Pregnant Women’s Experiences and Views on an “Opt-Out” Referral Pathway to Specialist Smoking Cessation Support: A Qualitative Evaluation

Introduction: Smoking in pregnancy remains an important and costly public health concern with policy makers worldwide researching methods to aid cessation. UK government guidelines recommend implementation of an ‘opt-out’ (i.e. whether requested or not) referral pathway for pregnant smokers to specialist smoking cessation support using carbon monoxide (CO) screening. This study explores the views of pregnant smokers who experienced this new pathway in one UK hospital trust. Methods Eighteen semi-structured telephone interviews with women who experienced the ‘opt-out’ pathway were undertaken. Data were analysed thematically. Results Three themes were identified relating to expectations, acceptability and impact of the pathway. Women were generally very accepting of the CO testing especially when it met their prior expectations and was perceived as being a routine component of antenatal care. They considered the visual feedback from the CO monitoring improved their motivation to quit. Views on the automatic referral for cessation support were divided with questions raised as to the removal of choice, with many women also expressing dissatisfaction about perceived lack of contact by Stop Smoking Services (SSS) following referral. Conclusion The ‘opt-out’ pathway is potentially an acceptable addition to current practice. The women considered CO monitoring to be the most valuable element of the pathway. Women keen to engage with SSS desired a more efficient system of contact.This article presents independent research funded by the National Institute for Health Research (NIHR) under the Programme Grants for Applied Research programme (RP-PG-0109-10020). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.This is the author accepted manuscript. The final version is available from Oxford University Press via http://dx.doi.org/10.1093/ntr/ntv27

Pregnant women’s experiences and views on an “opt-out” referral pathway to specialist smoking cessation support: a qualitative evaluation

Introduction: Smoking in pregnancy remains an important and costly public health concern with policy makers worldwide researching methods to aid cessation. UK government guidelines recommend implementation of an “opt-out” (ie, whether requested or not) referral pathway for pregnant smokers to specialist smoking cessation support using carbon monoxide (CO) screening. This study explores the views of pregnant smokers who experienced this new pathway in one UK hospital trust. Methods: Eighteen semi-structured telephone interviews with women who experienced the opt-out pathway were undertaken. Data were analyzed thematically. Results: Three themes were identified relating to expectations, acceptability and impact of the pathway. Women were generally very accepting of the CO testing especially when it met their prior expectations and was perceived as being a routine component of antenatal care. They considered the visual feedback from the CO monitoring improved their motivation to quit. Views on the automatic referral for cessation support were divided with questions raised as to the removal of choice, with many women also expressing dissatisfaction about perceived lack of contact by Stop Smoking Services (SSS) following referral. Conclusion: The opt-out pathway is potentially an acceptable addition to current practice. The women considered CO monitoring to be the most valuable element of the pathway. Women keen to engage with SSS desired a more efficient system of contact. Implications: This study presents a unique insight into pregnant women’s views on the implementation of opt-out referrals for smoking cessation. Introducing CO testing and opt-out referrals at the time of antenatal ultrasound examination can potentially increase motivation to stop smoking in pregnancy. The findings demonstrate that facilitating access to SSS was not always achieved, and further refinement is needed to ensure more effective contact procedures. Ensuring all women are fully informed prior to the CO testing may further improve both the impact of the opt-out referral pathway and the chance of successfully engaging with SSS

Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial.

BACKGROUND: Breathlessness is common in advanced cancer. The Breathlessness Intervention Service (BIS) is a multi-disciplinary complex intervention theoretically underpinned by a palliative care approach, utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease. We sought to establish whether BIS was more effective, and cost-effective, for patients with advanced cancer and their carers than standard care. METHODS: A single-centre Phase III fast-track single-blind mixed-method randomised controlled trial (RCT) of BIS versus standard care was conducted. Participants were randomised to one of two groups (randomly permuted blocks). A total of 67 patients referred to BIS were randomised (intervention arm n = 35; control arm n = 32 received BIS after a two-week wait); 54 completed to the key outcome measurement. The primary outcome measure was a 0 to 10 numerical rating scale for patient distress due to breathlessness at two-weeks. Secondary outcomes were evaluated using the Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Services Receipt Inventory, EQ-5D and topic-guided interviews. RESULTS: BIS reduced patient distress due to breathlessness (primary outcome: -1.29; 95% CI -2.57 to -0.005; P = 0.049) significantly more than the control group; 94% of respondents reported a positive impact (51/53). BIS reduced fear and worry, and increased confidence in managing breathlessness. Patients and carers consistently identified specific and repeatable aspects of the BIS model and interventions that helped. How interventions were delivered was important. BIS legitimised breathlessness and increased knowledge whilst making patients and carers feel 'not alone'. BIS had a 66% likelihood of better outcomes in terms of reduced distress due to breathlessness at lower health/social care costs than standard care (81% with informal care costs included). CONCLUSIONS: BIS appears to be more effective and cost-effective in advanced cancer than standard care. TRIAL REGISTRATION: RCT registration at ClinicalTrials.gov NCT00678405 (May 2008) and Current Controlled Trials ISRCTN04119516 (December 2008).The study was supported by the following funders: NIHR Research for Patient Benefit (for Phase III RCT funding); Macmillan Cancer Support (MF’s post-doctoral fellowship); The Gatsby Foundation for the initial funding of BIS; and AT Prevost was supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. The study sponsor was CUHNFT.This is the final published version. It first appeared at http://www.biomedcentral.com/1741-7015/12/194

Pregnant women’s experiences and views on an “opt-out” referral pathway to specialist smoking cessation support: a qualitative evaluation

Introduction: Smoking in pregnancy remains an important and costly public health concern with policy makers worldwide researching methods to aid cessation. UK government guidelines recommend implementation of an “opt-out” (ie, whether requested or not) referral pathway for pregnant smokers to specialist smoking cessation support using carbon monoxide (CO) screening. This study explores the views of pregnant smokers who experienced this new pathway in one UK hospital trust. Methods: Eighteen semi-structured telephone interviews with women who experienced the opt-out pathway were undertaken. Data were analyzed thematically. Results: Three themes were identified relating to expectations, acceptability and impact of the pathway. Women were generally very accepting of the CO testing especially when it met their prior expectations and was perceived as being a routine component of antenatal care. They considered the visual feedback from the CO monitoring improved their motivation to quit. Views on the automatic referral for cessation support were divided with questions raised as to the removal of choice, with many women also expressing dissatisfaction about perceived lack of contact by Stop Smoking Services (SSS) following referral. Conclusion: The opt-out pathway is potentially an acceptable addition to current practice. The women considered CO monitoring to be the most valuable element of the pathway. Women keen to engage with SSS desired a more efficient system of contact. Implications: This study presents a unique insight into pregnant women’s views on the implementation of opt-out referrals for smoking cessation. Introducing CO testing and opt-out referrals at the time of antenatal ultrasound examination can potentially increase motivation to stop smoking in pregnancy. The findings demonstrate that facilitating access to SSS was not always achieved, and further refinement is needed to ensure more effective contact procedures. Ensuring all women are fully informed prior to the CO testing may further improve both the impact of the opt-out referral pathway and the chance of successfully engaging with SSS

The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial.

BACKGROUND: Breathlessness is the most common and intrusive symptom of advanced non-malignant respiratory and cardiac conditions. The Breathlessness Intervention Service (BIS) is a multi-disciplinary complex intervention, theoretically underpinned by a palliative care approach, utilising evidence-based non-pharmacological and pharmacological interventions to support patients with advanced disease in managing their breathlessness. Having published the effectiveness and cost effectiveness of BIS for patients with advanced cancer and their carers, we sought to establish its effectiveness, and cost effectiveness, in advanced non-malignant conditions. METHODS: This was a single-centre Phase III fast-track single-blind mixed method RCT of BIS versus standard care for breathless patients with non-malignant conditions and their carers. Randomisation was to one of two groups (randomly permuted blocks). Eighty-seven patients referred to BIS were randomised (intervention arm n = 44; control arm n = 43 received BIS after four-week wait); 79 (91 %) completed to key outcome measurement. The primary outcome measure was 0-10 numeric rating scale for patient distress due to breathlessness at four weeks. Secondary outcome measures were Chronic Respiratory Questionnaire, Hospital Anxiety and Depression Scale, Client Service Receipt Inventory, EQ-5D and topic-guided interviews. RESULTS: Qualitative analyses showed the positive impact of BIS on patients with non-malignant conditions and their carers; quantitative analyses showed a non-significant greater reduction in the primary outcome ('distress due to breathlessness'), when compared to standard care, of -0.24 (95 % CI: -1.30, 0.82). BIS resulted in extra mean costs of £799, reducing to £100 when outliers were excluded; neither difference was statistically significant. The quantitative findings contrasted with those previously reported for patients with cancer and their carers, which showed BIS to be both clinically and cost effective. For patients with non-malignant conditions there was a notable trend of improvement over both trial arms to the key measurement point; participants may have experienced a therapeutic effect from the research interviews, diluting the intervention's impact. CONCLUSIONS: BIS had a statistically non-significant effect for patients with non-malignant conditions, and slightly increased service costs, but had a qualitatively positive impact consistent with findings for advanced cancer. Trials of palliative care interventions should consider multiple, mixed method, primary outcomes and ensure that protocols limit potential contaminating therapeutic effects in study designs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN04119516 (December 2008); ClinicalTrials.gov NCT00678405 (May 2008).MF, ATP, PM, BBP, AB, IJH, CJT, SB had support from NIHR (Research for Patient Benefit grant) for the submitted work; MF had support from Macmillan Cancer Support (Post-Doctoral Fellowship) for the submitted work; IJH had support from Cicely Saunders International; SB had support from Macmillan Cancer Support (funded online learning module connected to BIS), the Gatsby Foundation (funded the pilot BIS and its evaluation), and a capacity building grant from NIH