Enhanced invitation methods and uptake of health checks in primary care. Rapid randomised controlled trial using electronic health records

Background: A national programme of health checks to identify risk of cardiovascular disease is being rolled out but is encountering difficulties of low uptake. Objective: To evaluate the effectiveness of an enhanced invitation method using the Question-Behaviour Effect (QBE), with or without the offer of a financial incentive to return the QBE questionnaire, at increasing the uptake of health checks. Secondary objectives were to evaluate reasons for low uptake of invitations and to compare case-mix for invited and opportunistic health checks. Trial design: Three-arm randomised trial. Participants: All participants invited for health checks from 18 general practices. Randomisation: Individual participants were randomised. Interventions: i) standard health check invitation only, ii) QBE questionnaire followed by standard invitation; iii) QBE questionnaire with offer of a financial incentive to return the questionnaire, followed by standard invitation. Outcomes: The primary outcome was completion of health check within six months of randomisation. A P value of 0.0167 was used for significance. Case-mix was evaluated for invited and opportunistic health checks. Blinding: Participants were not aware that several types of invitation were in use. The research team were blind to trial arm allocation at outcome data extraction. Results: There were 12,459 participants allocated and health check uptake was evaluated for 12,052 participants for whom outcome data were collected. Health check uptake was: standard invitation, 590 / 4,095 (14.4%); QBE questionnaire, 630 / 3,988 (15.8%); QBE questionnaire and financial incentive, 629 / 3,969 (15.9%). The increase in uptake associated with QBE questionnaire was 1.43% (95% confidence interval -0.12 to 2.97%, P=0.070) and for the QBE questionnaire and offer of financial incentive was 1.52% (-0.03 to 3.07%, P=0.054). The difference in uptake associated with the offer of an incentive to return the QBE questionnaire was -0.01% (-1.59 to 1.58%, P=0.995). During the study, 58% of health check cardiovascular risk assessments did not follow a trial invitation. People who received ‘opportunistic’ health checks had greater odds of ≥10% cardiovascular disease (CVD) risk; adjusted odds ratio 1.70, 95% confidence interval 1.45 to 1.99, P<0.001) compared with invited health checks. Conclusion: Uptake of health checks following an invitation letter is low and is not increased through an enhanced invitation method using the QBE, with or without an incentive. A high proportion of all health checks are performed opportunistically. Participants receiving opportunistic checks are at higher risk of CVD than those responding to standard invitations. Trial registration: Current Controlled Trials ISRCTN42856343

Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling (PRE-EMPT): protocol for a general practice-based cluster randomised trial

BACKGROUND: Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours. METHODS/DESIGN: This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse) from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted. DISCUSSION: Opportunistic engagement by health professionals potentially represents a cost effective medical intervention. This study integrates an existing, innovative intervention method with an innovative training model to enable clinicians to routinely use BCC, providing them with new tools to encourage and support people to make healthier choices. This trial will evaluate effectiveness in primary care and determine costs of the intervention

An evidence-based approach to the use of telehealth in long-term health conditions: development of an intervention and evaluation through pragmatic randomised controlled trials in patients with depression or raised cardiovascular risk

Background: Health services internationally are exploring the potential of telehealth to support the management of the growing number of people with long-term conditions (LTCs). Aim: To develop, implement and evaluate new care programmes for patients with LTCs, focusing on two common LTCs as exemplars: depression or high cardiovascular disease (CVD) risk. Methods Development: We synthesised quantitative and qualitative evidence on the effectiveness of telehealth for LTCs, conducted a qualitative study based on interviews with patients and staff and undertook a postal survey to explore which patients are interested in different forms of telehealth. Based on these studies we developed a conceptual model [TElehealth in CHronic disease (TECH) model] as a framework for the development and evaluation of the Healthlines Service for patients with LTCs. Implementation: The Healthlines Service consisted of regular telephone calls to participants from health information advisors, supporting them to make behaviour change and to use tailored online resources. Advisors sought to optimise participants’ medication and to improve adherence. Evaluation: The Healthlines Service was evaluated with linked pragmatic randomised controlled trials comparing the Healthlines Service plus usual care with usual care alone, with nested process and economic evaluations. Participants were adults with depression or raised CVD risk recruited from 43 general practices in three areas of England. The primary outcome was response to treatment and the secondary outcomes included anxiety (depression trial), individual risk factors (CVD risk trial), self-management skills, medication adherence, perceptions of support, access to health care and satisfaction with treatment. Trial results Depression trial: In total, 609 participants were randomised and the retention rate was 86%. Response to treatment [Patient Health Questionnaire 9-items (PHQ-9) reduction of ≥ 5 points and score of < 10 after 4 months] was higher in the intervention group (27%, 68/255) than in the control group (19%, 50/270) [odds ratio 1.7, 95% confidence interval (CI) 1.1 to 2.5; p = 0.02]. Anxiety also improved. Intervention participants reported better access to health support, greater satisfaction with treatment and small improvements in self-management, but not improved medication adherence. CVD risk trial: In total, 641 participants were randomised and the retention rate was 91%. Response to treatment (maintenance of/reduction in QRISK®2 score after 12 months) was higher in the intervention group (50%, 148/295) than in the control group (43%, 124/291), which does not exclude a null effect (odds ratio 1.3, 95% CI 1.0 to 1.9; p = 0.08). The intervention was associated with small improvements in blood pressure and weight, but not smoking or cholesterol. Intervention participants were more likely to adhere to medication, reported better access to health support and greater satisfaction with treatment, but few improvements in self-management. The Healthlines Service was likely to be cost-effective for CVD risk, particularly if the benefits are sustained, but not for depression. The intervention was implemented largely as planned, although initial delays and later disruption to delivery because of the closure of NHS Direct may have adversely affected participant engagement. Conclusion: The Healthlines Service, designed using an evidence-based conceptual model, provided modest health benefits and participants valued the better access to care and extra support provided. This service was cost-effective for CVD risk but not depression. These findings of small benefits at extra cost are consistent with previous pragmatic research on the implementation of comprehensive telehealth programmes for LTCs