Effectiveness of shared pharmaceutical care for older patients: RESPECT trial findings

Abstract

The pharmaceutical care approach serves as a model for medication review, involving collaboration between GPs, pharmacists, patients, and carers. Its use is advocated with older patients who are typically prescribed several drugs. However, it has yet to be thoroughly evaluated. AimTo estimate the effectiveness of pharmaceutical care for older people, shared between GPs and community pharmacists in the UK, relative to usual care. Design of studyMultiple interrupted time-series design in five primary care trusts which implemented pharmaceutical care at 2-month intervals in random order. Patients acted as their own controls, and were followed over 3 years including their 12 months' participation in pharmaceutical care. SettingIn 2002, 760 patients, aged ≥75 years, were recruited from 24 general practices in East and North Yorkshire. Sixty-two community pharmacies also took part. A total of 551 participants completed the study. MethodPharmaceutical care was undertaken by community pharmacists who interviewed patients, developed and implemented pharmaceutical care plans together with patients' GPs, and thereafter undertook monthly medication reviews. Pharmacists and GPs attended training before the intervention. Outcome measures were the UK Medication Appropriateness Index, the Short Form-36 Health Survey (SF-36), and serious adverse events. ResultsThe intervention did not lead to any statistically significant change in the appropriateness of prescribing or health outcomes. Although the mental component of the SF-36 decreased as study participants become older, this trend was not affected by pharmaceutical care. ConclusionThe RESPECT model of pharmaceutical care (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) shared between community pharmacists and GPs did not significantly change the appropriateness of prescribing or quality of life in older patients. Keywordshealth services for the aged; medication therapy management; pharmaceutical care; polypharmacy; randomised controlled trial.

Predictive risk stratification model: a randomised stepped-wedge trial in primary care (PRISMATIC)

“…23 To ensure that all participating practices had the opportunity to implement and use the intervention during the study period, we used a progressive cluster randomised trial design (also known as randomised multiple interrupted time series or stepped-wedge design). [61][62][63] As the trial progressed, the number of intervention practices increased and the number of control practices fell ( Figure 2). This design protects against some sources of bias, including inherent differences and contamination between practices, as well as the 'resentful demoralisation' of controls deprived of the intervention.…”

Cost-effectiveness of shared pharmaceutical care for older patients: RESPECT trial findings

“…The differences in benefits and costs between intervention and usual care are small and do not always reach conventional levels of statistical significance. Although hypothesis tests underpin the clinical analysis of RESPECT, 1 there are good reasons not to use statistical inference as a basis for decision making about resource allocation in health care; 19 this is the general approach for economic analysis supported by NICE. However, policymakers should be aware of the uncertainty associated with e26 encouraging the use of pharmaceutical care.…”

“…In addition to the data collection as described in the clinical paper, 1 participants also completed EQ-5D questionnaires at five points in time during the study: at recruitment; immediately before pharmaceutical care began; 3 and 12 months thereafter; and at the end of the study period, some 3 years after the start of recruitment.…”

“…The design and clinical results of that trial have been reported in an accompanying article 1 and, although it is reported that there were no statistically significant differences in outcomes, economic evaluation typically used estimation rather than hypothesis testing. This article, therefore, uses RESPECT trial data to estimate the mean cost-effectiveness of pharmaceutical care and looks at the uncertainty in that estimate.…”

NICE work: how NICE decides what we should pay for

“…The UK-MAI is unlikely to be an appropriate outcome measure for a cost-effectiveness analysis because it is doubtful that it is linear in the sense that a decision maker would be prepared to pay twice as much for two units of benefit as it would for one unit of benefit. Thus, the RESPECT trial team's studies 3,4 come to different conclusions regarding clinical effectiveness and cost-effectiveness, not least because they are addressing different objectives based on different outcome measures.…”