scholarly journals Protocol for a Feasibility study incorporating a Randomised Pilot Trial with an Embedded Process Evaluation and Feasibility Economic Analysis of ThinkCancer!: A primary care intervention to expedite cancer diagnosis in Wales

2020 ◽  
Author(s):  
Stefanie Disbeschl ◽  
Alun Surgey ◽  
Jessica L Roberts ◽  
Annie Hendry ◽  
Ruth Lewis ◽  
...  
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Economic Analysis ◽  
Process Evaluation ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Conversion Rates ◽  
Diagnosis Of Cancer ◽  
Embedded Process ◽  
Safety Netting

ABSTRACTBackgroundRelative to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more crucial due to the ongoing Covid-19 pandemic and its major impact on cancer referrals. The ThinkCancer! Workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan, and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the ThinkCancer! Intervention for a future definitive randomised controlled trial.MethodsThe ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect Primary Care Intervals (PCI), Two Week Wait (2WW) referral rates, conversion rates and detection rates at baseline and six months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation.DiscussionThis study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future design of a full-scale definitive phase III trial.Trial registratiointended registry: clinicaltrials.gov

scholarly journals Protocol for a feasibility study incorporating a randomised pilot trial with an embedded process evaluation and feasibility economic analysis of ThinkCancer!: a primary care intervention to expedite cancer diagnosis in Wales

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Stefanie Disbeschl ◽  
Alun Surgey ◽  
Jessica L. Roberts ◽  
Annie Hendry ◽  
Ruth Lewis ◽  
...  
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Economic Analysis ◽  
Process Evaluation ◽  
Phase Iii ◽  
Feasibility Trial ◽  
Conversion Rates ◽  
Diagnosis Of Cancer ◽  
Embedded Process ◽  
Safety Netting

Abstract Background Compared to the rest of Europe, the UK has relatively poor cancer outcomes, with late diagnosis and a slow referral process being major contributors. General practitioners (GPs) are often faced with patients presenting with a multitude of non-specific symptoms that could be cancer. Safety netting can be used to manage diagnostic uncertainty by ensuring patients with vague symptoms are appropriately monitored, which is now even more crucial due to the ongoing COVID-19 pandemic and its major impact on cancer referrals. The ThinkCancer! workshop is an educational behaviour change intervention aimed at the whole general practice team, designed to improve primary care approaches to ensure timely diagnosis of cancer. The workshop will consist of teaching and awareness sessions, the appointment of a Safety Netting Champion and the development of a bespoke Safety Netting Plan and has been adapted so it can be delivered remotely. This study aims to assess the feasibility of the ThinkCancer! intervention for a future definitive randomised controlled trial. Methods The ThinkCancer! study is a randomised, multisite feasibility trial, with an embedded process evaluation and feasibility economic analysis. Twenty-three to 30 general practices will be recruited across Wales, randomised in a ratio of 2:1 of intervention versus control who will follow usual care. The workshop will be delivered by a GP educator and will be adapted iteratively throughout the trial period. Baseline practice characteristics will be collected via questionnaire. We will also collect primary care intervals (PCI), 2-week wait (2WW) referral rates, conversion rates and detection rates at baseline and 6 months post-randomisation. Participant feedback, researcher reflections and economic costings will be collected following each workshop. A process evaluation will assess implementation using an adapted Normalisation Measure Development (NoMAD) questionnaire and qualitative interviews. An economic feasibility analysis will inform a future economic evaluation. Discussion This study will allow us to test and further develop a novel evidenced-based complex intervention aimed at general practice teams to expedite the diagnosis of cancer in primary care. The results from this study will inform the future design of a full-scale definitive phase III trial. Trial registration ClinicalTrials.gov NCT04823559.

scholarly journals Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Julie Stevens ◽  
Peter Pype ◽  
Kim Eecloo ◽  
Luc Deliens ◽  
Koen Pardon ◽  
...  
Keyword(s):  
General Practice ◽  
Process Evaluation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Phase Iii ◽  
Practice Setting ◽  
Randomized Controlled ◽  
Advance Care ◽  
Secondary Outcomes ◽  
Cluster Randomized

Abstract Background Advance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner. Ideally situated for this initiation is the general practitioner (GP). The intervention to improve the initiation of ACP for patients with a chronic life-limiting illness in general practice (ACP-GP) includes an ACP workbook for patients, ACP communication training for GPs, planned ACP conversations, and documentation of ACP conversation outcomes in a structured template. We present the study protocol of a Phase-III randomized controlled trial (RCT) of ACP-GP that aims to evaluate its effects on outcomes at the GP, patient, and surrogate decision maker (SDM) levels; and to assess the implementation process of the intervention. Methods This RCT will take place in Flanders, Belgium. Thirty-six GPs, 108 patients with a chronic, life-limiting illness, and their (potential) SDM will be recruited, then cluster-randomized to the ACP-GP intervention or the control condition. The primary outcome for GPs is ACP self-efficacy; primary outcome for patients is level of ACP engagement. Secondary outcomes for GPs are ACP practices, knowledge and attitudes; and documentation of ACP discussion outcomes. Secondary outcomes for patients are quality of life; anxiety; depression; appointment of an SDM; completion of new ACP documents; thinking about ACP; and communication with the GP. The secondary outcome for the SDM is level of engagement with ACP. A process evaluation will assess the recruitment and implementation of the intervention using the RE-AIM framework. Discussion While the general practice setting holds promise for timely initiation of ACP, there is a lack of randomized trial studies evaluating the effectiveness of ACP interventions implemented in this setting. After this Phase-III RCT, we will be able to present valuable evidence of the effects of this ACP-GP intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice. The results of the process evaluation will provide insight into what contributes to or detracts from implementation success, as well as how the intervention can be adapted to specific contexts or needs. Trial registration Prospectively registered at with ISRCTN (ISRCTN12995230); registered 19/06/2020.

scholarly journals Feasibility of a multifaceted implementation intervention to improve attendance at diabetic retinopathy screening in primary care in Ireland: a cluster randomised pilot trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e051951
Author(s):  
Fiona Riordan ◽  
Aileen Murphy ◽  
Christina Dillon ◽  
John Browne ◽  
Patricia M Kearney ◽  
...  
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Diabetic Retinopathy ◽  
Process Evaluation ◽  
Pilot Trial ◽  
Delivery Cost ◽  
Definitive Trial ◽  
Diabetic Retinopathy Screening ◽  
Cluster Randomised ◽  
Retinopathy Screening

ObjectivesDiabetic retinopathy screening (DRS) uptake is suboptimal in many countries with limited evidence available on interventions to enhance DRS uptake in primary care. We investigated the feasibility and preliminary effects of an intervention to improve uptake of Ireland’s national DRS programme, Diabetic RetinaScreen, among patients with type 1 or type 2 diabetes.Design/settingWe conducted a cluster randomised pilot trial, embedded process evaluation and cost analysis in general practice, July 2019 to January 2020.ParticipantsEight practices participated in the trial. For the process evaluation, surveys were conducted with 25 staff at intervention practices. Interviews were conducted with nine staff at intervention practices, and 10 patients who received the intervention.InterventionsThe intervention comprised practice reimbursement, an audit of attendance, electronic prompts targeting professionals, General Practice-endorsed patient reminders and a patient information leaflet. Practices were randomly allocated to intervention (n=4) or wait-list control (n=4) (usual care).OutcomesStaff and patient interviews explored their perspectives on the intervention. Patient registration and attendance, including intention to attend, were measured at baseline and 6 months. Microcosting was used to estimate intervention delivery cost.ResultsThe process evaluation identified that enablers of feasibility included practice culture and capacity to protect time, systems to organise care, and staff skills, and workarounds to improve intervention ‘fit’. At 6 months, 22/71 (31%) of baseline non-attenders in intervention practices subsequently attended screening compared with 15/87 (17%) in control practices. The total delivery cost across intervention practices (patients=363) was €2509, averaging €627 per practice and €6.91 per audited patient. Continuation criteria supported proceeding to a definitive trial.ConclusionsThe Improving Diabetes Eye screening Attendance intervention is feasible in primary care; however, consideration should be given to how best to facilitate local tailoring. A definitive trial of clinical and cost-effectiveness is required with preliminary results suggesting a positive effect on uptake.Trial registration numberNCT03901898.

Learning from the introduction of ‘skill-mix’ changes in general practice: a qualitative process evaluation

2018 ◽  
Vol 68 (suppl 1) ◽  
pp. bjgp18X696701
Author(s):  
Pauline Nelson ◽  
Anne-Marie Martindale ◽  
Anne McBride ◽  
Damian Hodgson
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Process Evaluation ◽  
Unintended Consequences ◽  
Active Management ◽  
Early Adopter ◽  
Snowball Sampling ◽  
Structured Interviews ◽  
Skill Mix ◽  
Qualitative Process Evaluation

Background‘Skill-mix’ change (changing mix of staff roles or introducing new ways of working) is increasingly promoted to relieve pressure in general practice teams. As part of a primary care workforce strategy, one locality in Greater Manchester is seeking to integrate three ‘non-medical’ roles – Advanced Practitioners (APs), Physician Associates (PAs) and Clinical Pharmacists (CPs) – to work alongside practice staff.AimA qualitative process evaluation studied the integration of these roles to: establish the aims and priorities of the new services; understand and compare the ways in which the roles are being established with identification of measurable impacts and unintended consequences.MethodA rapid scoping review of the primary care skill-mix literature was conducted to inform the evaluation. Purposive and ‘snowball’ sampling enabled semi-structured interviews (12) and focus groups (2) to be conducted with 27 key individuals (workforce/training leads for the new services; APs/PAs/CPs; GPs/practice managers), before being transcribed, anonymised and analysed thematically with a combination of a priori and grounded codes. Analysis of relevant service/training plans supplemented interview/focus group data.ResultsA number of organisational and operational factors affecting implementation success in early adopter sites were identified including: the intended scope and function of new roles with corresponding implications for measuring impacts; leadership/active management of workforce changes; appropriate training and education; inter-professional tensions; regulatory provisions, and sustainability.ConclusionThere is variation in how the three skill-mix initiatives are being implemented in early adopter sites, with implications for success. Key considerations for introducing skill-mix changes in general practice are being identified.

scholarly journals Cluster randomised feasibility trial to test the routine use of the Needs Assessment Tool: Cancer (NAT:-C) in primary care to reduce unmet patient and carer needs and determine the feasibility of a definitive trial

2019 ◽  
Vol 69 (suppl 1) ◽  
pp. bjgp19X702857
Author(s):  
Joseph Clark ◽  
Elvis Amoakwa ◽  
John Blenkinsopp ◽  
David Currow ◽  
Amanda Farrin ◽  
...  
Keyword(s):  
Primary Care ◽  
Focus Groups ◽  
Process Evaluation ◽  
Assessment Tool ◽  
Unmet Need ◽  
Cancer Registries ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Care Needs ◽  
Definitive Trial

BackgroundPeople with cancer commonly have unidentified palliative care needs. The NAT-C is a validated tool to identify and triage unmet needs.AimTo assess the feasibility and acceptability of a primary care cRCT of the NAT-C: 1) recruiting four GP-practices and 40–60 patients, 2) uptake of NAT-C, 3) questionnaire completion 4) acceptability of measures.MethodA non-blinded cRCT with process evaluation. Patients with active cancer were identified through cancer registries or opportunistically. Carers were nominated by patient-participant. Participants completed measures at baseline, 1, 3, and 6 months. Patients booked a 20-minute GP-assessment post-baseline. Patients, carers, and GP practice staff participated in interviews and focus groups.ResultsFive GP practices were approached, four recruited and trained in the use of the NAT-C. Practices were randomised (1:1) to provide a consultation with a known NAT-C trained clinician, or a clinician as usual. Forty-seven patients and 17 carers were recruited. Process evaluation informed refinement of study invitations. Recruitment rate showed a trial was feasible. Forty-three (94%) patients received a study appointment, 42/43 (95%) attended and 32/43 (76%) a NAT-guided consultation. The proposed primary outcome measure (Supportive Care Needs Survey) was completed by 43 (91%) at 1 month and the proportion with ≥1 moderate–severe unmet need fell from 72% (baseline) to 45%. Fifteen patient interviews and four focus groups with GP practices were conducted. Participants supported the definitive trial and found measures acceptable.ConclusionA definitive cRCT is feasible based on the recruitment rate, intervention uptake, and data collection.

scholarly journals General practice responses to opioid prescribing feedback: a qualitative process evaluation

2021 ◽  
pp. BJGP.2020.1117
Author(s):  
Su Wood ◽  
Robbie Foy ◽  
T. A. Willis ◽  
Paul Carder ◽  
Stella Johnson ◽  
...  
Keyword(s):  
Primary Care ◽  
General Practice ◽  
Process Evaluation ◽  
High Achievers ◽  
Normalisation Process Theory ◽  
Structured Interviews ◽  
Feedback Intervention ◽  
Practice Staff ◽  
Opioid Prescribing ◽  
Qualitative Process Evaluation

Background: The rise in opioid prescribing in primary care represents a significant public health challenge, associated with increased psychosocial problems, hospitalisations and mortality. We developed and implemented an evidence-based bi-monthly feedback intervention to reduce opioid prescribing targeting 316 general practices in West Yorkshire over one year. Aim: To understand how general practice staff received and responded to the feedback intervention. Design and Setting: Qualitative process evaluation involving semi-structured interviews, guided by Normalisation Process Theory (NPT), of primary care healthcare professionals targeted by feedback. Method: We purposively recruited participants according to baseline opioid prescribing levels and degree of change following feedback. Interview data were coded to NPT constructs, and thematically analysed. Results: We interviewed 21 staff from 20 practices. Reducing opioid prescribing was recognised as a priority. Whilst high achievers had clear structures for quality improvement, feedback encouraged some less structured practices to embed changes. The non-prescriptive nature of the feedback reports allowed practices to develop strategies consistent with their own ways of working and existing resources. Practice concerns were allayed by the credibility of the reports and positive experiences of reducing opioid prescribing. The scale, frequency and duration of feedback may have ensured a good overall level of practice population reach. Conclusion: The intervention engaged general practice staff in change by targeting an issue of emerging concern and allowing adaption to different ways of working. Practice efforts to reduce opioid prescribing were reinforced by regular feedback, credible comparative data showing progress, and shared experiences of patient benefit.

scholarly journals Optimising management of UTIs in primary care: a qualitative study of patient and GP perspectives to inform the development of an evidence-based, shared decision-making resource

2020 ◽  
Vol 70 (694) ◽  
pp. e330-e338 ◽  
Author(s):  
Donna M Lecky ◽  
Jessica Howdle ◽  
Christopher C Butler ◽  
Cliodna AM McNulty
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
General Practice ◽  
Shared Decision Making ◽  
Antibiotic Treatment ◽  
Self Care ◽  
Evidence Based ◽  
Shared Decision ◽  
Tract Infections ◽  
Safety Netting

BackgroundUrinary tract infections (UTIs) are one of the most common bacterial infections managed in general practice. Many women with symptoms of uncomplicated UTI may not benefit meaningfully from antibiotic treatment, but the evidence base is complex and there is no suitable shared decision-making resource to guide antibiotic treatment and symptomatic care for use in general practice consultations.AimTo develop an evidence-based, shared decision-making intervention leaflet to optimise management of uncomplicated UTI for women aged <65 years in the primary care setting.Design and settingQualitative telephone interviews with GPs and patient focus group interviews.MethodIn-depth interviews were conducted to explore how consultation discussions around diagnosis, antibiotic use, self-care, safety netting, and prevention of UTI could be improved. Interview schedules were based on the Theoretical Domains Framework.ResultsBarriers to an effective joint consultation and appropriate prescribing included: lack of GP time, misunderstanding of depth of knowledge and miscommunication between the patient and the GP, nature of the consults (such as telephone consultations), and a history of previous antibiotic therapy.ConclusionConsultation time pressures combined with late symptom presentation are a challenge for even the most experienced of GPs: however, it is clear that enhanced patient–clinician shared decision making is urgently required when it comes to UTIs. This communication should incorporate the provision of self-care, safety netting, and preventive advice to help guide patients when to consult. A shared decision-making information leaflet was iteratively co-produced with patients, clinicians, and researchers at Public Health England using study data.

scholarly journals Health providers’ experiences with mental health specialist video consultations in primary care: a qualitative study nested within a randomised feasibility trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e047829
Author(s):  
Markus W Haun ◽  
Mariell Hoffmann ◽  
Alina Wildenauer ◽  
Justus Tönnies ◽  
Michel Wensing ◽  
...  
Keyword(s):  
Mental Health ◽  
Primary Care ◽  
Process Evaluation ◽  
Mental Healthcare ◽  
Feasibility Trial ◽  
Health Providers ◽  
Therapeutic Alliances ◽  
Mental Health Specialist ◽  
Health Specialist ◽  
Qualitative Process Evaluation

ObjectiveDespite available effective treatments for mental health disorders, few patients in need receive even the most basic care. Integrated telepsychiatry services may be a viable option to increase access to mental healthcare. The aim of this qualitative process evaluation embedded in a randomised controlled feasibility trial was to explore health providers’ experiences with a mental healthcare model integrating mental health specialist video consultations (MHSVC) and primary care.MethodsA qualitative process evaluation focusing on MHSVC in primary care was conducted. In 13 semistructured interviews, we assessed the experience of all mental health specialists, primary care physicians and medical assistants who participated in the trial. A thematic analysis, focusing on the implementation, mechanisms of impact and context, was applied to investigate the data.ResultsConsidering (1) the implementation, participants evaluated the consultations as feasible, easy to use and time saving. Concerning (2) the mechanisms of impact, the consultations were regarded as effective for patients. Providers attributed the patients’ improvements to two key aspects: the familiarity of the primary care practice and the fast access to specialist mental healthcare. Mental health specialists observed trustful therapeutic alliances emerging and described their experience as comparable to same-room care. However, compared with same-room care, specialists perceived the video consultations as more challenging and sometimes more exhausting due to the additional effort required for establishing therapeutic alliances. Regarding (3) the intervention’s context, shorter travel distances for patients positively affected the implementation, while technical failures, that is, poor Internet connectivity, emerged as the main barrier.ConclusionsMHSVCs in primary care are feasible and successful in improving access to mental healthcare for patients. To optimise engagement and comfort of both patients and health providers, future work should focus on empirical determinants for establishing robust therapeutic alliances with patients receiving MHSVC (eg, leveraging non-verbal cues for therapeutic purposes).Trial registration numberDRKS00015812; Results.

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