full final report full final report

Click here to load reader

Post on 11-Sep-2021

2 views

Category:

Documents

0 download

Embed Size (px)

TRANSCRIPT

e4530ea6-86bd-4e02-b5fb-69058f6f9728.pdfIncreasing Community Pharmacy Involvement in the Prevention of Cardiovascular Disease
Researchers: A/Prof Kay Stewart (Chief Investigator), Dr Johnson George, Dr Shane L Jackson, Prof Gregory M Peterson, Prof Jeffery D Hughes, Kevin P Mc Namara, A/Prof Michael J Bailey, Dr Arthur Hsueh, Jenny McDowell, Dr Luke Bereznicki, Peter Gee
THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING
AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT
FULL FINAL REPORT
Acknowledgements
We would like to acknowledge the excellent work throughout this project of Dr Rosalind Lau (Project Manager, Monash University), Dr Diana Bortoletto (Research Fellow, Monash University), Thomas Donovan (Project Officer, Monash University), Elsamaul Elhebir (Research Assistant, Curtin University of Technology), Angus Thompson (Project Officer, University of Tasmania) and Jill Finch (Research Assistant, University of Tasmania).
We are also grateful to:
• the pharmacists involved in the project for their commitment to the project
• the patients for their participation in the project
• the GPs for their involvement in the project
• the Project Advisory Panel for their valuable contributions at various stages of the project
Bill Kelly The Australian Association of Consultant Pharmacy
Paul Feldman Department of Health and Ageing
Toni Riley The Pharmacy Guild of Australia
Julianne Drewitt The Pharmacy Guild of Australia
Maxine Goodman Pharmaceutical Society of Australia
Mary Collins Australian General Practice Network
Vicky Cogley The National Heart Foundation
Sheila Rimmer Consumer Representative
• Alex Zhang, research assistant to Dr Arthur Hsueh, Centre for Health Policy, Programs and Economics, The University of Melbourne, for undertaking economic cost analysis associated with the project
.
This report was produced with the financial assistance of the Australian Government Department of Health and Ageing. The financial assistance provided must not be taken as endorsement of the contents of this report.
The Pharmacy Guild of Australia manages the Fourth Community Pharmacy Agreement Research & Development which supports research and development in the area of pharmacy practice. The funded projects are undertaken by independent researchers and therefore, the views, hypotheses and subsequent findings of the research are not necessarily those of the Pharmacy Guild.
3
BP Blood pressure
CHD Coronary heart disease
CMI Consumer Medicine Information
EOI Expression of interest
HCG Hidden Control Group
HMR Home medicines review
LYs Life-years
NHMRC National health and Medicine Research Council
PBS Pharmaceutical Benefits Scheme
PCG Pharmacist Care Group
QALYs Quality Adjusted Life Years
QoL Quality of life
RCT Randomised controlled trial
TABS Tool for Adherence Behaviour Screening
UCG Usual Care Group
WTP Willingness to pay
antihypertensive blood pressure lowering
blood pressure the force of blood pressing against the walls of the blood vessels (arteries) delivering oxygen-rich blood from the heart to all parts of the body
cardiovascular disease any disorder affecting the ability of the heart or blood vessels to function normally
cardiovascular event a severe or acute condition relating to the heart or blood vessels, including the following: myocardial infarction, stroke, transient ischaemic attack, peripheral vascular disease, angina and congestive heart failure
co-morbidity the presence of one or more conditions (or diseases) in addition to a primary disease or disorder
coronary atherosclerosis thickening and loss of elasticity of the coronary arteries, leading to progressive insufficiency of the arteries (coronary heart disease)
coronary heart disease a condition of the heart caused by narrowing of the blood vessels that supply the heart muscle
diastolic BP the pressure in the arteries when the heart is at rest
heart failure inability of the heart to pump enough blood to sustain normal bodily functions
hypertension high blood pressure
medicines adherence the extent to which a person takes their medicine in accordance with agreed recommendations from a health professional
primary care essential healthcare made available in the community as the first contact in the medical management of a condition
stroke the sudden death of some brain cells due to a lack of oxygen when the blood flow to the brain is impaired by blockage or rupture of an artery to the brain
syncope a transient loss of consciousness and postural tone caused by diminished blood flow to the brain
systolic BP the pressure in the arteries when the heart contracts
unstable angina a form of pain that is prodromal to acute heart attack and typically has a sudden onset, sudden worsening, and stuttering recurrence over days and weeks
5
Phase 2 Stakeholders Focus Groups and Interviews ............................................................................................... 16
Aim ...................................................................................................................................................................... 16
Methods .............................................................................................................................................................. 16
Results ................................................................................................................................................................ 16
Limitations ........................................................................................................................................................... 27
Discussion ........................................................................................................................................................... 27
Conclusion .......................................................................................................................................................... 28
Phase 3 Intervention Phase: Hypertension Adherence Program in PharmacY (HAPPY) Trial ................................ 29
Research objective and research questions ....................................................................................................... 29
Primary outcome measures ................................................................................................................................ 29
Secondary outcome measures ........................................................................................................................... 29
Results – Randomised Control Trial ................................................................................................................... 37
Pharmacies .................................................................................................................................................... 37
Patients .......................................................................................................................................................... 42
Changes to key parameters at three months (PCG group only) ................................................................... 45
Changes to key parameters at six months .................................................................................................... 45
Hidden Control Group .................................................................................................................................... 55
Phase 4 Stakeholders Post-trial Focus Groups and Interviews ................................................................................ 71
Aim ...................................................................................................................................................................... 71
Methods .............................................................................................................................................................. 71
Results ................................................................................................................................................................ 72
Limitations ........................................................................................................................................................... 77
Discussion ........................................................................................................................................................... 78
References .................................................................................................................................................................. 84
Appendix 1: Phase 1 - Systematic Review Search Terms and Criteria .................................................................... 91
Appendix 2: Phase 2 - Consumer Explanatory Statement ........................................................................................ 95
Appendix 3: Phase 2 - Pharmacist Explanatory Statement ....................................................................................... 98
Appendix 4: Phase 2 - General Practitioner Explanatory Statement....................................................................... 101
Appendix 8: Phase 2 - General Practitioner Consent Form .................................................................................... 110
Appendix 9: Phase 3 - Pharmacist Explanatory Statement ..................................................................................... 112
Appendix 10: Phase 3 - Pharmacy Eligibility Form.................................................................................................. 116
Appendix 11: Phase 3 - Assessment of Knowledge form (PCG) ............................................................................ 118
Appendix 12: Phase 3 - Assessment of Knowledge form (UCG) ............................................................................ 122
Appendix 13: Phase 3 – Evaluation of training form (PCG) .................................................................................... 124
Appendix 14: Phase 3 – Evaluation of training form (UCG) .................................................................................... 127
Appendix 15: Phase 3 - General Practitioner Letter and Faxback Form ................................................................. 130
Appendix 16: Phase 3 - Consumer Expression of Interest Letter ........................................................................... 133
Appendix 17: Phase 3 - Patient Eligibility Form ....................................................................................................... 135
Appendix 18: Phase 3 - Consumer Explanatory Statement .................................................................................... 137
Appendix 19: Phase 3 - Baseline Collection Data Form ......................................................................................... 141
Appendix 20: Phase 3 - Three-month Collection Data Form (PCG) ....................................................................... 152
Appendix 21: Phase 3 - Six-month Collection Data Form ....................................................................................... 156
Appendix 22: Phase 3 - Pharmacist Consent Form ................................................................................................ 167
Appendix 23: Phase 3 - Consumer Consent Form .................................................................................................. 169
Appendix 24: Phase 3 - Business Case Evaluation Form (PCG) ............................................................................ 171
Appendix 25: Phase 4 - Consumer Expression of Interest Letter ........................................................................... 173
Appendix 26: Phase 4 - Consumer Explanatory Statement .................................................................................... 176
Appendix 27: Phase 4 - Pharmacist Explanatory Statement ................................................................................... 179
Appendix 28: Phase 4 - General Practitioner Explanatory Statement .................................................................... 182
Appendix 29: Phase 4 - Consumer Focus Group/Interview Guide .......................................................................... 185
Appendix 30: Phase 4 Pharmacist Focus Group/Interview Guide .......................................................................... 189
Appendix 31: Phase 4 - General Practitioners Focus Group/Interview Guide ........................................................ 194
Appendix 32: Phase 4 - Consumer Consent Form .................................................................................................. 198
Appendix 33: Phase 4 - Pharmacist Consent Form ................................................................................................ 200
Appendix 34: Phase 4 - General Practitioner Consent Form .................................................................................. 202
Logos ........................................................................................................................... Error! Bookmark not defined.
7
Hypertension in Australia
In 2004-2005, the prevalence of high blood pressure (known as hypertension) in Australia was 10% 1 . In 2003,
hypertension accounted for 7.6% of the total burden of disease in Australia 2 and was responsible for the greatest
amount of burden in the 65 years or over age group in both males and females 3 .
Risk factors
The link between blood pressure control and health outcomes is clearly established. One of the key studies illustrating this is a meta-analysis of large-scale observational studies demonstrating a progressive positive correlation between increasing BP and death
4 . Numerous clinical trials and meta-analyses have concluded that
antihypertensive medications substantially reduce the risk of CVD 5,6
. For example, a reduction in systolic blood pressure of 12 to 13 mmHg over four years of follow-up can reduce heart attacks by 21%, strokes by 37%, and all deaths from coronary vascular disease by 25%
7 . It is important to remember that the patient must actually take the
drug prescribed in order to receive the benefit, underscoring the threefold importance of screening, optimal prescribing and adherence/persistence with medication.
Nonadherence is the primary reason for suboptimal disease management 8 . In a major Australian study
9 comparing
self-reported antihypertensive medication adherence and cardiovascular disease outcomes, patients who were defined as being adherent to their medication regimen were 29% less likely to experience a fatal cardiovascular event or 42% less likely to experience a first occurrence of heart failure. Those 23% of patients who admitted to ever forgetting to take their medication were 28% more likely to experience a first cardiovascular event or death, whilst 11% of respondents who admitted to discontinuing medication had twice the risk of experiencing heart failure. In total, 33% of respondents were nonadherent in some way.
Persistence and adherence with antihypertensive medication
Barriers to medication adherence are numerous, and include the prescription of complex
medication regimens,
10 . Improving adherence
labour-intensive, and often needs to address individual patient circumstances 11
. Thus, there are no accepted, fully
effective strategies in widespread clinical use.
Medication nonadherence is particularly problematic for asymptomatic conditions, such as hypertension and
hyperlipidemia, despite the favourable tolerability profile of many medications used in their treatment. An analysis of
21 phase IV antihypertensive medication trials 12
found persistence after one year to be less than 50% (Figure 1), supporting findings in previous studies
13,14 . Ten per cent of doses were omitted on any given day among those still
taking medications, with almost half of these stemming from ‘drug holidays’ of several days 12
. It is important to note that day-to-day adherence with therapy and evidence of ‘drug holidays’ were predictors of persistence with medication use.
Figure 1: Persistence and adherence with antihypertensives 12
8
Taking multiple medications may further reduce adherence. In a retrospective study 15
of 8406 patients who had
been initiated on treatment with prescribed medications for both hypertension and hyperlipidemia, the adherence
rate to both classes of medication decreased rapidly to 44.7% at the three-month interval, then
to 35.8% at six
months and thereafter stabilised. Choice of medication is also an important factor to take into account when adherence is being considered. Recent literature identifies differential levels of adherence for different drugs
16-21 .
Figure 2 presents evidence of this in Australia.
Figure 2: Persistence curves for the three main classes of antihypertensive drugs 20
The most important relationships between patients’ medication taking behaviour and patient characteristics (age, gender etc.) appear to be:
22,23
• physical and social vulnerability of the patient (e.g. being old, suffering a mental illness); and • failure in communication (largely due to differences in health beliefs of doctors and patients).
The need to improve adherence with antihypertensive medication
Medication adherence is a particularly important factor to consider in the management of hypertension. The majority of patients on antihypertensive medicines fail to achieve their recommended target BP
21,22 . It is now clear
that poor adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target BP
23 . Some experts even refer to these issues as two separate CVD risk factors.
Unfortunately, therapy discontinuation is common for conditions such as hypertension because patients experience no symptoms from the condition, but persistence with therapy may be associated with costs (e.g. attending appointments, side effects, paying for medicines). Success at a population level in controlling hypertension is largely the product of individual patient care by health practitioners, and evidence exists that a more rigorous, evidence-based approach to BP management is the key to achieving this
24 .
The majority of patients taking medication for hypertension require more than one medicine to achieve their target BP
25 . Therefore, the likely impact of adverse events and medication costs will be greater for this condition than for
many others. As well as elderly patients, young male patients are especially likely to be nonadherent with blood pressure medication
26 . They are less concerned about the dangers of hypertension, less likely to practise lifestyle
modification, generally know less about blood pressure issues, and are more likely to stop taking medication without telling their doctor
26 . Richardson et al
27 found that concerns about side effects were a major barrier to
adherence with antihypertensive therapy by the young and those newly initiated on therapy. This is more likely when the patient poorly understands the benefits of therapy. Potential nonadherence should always be investigated where there is failure to reach target blood pressure, resistant hypertension, or sudden loss of BP control. The counselling issues in Table 1 have been demonstrated to improve BP control, and highlight the importance of using behavioural modification techniques for all adherence interventions
28 .
9
Table 1: Effective patient counselling points for blood pressure
• Advise the patient of their blood pressure and give them a written copy of their reading
• Determine how well the patient understands their hypertension, explore any concerns they may have, and address misperceptions that arise
• Engage in patient-centred care that allows pharmacists to elicit and respond to key issues from the patient perspective
• Reach consensus with the patient about their target blood pressure
• Explain the recommended treatment
• Evaluate patient confidence with treatment and address any lack of confidence
• Emphasise and provide supporting information about the importance of lifestyle modification
• Emphasise the chronic nature of hypertension and its treatment, even when blood pressure is controlled
• Encourage the patient to propose any ideas they may have to modify their lifestyle.
Pharmacist promotion of adherence with blood pressure medication
As the medicines experts in the community, pharmacists are in an ideal position to address nonadherence and nonpersistence issues in people with hypertension. Pharmacists have proven their abilities in helping patients to achieve target BP
29 . US guidelines advocate that doctors “must work with” other health professionals, including
pharmacists, to address issues surrounding medication adherence and persistence 28
. A meta-analysis of 2246 patients in 13 studies, found that pharmacists’ interventions significantly (and substantially) reduced systolic and diastolic blood pressure. Improving adherence must be a core component of this role
30 . In a US study of 200
community-dwelling elderly patients (92% drug-treated for hypertension) attending an Army Medical Centre, medication adherence increased from 61% to 97% following pharmacist intervention
31 , and was associated with
improved cardiovascular outcomes. The intervention group also had significantly increased persistence at six months – 96% (intervention) vs. 69% (control). The community pharmacist is uniquely positioned in the Australian health care system to undertake a role in cardiovascular medication management, a role supported by public opinion
32 . Leading Australian and international guidelines for BP management
31,33,34 recognise the widespread
detrimental impact of poor adherence and persistence with medications on BP control. When BP is uncontrolled, as previously stated, the patient is very unlikely to experience symptoms – unlike with conditions such as asthma or epilepsy
26 . This can affect the priority given to adherence on the part of both the prescriber and the patient.
Doctors are more likely to accept therapeutic inertia and may be less likely to investigate or address nonadherence
28 .
In designing an intervention involving pharmacists, it is essential to offer a complex range of strategies – adherence involves a complex set of issues for which homogenous simple interventions applied across the target group will not have an impact
35 . Examples of strategies that can help appropriate patients with adherence to blood pressure
medication and other long-term treatments – as part of an overall strategy, not in isolation – include simplification of the medication regimen, motivational interviewing, label reminders to patients, information, counselling, reinforcement, family therapy, psychological therapy, mailed communications, manual telephone follow-up, and other forms of additional supervision or attention (e.g. electronic prompts, SMS reminders)
33-36 . The importance of
motivating patients stems from a combination of issues that are relatively unique to BP treatment. The JNC-7 hypertension management guidelines
28 specifically state the need for health professionals such as pharmacists to
use motivational techniques to encourage patient adherence:
“Behavioral models suggest that the most effective therapy prescribed by the most careful clinician will control hypertension only if the patient is motivated to take the medication as directed and to establish and maintain a health-promoting lifestyle. Motivation improves when patients have positive experiences with, and trust in, their clinicians. Better communication improves outcomes; empathy builds trust and is a potent motivator”.
10
Blood pressure self-monitoring is another option with significant potential 37
. Other issues that can be addressed through existing pharmacy programs are medication profiling, home medication reviews and the use of dose administration aids. It is logical to integrate these existing options into new programs, not only to optimise impact for consumers but also to promote uptake by practitioners. A systematic review of interventions by community pharmacists to improve adherence to chronic medication use
38 , noted that further research was required to identify
an overall successful adherence improving strategy performed by pharmacists.
Project Phases
This project had several phases. Phase 1 was a systematic review of published studies of cardiovascular healthcare services, with particular emphasis on those that feature strategies to improve BP control, mostly those focused on management of hypertension. Phase 2 comprised focus group discussions and interviews with stakeholders (consumers, community pharmacists and GPs) about aspects of adherence and adherence and persistence, particularly in relation to experience with antihypertensive medicines. The focus was on the desirable features of, and barriers and facilitators to, implementing a best practice adherence /persistence-enhancing service through Australian community pharmacies for people taking antihypertensive medicines. Phase 3 was a randomised controlled trial of a package of intervention strategies in a multi-state sample. Phase 4 comprised focus group discussions and interviews with stakeholders (consumers, community pharmacists and GPs) about their experiences with the intervention.
Phase 1
Systematic Review
Introduction
In order to inform the development of the interventions in Phase 3, a systematic review was undertaken of published studies describing cardiovascular disease programs, with a focus on those studies relevant to community pharmacy, the management of hypertension and adherence/persistence with antihypertensive medication. Meta analysis was considered inappropriate due to the lack of consistency in study methodology, study environment, patient groups and measures of adherence/persistence in the published studies that were identified.
Although many of the studies identified were randomised controlled trials, a lack of blinding and other methodological limitations meant that the overall quality of the evidence ranged from poor to fair. Previous related reviews
38,39 and meta-analyses
30,31,40 have drawn similar conclusions. Nonetheless, the review identified that a
significant number of relevant studies have been conducted and the findings of some of these helped to inform the proposed intervention in the HAPPY Trial. A large proportion of relevant research was from the US, with major contributions also from the United Kingdom and Canada. Despite differences in the healthcare systems between these countries and Australia, some of the findings were generalisable and applicable to community pharmacy practice in Australia. Although the review focused on hypertension, studies examining other chronic medical conditions which are related, either by the nature of the drugs used (e.g. heart failure), or by their asymptomatic nature (e.g. dyslipidaemia), were included in the review where they met inclusion criteria. A summary of the reviewed papers by disease state and the associated grade of evidence is provided below:
Summary of papers reviewed by therapeutic area and evidence grade
E1 E2 E3-1 E3-2 E3-3 E-4 Total Asthma / COPD 2 2 Chronic…