Maximising recruitment and retention of general practices in clinical trials: a case study

Background

There is limited evidence regarding the factors that facilitate recruitment and retention of general practices in clinical trials. It is therefore pertinent to consider the factors that facilitate research in primary care.

Aim

To formulate hypotheses about effective ways of recruiting and retaining practices to clinical trials, based on a case study.

Design of study

Case study of practice recruitment and retention to a trial of delivering antenatal sickle cell and thalassaemia screening.

Setting

Two UK primary care trusts with 123 practices, with a high incidence of sickle cell and thalassaemia, and high levels of social deprivation.

Method

Practices were invited to take part in the trial using a research information sheet for practices. Invitations were sent to all practice managers, GPs, practice nurses, and nurse practitioners. Expenses of approximately £3000 per practice were available. Practices and the research team signed research activity agreements, detailing a payment schedule based on deliverables. Semi-structured interviews were completed with 20 GPs who participated in the trial. Outcome measures were the number of practices recruited to, and completing, the trial.

Results

Four practices did not agree to randomisation and were excluded. Of 119 eligible practices, 29 expressed an interest in participation. Two practices withdrew from the trial and 27 participated (two hosted pilot studies and 25 completed the trial), giving a retention rate of 93% (27/29). The 27 participating practices did not differ from non-participating practices in list size, number of GPs, social deprivation, or minority ethnic group composition of the practice population.

Conclusion

Three factors appeared important in recruiting practices: research topic, invitation method, and interest in research. Three factors appeared important in retaining practices: good communication, easy data-collection methods, and payment upon meeting pre-agreed targets. The effectiveness of these factors at facilitating recruitment and retention requires assessment in experimental studies.     

Strategies for improving patient recruitment to focus groups in primary care: a case study reflective paper using an analytical framework

Background  

Recruiting to primary care studies is complex. With the current drive to increase numbers of patients involved in primary care studies, we need to know more about successful recruitment approaches. There is limited evidence on recruitment to focus group studies, particularly when no natural grouping exists and where participants do not regularly meet. The aim of this paper is to reflect on recruitment to a focus group study comparing the methods used with existing evidence using a resource for research recruitment, PROSPeR (Planning Recruitment Options: Strategies for Primary Care).     

Trials within trials? Researcher,funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials

Background  

Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies.     

A clinical trial alert tool to recruit large patient samples and assess selection bias in general practice research

Background  

Many research projects in general practice face problems when recruiting patients, often resulting in low recruitment rates and an unknown selection bias, thus limiting their value for health services research. The objective of the study is to evaluate the recruitment performance of the practice staff in 25 participating general practices when using a clinical trial alert (CTA) tool.     

Comparing recruitment strategies in a study of acupuncture for chronic back pain

Background  

Meeting recruitment goals is challenging for many clinical trials conducted in primary care populations. Little is known about how the use of different recruitment strategies affects the types of individuals choosing to participate or the conclusions of the study.     

Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care

Background  

Recruitment and retention of patients and healthcare providers in randomised controlled trials (RCTs) is important in order to determine the effectiveness of interventions. However, failure to achieve recruitment targets is common and reasons why a particular recruitment strategy works for one study and not another remain unclear. We sought to describe a strategy used in a multicentre RCT in primary care, to report researchers' and participants' experiences of its implementation and to inform future strategies to maximise recruitment and retention.     

Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

Background  

A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial.     

Introducing case management for people with dementia in primary care: a mixed-methods study

Background

Case management may be a feasible solution to the problem of service fragmentation for people with dementia.

Aim

To adapt a US model of primary care-based case management for people with dementia and test it in general practice.

Design and setting

Mixed-methodology case studies of case management implementation in four general practices: one rural, one inner-city, and two urban practices. Practice nurses undertook the case manager role in the rural and inner-city practices, and were allocated one session per week for case management by their practices. A seconded social worker worked full time for the two urban practices.

Method

Participants were community-dwelling patients with dementia who were living at home with a family carer, and who were not receiving specialist care coordination. Case study methods included analysis of case loads and interviews with patients, carers, local NHS and other stakeholders, and case managers. Measures included numbers of patients with dementia and their carers, number of unmet needs identified, and actions taken to meet needs. Case manager records were compared with findings from interviews with patients and carers, and with other stakeholders.

Results

The number of eligible patients was smaller than expected. No practice achieved its recruitment target. Researchers identified more unmet needs than case managers. The practice nurse case managers reported lack of time and found research documentation burdensome. Patients and carers were positive about case management as a first point of contact with the practice, as a ‘safety net’, and for creating a one-to-one therapeutic relationship.

Conclusion

Further investigation is required before case management for people with dementia and their carers can be implemented in primary care.     

Recruitment rates and reasons for community physicians' non-participation in an interdisciplinary intervention study on leg ulceration

Background  

This article describes the challenges a research team experienced recruiting physicians within a randomised controlled trial about leg ulcer care that seeks to foster the cooperation between the medical and nursing professions. Community-based physicians in North Rhine-Westphalia, Germany, were recruited for an interdisciplinary intervention designed to enhance leg ulcer patients' self-care agency. The aim of this article is to investigate the success of different recruitment strategies employed and reasons for physicians' non-participation.     

Primary care characteristics and population-orientated health care across Europe: an observational study

Background

The number of patients with chronic diseases is increasing which poses a challenge to healthcare organisations. A proactive, structured, and population-orientated approach is needed: the chronic care model (CCM) provides such a framework.

Aim

To assess organisational conditions for providing structured chronic care according to the CCM across different healthcare systems.

Design of study

International observational study.

Setting

A stratified sample of 315 primary care practices in 10 European countries and Israel in 2008 and 2009.

Method

Practice questionnaires and interviews. Outcome measures were mean practice scores on CCM domains per country, as a percentage of the maximum score, and the influence of practice size and urbanisation on these scores.

Results

Practice size showed large differences with the largest practices in Spain, England, Finland, and Israel. These countries, with a strong primary care orientation, had most physicians and staff involved per practice. The CCM domains ‘clinical information systems’ and ‘decision support’ had total practice means of 90%; other domains scored about 50%. Spain and England scored above average on almost all domains. Practice size and urbanisation had little impact.

Conclusion

Characteristics for chronic care delivery differed for most CCM domains. The most common characteristics related to computerisation, providing a good starting point and high potential everywhere. All countries showed room for improvement. Further research should focus on relations between practice characteristics, organisational features, including health system and primary care orientation, and outcomes. Primary care seems suited for chronic care delivery; however, a stronger primary care was associated with better scores.     

Ankle brachial index measurement in primary care: are we doing it right?

Background

The reference standard for diagnosing peripheral arterial disease in primary care is the ankle brachial index (ABI). Various methods to measure ankle and brachial blood pressures and to calculate the index are described.

Aim

To compare the ABI measurements performed in primary care with those performed in the vascular laboratory. Furthermore, an inventory was made of methods used to determine the ABI in primary care.

Design of study

Cross-sectional study.

Setting

Primary care practice and outpatient clinic.

Method

Consecutive patients suspected of peripheral arterial disease based on ABI assessment in primary care practices were included. The ABI measurements were repeated in the vascular laboratory. Referring GPs were interviewed about method of measurement and calculation of the index. From each patient the leg with the lower ABI was used for analysis.

Results

Ninety-nine patients of 45 primary care practices with a mean ABI of 0.80 (standard deviation [SD] = 0.27) were included. The mean ABI as measured in the vascular laboratory was 0.82 (SD = 0.26). A Bland–Altman plot demonstrated great variability between ABI measurements in primary care practice and the vascular laboratory. Both method of blood pressure measurements and method of calculating the ABI differed greatly between primary care practices.

Conclusion

This study demonstrates that the ABI is often not correctly determined in primary care practice. This phenomenon seems to be due to inaccurate methods for both blood pressure measurements and calculation of the index. A guideline for determining the ABI with a hand-held Doppler, and a training programme seem necessary.     

Randomised controlled trial of a new palliative care service: Compliance,recruitment and completeness of follow-up

Background  

Palliative care has been proposed for progressive non-cancer conditions but there have been few evaluations of service developments. We analysed recruitment, compliance and follow-up data of a fast track (or wait list control) randomised controlled trial of a new palliative care service – a design not previously used to assess palliative care.     

Recruitment difficulties in a primary care cluster randomised trial: investigating factors contributing to general practitioners' recruitment of patients

Background  

Recruitment of patients by health professionals is reported as one of the most challenging steps when undertaking studies in primary care settings. Numerous investigations of the barriers to patient recruitment in trials which recruit patients to receive an intervention have been published. However, we are not aware of any studies that have reported on the recruitment barriers as perceived by health professionals to recruiting patients into cluster randomised trials where patients do not directly receive an intervention. This particular subtype of cluster trial is commonly termed a professional-cluster trial. The aim of this study was to investigate factors that contributed to general practitioners recruitment of patients in a professional-cluster trial which evaluated the effectiveness of an intervention to increase general practitioners adherence to a clinical practice guideline for acute low-back pain.     

Developing a Dementia Research Registry: a descriptive case study from North Thames DeNDRoN and the EVIDEM programme

Aim  

To describe the development of a dementia research registry, outlining the conceptual, practical and ethical challenges, and to report initial experiences of recruiting people with dementia to it from primary and secondary care.     

Does practice size matter? Review of effects on quality of care in primary care

Background

There is a trend towards consolidating smaller primary care practices into larger practices worldwide. However, the effects of practice size on quality of care remain unclear.

Aim

This review aims to systematically appraise the effects of practice size on the quality of care in primary care.

Design and setting

A systematic review and narrative synthesis of studies examining the relationship between practice size and quality of care in primary care.

Method

Quantitative studies that focused on primary care practices or practitioners were identified through PubMed, CINAHL, Embase, Cochrane Library, CRD databases, ProQuest dissertations and theses, conference proceedings, and MedNar databases, as well as the reference lists of included studies. Independent variables were team or list size; outcome variables were measures of clinical processes, clinical outcomes, or patient-reported outcomes. A narrative synthesis of the results was conducted.

Results

The database search yielded 371 articles, of which 34 underwent quality assessment, and 17 articles (13 cross-sectional studies) were included. Ten studies examined the association of practice size and clinical processes, but only five found associations of larger practices with selected process measures such as higher specialist referral rates, better adherence to guidelines, higher mammography rates, and better monitoring of haemoglobin A1c. There were mixed results for cytology and pneumococcal coverage. Only one of two studies on clinical outcomes found an effect of larger practices on lower random haemoglobin A1 value. Of the three studies on patient-reported outcomes, smaller practices were consistently found to be associated with satisfaction with access, but evidence was inconsistent for other patient-reported outcomes evaluated.

Conclusion

There is limited evidence to support an association between practice size and quality of care in primary care.     

Economic influences on GPs' decisions to provide out-of-hours care

Background

Introduction of the new general medical services contract offered UK general practices the option to discontinue providing out-of-hours (OOH) care. This aimed to improve GP recruitment and retention by offering a better work–life balance, but put primary care organisations under pressure to ensure sustainable delivery of these services. Many organisations arranged this by re-purchasing provision from individual GPs.

Aim

To analyse which factors influence an individual GP''s decision to re-provide OOH care when their practice has opted out.

Design of study

Cross-sectional questionnaire survey.

Setting

Rural and urban general practices in Scotland, UK.

Method

A postal survey was sent to all GPs working in Scotland in 2006, with analyses weighted for differential response rates. Analysis included logistic regression of individuals'' decisions to re-provide OOH care based on personal characteristics, work and non-work time commitments, income from other sources, and contracting primary care organisation.

Results

Of the 1707 GPs in Scotland whose practice had opted out, 40.6% participated in OOH provision. Participation rates of GPs within primary care organisations varied from 16.7% to 74.7%. Males with young children were substantially more likely to participate than males without children (odds ratio [OR] 2.44, 95% confidence interval [CI] = 1.36 to 4.40). GPs with higher-earning spouses were less likely to participate. This effect was reinforced if GPs had spouses who were also GPs (OR 0.52, 95% CI = 0.37 to 0.74). GPs with training responsibilities (OR 1.36, 95% CI = 1.09 to 1.71) and other medical posts (OR 1.38, 95% CI = 1.09 to 1.75) were more likely to re-provide OOH services.

Conclusion

The opportunity to opt out of OOH care has provided flexibility for GPs to raise additional income, although primary care organisations vary in the extent to which they offer these opportunities. Examining intrinsic motivation is an area for future study.     

Practice size and service provision in primary care: an observational study

Background

In 2004, primary care payments for basic services and enhanced services were separated. This change has greatly facilitated the evaluation of the breadth and volume of services.

Aim

To determine whether larger practices produce a higher volume and greater diversity of enhanced services.

Design of study

Cross-sectional observational study using practice data obtained under the Freedom of Information Act 2000.

Setting

A total of 384 practices in 14 English primary care trusts.

Method

Practice data for all practices were collated for enhanced services, practice size, and deprivation. Diversity and volume of enhanced services were used as dependent variables in a series of multiple regression models to ascertain the effect of practice size, and any relationship with deprivation.

Results

Larger practices provided a greater diversity of services (P = 0.002), although this effect was not present in practices with more than 6330 patients. Practice size seems to influence the volume of enhanced services in general medical services, but this effect disappeared when deprivation was taken into account. Deprivation had a negative influence on the volume of enhanced services provided (P = 0.019). The effect of deprivation on volume persisted in practices with more than 6330 patients.

Conclusion

Current average-sized practices provide similar volume and diversity of enhanced services as those in the largest quartile; therefore, there seems to be little merit in creating ‘supersurgeries’ if the aim is to transfer work from secondary to primary care. There does not seem to be an upper threshold above which practice size creates spare capacity and expertise to deliver a significantly greater volume or more diversity of extra services.     

Perceptions on the importance of gerontological education by teachers and students of undergraduate health sciences

Background  

The main challenge of higher education institutions throughout the world is to develop professionals capable of understanding and responding to the current social priorities of our countries. Given the utmost importance of addressing the complex needs of an increasingly elderly population in Mexico, the National Autonomous University of Mexico has systematically incorporated modules dealing with primary gerontological health care into several of its undergraduate programs in health sciences. The objective of this study was to analyze teacher's and student's perceptions about the current educational practices on gerontology.