Public Health Impact: Nurse-led BP Monitoring

Health Impact of Nurse-led Telemetry Services (HITS: Hypertension) Sharing Responsibility: The public health impact of a nurse-led telemetric home blood pressure monitoring service CONTENTS 1. 2. 3. 4. 5. Introduction........................................................................................................ 3 Aims .................................................................................................................. 5 Research Questions .......................................................................................... 5 Outcome Measures ........................................................................................... 5 Methods ............................................................................................................ 5 5.1. Sample ...................................................................................................... 5 5.2. Recruitment ............................................................................................... 7 5.3. Consent and screening .............................................................................. 7 5.4. Baseline measurements ............................................................................ 7 5.5. Randomisation........................................................................................... 8 5.6. Blinding...................................................................................................... 8 5.7. Intervention................................................................................................ 8 Control Group.................................................................................................... 9 5.8. Duration of Intervention.............................................................................. 9 5.9. Follow up measurements ........................................................................... 9 5.10. Data management and analysis ............................................................. 9 5.11. Qualitative study .................................................................................. 10 6. Exit strategy..................................................................................................... 10 7. Risk management strategy .............................................................................. 10 8. Project Team and Task allocation.................................................................... 12 9. Project management and quality assurance .................................................... 12 10. Reporting..................................................................................................... 13 11. Finance........................................................................................................ 13 12. References .................................................................................................. 13 HITS: Hypertension Protocol Version 2 16/12/2008 2 1. Introduction The benefit of reducing blood pressure is well established. In the population every 10mmHg rise in usual systolic blood pressure over 115 mmHg is associated with approximately 40% increase in risk of death from stroke and 30% higher risk of death from ischaemic heart disease1. In the UK up to 40% of the adult population have hypertension (defined as persistently raised blood pressure over 140/90 mm Hg)2, with associated raised cardiovascular risk. Trials have shown that reducing blood pressure using drugs reduces the risk of stroke to almost normal levels and cardiovascular disease by about half 3. Lifestyle modification can also reduce blood pressure4. The current medical model for identifying and managing hypertension in Primary Care is costly, does not necessarily engage individuals in a self-care approach, and may not lead to treatment being well targeted as ‘one off’ measurements in the surgery are poor predictors of the real risk factor which is average blood pressure10,11. Current care is costly because hypertension is one of the most common reasons for consulting in primary care in Scotland,5 and prevalence of hypertension can be expected to increase in association with ageing of the population and increasing prevalence of overweight and obesity. Experts now advocate more intensive risk identification and management in relation to blood pressure including reducing the threshold at which intervention should start6. This cannot easily be accommodated within the current model of service due to increases in both the numbers of consultations per patient required to achieve ambitious management targets and the number of people defined as hypertensive. Other models will need to be considered and the one advocated in current NHS policy is self-care, where the individual takes greater responsibility for his/ her health7. However, high blood pressure is largely asymptomatic so people with hypertension get little feedback on the impact of lifestyle changes or their medication between surgery visits. Possibly for this reason, adherence to both lifestyle advice and prescribed medication is generally poor within this group8. Nevertheless a growing private market for home blood pressure monitors9 suggests many patients do want to monitor their own blood pressure. Lack of NHS support for this may therefore be a missed opportunity to engage people in improving self-care. An additional difficulty for those attempting to identify and manage patients with high blood pressure is the inherent variability of blood pressure. Single measurements taken in the surgery are poorly correlated with average blood pressure measured by either ambulatory recording or home monitoring10. This is important because there is evidence that average ambulatory blood pressure is a better predictor of cardiovascular morbidity and mortality than surgery readings and growing evidence that average blood pressure based on home monitoring is also superior to office readings11. Guidance to professionals recognises the possibility of false positives when checking blood pressure and recommends that a diagnosis of hypertension is only made if the measurement is over 140/90 mmHg on three occasions 12. The possibility of false negatives is not routinely taken into account and a ‘normal’ blood pressure is unlikely to be rechecked either in a screening situation or as part of ongoing management. Indeed the Quality and Outcomes Framework which determines general practitioner (GP) payments13 now provides a financial disincentive for doing so because a subsequent high measurement in the record may lead to reduced practice payments. In public health terms, the need to check blood pressure on several occasions to establish that it is consistently high is burdensome HITS: Hypertension Protocol Version 2 16/12/2008 3 to patients and professionals and is likely to slow needed changes to treatment. Moreover, some people will have been falsely reassured that their blood pressure is well controlled. Self-monitoring has been suggested as a possible means of providing good quality data which will correlate well with outcomes. However, the evidence that self monitoring alone is beneficial in hypertension and other chronic conditions is equivocal. The most recent Cochrane review suggests that home monitoring without telemetry can lead to falls in diastolic blood pressure of 2-3mm Hg, but that only a non-statistically significant trend was found for reduction in systolic blood pressure and also that intensive monitoring and treatment can lead to falls in systolic blood pressure of more than 5mmHg 14. However, the meta-analysis which led to the latter finding was dominated by a very large trial carried out in the 1970s in the US and the applicability to a UK context and modern medication regimens cannot be assumed. In other conditions such as diabetes self monitoring has not been shown to be effective22. Some authors have suggested that one reason why self-monitoring has not been as successful as had been hoped in long term condition management has been that patients perceive that professionals pay little heed to their results or data are not shared23. Additionally long periods can pass before data are reviewed in a clinic. Telemetry and telehealth offer a convenient means of supporting patients with hypertension, offering opportunities to harness the benefits of reminder systems (thus encouraging self-testing), biofeedback (enabling patients to ‘see’ the impacts of lifestyle and medication compliance) and remote support from professionals or peers (e.g. medication changes, alerts or motivational messages). While these features have potential to positively impact patients’ blood pressure and associated health outcomes, evidence on the clinical benefits of telemonitoring for hypertension is still thin and further research is urgently needed to fill this knowledge gap24. The introduction of a nurse led, telemetric, home blood pressure monitoring service could potentially address a number of these issues. It is anticipated that it will work at two levels. The first is at the patient level. Patients will have control of the measurement of their blood pressure. They will be able to get timely feedback on the impact of changes to lifestyle and medication, reminders, alerts, on-line information and will also be able to contact their practice nurse (who will be able to see their blood pressure record on the internet) via telephone or email. They will not have to visit the practice for routine blood pressure checks. It is anticipated that this will provide increased motivation and facilitation for individuals to improve self-care. The intervention will also work at a professional level. Professionals will have remote access at any time to a reliable estimate of average blood pressure. There has been little investigation of the impact of the difficulty in estimating average blood pressure from surgery measurements on professional practice, but logic suggests it is likely to make professionals more cautious – waiting for a few more readings before suggesting changes to treatment. The availability of the home monitoring results may give professionals more confidence in their assessment of the effectiveness of the patient’s self-care and medication and lead to effective regimens being established more quickly. The literature suggests that this approach is likely to be effective. Supporting self monitoring would require major changes to the way in which primary health care providers interact with patients and there is also concern within the medical literature that home blood pressure monitoring may make some people more anxious4. However, the published evidence on the benefits and drawbacks of home HITS: Hypertension Protocol Version 2 16/12/2008 4 blood pressure monitoring is still limited, particularly for longer term monitoring. Our pilot study, carried out in a deprived area, comparing surgery and home monitoring with ambulatory monitoring suggested that; people find home monitoring easy, it does not increase anxiety, it increases the accuracy of average blood pressure estimation and, provides motivation for some people to improve self care. However, this was a short term study involving 90 patients and a larger, longer term, trial is now needed. 2. Aims To carry out a randomised controlled trial of a primary care based, nurse-led telemetric home blood pressure monitoring service, measuring the effect on blood pressure control and other cardiovascular risk factors and exploring the impact of a different model of service on patients and health care providers. 3. Research Questions 3.1. Is there any reduction in average blood pressure and other specific cardiovascular risk factors in the group using the telemetric home blood pressure monitoring service compared to a control group that receive usual care? 3.2. Is there any difference in adherence to lifestyle advice (smoking, diet, alcohol and salt intake, exercise) compared with a control group? 3.3. Is there any difference in the number and type of contacts with primary care amongst the group using telemetric home blood pressure monitoring compared with a control group? 3.4. What are people’s experiences and opinions of this service including impact on behaviour, mood, positive and negative experiences and change in relationship with their health care provider? 3.5. What are health care providers’ experiences and opinions of this service? 4. Outcome Measures Outcome measures - Primary outcome: average daytime systolic BP at 6 months measured by ambulatory monitoring. Secondary outcome: average diastolic BP, surgery measured BP, serum cholesterol, body mass index, breath carbon monoxide, spot urinary sodium/creatinine ratio, HbA1c, self-reported alcohol intake and smoking, anxiety and depression (HADS)15, quality of life (euroqol)27, selfefficacy (short version)16 and medication adherence17, grip strength, self - reported exercise frequency18, self-reported exercise tolerance19, number of attendances at practice nurse, GP, accident and emergency and out of hours care, prescriptions for anti-hypertensives taken from GP practice records, number of telephone / email contacts with practice nurses and GPs. 5. Methods 5.1. Sample Setting: At least 5 socially diverse practices, representing a spread of social groups and local resources, will be recruited via the Scottish Primary Care Research Network. The practices recruited will all already have nurse-led hypertension clinics run either by nurse prescribers or by non-prescribers in practices with a robust protocol based on the Lothian Hypertension Guideline for arranging changes to medication. Training for the practices will be provided by the researchers. HITS: Hypertension Protocol Version 2 16/12/2008 5 Participants: 400 patients will be recruited from the five practices. Practice hypertension registers will be searched for potentially eligible patients and the list generated will be checked by GPs for exclusion criteria not readily available from the electronic record. Inclusion: • On practices’ hypertension registers • Aged over 18years • Last recorded surgery blood pressure over 145 mmHg systolic or 85 mmHg diastolic Exclusion: • Secondary hypertension • Hypertension or renal disease being managed in secondary care • On practice stroke register (will be included in separate study) • Treatment for cardiac event, or other life-threatening illness within the past 6 months or surgery within the last 3 months • Unable to consent • Unable to use self-monitoring equipment • Atrial fibrillation • Patients with diabetes will also be excluded from this trial because they have different blood pressure targets and excluding them will simplify the initial introduction of the home monitoring service for GPs and practice nurses • Pregnancy • Daytime ambulatory blood pressure <135/85 mmHg Sample size We plan to recruit approximately 80 patients from each practice (n=400) to ensure 2 final group sizes of over 155. The proposed sample size is based on the mean daytime ambulatory systolic BP measured at the end of our pilot work on home monitoring. This had a standard deviation of 14 mmHg and an average systolic BP of 142 and provides a reasonable assumption for the care as usual group in this trial. To give 80% power to identify a difference between intervention and control of 4.5 mmHg in systolic BP in a 2-tailed test with alpha set at 0.05, 155 patients per group will be needed, and thus the total number of patients required is 310. The figure of 4.5mm Hg difference in systolic blood pressure was chosen because previous RCTs of patient management interventions have tended to show reductions in mean systolic or diastolic blood pressure of about 4.5-5 mmHg and 3 mmHg respectively (about 3%)14. In an earlier study25 60% of patients on a practice hypertension register agreed to take part and 82% were retained within the trial and we anticipate similar recruitment and retention rate in this study. To allow for drop outs and ensure that the study is well powered to detect this level of change, 200 patients will be recruited to each group. However, every effort will be made to maximise retention. Patients may wish to stop using the intervention whenever they wish but will be encouraged to have their follow-up data collected at the end of the trial regardless of their usage. HITS: Hypertension Protocol Version 2 16/12/2008 6 5.2. Recruitment Potentially eligible patients will be sent the study materials by their general practice with a covering letter and asked to contact the researcher if they are interested in participating. Feasibility. Recruitment will be staged across practices to avoid overloading practice staff. We intend to recruit around 15 patients a month, over six months, from each of the five participating practices. 5.3. Consent and screening Once a patient has indicated interest in participating they will be invited to a clinic in their GP’s surgery run by the Wellcome Trust Clinical Research Facility research nurses (two appointments on consecutive working days). At the first appointment the nurse will go through the study information with the patient, check eligibility, take written informed consent, ask the patient to complete a short questionnaire on their past and current self monitoring of blood pressure and initiate 24 hour ambulatory blood pressure monitoring using the Spacelab Ambulatory Blood Pressure Monitor21. The patient will be asked to return with the ambulatory monitor the following day. Their average daytime ambulatory BP will be checked for proper recording, but not released to the patient or practice (in order to reduce the risk of contamination – see below for further detail) unless • It is below 135/85mmHg in which case the patient will not be eligible for randomisation. • It is above 210/135mmHg in which case arrangements will be made for the patient to see a doctor and they will not be randomised. 5.4. Baseline measurements At baseline all participants will • Have height and weight, BP measured electronically (using (Stabil-OGraph20 device) after a five minute rest, using an appropriately sized cuff on the non-dominant arm), three times and an average of the second and third taken, • Have exhaled carbon monoxide measured, • Have blood taken for cholesterol , HbA1c • Be asked to provide a fasting urine sample for sodium/ creatinine ratio26* • Be asked to complete questionnaires on exercise frequency18 and tolerance19 questionnaire and have their grip strength measured. • Be asked to complete a Hospital Anxiety and Depression Score questionnaire15, a quality of life questionnaire27, a self efficacy questionnaire (short version)16, a medication adherence self-report scale17 and smoking and alcohol history. Body mass index (derived from weight in kg divided by height in metres squared) and the surgery measured blood pressure will be entered into the patients’ general practice record and a list given to the practice nurse so that she can decide whether to take further action based on the data which would have been collected at a routine clinic. The practice will have access to the lab results via the SCI lab system. The other data collected will not be released to the practice. HITS: Hypertension Protocol Version 2 16/12/2008 7 *the sodium/creatinine ratio will be available to the practice via the SCI lab system, but a spot measure is not of use for individual patient management –aggregated group data will be used to identify changes in salt intake. 5.5. Randomisation Following confirmation of eligibility the patient will be randomised using a telephone service run by Edinburgh Clinical Trials. We will use minimisation including a random element. Minimisation will be based on age, sex, practice, three or more hypertension drugs used and blood pressure self-monitoring history (never, occasionally, regularly). The patient will be informed of the randomisation. The allocated treatment code will be generated by the Edinburgh Clinical Trials Unit. Randomisation will be performed by telephone. 5.6. Blinding The end-point data will be collected by a different research nurse and he/ she will be blinded to the patient allocation group. Patients will be asked not to reveal which group they are in or return their equipment until the final ambulatory blood pressure monitoring has been carried out. The research nurses will be asked to report if they have been unblinded prior to this. 5.7. Intervention Patients in the intervention group will be given blood pressure monitors (Stabil-OGraph20) which use Bluetooth to transmit readings via a (supplied) mobile phone to a remote server. The user may securely access their record on the server at any time (either at home if they have internet access, or in a library or other public internet access point). Their GP and practice nurse will also be able to access this record via the internet. Users will also receive regular automated text or email feedback (or both if they wish) based on the reading they just sent and their rolling average blood pressure over the past 10 readings. The system can be set to provide reminders to check blood pressure and alerts to both the user (via the mobile phone) and the GP practice (via email) when the rolling average blood pressure remains high. If an individual user is unable to use text or email, it will be possible to arrange for feedback and alerts to be printed in the practice and posted to them or a voicemail system to be used. Users of this service will be trained in its use and the demonstration will be backed up by written information. The written information will also contain suggestions about initiating or maintaining lifestyle changes and how long it is likely to be before any lifestyle or medication change will have an impact on their rolling average blood pressure. The suggested lifestyle changes will include weight control, reducing salt in the diet and increasing physical activity. The user will also be given telephone and email contacts for the practice nurse and encouraged to make contact by email or by telephoning at specified times if their blood pressure remains high, to discuss future treatment. In the event of a very high blood pressure patients will be asked to repeat it once and if it remains high advised to contact their practice urgently. Practice nurses will be encouraged to review weekly the alerts they are sent about patients whose blood pressure remains high or who have not checked their blood pressure within the agreed time frame. They may choose to contact the patient to offer further treatment or support and will be asked to record such contacts in the practice electronic record. The practice nurses will also formally review each record at an agreed time to transfer the current average blood pressure into the primary care record. HITS: Hypertension Protocol Version 2 16/12/2008 8 Users will be encouraged to check their blood pressure 10-20 times over the first seven days to establish a reliable average and then about 4 times a month if their average blood pressure is at or below the target of 135/85 mmHg. If blood pressure is above the target and any changes to lifestyle or medication are made, the users will be asked to undertake another more intensive period of monitoring (10-20 readings over seven days) after an appropriate time (usually 3-4 weeks depending on medication change) in order to establish the impact on the rolling average blood pressure. The guidance will not be restrictive – this tool is being provided for patients to use to better understand their blood pressure and manage their own health. Within GP practices, no additional infrastructure is required, but practice nurses will need to set aside some time to answer telephone/ text/ email queries from patients, with access to the records on the remote server. This time should be offset by a reduction in face to face consultations for blood pressure checks. This way of working represents a major change for practice nurses in that it is the patient who knows what their blood pressure is, decides when to recheck it and decides when to contact a professional. Control Group The control group will also be given written information on lifestyle changes, but otherwise will receive care as usual. Both groups Will be medically managed following a protocol based on the Lothian Hypertension guidelines (Appendix A) with additional guidance on timing of treatment changes based on home monitoring data for the intervention group (Appendix B) 5.8. Duration of Intervention 6 months 5.9. Follow up measurements The baseline measures (excluding height) will be repeated at the end of the 6 month intervention period 5.10. Data management and analysis Data will be entered from questionnaires and paper records by the trial manager.with 10% checked for accuracy. If we detect systematic errors we will re-enter all the data. Data analysis will be carried out by the Edinburgh Clinical Trials Unit, supervised by Dr Steff Lewis. Analysis will be on a modified intention to treat basis. In the primary analysis we will remove patients with missing outcome data, but will perform sensitivity analyses to investigate the effect of this. Binary outcomes will be presented both as relative and absolute risk reductions. For blood pressure, and other normally distributed measurements that are taken at baseline and follow-up, the baseline measures will be adjusted for using analysis of covariance. For the primary outcome, subgroup analyses will be performed based on age, sex and socioeconomic status (determined by post-code). These factors may all reasonably be hypothesised to affect the uptake of the intervention. Subgroup analyses will be performed by adding the interaction between these factors and treatment into the HITS: Hypertension Protocol Version 2 16/12/2008 9 analysis of covariance model and observing whether the fit of the model is statistically significantly improved. 5.11. Qualitative study A sub sample of participants in the randomised controlled trial and screening study will be recruited to the nested qualitative study. Twenty participants from the intervention group and 5-10 from the screening group will be recruited for semistructured interviews plus a further 10-12 for two focus groups. The purpose of the focus groups will be to allow the group to explore shared ideas and experiences relating to hypertension and their experiences in managing it. The interviews with individuals will cover similar subjects but will allow private discussion of issues such as not using medication in the prescribed way (which people may not be willing to discuss in a public situation). A maximum variation sample in relation to age, social class, ethnicity (if ethnicity varies sufficiently between participants) and blood pressure control at recruitment, plus level of use of the system will be sought. If possible, interviews will also be sought with patients who develop additional health problems during the trial to explore how this affects their views and use of the system. Interviews will seek to investigate participants’: understandings of hypertension, its control and the contribution of lifestyle factors; how these understandings of hypertension relate to their management of the condition on a day to day basis including manipulation of medication. In addition, the interviews with the intervention group will investigate participants’ perceptions of the benefits (or otherwise) of the intervention, experiences of implementing and maintaining it and the barriers and facilitators they have experienced. The semi structured interviews will explore participants’: understandings of hypertension, its control and the contribution of lifestyle factors; managing the condition on a day to day basis including manipulation of medication; perceptions of the advantages and disadvantages of using the system; experiences of implementing and maintaining the intervention including barriers and facilitators; attitudes towards their own health more generally. The interviews will be tape-recorded and fully transcribed. For the purpose of this study the transcripts will be read repeatedly and coded for analysis. Anticipated themes include: anxiety about raised blood pressure, reassurance, encouragement to adhere to beneficial lifestyle and drug therapy, inconvenience and sense of control, Researchers will also specifically search for emergent, unanticipated themes. Constant comparison (checking experiences against those of others in the sample) will ensure that the thematic analysis represents all perspectives and negative cases will be sought. Health care providers’ experience of the new service will be elicited by taped discussions/ interviews in each participating practice. 6. Exit strategy It will be clear in the study information that the patient will be expected to return the equipment after 6 months and that their practice will not be able to support this type of service outside the trial. 7. Risk management strategy The main risks associated with this study are data security within the telemetry system, contamination between the intervention and control groups, home monitoring HITS: Hypertension Protocol Version 2 16/12/2008 10 resulting in the identification of problems (eg extremes of blood pressure measurement or onset of atrial fibrillation) which need intervention and create excess workloads for practices, and equipment failures. Data security within the telemetry system: The only identifiable data variable which is sent via the internet is the serial number of the blood pressure monitor. This is used for the patient log in (although the patient can associate a nickname with the log in to make it easier). Client software on the GP surgery server stores the patient names and contact details and downloads the patients’ measurements from the internet for use within the practice. Contamination between the intervention and control groups: The decision to randomise at the patient rather than the practice level avoids the methodological difficulties associated with cluster randomisation but raises the possibility of contamination – the research also affecting the way patients in the control group are treated. This has been considered carefully and two potential forms of contamination identified. 1. The ambulatory monitoring at the start of the study will provide professionals with a much more reliable estimate of average blood pressure than they normally have available and may lead to intensification of treatment in the control group. It was therefore decided that the results of ambulatory monitoring will not be released to the practice unless they show a very high daytime ambulatory blood pressure which it would be ethically unacceptable to withhold. However, it will be clear from the fact that the patient is eligible that their blood pressure is uncontrolled and this should be confirmed by the surgery blood pressure performed at the initial attendance. 2. If the new model of care appears to be effective, professionals may try more intensive monitoring and treatment for the control group. However, we think this is unlikely. The control group (40 patients) will only form a small proportion of the hypertensive patients in each practice (about 800 is typical). Increasing the intensity of monitoring and treatment change without the home monitoring service would require a lot of additional appointments. Also, the control group will have been recruited and assessed by the research nurses so, although the practice nurses will not formally be blinded to the fact they are in the study, they will not be particularly aware of them. As an additional check, data on patient contacts for 6 months prior to the study will be collected to see if there is a major change during the study. Home monitoring revealing problems which need intervention: It is possible that home monitoring may reveal something which, now it is known, is of concern. This could include very high blood pressure (very high average blood pressure is unlikely given the ambulatory monitoring at the start of the study, but single high readings will occur), low blood pressure causing symptoms or the patient being unable to record his/her blood pressure (possibly because of the onset of atrial fibrillation). The written information will tell the patient what to do in each instance and the patient will also be sent an automated alert via the system advising them what to do. Any adverse events will be recorded by GPs on a form and this will be entered onto the database. These will be monitored monthly and reported to the trial steering committee as a standing item. Excess workloads for practices: It is not envisaged that, when fully operational, the home monitoring service will involve any more work for practices than the current system. Although some patients will require more attention, this will be offset by avoiding the need for many patients to attend the surgery for routine blood pressure checks. However, in the context of this trial, the rapid recruitment of 40 patients with poor blood pressure control to the home monitoring service could cause problems. HITS: Hypertension Protocol Version 2 16/12/2008 11 Therefore the research nurses will move between the practices, recruiting a few patients from each practice at a time. Equipment failures: There is no maintenance contract for the equipment loaned to the patient - non functioning blood pressure monitors and phones will be replaced from a small stock held by the trial manger. The functioning of the system will be audited by checking the online records of at least 10% of users against the stored values in their blood pressure monitors. 8. Project Team and Task allocation • • • • • The overall project will be led by Dr Janet Hanley The trial will be led by Dr Brian McKinstry with the support of Edinburgh Clinical Trials. Dr McKinstry will line manage the trial manager who will be employed by Edinburgh University. The qualitative study will be led by Dr Janet Hanley who will line manage the qualitative researcher and project secretary who will be employed by Napier University. Statistical support will be provided by Dr Steff Lewis Research nurses will be employed through the Wellcome Trust Clinical research Facilities in Edinburgh 9. Project management and quality assurance • • • • • • The project team, consisting of grantholders and research staff, will meet monthly. There will be a weekly meeting between the lead researchers and Edinburgh Clinical trials to discuss the progress of the whole programme, including this study The project will be overseen by the independent programme steering group. which will comprise the chief investigator; an independent chairperson; the applicants, trial staff and representatives of the funding body; and a patient representative (if possible). Three experienced trialists have agreed to oversee the individual RCTs for the telehealth programme of which this trial is a part, although separately funded; Professor Chris Griffiths (COPD trial) Professor Lewis Richie (hypertension and stroke), and Professor AnneLouise Kinmonth (diabetes). The study will be carried out to GCP standards and managed within the Research Governance Framework. Ethical approval will be sought via the National Research Ethics Service and management approval from NHS Lothian. The Independent Trial Steering Committee will take on the role of a data monitoring committee. Adverse events will be analysed on a regular basis and where necessary the ITSC will be empowered to terminate the study should there be any safety concerns to ensure the rights and well being of the trial participants. If examination of unblinded data is required to make a decision about the continuation of the study for any reason then an experienced independent trial statistician will be appointed to review the data and advise the committee. Timescale HITS: Hypertension Protocol Version 2 16/12/2008 12 10. Reporting Six monthly progress reports and a final report will be provided to the funder in the format required. Reports will also be provided as required for the programme management group, steering group and data monitoring committee. 11. • • • • • 12. Finance The project is funded by a specialist grant from the BUPA foundation. This award does not include university full economic costs. University overheads are provided through the AMRC scheme. The funding is managed by Napier University There will be a service level agreement between Edinburgh and Napier Universities for the clinical trial activity to be carried out by Edinburgh University Support for science costs will be sought from NHS Lothian to recompense GP practices for time spent setting up this study including record searches and review and training There will be service level agreements with the Wellcome Trust Clinical Research Facility and Scottish Primary Care Research Network for their contribution to the study References 1. Prospective studies collaboration (2002). Age specific relevance of usual blood pressure to vascular mortality: a meta analysis of individual data for 1 million adults in 61 prospective studies. The Lancet; 360:1903-1913 2. Health Survey for England: Cardiovascular Disease 1999. The Stationary Office: London 3. Collins R, Peto R, MacMahon S, et al. Blood pressure, stroke and coronary heart disease. Part 2, short-term reductions in blood pressure: overview of randomised drug trials in their epidemiological context. Lancet 1990;335:827-838. 4. Essential Hypertension: managing adults in primary Care. Centre for Health Services Research, University of Newcastle upon Tyne. 2004 5. ISD Scotland Scottish Health Statistics 2004 http://www.isdscotland.org/isd/info3.jsp?pContentID=3687&p_applic=CCC&p_service=Co ntent.show& Last accessed 19.7.2006 6. Chobanian A, Bakris G, Black H, Cushman W et al. Detection, evaluation and treatment of blood pressure (The JNC Report). JAMA 2003; 289:2560-72 7. Scottish Executive. Delivering for Health, Scottish Executive, Edinburgh 2005 8. Messerli, FH Williams B, Ritz E. Essential Hypertension. Lancet 2007;370:591-603 9. http://www.mtbeurope.info/news/2007/701030.htm 10. Little P, Barnett J, Barnsley L, Marjoram J, Fitzgerald-Barron A, Mant D. Comparison of agreement between different measures of blood pressure in primary care and daytime ambulatory monitoring. BMJ 2002, 325:254-230 HITS: Hypertension Protocol Version 2 16/12/2008 13 11. Pickering T, Hall JE, Lawrence J et. al. Recommendations for blood pressure measurement in humans and experimental animals Part 1:Blood pressure measurement in humans. Hypertension 2005;45:142-161 12. National Institute for Health and Clinical Excellence. NICE guideline CG034: Management of hypertension in adults in Primary Care. NICE, London 2006 13. http://www.ic.nhs.uk/services/qof 14. Fahey T, Schroeder K, Ebrahim S. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD005182. DOI: 10.1002/14651858.CD005182.pub3 15. Zigmond A, Snaith R. The hospital anxiety and depression scale. Acta Psychiatrica Scandinavia 1983; 67:361-370. 16. Stanford Self-Efficacy for Managing Chronic Disease Scale. Source reference. Lorig KR, Sobel, DS, Ritter PL, Laurent, D, Hobbs, M. Effect of a self-management program for patients with chronic disease. Effective Clinical Practice, 4, 2001,pp. 256-262. 17. Morisky Donald E., Green Lawrence W. and Levine David M. Concurrent and Predictive Validity of a Self-Reported Measure of Medication Adherence Medical Care, Vol. 24, No. 1 (Jan., 1986), pp. 67-74 1 18. Isaacs AJ, Critchley JA, See Tai S, Buckingham K, Westley D, Harridge SDR, Smith C, Gottleib J. Exercise evaluation randomised trial (EXERT). Health Technology Assessment 2007; 11 no 10. 19. Myers J, Bader D, Madhaven R, Froelicher V. Validation of a specific activity questionnaire to estimate exercise tolerance in patients referred for exercise testing. American Heart Journal 2001. 142:1041-6 1 20. Westhoff TH, Schmidt S , Zidek W, van der Giet M. Validation of the Stabil-O-Graph blood pressure self-measurement device Journal of Human Hypertension 22: 233–235, 2008 21. O'Brien E, Mee F, Atkins N, O'Malley K. Accuracy of the Spacelabs 90207 determined by to the British Hypertension Society Protocol. J Hypertens 1991;9(suppl 5):S25-S31 22. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth A-L, Neil A. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ; 335: 132-6, 2007 23. Peel E, Douglas M, Lawton J. Self monitoring of blood glucose in type 2 diabetes: longitudinal qualitative study of patients' perspectives. BMJ 2007;335:493 24. Pare G, Jaana M, Sicotte C. Systematic review of home telemonitoring for chronic diseases: the evidence base. J Am Med Inform Assoc 2007;14:269–77 25. McKinstry B, Hanley J, McCloughan L, Heaney D, Webb D. Impact on hypertension control of patient-held guideline; a randomised controlled trial. Accepted Br J Gen Pract 2006 26. http://www.foodstandards.gov.uk/multimedia/pdfs/scotlandsodiumreport.pdf 27. Brooks R, Rabin R, de Charro F, (eds): The Measurement and Valuation of Health Status Using EQ-5D: A European Perspective: Evidence from the EuroQol BIO MED Research Programme.Rotterdam: Kluwer Academic Publishers; 2003 HITS: Hypertension Protocol Version 2 16/12/2008 14 Appendix A See “Lothian Hypertension Guidelines 2005” HITS: Hypertension Protocol Version 2 16/12/2008 15 Appendix B Protocol for managing blood pressure in patients where home monitoring permits rapid escalation of treatment. This rapid treatment protocol is base on the Lothian Hypertension guidelines with the addition of timing suggestions and one change. The addition of a thiazide which is an optional first step in the Lothian Hypertension guideline (and also the NICE hypertension guideline) is delayed until step 3 because thiazides take some weeks to show an effect. Treatment steps if control not achieved Step 1
Dose titration After 2 weeks
Step 2 After a further 2 weeks
Dose titration After a further 2 weeks After a further 2 weeks After a further 4 weeks (thiazides take longer to work) After a further 4 weeks Calcium Channel Blocker or ACE inhibitor depending upon age (> 50 CCB) – low dose After 2 weeks dose titration of first drug (e.g. 5 to 10 mgs amlodipine or 10 to 20 mgs lisinopril) Calcium Channel Blocker and ACE inhibitor After 2 weeks dose titration of second drug (e.g. 5 to 10 mgs amlodipine or 10 to 20 mgs lisinopril)
Step 3 Add a thiazide
Step 4 Add a ß blocker or spironolactone
Step 5 Add whichever of step 4 had not been added HITS: Hypertension Protocol Version 2 16/12/2008 16 Appendix C Theoretical framework for Telehealth studies The technologies being trialled in this programme enable frequent self monitoring, organisation of the resultant data, and sharing of the data between patients and healthcare professionals in a way which has not been previously available in Primary Care. This is a complex intervention involving the following elements: • Self monitoring. Although everyone monitors their own health, for most of the patients involved in this trial, formal measurement of symptoms and vital signs will be new to them – it was previously the responsibility of healthcare professionals. The exceptions will be blood glucose measurement for the diabetic patients and blood pressure monitoring for the 30% of patients who are expected to have purchased their own home monitors. • The information itself. In most cases the parameters of interest have not been frequently monitored so the data, in conjunction with the way in which it is organised and shared, provides novel information about the condition to the patients themselves and to healthcare professionals. • The organisation of the data. The systems used in these trials are able to organise and display the data provided in different ways eg an average blood pressure. They also provide a level of interpretation of the data based on predetermined parameters. • Automated feedback and reminders. The systems used in this trial are able to provide reminders and automated feedback for patients, which will not have been previously available to them • The way in which the data is shared and used. The data record will be almost instantly available to both patients and healthcare professionals. It is hypothesised that the impact will be on three levels – the information will assist and encourage the patient to improve their own self-care, it will facilitate clinical decision making, and both will be enhanced by the new channels of communication between patients and health care providers. The intervention is congruent with the self-care models described by Glasziou et al and Kennedy et al. The theoretical model developed by Glasziou et al. describes the complementary and evolving roles of periodic professional reviews and on-going patient self-monitoring. 1 A newly diagnosed condition is assessed and brought under control with professional support, before the patient assumes responsibility for self-management as the stable maintenance phase is established. HITS: Hypertension Protocol Version 2 16/12/2008 17 The context for the tele-monitoring trials is the maintenance phase where patients are monitoring a relatively stable situation, and expected to act (either by initiating treatment, or seeking appropriate professional advice) if measurements fall outside pre-defined limits. In COPD patients often have difficulty distinguishing the onset of an exacerbation from a ‘bad day’2,3and one possible mode of action is that telemonitoring will define exacerbations more clearly and increase patient’s confidence to commence treatment promptly. Kennedy argues for a whole systems approach to the provision of effective support for self-care. Tele-monitoring may impact at each of these three levels: 1. Patients may improve their knowledge and understanding of their condition as they monitor and receive timely and relevant feedback on their situation. 2. Professionals may feel more confident to offer self-management within the structure and on-going supervision of tele-monitoring 3. Access to services may be facilitated by the tele-monitoring as patients become more confident when they need help and advice and with the easy sharing of monitoring data. HITS: Hypertension Protocol Version 2 16/12/2008 18 The anticipated outcomes are dependant on changes to behaviour - both patients and professionals successfully using the equipment and changing the way they manage the long term conditions being monitored. However, the way people act when they come into contact with an innovation does not always appear logical. There is a large literature on both the diffusion of innovations literature and health behaviour change, both underpinned by social learning theory4 which suggests people’s perceptions of a situation determine how they behave. Factors likely to influence this include • • • • self-efficacy, or belief in one’s ability to perform a behaviour5 Perceived benefits weighed against perceived barriers to the action6,7 Perceptions of the attitudes of important others to the behaviour6,8 Reinvention and identity6, 9 The diffusion of innovations6 is the most comprehensive descriptive model how new technologies (including behaviours) are adopted. It includes the pattern in which an innovation spreads through a social group, a comparison of characteristics of those who adopt the innovation at different stages of its spread, and a staged model of the innovation-decision process (knowledge, persuasion, decision, implementation, confirmation), which an individual goes through when deciding to adopt or reject an innovation. Factors which may influence this process include the mode of communication (e.g. the presence of a change agent), prior conditions (including previous practice, felt needs and problems, innovativeness and norms of the social system), perceived characteristics of the innovation, disruptive or competing technologies or path dependence which may lock other technologies in place. A (self) criticism of this model6 is that it does not explain why individuals adopt or reject particular innovations at an early stage, sometimes seemingly irrationally. A related, but more explanatory model, the technology transfer communication and feedback model7 suggests that much of the unpredictability in the adoption of new technologies arises because individuals do not share a common perception of it or their need for it. It introduces the concepts of technology push, which is based on the perceived merits of the new technology, and market pull, which is the perceived need for the new technology, both being required for the successful transfer of the new technology into practice. Because of the complexity of the intervention, the explanatory aspect of this programme will be qualitative and involve interviews, focus groups and observation with patients, professionals, carers, and service planners. It will explore prior perceptions and conditions, the experience of using the system, and changes to perceptions and behaviour. The initial topic guides and data coding frame will based on the factors identified by the diffusion of innovations, social learning theory and our pilot work, but will be developed iteratively and open to new approaches. The exception to the qualitative approach will be that patients will be asked to complete a quantitative measure of self-efficacy in chronic disease10. This is a widely used scale and will give some comparability with other research. A major aim of the qualitative work will be to explore the apparent paradox or tension in this service model where the aim is to increase self-care, but the model also increases professional surveillance of the patient. Our qualitative pilot work with hypertensive patients showed that even patients who were very committed to self-management welcomed this, but was not detailed enough to explain why. Work by Jane Ogden in the field of obesity management has also highlighted this paradox – that interventions which apparently take some control away from patients can result in their feeling of overall control HITS: Hypertension Protocol Version 2 16/12/2008 19 increasing11. These are important issues in a policy context which advocates increasing self-care. 1 Glasziou P, Irwig L, Mant D. Monitoring in chronic disease: a rational approach. BMJ 2005;330:644-8 2 Adams R, Chavannes N, Jones K, Subbe-Ostergaard M, Price D Exacerbations of chronic obstructive pulmonary disease - a patients' perspective . Prim Care Respir J 2006; 15: 102-9 3 Calverley P, Pauwels R, Lofdahl G-G, Svensson K, Higenbottam T, Carlsson L-G, Stahl E. Relationship between respiratory symptoms and medical treatment in exacerbations of COPD. Eur Respir J 2005; 26: 406-413 4Bandura A (1977) Social Learning Theory, Prentice-Hall, Englewood Cliffs, New Jersey 5Bandura A (1986) Social Foundations of Thought and Action – A Social Cognitive Theory. Prentice-Hall, Englewood Cliffs, New Jersey 6Rogers E (2003). Diffusion of Innovations, 5th Edition, Macmillan, London 7Williams F, Gibson DV. Technology Transfer: A Communication Perspective. Sage, Newbury Park 1990 8 Mittman BS, Tonesk X, Jacobson PD. Implementing Clinical Practice Guidelines: Social Influence Strategies and Practitioner Behaviour Change. Quality Review Bulletin 1992; 18: 413-422 9Ogden J, http://www.dhp2007.org.uk/document-download-area/document-download$.cfm?file_uuid=F9AEFFB01143-DFD0-7EA4-7FB84D95F79C&ext=doc 10Stanford Patient Education Research Center. Self-Efficacy for Managing Chronic Disease 6-Item Scale. http://patienteducation.stanford.edu/research/secd6.html 11 Ogden, J., Clementi, C., Aylwin, S., Patel, A. (2005) Exploring the impact of obesity surgery on patient’s health status: a quantitative and qualitative study. Obesity Surgery, 15, 266-272. HITS: Hypertension Protocol Version 2 16/12/2008 20 HITS: Hypertension Protocol Version 2 16/12/2008 21 HITS: Hypertension Protocol Version 2 16/12/2008 22