A Lay Health Worker Intervention to Increase Uptake and Completion of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease: Assessing Fidelity of Intervention Delivery

“This is an Accepted Manuscript of an article published by Taylor & Francis Group in COPD: Journal of Chronic Obstructive Pulmonary Disease on 17 Aug 2020, available online: https://doi.org/10.1080/15412555.2020.1797658

The lay health worker-patient relationship in promoting pulmonary rehabilitation (PR) in COPD: What makes it work?

Lay health workers (LHWs) can improve access to services and adherence to treatment, as well as promoting self-care and prevention. Their effect in promoting uptake and adherence in pulmonary rehabilitation (PR) for chronic obstructive pulmonary disease (COPD) has not been tested. PR is the most effective treatment for the symptoms and disability of COPD, but this effectiveness is undermined by poor rates of completion. Trained LHWs with COPD, who also have first-hand experience of PR, are well placed to help overcome the documented barriers to its completion. The relationship between LHWs and patients may be one of the keys to their effectiveness but it has been little explored. Semi-structured qualitative interviews were used with the aim of examining the LHW-patient partnership in a feasibility study of trained PR-experienced LHWs used to support COPD patients referred to PR. Twelve volunteers with COPD who completed LHW training supported 66 patients referred for PR. All 12 of these LHWs gave end-of-study interviews, 21 COPD patients supported by LHWs were also interviewed. Patients reported that the LHWs were keen to share their experiences of PR, and that this had a positive impact. The enthusiasm of the LHWs for PR was striking. The common bond between LHWs and patients of having COPD together with the LHWs positive, first-hand experience of PR were dominant and recurring themes in their relationship.This article presents independent research funded by the NIHR under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG0214-30052). SL receives additional funding from the South African Medical Research Council. SJCT was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart’s Health NHS Trust

The Improve Trial: Study Protocol for a Pragmatic Cluster Randomised Controlled Trial to Assess the Effectiveness of Using Lay Health Workers to Improve Uptake and Completion of Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease

Background Pulmonary rehabilitation (PR) is a programme of exercise and education and the most effective treatment for the symptoms and disability associated with chronic obstructive pulmonary disease. However, the benefits of PR are limited by poor uptake and completion. This trial will determine whether using trained volunteer lay health workers, called “PR buddies,” improves uptake and completion of PR and is cost-effective. This trial protocol outlines the methods for evaluating effectiveness, cost-effectiveness, and acceptability. Methods The IMPROVE trial is a pragmatic, open, cluster randomised controlled trial planned in 38 PR services across England and Wales. PR services will be randomised to either intervention arm—offering support from PR buddies to patients with chronic obstructive pulmonary disease—or to usual care as the control arm. PR staff in trial sites randomised to the intervention arm will receive training in recruiting and training PR buddies. They will deliver training to volunteers, recruited from among people who have recently completed PR in their service. The 3-day PR-buddy training programme covers communication skills, confidentiality, boundaries of the PR-buddy role and behaviour change techniques to help patients overcome obstacles to attending PR. An internal pilot will test the implementation of the trial in eight sites (four intervention sites and four in control arm). The primary outcome of the trial is the uptake and completion of PR. A process evaluation will investigate the acceptability of the intervention to patients, PR staff and the volunteer PR buddies, and intervention fidelity. We will also conduct a cost-effectiveness analysis. Discussion Improving outcomes for chronic obstructive pulmonary disease and access to PR are priorities for the UK National Health Service (NHS) in its long-term plan. The trial hypothesis is that volunteer PR buddies, who are recruited and trained by local PR teams, are an effective and cost-effective way to improve the uptake and completion rates of PR. The trial is pragmatic, since it will test whether the intervention can be incorporated into NHS PR services. Information obtained in this trial may be used to influence policy on the use of PR buddies in PR and other similar services in the NHS

Understanding physician behaviour in the 6-8 weeks hip check in primary care:A qualitative study using the COM-B

Objectives A compulsory hip check is performed on an infant at 6–8 weeks in primary care for the detection of developmental dysplasia of the hip (DDH). Missed diagnoses and infants incorrectly labelled with DDH remain an important problem. The nature of physician behaviour as a likely source of this problem has not been explored. The aims of this study were to make a behavioural diagnosis of general practitioners (GPs) who perform these hip checks, and identify potential behavioural change techniques that could make the hip checks more effective.Design Qualitative study with in-depth semistructured interviews of 6–8 weeks checks. We used the Capability, Opportunity, Motivation and Behaviour model in making a behavioural diagnosis and elicited factors that can be linked to improving the assessment.Setting Primary care.Participants 17 GPs (15 female) who had between 5 and 34 years of work experience were interviewed.Results Capability related to knowledge of evidence-based criteria and skill to identify DDH were important behavioural factors. Both physical (clinic time and space) and social (practice norms), opportunity were essential for optimal behaviour. Furthermore, motivation related to the importance of the 6–8 weeks check and confidence to perform the check and refer appropriately were identified in the behavioural diagnosis.Conclusion Aspects of capability, opportunity and motivation affect GPs’ diagnosis and referral behaviours in relation to DDH. The findings from this work extend current knowledge and will inform the development of an intervention aimed at improving the diagnosis of DDH

Perceptions of COPD patients of the proposed withdrawal of inhaled corticosteroids prescribed outside guidelines: a qualitative study

Global Initiative for Chronic Obstructive Lung Disease guidelines support the prescription of fixed combination inhaled corticosteroids (ICS) and long-acting β-agonists in symptomatic COPD patients with frequent or severe exacerbations, with the aim of preventing them. ICS are frequently also prescribed to COPD patients with mild or moderate airflow limitation, outside guidelines, with the risk of unwanted effects. No investigation to date has addressed the views of these milder COPD patients on ICS withdrawal. The objective is to assess the views of COPD patients with mild or moderate airflow limitation on the staged withdrawal of ICS prescribed outside guidelines. One-to-one semi-structured qualitative interviews exploring COPD patients’ views about ICS use and their attitudes to proposed de-prescription were conducted. Interviews were audio-recorded and transcribed verbatim. Thematic analysis was completed. Seventeen eligible COPD patients were interviewed. Many participants were not aware they were using an ICS. None was aware that prevention of exacerbations was the indication for ICS therapy or the risk of associated side effects. Some were unconcerned by what they perceived as low individual risk. Others expressed fears of worsening symptoms on withdrawal. Most with mild or moderate airflow limitation would have been willing to attempt withdrawal or titration to a lower dosage of ICS if advised by their clinician, particularly if a reasoned explanation were offered. Attitudes in this study to discontinuing ICS use varied. Knowledge of the drug itself, the indications for its prescription in COPD and potential for side effects, was scant. The proposed withdrawal of ICS is likely to be challenging and requires detailed conversations between patients and respiratory healthcare professionals.</p

Parents' expectations and experiences of the 6-week baby check:a qualitative study in primary care

BACKGROUND: The Newborn and Infant Physical Examination (NIPE) programme requires all babies to have a comprehensive health-check at 6-8 weeks of age. These are typically completed by general practitioners (GPs). Although person-centred care has achieved prominence in maternity care policy in recent years there is limited empirical evidence on what parents/carers expect from the check, and how far experiences meet their needs. AIM: To explore the expectations and experiences of parents attending their GP for a baby check. DESIGN AND SETTING: Qualitative study in primary care in London. METHOD: Content analysis of transcripts of semi-structured interviews with 16 parents who had recently attended for a 6-week check for their baby. RESULTS: Despite the availability of plentiful sources of general advice on infants' health and development, a thorough check by a trusted GP was an important milestone for most parents. They had few specific expectations of the check in terms of what examinations were undertaken, but even experienced parents anticipated reassurance about their baby's normal development. Many also hoped for reassurance about their own parenting. Parents appreciated: GPs who explained what they were doing during the examination; space to raise any concerns; and combined mother and baby checks. Referrals to secondary care were generally experienced as reassuring rather than a source of anxiety. CONCLUSION: The baby check meets needs beyond those of the NIPE screening programme; protecting the time for a thorough consultation is important for parents at what can be a vulnerable time

Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care:a feasibility randomised trial

BACKGROUND: Inhaled corticosteroids (ICS) are frequently prescribed outside guidelines to patients with chronic obstructive pulmonary disease (COPD) with mild/moderate airflow limitation and low exacerbation risk. This primary care trial explored the feasibility of identifying patients with mild/moderate COPD taking ICS, and the acceptability of ICS withdrawal. METHODS: Open feasibility trial. Outcome measures included prevalence of suitable participants, feasibility of their identification, their willingness-to-accept open randomisation to ICS withdrawal or continuation over 6 months follow-up. RESULTS: 392 (13%) of 2967 patients with COPD from 20 practices (209 618 population) identified as eligible for ICS withdrawal by electronic search algorithm. After individual patient record review, 243 (62%) were excluded because of: severe airflow limitation (65, 17%); one or more severe or two or more moderate COPD exacerbations in the previous year (86, 22%); asthma (15, 4%); and severe comorbidities (77, 20%). After exclusion, 149 patients with COPD were invited to participate and 61 agreed to randomisation. At clinical assessment, 10 patients exhibited undocumented airflow reversibility (forced expiratory volume in 1 s (FEV(1)) reversibility >12% and >200 mL); 2 had suffered two or more undocumented, moderate exacerbations in the previous year; 7 had severe airflow limitation; and 2 had normal spirometry. Finally, 40 were randomised. One patient died and one was lost to follow-up. 18 (45%) of the 38 (10 withdrawal and 8 usual care) exhibited previously undocumented FEV(1) variability suggestive of asthma, supported in the withdrawal group by significant associations with elevated fractional exhaled nitric oxide (p=0.04), elevated symptom score (p=0.04), poorer quality of life (p=0.04) and atopic status (p=0.01). CONCLUSIONS: Identifying primary care patients with mild/moderate COPD suitable for ICS withdrawal is feasible but requires real-time verification because of unreliable recording of exacerbations and lung function. Suitable patients accepted randomisation to ICS withdrawal or continuation for the purposes of future studies. Follow-up compliance was high. Nearly 50% of participants with a diagnosis of mild/moderate COPD demonstrated previously undocumented FEV(1) variability during follow-up, mandating monitoring for at least 6 months following withdrawal to exclude undiagnosed asthma

A case management occupational health model to facilitate earlier return to work of NHS staff with common mental health disorders:a feasibility study

BACKGROUND: The NHS is the biggest employer in the UK. Depression and anxiety are common reasons for sickness absence among staff. Evidence suggests that an intervention based on a case management model using a biopsychosocial approach could be cost-effective and lead to earlier return to work for staff with common mental health disorders.OBJECTIVE: The objective was to assess the feasibility and acceptability of conducting a trial of the clinical effectiveness and cost-effectiveness of an early occupational health referral and case management intervention to facilitate the return to work of NHS staff on sick leave with any common mental health disorder (e.g. depression or anxiety).DESIGN: A multicentre mixed-methods feasibility study with embedded process evaluation and economic analyses. The study comprised an updated systematic review, survey of care as usual, and development of an intervention in consultation with key stakeholders. Although this was not a randomised controlled trial, the study design comprised two arms where participants received either the intervention or care as usual.PARTICIPANTS: Participants were NHS staff on sick leave for 7 or more consecutive days but less than 90 consecutive days, with a common mental health disorder.INTERVENTION: The intervention involved early referral to occupational health combined with standardised work-focused case management.CONTROL/COMPARATOR: Participants in the control arm received care as usual.PRIMARY OUTCOME: The primary outcome was the feasibility and acceptability of the intervention, study processes (including methods of recruiting participants) and data collection tools to measure return to work, episodes of sickness absence, workability (a worker's functional ability to perform their job), occupational functioning, symptomatology and cost-effectiveness proposed for use in a main trial.RESULTS: Forty articles and two guidelines were included in an updated systematic review. A total of 49 of the 126 (39%) occupational health providers who were approached participated in a national survey of care as usual. Selected multidisciplinary stakeholders contributed to the development of the work-focused case management intervention (including a training workshop). Six NHS trusts (occupational health departments) agreed to take part in the study, although one trust withdrew prior to participant recruitment, citing staff shortages. At mixed intervention sites, participants were sequentially allocated to each arm, where possible. Approximately 1938 (3.9%) NHS staff from the participating sites were on sick leave with a common mental health disorder during the study period. Forty-two sick-listed NHS staff were screened for eligibility on receipt of occupational health management referrals. Twenty-four (57%) participants were consented: 11 (46%) received the case management intervention and 13 (54%) received care as usual. Follow-up data were collected from 11 out of 24 (46%) participants at 3 months and 10 out of 24 (42%) participants at 6 months. The case management intervention and case manager training were found to be acceptable and inexpensive to deliver. Possible contamination issues are likely in a future trial if participants are individually randomised at mixed intervention sites.HARMS: No adverse events were reported.LIMITATIONS: The method of identification and recruitment of eligible sick-listed staff was ineffective in practice because uptake of referral to occupational health was low, but a new targeted method has been devised.CONCLUSION: All study questions were addressed. Difficulties raising organisational awareness of the study coupled with a lack of change in occupational health referral practices by line managers affected the identification and recruitment of participants. Strategies to overcome these barriers in a main trial were identified. The case management intervention was fit for purpose and acceptable to deliver in the NHS.TRIAL REGISTRATION: Current Controlled Trials ISRCTN14621901.FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 12. See the NIHR Journals Library website for further project information. </p