evidence-based care plan.In this nonrandomized controlled trial, a prospective multicentre mixed methods study will be performed. The main inclusion criterion was the cooccurrence of three chronic diseases. For data collection in the intervention group (n = 817), routine data from health insurance companies and association of statutory health insurance physicians (ASHIP) will be used, as well as qualitative interviews. In addition, the intervention will be assessed through documentation of the care process and standardized questionnaires using a longitudinal design. The control group (n = 1634) will receive standard care. For the evaluation, routine data from health insurance companies are matched at a ratio of 1:2.Outcomes will be measured using emergency contacts and GP visits, treatment costs, health status of the patients and the satisfaction of parties involved.The statistical analyses will include Poisson regression to compare outcomes between the intervention and control groups. Descriptive and analytical statistical methods will be used in the longitudinal analysis of the intervention group data. Cost analysis will compare total costs and subgroup costs between the intervention and control groups. Qualitative data will be analysed using content analysis.DiscussionChallenges to this protocol could include the political and strategic environment as well as the planned number of participants.Trial registrationDRKS00026172 on DRKS.

PANDORA dyadic project: hope, spiritual well-being and quality of life of dyads of patients with chronic obstructive pulmonary disease in Switzerland – a multicentre longitudinal mixed-methods protocol study

IntroductionChronic obstructive pulmonary disease (COPD) is responsible for 2.9 million deaths annually in Europe. Symptom burden and functional decline rise as patients reach advanced stages of the disease enhancing risk...

Designing and evaluating a patient decision aid for patients with locally advanced or locally recurrent rectal cancer: a national multicentre mixed methods study protocol

IntroductionApproximately 5%–10% of new rectal cancers are locally advanced (locally advanced rectal cancer (LARC)) at presentation with 4%–8% recurring (locally recurrent rectal cancer (LRRC)) after initial treatment. Patients with potentially...

Frontline Healthcare Professionals' Views Regarding the Impact of COVID-19 on Ethical Decision-Making: A Multicentre Mixed-Methods Study from Estonia.

Background: The objective of the study was to investigate frontline healthcare professionals’ experiences and attitudes in relation to the COVID-19 pandemic’s ethical and psychosocial aspects in Estonia. There were two research foci: first, ethical decision-making related to treating patients in the context of potential medical resource scarcity, and second, other psychosocial factors for healthcare professionals pertaining to coping, role conflicts, and the availability of institutional support. Methods: An online survey was conducted in the fall of 2020 amongst the frontline healthcare professionals working in the three most impacted hospitals; respondents were also drawn from two ambulance services. The focus of the survey was on the first wave of COVID-19 (spring 2020). A total of 215 respondents completed the quantitative survey and qualitative data were gathered from open comments. Results: Over half of the surveyed healthcare professionals in Estonia expressed confidence in their roles during the pandemic. More than half cited the complex ethical aspects related to their decisions as their main source of doubt and uncertainty. In response to this uncertainty, Estonian healthcare professionals drew on their previous training and experience, the policies and guidelines of their institution, and support from their colleagues, to aid their decision-making during the pandemic. Conclusions: Although frontline healthcare professionals faced difficult decisions during the first wave of the pandemic, overall, most agreed that experiencing the pandemic reconfirmed that their work mattered greatly.

Experience of hospital-initiated medication changes in older people with multimorbidity: a multicentre mixed-methods study embedded in the OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM) trial

BackgroundA patient-centred approach to medicines optimisation is considered essential. The OPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people (OPERAM) trial evaluated the effectiveness of medication review with...

Countermeasures against COVID-19: how to navigate medical practice through a nascent, evolving evidence base — a European multicentre mixed methods study

ObjectivesIn a previously published Delphi exercise the European Pediatric Dialysis Working Group (EPDWG) reported widely variable counteractive responses to COVID-19 during the first week of statutory public curfews in 12...

ZORA Robot Based Interventions to Achieve Therapeutic and Educational Goals in Children with Severe Physical Disabilities

This study aimed (1) to examine the contribution of robot ZORA in achieving therapeutic and educational goals in rehabilitation and special education for children with severe physical disabilities, and (2) to discover the roles professionals attribute to robot ZORA when it is used in robot-based play interventions in rehabilitation and special education for children with severe physical disabilities. A multi-centre mixed methods study was conducted among children with severe physical disabilities in two centres for rehabilitation and one school for special education. The participating children played with robot ZORA six times during a period of 6 weeks, in individual or group sessions. Quantitative data were gathered about the contribution of ZORA in reaching individual goals for all of the participating children, using the Individually Prioritized Problem Assessment (IPPA). Playfulness was measured with a visual analogue scale (0–10) and children could indicate whether they liked the sessions using a scale consisting of smileys. Video-stimulated recall interviews were used to collect qualitative data about the different roles of ZORA. In total, 33 children and 12 professionals participated in the study. The results of the IPPA showed a significant contribution of ZORA to the achievement of (children’s) individual goals. The data gathered using the IPPA during the ZORA-based interventions showed that the largest contributions of robot ZORA lie in the domains of movement skills and communication skills. Playfulness of the sessions was 7.5 on average and 93% of the sessions were evaluated as ‘enjoyable’ by the children. Overall, ZORA could positively contribute to the achievement of individual goals for children with severe physical disabilities. According to the participating professionals the most promising roles in which robot ZORA can be used are motivator, rewarder or instructor.

Patients’ and caregivers’ perspectives on factors that influence understanding of and adherence to hospital discharge instructions: a qualitative study

Many patients have difficulty understanding and adhering to discharge instructions once home from hospital. We assessed patient and family caregiver perspectives on factors that influence understanding of and adherence to discharge instructions. We conducted a qualitative study using semistructured interviews of participants aged 18 years or more enrolled in a multicentre mixed-methods study who were discharged from 3 acute care hospitals across Ontario with a diagnosis of congestive heart failure, chronic obstructive pulmonary disease or pneumonia. Patients were recruited between March and November 2016. We used directed content analysis to derive themes and subthemes. Twenty-seven participants (16 patients and 11 family members) described 5 themes that affected their understanding of and adherence to discharge instructions: 1) the role of caregivers, 2) relationships with inpatient and outpatient health care providers, 3) previous hospital stay, 4) barriers to accessing postdischarge care and 5) system-level processes. Subthemes highlighted the importance participants attributed to who provides the instructions, the development of resilience and advocacy through previous admissions, the benefits of addressing language and physical disability barriers, reviewing instructions in a unhurried manner, and ensuring that written instructions are meaningful and actionable. Care transition interventions targeting improved communication are unlikely to improve understanding of and adherence to discharge instructions on their own. A patient-centred framework that promotes positive relationships with a patient's circle of care, reflects previous experiences with discharge, addresses equity barriers, and enhances strategies for patient and caregiver engagement at the time of discharge may optimize understanding and adherence once the patient is home.

Spiritual care by nurses in curative oncology: a mixed-method study on patients' perspectives and experiences.

AimsSpirituality can be important in adjusting to the experience of cancer and its medical treatment. Since nurses have frequent contact with patients, they seem to have a unique role in providing spiritual care. Nurses consider spiritual care important; however, little is known about how patients in a curative setting experience and value spiritual care. Therefore, this study aimed to give insight into patients’ experiences with and opinions about spiritual care as provided by nurses in curative cancer care.MethodsThis is a national, multicentre mixed‐methods study, combining a quantitative approach using questionnaires (n = 62) and a qualitative analysis of semi‐structured interviews (n = 61). Nonparametric tests were used for quantitative data, and qualitative data were analysed inductively.FindingsMost patients rarely received spiritual care by nurses. If spiritual care was provided, it mainly consisted of noticing problems and referring to other professionals. This appeared to be dependent on certain ‘triggers’, such as age. Structural discussions on spirituality with a nurse were experienced rarely. This was explained by, among other factors, the hospital setting. Yet, the majority (79%) of patients found the attention to spirituality sufficient or very good. Furthermore, a majority (58%) viewed spiritual care as a nursing task: nurses should notice spiritual problems and refer to other professionals, though extensively discussing patients’ spirituality was neither considered nurses’ task nor capability.ConclusionsAttention to spiritual care in a curative setting, though not so much desired by most patients, should be pursued, because of its importance in performing person‐centred nursing care and its positive impact on patients’ health. By training nurses in offering spiritual care in proactive and ‘nonactive’ (accepting) ways, spiritual care could be structurally offered in clinical practice in personalised forms. Since younger and less spiritual patients are not much satisfied with spiritual care by nurses, they need special attention.

Feasibility, acceptability and adaption of dignity therapy: a mixed methods study achieving 360\xb0 feedback

BackgroundDignity Therapy (DT) is a short-term intervention to reduce psychological suffering in end-of-life care. Its strength lies in evidenced-based development and investigation. The aim of the present study is to investigate the feasibility of DT at German palliative care units (PCU), as well as the acceptability and adaption of a German version of the DT question protocol (DTQP).MethodA clinical multicentre mixed methods study, whereby patients and relatives provided quantitative (feedback questionnaires) and qualitative (cognitive interviews) data on the DT intervention. Before using the DTQP on patients, healthcare professionals (HCP) were invited to participate in cognitive interviews to provide input on DT. Therefore 360° feedback was achieved. Finally, the conducted DT interviews were examined.The study took place at two German PCUs (Mainz and Würzburg). Participating HCPs were physicians, psychologists, nurses and chaplains. Patients admitted to the PCUs were eligible to participate if they had a terminal illness and a life expectancy ranging from 2 weeks to 12 months.Results: Out of 410 admitted patients, 72 were eligible and 30 (7.3% of all patients and 41.7% of eligible patients) participated. On average, 9 questions from the DTQP were used per DT interview. Subsequent cognitive interviews with patients produced four main categories of feedback (on the title, the question protocol, wording, and the questions actually asked). Finally, of the 30 participants, 19 completed the feedback questionnaire, as did 26 relatives. Of those, 18 patients and 24 relatives evaluated DT as helpful.ConclusionsDT is feasible for German PCUs. Our research yielded a validated German translation of the DTQP following EORTC guidelines and findings were reported according to the COREQ checklist for qualitative design.Trial registration.The study was registered retrospectively on the 22nd of December 2017 at the German Clinical Trials Register (DRKS00013627).

Protocol for a multicentre study to assess feasibility, acceptability, effectiveness and direct costs of TRIumPH (Treatment and Recovery In PsycHosis): integrated care pathway for psychosis

IntroductionDuration of untreated psychosis (time between the onset of symptoms and start of treatment) is considered the strongest predictor of symptom severity and outcome. Integrated care pathways that prescribe timeframes...

Identifying health service barriers in the management of co-morbid diabetes and chronic kidney disease in primary care: a mixed-methods exploration.

Co-morbid diabetes and chronic kidney disease (CKD) are common in primary care but health care can be suboptimal. In this multi-centre mixed-methods study, we investigated GPs' perspectives on health service barriers in managing diabetes and CKD as an initial step towards health care improvement. Four focus groups were conducted among GPs in Australia's two largest cities. Transcripts underwent content analysis to inform development of a survey exploring health service barriers. This survey was then emailed/mailed to 840 GPs. Statistical analyses were performed using STATA v2.1. Responses were received from 13.7% of GPs (n = 115), mean (±SD) age 55.3 (10.1) years and mean duration of practice 26.6 (10.6). The majority (88.4%) reported wanting to manage diabetes and CKD in primary care with specialist assistance. However, 34.8% were unclear about the definition of CKD with 73.2% wanting more education. Access to specialist services was problematic with 39.3% and 28.2% reporting the process of referring patients to diabetes or CKD services, respectively, as hard. Coordination of care was also a problem with 35.6% unclear about each health care provider's role, 50.5% believing patients faced difficulties due to poor coordination across providers and 51.6% reporting duplication of tests. GPs expressed a clear interest in being the principal health care providers for patients with co-morbid diabetes and CKD. Supporting GPs and health care improvement focusing on overcoming reported barriers such as inadequate knowledge about CKD, access to specialist services and coordination of care may improve outcomes for people with co-morbid diabetes and CKD.

The care needs of patients with idiopathic pulmonary fibrosis and their carers (CaNoPy): results of a qualitative study.

BackgroundIdiopathic pulmonary fibrosis (IPF) is a chronic, fibrotic interstitial lung disease of unknown origin. It has a median survival of three years but a wide range in survival rate which is difficult to predict at the time of diagnosis. Specialist guidance promotes a patient centred approach emphasising regular assessment, information giving and supportive care coordinated by a multidisciplinary team (MDT). However understanding of patient and carer experience across the disease trajectory is limited and detailed guidance for MDTs on communication, assessment, and triggers for supportive and palliative interventions is lacking. This study addresses uncertainties relating to care needs of patients and carers at different stages of the IPF disease trajectory.MethodsFollowing ethical approval a multi-centre mixed-methods study recruited participants with IPF at four stages of the disease trajectory. Qualitative analysis was used to analyse 48 semi-structured interviews with patients (27) and paired carers (21).ResultsPatients and carers outlined key elements of MDT activity capable of having significant impact on the care experience. These were structured around:Focus of clinical encountersTimely identification of changes in health status and functional activityUnderstanding of symptoms and medical interventionsCoping strategies and carer roles.ConclusionsPatients diagnosed with IPF have a clear understanding of their prognosis but little understanding of how their disease will progress and how it will be managed. In depth analysis of the experiences of patients and carers offers guidance for refining IPF clinical pathways. This will support patients and carers at key transition points in line with National Institute for Health and Care Excellence (NICE) guidance.Electronic supplementary materialThe online version of this article (doi:10.1186/s12890-015-0145-5) contains supplementary material, which is available to authorized users.

CANOPY: CARE NEEDS OF PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS AND THEIR CARERS

IntroductionIdiopathic pulmonary fibrosis (IPF) is a chronic, fibrotic interstitial lung disease of unknown origin and median survival of three years. National Institute for Clinical Excellence guidelines promote patient and carer...

Opioid therapy for refractory dyspnea in patients with advanced chronic obstructive pulmonary disease: patients' experiences andoutcomes.

Dyspnea that is refractory to conventional treatments affects up to 50% of patients with advanced chronic obstructive pulmonary disease (COPD). Although professional societies recommend opioids in this setting, evidence supporting their use over months is limited. We conducted a multicentre mixed-methods study to understand patients' experiences when opioids are added to optimized conventional treatments for advanced COPD. A total of 44 patients (median age 74, range 51-89 years) agreed to participate in this 6-month study. After baseline assessments, immediate-release morphine sulfate syrup (initially 0.5 mg twice daily) was slowly titrated upward based on weekly assessments of symptoms. We conducted semistructured interviews and collected contemporaneous measures of health-related quality of life, severity of dyspnea, anxiety, depression, global ratings of opioid "helpfulness" and adverse effects before, at 2 months and at 4-6 months after opioids were started. Of the 44 patients, 32 (73%) completed the trial; 27 (90%) of 30 patients reported the opioid treatment as very (43%) or somewhat (47%) helpful. Three main themes emerged from the patients' overall positive experiences: small gains have big impact; realign hopes with reality; and "try it." Significant improvements were observed in median (interquartile range) scores between baseline and 4-6 months' assessment for health-related quality of life (Chronic Respiratory Questionnaire: 3.5 [2.8-4.0] v. 4.2 [3.6-4.8]; and Chronic Respiratory Questionnaire-Dyspnea domain: 2.8 [2.3-3.6] v. 3.9 [2.8-4.5]) and decreases in severity of dyspnea (numerical rating scale: 7.0 [5.0-8.0] v. 5.0 [4.0-6.0]). Adverse effects were minimal for most patients. Opioids were a helpful and acceptable intervention for refractory dyspnea in patients with advanced COPD. Many of the patients experienced sustained benefits over months, which supports recent recommendations to consider opioids in this setting. ClinicalTrial.gov, no. NCT00982891.