scholarly journals Improving Primary Care After Stroke (IPCAS) randomised controlled trial: protocol for a multidimensional process evaluation

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036879
Author(s):  
Maria Raisa Jessica (Ryc) Aquino ◽  
Ricky Mullis ◽  
Elizabeth Kreit ◽  
Vicki Johnson ◽  
Julie Grant ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Semistructured Interviews ◽  
Self Reports ◽  
Randomised Controlled ◽  
Audio Video ◽  
Purposive Sample

IntroductionPrimary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.Methods and analysisMixed methods will be used: (1) design: intervention content will be compared with ‘usual care’; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.Ethics and disseminationFavourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.Trial registration numberNCT03353519; Pre-results.

scholarly journals Using mHealth for the management of hypertension in UK primary care: an embedded qualitative study of the TASMINH4 randomised controlled trial

2019 ◽  
Vol 69 (686) ◽  
pp. e612-e620 ◽  
Author(s):  
Sabrina Grant ◽  
James Hodgkinson ◽  
Claire Schwartz ◽  
Peter Bradburn ◽  
Marloes Franssen ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Home Monitoring ◽  
Data Communication ◽  
Free Text ◽  
Self Monitoring ◽  
Structured Care ◽  
Randomised Controlled

BackgroundSelf-monitoring of blood pressure is common but how telemonitoring with a mobile healthcare (mHealth) solution in the management of hypertension can be implemented by patients and healthcare professionals (HCPs) is currently unclear.AimEvaluation of facilitators and barriers to self- and telemonitoring interventions for hypertension within the Telemonitoring and Self-monitoring in Hypertension (TASMINH4) trial.Design and settingAn embedded process evaluation of the TASMINH4 randomised controlled trial (RCT), in the West Midlands, in UK primary care, conducted between March 2015 and September 2016.MethodA total of 40 participants comprising 23 patients were randomised to one of two arms: mHealth (self-monitoring by free text/short message service [SMS]) and self-monitoring without mHealth (self-monitoring using paper diaries). There were also15 healthcare professionals (HCPs) and two patient caregivers.ResultsFour key implementation priority areas concerned: acceptability of self- and telemonitoring to patients and HCPs; managing data; communication; and integrating self-monitoring into hypertension management (structured care). Structured home monitoring engaged and empowered patients to self-monitor regardless of the use of mHealth, whereas telemonitoring potentially facilitated more rapid communication between HCPs and patients. Paper-based recording integrated better into current workflows but required additional staff input.ConclusionAlthough telemonitoring by mHealth facilitates easier communication and convenience, the realities of current UK general practice meant that a paper-based approach to self-monitoring could be integrated into existing workflows with greater ease. Self-monitoring should be offered to all patients with hypertension. Telemonitoring appears to give additional benefits to practices over and above self-monitoring but both need to be offered to ensure generalisability.

scholarly journals Process evaluation of a randomised controlled trial of a pharmacological strategy to improve hypertension control: protocol for a qualitative study

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e022317 ◽  
Author(s):  
Abdul Salam ◽  
Ruth Webster ◽  
Anushka Patel ◽  
Pavithra Godamunne ◽  
Arunasalam Pathmeswaran ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Healthcare Professionals ◽  
Antihypertensive Drugs ◽  
Controlled Trial ◽  
Uncontrolled Hypertension ◽  
Hypertension Control ◽  
Framework Analysis ◽  
Middle Income ◽  
Randomised Controlled

IntroductionGlobally, the prevalence of uncontrolled hypertension is high, particularly in low- and middle-income countries. There is a critical need for strategies to improve hypertension control. The early use of a fixed low-dose combination of three antihypertensive drugs (triple pill) has the potential to significantly improve hypertension control. TheTRIple Pill vs.Usual careManagement forPatients with mild-to- moderateHypertension (TRIUMPH) randomised controlled trial (RCT) is designed to test the effects of this strategy compared with usual care in patients with mild-to-moderate hypertension. This paper reports the protocol of a process evaluation of the TRIUMPH RCT. The objectives are to understand factors related to implementation of the intervention, mechanisms of effect, contextual factors that underpin the effectiveness of the triple pill strategy and the potential barriers and facilitators to implementing the strategy in clinical practice.Methods and analysisFace-to-face semistructured in-depth interviews with a purposive sample of TRIUMPH RCT participants and healthcare professionals in Sri Lanka will be conducted. Healthcare professionals will include physicians and their staff who were involved in conducting the TRIUMPH RCT. Interviewees will be recruited sequentially until thematic saturation is achieved. Interviews will be audio recorded, transcribed verbatim and analysed in NVivo using framework analysis methods.Ethics and disseminationThe TRIUMPH RCT and process evaluation have received approval from the relevant Ethics Review Committee. All participants will be asked to provide written consent before participation. Findings from the study will be disseminated through publications and conference presentations.Trial registration numberACTRN12612001120864 , SLCTR/2015/020 ; Pre-results.

scholarly journals Protocol for a mixed methods process evaluation of the LinkMM randomised controlled trial “Use of link workers to provide social prescribing and health and social care coordination for people with complex multimorbidity in socially deprived areas”

2021 ◽  
Vol 4 ◽  
pp. 38
Author(s):  
Bridget Kiely ◽  
Patrick O'Donnell ◽  
Vivienne Byers ◽  
Emer Galvin ◽  
Fiona Boland ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Process Evaluation ◽  
Care Coordination ◽  
Social Care ◽  
Controlled Trial ◽  
Well Being ◽  
Social Prescribing ◽  
Health And Social Care ◽  
Randomised Controlled

Background Multimorbidity, defined as two or more chronic conditions is increasing in prevalence and is associated with increased health care use, fragmented care and poorer health outcomes. Link workers are non-health or social care professionals who support people to connect with resources in their community to improve their well-being, a process commonly referred to as social prescribing.  The use of link workers in primary care may be an effective intervention in helping those with long‐term conditions manage their illness and improve health and well‐being, but the evidence base in limited. The LinkMM study is a randomised controlled trial of the effectiveness of link workers based in primary care, providing social prescribing and health and social care coordination for people with multimorbidity. The aim of the LinkMM process evaluation is to investigate the implementation of the link worker intervention, mechanisms of impact and influence of the specific context on these, as per the Medical Research Council framework, using quantitative and qualitative methods. Methods Quantitative data will be gathered from a number of sources including researcher logbooks, participant baseline questionnaires, client management database, and will be analysed using descriptive statistics. Semi structured interviews with participants will investigate their experiences of the intervention. Interviews with link workers, practices and community stakeholders will explore how the intervention was implemented and barriers and facilitators to this. Thematic analysis of interview transcripts will be conducted. Discussion The process evaluation of the LinkMM trial will provide important information allowing a more in-depth understanding of how the intervention worked and lessons for future wider scale implementation.

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