A Mixed-Methods Feasibility Study of an Arts-Based Intervention for Patients Receiving Maintenance Haemodialysis.

Abstract BackgroundHaemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysisMethodsA parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. ResultsOut of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n=3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n=11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. ConclusionAn arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

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A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis

BMC Nephrology ◽

10.1186/s12882-020-02162-4 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Claire Carswell ◽

Joanne Reid ◽

Ian Walsh ◽

William Johnston ◽

Helen McAneney ◽

...

Keyword(s):

Mixed Methods ◽

Process Evaluation ◽

Healthcare Professionals ◽

Phase 1 ◽

Well Being ◽

Patient Choice ◽

Control Group ◽

Cluster Rct ◽

Definitive Trial ◽

Qualitative Process Evaluation

Abstract Background Haemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysis. Methods A parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. Results Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n = 3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n = 11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. Conclusion An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial. Trial registration The trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

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A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis

10.21203/rs.3.rs-59545/v2 ◽

2020 ◽

Author(s):

Claire Carswell ◽

Joanne Reid ◽

Ian Walsh ◽

William Johnston ◽

Helen McAneney ◽

...

Keyword(s):

Mixed Methods ◽

Process Evaluation ◽

Healthcare Professionals ◽

Phase 1 ◽

Well Being ◽

Patient Choice ◽

Control Group ◽

Cluster Rct ◽

Definitive Trial ◽

Qualitative Process Evaluation

Abstract BackgroundHaemodialysis can negatively impact quality of life and mental health. Arts-based interventions used successfully in other settings to improve health and well-being, could help address the impact of haemodialysis. This study aimed to evaluate the feasibility and acceptability of conducting a randomised controlled trial (RCT) of an arts-based intervention for patients receiving haemodialysisMethodsA parallel convergent mixed-methods design was used, including a pilot cluster RCT and qualitative process evaluation. Phase 1 evaluated recruitment and retention rates through a pilot cluster RCT at a single haemodialysis unit in Northern Ireland. Participants included patients who received haemodialysis for ESKD, were over the age of 18 and had the capacity to consent. These participants were randomised to the intervention or control group according to their haemodialysis shift. The intervention involved six one-hour, one-to-one facilitated arts sessions during haemodialysis. Phase 2 explored intervention and trial acceptability through a qualitative process evaluation using semi-structured interviews based on the RE-AIM framework. Participants included 13 patients who participated in phase 1 of the study, including 9 participants from the experimental group and four participants from the control group, and nine healthcare professionals who were present on the unit during implementation. Results:Out of 122 outpatient haemodialysis patients, 94 were assessed as eligible for participation. Twenty-four participants were randomised, meaning 80% of the target sample size was recruited and the attrition rate at 3 months was 12.5% (n=3). Participants viewed the arts as more accessible and enjoyable than anticipated following implementation. All participants who started the intervention (n=11) completed the full six sessions. Qualitative benefits of the intervention suggest improvements in mental well-being. Patient choice and facilitation were important factors for successful implementation. Conclusion:An arts-based intervention for patients receiving haemodialysis is acceptable for both patients and healthcare professionals, and a definitive trial is feasible. The intervention may help improve mental-wellbeing in patients receiving haemodialysis, but this requires further investigation in a definitive trial.Trial registrationThe trial was prospectively registered on clinicaltrials.gov on 14/8/2018, registration number NCT03629496.

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Research protocol for the exploration of experiences of Aboriginal Australian mothers and healthcare professionals when using the Edinburgh Postnatal Depression Scale: a process-oriented validation study using triangulated participatory mixed methods

BMJ Open ◽

10.1136/bmjopen-2018-022273 ◽

2018 ◽

Vol 8 (10) ◽

pp. e022273 ◽

Cited By ~ 3

Author(s):

Ai Wen Chan ◽

Petra Skeffington ◽

Corinne Reid ◽

Rhonda Marriott

Keyword(s):

Mixed Methods ◽

Postnatal Depression ◽

Mixed Methods Research ◽

Edinburgh Postnatal Depression Scale ◽

Healthcare Professionals ◽

Depression Scale ◽

Well Being ◽

Ethics Committee ◽

Research Protocol ◽

Process Oriented

IntroductionAdopting a process-oriented framework for test validation can help to establish whether this tool has the potential to be an acceptable, valid and reliable indicator of depression for mothers and mothers-to-be. This mixed-methods research protocol seeks to explore the views and experiences of Aboriginal mothers and healthcare professionals in relation to the Edinburgh Postnatal Depression Scale (EPDS), and is intended to highlight potential barriers in perinatal mental health conceptualisation, engagement and response style.Methods and analysisThematic analysis will be applied to interview transcripts of Aboriginal Australian mothers (n=6+) and healthcare professionals (n=6+) to identify key themes. The process-focused validation model will use narratives about experiences of using the EPDS as the priority point of analysis. Item-level data and process-level (experience) data are key phenomenological data. The interview-based narratives will be then compared with EPDS scores to check for points of congruence and divergence. This will be done at two time points, antenatally and postnatally, to assess changes in assessment processes and perceptions. Bridging evidence-based research with clinical practice in an Aboriginal Australian context will be facilitated by an investigation of the perceived cultural relevance and likely clinical effectiveness of EPDS. Such evidence is critical to understanding whether the EPDS fulfils its intended purpose. The guiding principles in designing this research protocol is to benefit the well-being of young Aboriginal families and communities through partnership with Aboriginal women.Ethics and disseminationEthics approval was obtained from Human Research Ethics Committee of Murdoch University and from Western Australian Aboriginal Health Ethics Committee (WAAHEC). Participating healthcare sites and services have provided letters of support. Results of this study will be submitted for publication in a peer-reviewed journal.

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Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation

JMIR Research Protocols ◽

10.2196/15634 ◽

2019 ◽

Vol 8 (12) ◽

pp. e15634 ◽

Cited By ~ 3

Author(s):

Stephanie Allan ◽

Hamish Mcleod ◽

Simon Bradstreet ◽

Sara Beedie ◽

Bethany Moir ◽

...

Keyword(s):

Mixed Methods ◽

Process Evaluation ◽

Relapse Prevention ◽

Evaluation Studies ◽

Well Being ◽

Mobile App ◽

Warning Signs ◽

Evaluation Framework ◽

Health Staff ◽

Negative Consequences

Background Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. Objective This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. Methods The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. Results The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. Conclusions The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. Trial Registration ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID) DERR1-10.2196/15634

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Impact of legal status change on undocumented migrants’ health and well-being (Parchemins): protocol of a 4-year, prospective, mixed-methods study

BMJ Open ◽

10.1136/bmjopen-2018-028336 ◽

2019 ◽

Vol 9 (5) ◽

pp. e028336 ◽

Cited By ~ 2

Author(s):

Yves Jackson ◽

Delphine S Courvoisier ◽

Aline Duvoisin ◽

Giovanni Ferro-Luzzi ◽

Patrick Bodenmann ◽

...

Keyword(s):

Mixed Methods ◽

Health Status ◽

Legal Status ◽

Well Being ◽

Living Conditions ◽

Mixed Methods Study ◽

Control Group ◽

Undocumented Migrants ◽

The Impact ◽

Health And Well Being

IntroductionMigrants without residency permit, known as undocumented, tend to live in precarious conditions and be exposed to an accumulation of adverse determinants of health. Only scarce evidence exists on the social, economic and living conditions-related factors influencing their health status and well-being. No study has assessed the impact of legal status regularisation. The Parchemins study is the first prospective, mixed-methods study aiming at measuring the impact on health and well-being of a regularisation policy on undocumented migrants in Europe.Methods and analysisThe Parchemins study will compare self-rated health and satisfaction with life in a group of adult undocumented migrants who qualify for applying for a residency permit (intervention group) with a group of undocumented migrants who lack one or more eligibility criteria for regularisation (control group) in Geneva Canton, Switzerland. Asylum seekers are not included in this study. The total sample will include 400 participants. Data collection will consist of standardised questionnaires complemented by semidirected interviews in a subsample (n=38) of migrants qualifying for regularisation. The baseline data will be collected just before or during the regularisation, and participants will subsequently be followed up yearly for 3 years. The quantitative part will explore variables about health (ie, health status, occupational health, health-seeking behaviours, access to care, healthcare utilisation), well-being (measured by satisfaction with different dimensions of life), living conditions (ie, employment, accommodation, social support) and economic situation (income, expenditures). Several confounders including sociodemographic characteristics and migration history will be collected. The qualitative part will explore longitudinally the experience of change in legal status at individual and family levels.Ethics and disseminationThis study was approved by the Ethics Committee of Geneva, Switzerland. All participants provided informed consent. Results will be shared with undocumented migrants and disseminated in scientific journals and conferences. Fully anonymised data will be available to researchers.

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Healthy Parent Carers programme: mixed methods process evaluation and refinement of a health promotion intervention

BMJ Open ◽

10.1136/bmjopen-2020-045570 ◽

2021 ◽

Vol 11 (8) ◽

pp. e045570

Author(s):

Jenny Lloyd ◽

Gretchen Bjornstad ◽

Aleksandra Borek ◽

Beth Cuffe-Fuller ◽

Mary Fredlund ◽

...

Keyword(s):

Mixed Methods ◽

Process Evaluation ◽

Qualitative Interviews ◽

Well Being ◽

Social Identification ◽

Feasibility Trial ◽

Special Educational Needs ◽

Registration Number ◽

Programme Content ◽

Problem Solve

ObjectivesParent carers of children with special educational needs or disability are at risk of poorer mental and physical health. In response to these needs, we codeveloped the ‘Healthy Parent Carers’ (HPC) programme. This study examined the views and experiences of participants in the HPC feasibility trial to inform programme refinement.Intervention, setting and participantsHPC is a peer-led group-based intervention (supported by online materials) for primary carers of disabled children, encouraging behaviours linked with health and well-being. It was delivered by two lead and six assistant peer facilitators in six community sites (one lead and one assistant per group) in South West England over six or 12 sessions. Control participants had online materials only. The trial involved 47 intervention and 45 control parent carers (97% female and 97% white) and eight facilitators (one male).DesignA preplanned mixed methods process evaluation using questionnaires and checklists (during and after the intervention), qualitative interviews with participants after intervention (n=18) and a focus group with facilitators after trial.ResultsHPC was highly acceptable to participants and facilitators and experiences were very positive. Participants reported that the programme increased awareness of what parent carers could and could not change and their self-efficacy to engage in health-promoting behaviours. The intended mechanisms of action (social identification and peer support) matched participants’ expectations and experiences. Control participants found the online-only programme flexible but isolating, as there were no opportunities to share ideas and problem solve with peers, the key function of the programme. Areas for improvement were identified for programme content, facilitator training and delivery.ConclusionHPC was acceptable, well received and offers considerable potential to improve the health of parent carers. Under the pandemic, the challenge going forward is how best to maintain reach and fidelity to function while delivering a more virtual programme.Trial registration numberISRCTN151144652.

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A Phase 1 Randomized Controlled Trial of an At-Home Positive Psychology Intervention for Individuals with Multiple Sclerosis

International Journal of MS Care ◽

10.7224/1537-2073.2020-020 ◽

2020 ◽

Author(s):

Melanie E. Freedman ◽

Brian C. Healy ◽

Jeff C. Huffman ◽

Tanuja Chitnis ◽

Howard L. Weiner ◽

...

Keyword(s):

Multiple Sclerosis ◽

Positive Psychology ◽

Controlled Trial ◽

Phase 1 ◽

Intervention Group ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Phone Calls ◽

At Home

Abstract Background: Positive psychology (PP) uses targeted activities to increase the frequency and intensity of positive feelings and may improve overall well-being in medically ill populations. In this pilot study, we examined the feasibility, acceptability and potential impact of a five-week, telephone-delivered, PP intervention for individuals with multiple sclerosis (MS). Methods: Participants were randomized 1:1 to a five-week at-home PP intervention or waitlist control condition. Participants engaged in weekly phone calls with a study trainer and completed one PP exercise, such as recalling a past success, each week. Feasibility was determined by the number of sessions completed, and acceptability was assessed by weekly post-exercise participant ratings (0–10) of ease and utility. Efficacy was explored by examining between-group differences in changes from baseline on psychological variables, health-related quality of life (HRQOL), and self-reported functional activities at five and ten weeks. Results: Thirty patients enrolled in the study. Ninety-three percent of participants (n = 28) completed all exercises. Ease scores ranged from 7.7–8.7 and utility scores ranged from 8.2–8.7. The PP intervention was associated with significantly greater increases (P < .05) in positive affect, optimism, state and trait anxiety, general health, and resilience in the intervention group compared to the control group. Approximately half of the PP participants maintained ≥ 50% of the improvement at 10 weeks. Conclusions: This five-week, telephone-based PP intervention was feasible and acceptable to individuals with MS. Larger randomized controlled trials are warranted to further investigate the utility of this intervention to improve well-being and other health outcomes in MS.

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Burnout among healthcare professionals during COVID-19 pandemic: a cross-sectional study

10.1101/2020.06.12.20129650 ◽

2020 ◽

Cited By ~ 3

Author(s):

Mohammad Jalili ◽

Mahtab Niroomand ◽

Fahimeh Hadavand ◽

Kataun Zeinali ◽

Akbar Fotouhi

Keyword(s):

Healthcare Workers ◽

Healthcare Professionals ◽

Well Being ◽

Personal Accomplishment ◽

Capital City ◽

Average Score ◽

Control Group ◽

Related Factors ◽

Cross Sectional ◽

Job Category

AbstractBackgroundThe unpredictable nature of the new COVID-19 pandemic and the already alarming incidence of healthcare workers being affected can have a significant impact on the psychological well-being of the staff.ObjectiveTo describe the prevalence of burnout among healthcare professionals and the associated factors.DesignCross-sectional survey.SettingEight university affiliated hospitals in the capital city of Tehran, Iran.ParticipantsAll healthcare workers at the study sites who had been taking care of COVID-19 patients.MeasurementsAge, gender, marital status, having children, hospital, job category, experience, and work load, as well as the level of burnout in each subscale.Results326 persons (53.0%) experienced high levels of burnout. The average score in emotional exhaustion, depersonalization and lack of personal accomplishment was 26.6, 10.2, and 27.3, respectively. The level of burnout in the three subscales varied based on the personal as well as work related factors and gender was the only variable that was associated with high levels of all three domains.LimitationsThere was no control group and thus we cannot claim a causal relationship between COVID-19 and the observed level of burnout. Not all confounding factors might have been accounted for.ConclusionsBurnout is prevalent among healthcare workers caring for COVID-19 patients. Age, gender, job category, and site of practice contribute to the level of burnout that the staff experience.Funding sourceNone

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Well-being programmes in prisons in England and Wales: a mixed-methods study

International Journal of Prisoner Health ◽

10.1108/ijph-03-2021-0021 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Mary Turner ◽

Nigel King ◽

Dara Mojtahedi ◽

Viv Burr ◽

Victoria Gall ◽

...

Keyword(s):

Mixed Methods ◽

Ad Hoc ◽

Phase 1 ◽

National Policy ◽

Well Being ◽

Phase 2 ◽

Prison Staff ◽

England And Wales ◽

Content Type ◽

Health And Well Being

Purpose In the past decade, there has been growing awareness of well-being and its importance and an increase in the development of activities or programmes aimed at improving well-being. The purpose of this study is to investigate what well-being programmes were being offered to prisoners in England and Wales and what benefits and other outcomes were experienced. Design/methodology/approach The study used a mixed-methods exploratory design in two phases. Phase 1 was a questionnaire survey of all adult prisons in England and Wales, completed by prison staff. In Phase 2, a sample of survey respondents took part in in-depth interviews. Findings The programmes identified in Phase 1 included physical activities, creative arts, mindfulness, horticulture, reading and animal-assisted activities. Prison staff reported a range of universally positive outcomes shared by all programmes, including enthusiasm from prisoners, enjoyment of the activities and being able to do something different from the usual prison routine. However, in Phase 2, interviewees rarely mentioned direct health and well-being benefits. The impetus for programmes was varied and there was little reference to national policy on health and well-being; this reflected the ad hoc way in which programmes are developed, with a key role being played by the Well-being Officer, where these were funded. Originality/value The literature on well-being programmes in prisons is limited and tends to focus on specific types of initiatives, often in a single prison. This study contributes by highlighting the range of activities across prisons and elucidating the perspectives of those involved in running such programmes.

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Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: Lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

10.21203/rs.2.10215/v1 ◽

2019 ◽

Author(s):

Arabella Scantlebury ◽

Sarah Cockayne ◽

Caroline Fairhurst ◽

Sara Rodgers ◽

David Torgerson ◽

...

Keyword(s):

Mixed Methods ◽

Hypothesis Testing ◽

Process Evaluation ◽

Group Analysis ◽

Falls Prevention ◽

Routine Practice ◽

Mixed Methods Approach ◽

Qualitative Process Evaluation ◽

Randomised Controlled ◽

Trial Participants

Abstract Background Ensuring fidelity to complex interventions is a challenge when conducting pragmatic randomised controlled trials. We explore fidelity through a qualitative process evaluation, which was conducted alongside a pragmatic, multi-centred, two-arm cohort randomised controlled trial – the REFORM (Reducing Falls with Orthoses and a Multifaceted podiatry intervention) trial. The paper aims, through a qualitative process evaluation, to explore some of the factors that may have affected the delivery of the REFORM intervention and highlight how project specific fidelity can be assessed using a truly mixed methods approach when informed by qualitative insights. Design Semi-structured qualitative interviews carried out as part of a process evaluation. Interviews were analysed thematically. Setting 7 NHS trusts in the UK and a University podiatry school in Ireland. Interviews were undertaken face-to-face or over the telephone. Participants 21 REFORM trial participants and 14 podiatrists who delivered the REFORM intervention Results Factors affecting fidelity included: how similar the intervention was to routine practice, challenges of delivering a multifaceted intervention to a heterogeneous older population, and practical issues with delivery such as time and training. Trial participants’ views of the intervention, whether falls prevention is a personal priority, their experience of being part of a trial, and individual factors such as medical conditions also may have affected intervention fidelity. Conclusions Our process evaluation highlighted factors that were perceived to have affected the fidelity of the REFORM intervention and in doing so demonstrates the importance of considering fidelity when designing and evaluating pragmatic trials. We propose a number of recommendations of how important project specific insights from qualitative work can be incorporated into the design of fidelity measurement of future trials, which build on existing conceptual fidelity frameworks. In particular, we encourage adopting a mixed methods approach whereby qualitative insights can be used to suggest ways to enhance quantitative data collection facilitating integration through hypothesis generation, hypothesis testing and seeking explanation for trial findings. This will provide a framework of enabling measures of fidelity to be incorporated into the understanding of trial results which has been relatively neglected by existing literature. Trial registration: ISRCTN68240461.

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