Caroline Gardner

The effectiveness and cost effectiveness of a national lay-led self care support programme for patients with long-term conditions: a pragmatic randomised controlled trial.

Objective: Supporting patients’ self care could have a major effect on the management of long-term conditions, which has led to worldwide interest in effective self care interventions. In England, self care support is being developed through the “Expert Patients Programme”, which provides lay-led generic courses to improve patients’ self care skills. However, the clinical and cost effectiveness of such courses remains unclear. Methods: Two-arm pragmatic randomised controlled trial design with waiting list control in community settings in England. 629 patients with a wide range of self-defined long-term conditions were studied. The lay-led self care support group involved 6-weekly sessions to teach self care skills. Primary outcomes were self-efficacy, reported energy and routine health services utilisation at 6 months. A cost-effectiveness analysis was also conducted. Results: Patients receiving immediate course access reported considerably greater self-efficacy and energy at 6-month follow-up, but reported no statistically significant reductions in routine health services utilisation over the same time period. The cost-effectiveness analysis showed that patients receiving immediate course access reported considerably greater health related quality of life, and a small reduction in costs. If a quality adjusted life year was valued at £20 000 (

Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial

39 191; €30 282), there was a 70% probability that the intervention was cost effective. Conclusions: Lay-led self care support groups are effective in improving self-efficacy and energy levels among patients with long-term conditions, and are likely to be cost effective over 6 months at conventional values of a decision-maker’s willingness to pay. They may be a useful addition to current services in the management of long-term conditions.

Cost effectiveness of the Expert Patients Programme (EPP) for patients with chronic conditions

Objective To determine the effectiveness of an intervention to enhance self management support for patients with chronic conditions in UK primary care. Design Pragmatic, two arm, cluster randomised controlled trial. Setting General practices, serving a population in northwest England with high levels of deprivation. Participants 5599 patients with a diagnosis of diabetes (n=2546), chronic obstructive pulmonary disease (n=1634), and irritable bowel syndrome (n=1419) from 43 practices (19 intervention and 22 control practices). Intervention Practice level training in a whole systems approach to self management support. Practices were trained to use a range of resources: a tool to assess the support needs of patients, guidebooks on self management, and a web based directory of local self management resources. Training facilitators were employed by the health management organisation. Main outcome measures Primary outcomes were shared decision making, self efficacy, and generic health related quality of life measured at 12 months. Secondary outcomes were general health, social or role limitations, energy and vitality, psychological wellbeing, self care activity, and enablement. Results We randomised 44 practices and recruited 5599 patients, representing 43% of the eligible population on the practice lists. 4533 patients (81.0%) completed the six month follow-up and 4076 (72.8%) the 12 month follow-up. No statistically significant differences were found between patients attending trained practices and those attending control practices on any of the primary or secondary outcomes. All effect size estimates were well below the prespecified threshold of clinically important difference. Conclusions An intervention to enhance self management support in routine primary care did not add noticeable value to existing care for long term conditions. The active components required for effective self management support need to be better understood, both within primary care and in patients’ everyday lives. Trial registration Current Controlled Trials ISRCTN90940049.

'Permission to participate?': a qualitative study of participation in patients from differing socio-economic backgrounds

Objective: To assess the cost effectiveness of the Expert Patients Programme (EPP) intervention compared to a treatment as usual alternative. Design: Two-arm pragmatic randomised controlled trial design with waiting list control. Setting: Community settings in England. Patients: Patients with a wide range of self-defined long-term conditions. Intervention: The EPP based on the US chronic disease self management program (CDSMP), a lay-led self-care group involving six weekly sessions to teach self-care support skills. Main outcome measures: Costs estimated over a 6-month period from a societal perspective. Health outcomes estimated in terms of quality adjusted life years (QALYs) generated by patients’ response to the EQ5D at baseline and 6-month follow-up. Results: The intervention group is associated with better patient outcomes, at slightly lower cost. Specifically, the intervention group has a 0.020 QALY gain compared with the control group, and a reduced cost of around £27 per patient. The intervention would therefore be considered dominant. While the QALYs gained are small in absolute terms, an additional 0.02 QALY is equivalent to an extra one week of perfect health per year. When the value of a QALY is £20 000 the EPP has a probability of 94% of being cost effective. Indeed, for all plausible values of willingness-to-pay for a QALY the EPP group is more likely to be cost effective than the control group. Conclusions: The EPP intervention evaluated in this trial is very likely to provide a cost effective alternative to usual care in people with long-term conditions.

Predicting who will benefit from an Expert Patients Programme self-management course

Participation in health care is an important element of self-management in chronic illness, and policy emphasises patient’s choice. Evidence suggests that this may be inequitable and inadequate, since active participation is strongly associated with socio-demographic variables. This qualitative study explores the perceptions of participation in people with differing socio-economic status with themes related to health literacy and relationship with health-care professionals. Patients perceive participation in different ways, related to their prior expectations of a health-care consultation, cultural expectations and social position. Policies aimed at simply improving ‘health literacy’ and choice will not be successful if these broader disparities are not addressed.

Effect of information and telephone-guided access to community support for people with chronic kidney disease: Randomised controlled trial

BACKGROUND In England, the Expert Patients Programme, a lay-led chronic disease self-management course, was developed to improve self-care support and skills. The course is designed for anyone with a self-defined long-term condition, and attracts a heterogeneous group of patients. A randomised controlled trial has demonstrated effectiveness in improving subjective health. However, it is not known whether particular patient characteristics predict the impact of the course. AIM To determine whether baseline characteristics predict clinical outcomes from attendance at a chronic disease self-management course; and to assess whether identification of such characteristics assists in targeting the course to individuals most likely to benefit. DESIGN OF STUDY A post-hoc subgroup analysis of data from a randomised controlled trial to explore predictors of three trial outcomes: self-efficacy, energy, and health-related quality of life. SETTING Participants with self-defined long-term conditions (n = 629) were recruited from community settings in all 28 strategic health authorities in England. METHOD Multiple regression was used to examine interactions between baseline variables and trial outcomes. RESULTS The predictors demonstrating significant interactions were: age and general health, and baseline values for self-efficacy, energy levels, and health-related quality of life. CONCLUSION Participants with lower self-efficacy and health-related quality of life at baseline demonstrated more positive health outcomes. The Expert Patients Programme may have a protective effect on health-related quality of life for patients with poor health and low confidence. Younger people benefited substantially more than older people. Results suggest that positive outcomes associated with the course will be demonstrated with a wide variety of patients, although it may be worthwhile encouraging attendance of younger patients, those lacking confidence, and those coping poorly with their condition.

What Outcomes Are Important to Patients with Long Term Conditions? A Discrete Choice Experiment

Background Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. Trial Registration Controlled-Trials.com ISRCTN45433299

Managing ‘difficult emotions’ and family life: exploring insights and social support within online self-management training

OBJECTIVE To assess how much patients with long-term conditions value self-efficacy (i.e., confidence in their ability to manage their condition) compared with other health outcomes, including measures of quality of life, and process outcomes including access to General Practitioners. METHODS Discrete Choice Experiment (DCE) set in UK community settings. PARTICIPANTS 367 patients (mean age 57.5) living in the community with a wide range of self-defined long-term conditions. MAIN OUTCOME MEASURES The relative value that individuals place on four specific outcomes, namely, self-efficacy, Health Related Quality of Life (HRQoL), access to General Practitioners, and level of isolation. RESULTS Most responders completed their questionnaire in a consistent manner. Most valuations of outcomes were in the expected direction and were statistically significant. A substantial minority of responders exhibited counter-intuitive preferences. The existence of a significant constant in all models raised concerns about model misspecification. Nevertheless, all models showed that participants were willing to trade substantial reductions in their HRQoL for improvements in their self-efficacy. CONCLUSIONS The majority of patients with chronic conditions were able to complete the DCE questionnaires. However, the existence of counter-intuitive preferences and evidence of model misspecification require further investigation. These issues are largely overlooked in the health economics literature. Self-efficacy is an important outcome for this group and is not included explicitly in conventional HRQoL measures. This is potentially important where decisions are made on the basis of cost-effectiveness using Quality Adjusted Life Years as the metric. Exclusion of these outcomes may lead to the cost-effectiveness of these interventions being understated.

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

Background: Previous research has demonstrated how the Internet can foster emotional support and provide a ‘private’ space for discussing sensitive issues. Whilst the family has been located as a primary source of support, empirical research on the dynamics of close personal relationships in chronic illness experience remains a challenge. Objective: To explore the role of family relationships in supporting self-care and the nature of social support exchanged within an online self-management training course. Methods: Qualitative thematic and narrative analysis of online discussion boards. Postings for 218 participants, divided between 11 groups were included for a course section that focused on ‘difficult emotions’. Results: Participants exchanged a high degree of emotional support and revealed much about their ‘real life’ relationships. The latter highlighted the complexities of managing illness within family contexts alongside additional pressures of daily life such as caring commitments and work roles. Discussion: The private interactive space created within the course allowed insights into the dynamics of family life associated with illness management that are challenging to research. Simultaneously, collective support was developed amongst this group of predominantly working women. The article points to the implications for such interventions and associated evaluative research beyond this selective group.

Patients’ Experiences of Shared Decision Making in Primary Care Practices in the United Kingdom

BackgroundImproving the quality of care for people with vascular disease is a key priority. Chronic kidney disease (CKD) has recently been included as a target condition for general practices to add to registers of chronic conditions as part of the Quality and Outcome Framework. This paper outlines the implementation and evaluation of a self-management intervention involving an information guidebook, tailored access to local resources and telephone support for people with stage 3 chronic kidney disease.Methods/DesignThe study involves a multi-site, longitudinal patient-level randomized controlled trial. The study will evaluate the clinical use and cost-effectiveness of a complex self-management intervention for people with stage 3 chronic kidney disease in terms of self-management capacity, health-related quality of life and blood pressure control compared to care as usual. We describe the methods of the patient-level randomized controlled trial.DiscussionThe management of chronic kidney disease is a developing area of research. The BRinging Information and Guided Help Together (BRIGHT) trial aims to provide evidence that a complementary package of support for people with vascular disease that targets both clinical and social need broadens the opportunities of self-management support by addressing problems related to social disadvantage.Trial registrationTrial registration reference: ISRCTN45433299