scholarly journals A Process Evaluation of ‘We Can Quit’: a Community-Based Smoking Cessation Intervention Targeting Women From Areas of Socio-Disadvantage in Ireland

2021 ◽  
Author(s):  
Catherine D Darker ◽  
Emma Burke ◽  
Stefania Castello ◽  
Karin O’Sullivan ◽  
Nicola O’Connell ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Community Pharmacists ◽  
Cluster Randomised Controlled Trial ◽  
Evaluation Framework ◽  
Structured Interviews ◽  
Low Literacy ◽  
Fidelity Assessment ◽  
Additional Support

Abstract Background: Smoking poses a serious risk of early preventable death and disease especially for women living with socio-economic disadvantage (SED). A smoking cessation programme ‘We Can Quit’ was developed in Ireland tailored to SED women. The programme includes group-based support delivered by trained lay local women and free nicotine replacement therapy (NRT). The intervention was pilot tested in a cluster randomised controlled trial, ‘We Can Quit 2’. A process evaluation assessed feasibility and acceptability of the programme and trial processes.Methods: Embedded qualitative design using the Medical Research Council’s (MRC) process evaluation framework. Semi-structured interviews with trial participants (N=18) and programme deliverers, the community facilitators (CFs; N=8). Thematic analysis was used for interview transcripts.Results: Results focused on programme and trial operational factors. Peer-modelling, a non-judgemental environment, and CFs supportive role of group support were viewed as facilitative. Potential for broader message diffusion into the social networks of participating women was observed. Free NRT was helpful for cessation. Some participants expressed concerns about NRT side effects. Community pharmacists provided guidance relating to NRT and additional support between programme meetings. Provision of saliva samples proved challenging. Low literacy was a barrier for engagement with programme and trial-related materials. Hypothetical scenarios of direct or indirect observational fidelity assessment for a future definitive trial (DT) were acceptable. Conclusions: The We Can Quit intervention and trial-related processes were feasible and acceptable to participants and Community Facilitators. Any future DT will need to address low literacy.Trial registration: Controlled trials ISRCTN74721694.

scholarly journals Process evaluation for the Care Homes Independent Pharmacist Prescriber Study (CHIPPS)

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Linda Birt ◽  
Lindsay Dalgarno ◽  
David J Wright ◽  
Mohammed Alharthi ◽  
Jackie Inch ◽  
...  
Keyword(s):  
Process Evaluation ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Care Home ◽  
Cluster Randomised Controlled Trial ◽  
Care Homes ◽  
Structured Interviews ◽  
Medicines Management ◽  
Care Home Staff ◽  
Care Plans

Abstract Background Medicines management in care homes requires significant improvement. CHIPPS was a cluster randomised controlled trial to determine the effectiveness of integrating pharmacist independent prescribers into care homes to assume central responsibility for medicines management. This paper reports the parallel mixed-methods process evaluation. Method Intervention arm consisted of 25 triads: Care homes (staff and up to 24 residents), General Practitioner (GP) and Pharmacist Independent Prescriber (PIP). Data sources were pharmaceutical care plans (PCPs), pharmacist activity logs, online questionnaires and semi-structured interviews. Quantitative data were analysed descriptively. Qualitative data were analysed thematically. Results were mapped to the process evaluation objectives following the Medical Research Council framework. Results PCPs and activity logs were available from 22 PIPs. Questionnaires were returned by 16 PIPs, eight GPs, and two care home managers. Interviews were completed with 14 PIPs, eight GPs, nine care home managers, six care home staff, and one resident. All stakeholders reported some benefits from PIPs having responsibility for medicine management and identified no safety concerns. PIPs reported an increase in their knowledge and identified the value of having time to engage with care home staff and residents during reviews. The research paperwork was identified as least useful by many PIPs. PIPs conducted medication reviews on residents, recording 566 clinical interventions, many involving deprescribing; 93.8% of changes were sustained at 6 months. For 284 (50.2%) residents a medicine was stopped, and for a quarter of residents, changes involved a medicine linked to increased falls risk. Qualitative data indicated participants noted increased medication safety and improved resident quality of life. Contextual barriers to implementation were apparent in the few triads where PIP was not known previously to the GP and care home before the trial. In three triads, PIPs did not deliver the intervention. Conclusions The intervention was generally implemented as intended, and well-received by most stakeholders. Whilst there was widespread deprescribing, contextual factors effected opportunity for PIP engagement in care homes. Implementation was most effective when communication pathways between PIP and GP had been previously well-established. Trial registration The definitive RCT was registered with the ISRCTN registry (registration number ISRCTN 17847169).

scholarly journals Implementation of a complex intervention to improve hospital discharge: process evaluation of a cluster randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e049872
Author(s):  
Yael Rachamin ◽  
Thomas Grischott ◽  
Stefan Neuner-Jehle
Keyword(s):  
Hospital Discharge ◽  
Process Evaluation ◽  
Medication Review ◽  
Controlled Trial ◽  
Implementation Fidelity ◽  
Cluster Randomised Controlled Trial ◽  
Evaluation Framework ◽  
Discharge Process ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesTo study the implementation of a cluster randomised controlled effectiveness-implementation hybrid trial testing the effectiveness of a medication review at hospital discharge combined with a communication stimulus between hospital physicians (HPs) and general practitioners (GPs) on rehospitalisation of multimorbid older patients.DesignExtension of Grant’s mixed method process evaluation framework to trials with multilevel clustering.SettingGeneral internal medicine wards in Swiss hospitals.ParticipantsConvenience samples of 15 chief physicians (of 21 hospitals participating in the effectiveness trial), 60 (74) senior HPs, 65 (164) junior HPs and 187 (411) GPs.Implementation strategyTwo-hour teaching sessions for senior HPs on a patient-centred, checklist-guided discharge routine.Process evaluation componentsData collection on recruitment, delivery and response from chief physicians (semistructured interviews), senior HPs, junior HPs, GPs (surveys) and patients (via HPs). Quantitative data were summarised using descriptive statistics, and interviews analysed using thematic analysis.Outcome measuresIntervention dose (quantitative), implementation fidelity (qualitative), feasibility and acceptability, facilitators and barriers, implementation support strategies.ResultsRecruitment of hospitals was laborious but successful, with 21 hospitals recruited. Minimal workload and a perceived benefit for the clinic were crucial factors for participation. Intervention dose was high (95% of checklist activities carried out), but intervention fidelity was limited (discharge letters) or unknown (medication review). Recruitment and retention of patients was challenging, partly due to patient characteristics (old, frail) and the COVID-19 pandemic: Only 612 of the anticipated 2100 patients were recruited, and 31% were lost to follow-up within the first month after discharge. The intervention was deemed feasible and helpful by HPs, and the relevance of the topic appreciated by both HPs and GPs.ConclusionsThe results from this evaluation will support interpretation of the findings of the effectiveness study and may inform researchers and policy makers who aim at improving hospital discharge.Trial registration numberISRCTN18427377.

scholarly journals Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e038351
Author(s):  
Xue Weng ◽  
Man Ping Wang ◽  
Ho Cheung William Li ◽  
Yee Tak Derek Cheung ◽  
Ching Yin Lau ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Hong Kong ◽  
Randomised Controlled Trial ◽  
Financial Incentive ◽  
Controlled Trial ◽  
Reduction Rate ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised ◽  
Smoking Cessation Services ◽  
Randomised Controlled

IntroductionEvidence-based smoking cessation treatments are effective but underutilised, accentuating the need for novel approaches to increase use. This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.Methods and analysisThis ongoing study is a two-arm, assessor-blinded, pragmatic, cluster randomised controlled trial with follow‐ups at 1, 2, 3 and 6 months after randomisation. We aim to enrol 1134 daily smokers from 70 community sites (clusters) in Hong Kong. All participants receive Ask, Warn, Advise, Refer, Do-it-again (AWARD) guided advice and a self-help booklet at baseline. Additionally, participants in the intervention group receive an offer of referral to smoking cessation services at baseline and a small financial incentive (HK$300≈US$38) contingent on using any of such services within 3 months. The primary outcomes are bioverified abstinence (exhaled carbon monoxide <4 ppm and salivary cotinine <10 ng/mL) at 3 and 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, quit attempts and the use of smoking cessation services at 3 and 6 months. Intention-to-treat approach and regression models will be used in primary analyses.Ethics and disseminationThis protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-318). The results of this trial will be submitted for publication in peer-reviewed journals, and the key findings will be presented at national and international conferences.Trial registration numberClinicalTrials.gov Registry NCT03565796.

Pharmacists in general practice: a qualitative process evaluation of the General Practice Pharmacist (GPP) study

2020 ◽  
Vol 37 (5) ◽  
pp. 711-718
Author(s):  
Oscar James ◽  
Karen Cardwell ◽  
Frank Moriarty ◽  
Susan M Smith ◽  
Barbara Clyne
Keyword(s):  
General Practice ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Qualitative Approach ◽  
Structured Interviews ◽  
Practice Staff ◽  
Practice Nurses ◽  
Practice Team ◽  
Prescribing Quality ◽  
Descriptive Qualitative

Abstract Background There is some evidence to suggest that pharmacists integrated into primary care improves patient outcomes and prescribing quality. Despite this growing evidence, there is a lack of detail about the context of the role. Objective To explore the implementation of The General Practice Pharmacist (GPP) intervention (pharmacists integrating into general practice within a non-randomized pilot study in Ireland), the experiences of study participants and lessons for future implementation. Design and setting Process evaluation with a descriptive qualitative approach conducted in four purposively selected GP practices. Methods A process evaluation with a descriptive qualitative approach was conducted in four purposively selected GP practices. Semi-structured interviews were conducted, transcribed verbatim and analysed using a thematic analysis. Results Twenty-three participants (three pharmacists, four GPs, four patients, four practice nurses, four practice managers and four practice administrators) were interviewed. Themes reported include day-to-day practicalities (incorporating location and space, systems and procedures and pharmacists’ tasks), relationships and communication (incorporating GP/pharmacist mode of communication, mutual trust and respect, relationship with other practice staff and with patients) and role perception (incorporating shared goals, professional rewards, scope of practice and logistics). Conclusions Pharmacists working within the general practice team have potential to improve prescribing quality. This process evaluation found that a pharmacist joining the general practice team was well accepted by the GP and practice staff and effective interprofessional relationships were described. Patients were less clear of the overall benefits. Important barriers (such as funding, infrastructure and workload) and facilitators (such as teamwork and integration) to the intervention were identified which will be incorporated into a pilot cluster randomized controlled trial.

scholarly journals A cluster RCT and process evaluation evaluating the effectiveness of an optimisation intervention to promote parental engagement in a childhood obesity prevention programme: Results of the Optimising Family Engagement in HENRY (OFTEN) trial

2021 ◽  
Author(s):  
Maria Bryant ◽  
Wendy Burton ◽  
Michelle Collinson ◽  
Amanda Farrin ◽  
Jane Nixon ◽  
...  
Keyword(s):  
Childhood Obesity ◽  
Process Evaluation ◽  
Obesity Prevention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Parental Engagement ◽  
Childhood Obesity Prevention ◽  
Prevention Intervention ◽  
The Impact ◽  
Children’S Centres

Abstract Background Low parental participation reduces the impact and sustainability of public health childhood obesity prevention programmes. Using data from a focused ethnography, we developed a multi-level, theory-based implementation optimisation intervention. The optimisation intervention aimed to support local authorities and children’s centres to adopt behaviours to promote engagement in ‘HENRY (Health Exercise Nutrition for the Really Young)’, a UK community obesity prevention intervention. Methods We evaluated the effectiveness of the optimisation intervention on programme enrolment and completion over a 12 implementation period in a cluster randomised controlled trial. We randomised 20 local government authorities (with 126 children’s centres) to HENRY plus the optimisation intervention or to HENRY alone. Primary outcomes were (1) the proportion of centres enrolling at least eight parents per programme and (2) the proportion of centres with a minimum of 75% of parents attending at least five of eight sessions per programme. Trial analyses adjusted for stratification factors (pre-randomisation implementation of HENRY, local authority size, deprivation) and allowed for cluster design. A parallel mixed-methods process evaluation used qualitative interview data and routine monitoring to explain trial results. Results Neither primary outcome differed significantly between groups; 17.8% of intervention centres and 18.0% of control centres achieved the parent enrolment target (adjusted difference -1.2%; 95%CI: -19.5%, 17.1%); 17.1% of intervention centres and 13.9% of control centres achieved the attendance target (adjusted difference 1.2%; 95%CI: -15.7%, 18.1%). Unexpectedly, the trial coincided with substantial national service restructuring, including centre closures and reduced funds. Some commissioning and management teams stopped or reduced implementation of both HENRY and the optimisation intervention due to competing demands. Thus, at follow up, HENRY programmes were delivered to approximately half the number of parents compared to baseline (n=433 vs. 881). Conclusions During a period in which services were reduced by policies outside the realm of this research, this first definitive trial found no evidence of effectiveness for an implementation optimisation intervention promoting parent engagement in an obesity prevention intervention. Trial registration: ClinicalTrials.gov Identifier: NCT02675699 registered 4th February 2016. https://clinicaltrials.gov/ct2/show/NCT02675699

scholarly journals Care to Quit: A stepped wedge cluster randomised controlled trial to implement best practice smoking cessation care in cancer centres

2021 ◽  
Author(s):  
Christine L Paul ◽  
Graham Warren ◽  
Shalini Vinod ◽  
Bettina Meiser ◽  
Emily Stone ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Best Practice ◽  
Controlled Trial ◽  
Critical Mass ◽  
Performance Status ◽  
Theoretical Domains Framework ◽  
Cluster Randomised Controlled Trial ◽  
Stepped Wedge ◽  
Treatment As Usual ◽  
Patients With Cancer

Abstract Background Cigarette smoking in people with cancer is associated with negative treatment related outcomes including increased treatment toxicity and complications, medication side effects, decreased performance status and morbidity. Evidence based smoking cessation care is not routinely provided to patients with cancer. The purpose of this study is to determine the effectiveness of a smoking cessation implementation intervention on abstinence from smoking in people diagnosed with cancer.Methods A stepped wedge cluster randomized design will be used. All sites begin in the control condition providing treatment as usual. In a randomly generated order, sites will move to the intervention condition. Based on the Theoretical Domains Framework, implementation of Care to Quit will include i) building the capability and motivation of a critical mass of key clinical staff and identifying champions; and ii) identifying and implementing cessation care models/pathways. 2160 patients with cancer (diagnosed in the prior six months), aged 18+, who report recent combustible tobacco use (past 90 days or in the 30 days prior to cancer diagnosis) and are accessing anti-cancer therapy, will be recruited at nine sites. Assessments will be conducted at baseline and 7-month follow-up. The primary outcome will be 6-month abstinence from smoking. Secondary outcomes include biochemical verification of abstinence from smoking, duration of quit attempts, tobacco consumption, nicotine dependence, variables, provision and receipt of smoking cessation care, mental health and quality of life and cost effectiveness of the intervention.Discussion This study will implement best practice smoking cessation care in cancer centres and has the potential for wide dissemination.Trial registration The trial is registered with ANZCTR (www.anzctr.org.au): ACTRN (submitted, awaiting approval due to ANZCTR delays) prior to the accrual of the first participant and will be updated regularly as per registry guidelines.

scholarly journals How feasible are lifestyle modification programs for disease prevention in general practice?

2012 ◽  
Vol 18 (2) ◽  
pp. 129 ◽  
Author(s):  
Heike Schütze ◽  
Elizabeth F. Rix ◽  
Rachel A. Laws ◽  
Megan Passey ◽  
Mahnaz Fanaian ◽  
...  
Keyword(s):  
General Practice ◽  
Vascular Disease ◽  
Lifestyle Modification ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Lifestyle Changes ◽  
Health Providers ◽  
Structured Interviews ◽  
Lifestyle Modification Program

Vascular disease is a leading cause of death and disability. While it is preventable, little is known about the feasibility or acceptability of implementing interventions to prevent vascular disease in Australian primary health care. We conducted a cluster randomised controlled trial assessing prevention of vascular disease in patients aged 40–65 by providing a lifestyle modification program in general practice. Interviews with 13 general practices in the intervention arm of this trial examined their views on implementing the lifestyle modification program in general practice settings. Qualitative study, involving thematic analysis of semi-structured interviews with 11 general practitioners, four practice nurses and five allied health providers between October 2009 and April 2010. Providing brief lifestyle intervention fitted well with routine health-check consultations; however, acceptance and referral to the program was dependent on the level of facilitation provided by program coordinators. Respondents reported that patients engaged with the advice and strategies provided in the program, which helped them make lifestyle changes. Practice nurse involvement was important to sustaining implementation in general practice, while the lack of referral services for people at risk of developing vascular disease threatens maintenance of lifestyle changes as few respondents thought patients would continue lifestyle changes without long-term follow up. Lifestyle modification programs to prevent vascular disease are feasible in general practice but must be provided in a flexible format, such as being offered out of hours to facilitate uptake, with ongoing support and follow up to assist maintenance. The newly formed Medicare Locals may have an important role in facilitating lifestyle modification programs for this target group.

Sign in / Sign up

Export Citation Format

Share Document