Preventing hospital admissions by reviewing medication (PHARM) in primary care: design of the cluster randomised, controlled, multi-centre PHARM-study

Abstract

BackgroundMedication can be effective but can also be harmful and even cause hospital admissions. Medication review or pharmacotherapy review has often been proposed as a solution to prevent these admissions and to improve the effectiveness and safety of pharmacotherapy. However, most published randomised controlled trials on pharmacotherapy reviews showed no or little effect on morbidity and mortality. Therefore we designed the PHARM (Preventing Hospital Admissions by Reviewing Medication)-study with the objective to study the effect of the total pharmaceutical care process on medication related hospital admissions and on adverse drug events, survival and quality of life.Methods/DesignThe PHARM-study is designed as a cluster randomised, controlled, multi-centre study in an integrated primary care setting. Patients with a high risk of a medication related hospital admission are included in the study with randomisation at GP (general practitioner) level. We aim to include 14200 patients, 7100 in each arm, from at least 142 pharmacy practices.The intervention consists of a patient-centred, structured, pharmaceutical care process. This process consists of several steps, is continuous and occurrs over multiple encounters of patients and clinicians. The steps of this pharmaceutical care process are a pharmaceutical anamnesis, a review of the patient's pharmacotherapy, the formulation and execution of a pharmaceutical care plan combined with the monitoring and follow up evaluation of the care plan and pharmacotherapy. The patient's own pharmacist and GP carry out the intervention. The control group receives usual care.The primary outcome of the study is the frequency of hospital admissions related to medication within the study period of 12 months of each patient. The secondary outcomes are survival, quality of life, adverse drug events and severe adverse drug events. The outcomes will be analysed by using mixed-effects Cox models.DiscussionThe PHARM-study is one of the largest controlled trials to study the effectiveness of the total pharmaceutical care process. The study should therefore provide evidence as to whether such a pharmaceutical care process should be implemented in the primary care setting.Trial RegistrationTrial number: NTR 2647

Preventing hospital admissions by reviewing medication (PHARM) in primary care: an open controlled study in an elderly population

“…The effect of a multicomponent pharmaceutical care intervention on medication‐related hospital admissions was studied in an open controlled design. The study protocol is described in detail elsewhere . The study protocol was approved by the medical ethical review board METOPP [‘Medisch Ethische Toetsing Onderzoek Patiënten en Proefpersonen' (medical–ethical assessment of studies involving patients or healthy volunteers)].…”

Drug-Related Hospital Visits and Admissions Associated with Laboratory or Physiologic Abnormalities—A Systematic-Review

“…Several broad recommendations for the reduction of preventable DRVs have been proposed such as improving communication between acute and ambulatory health care providers when patients transition between care settings; conducting regular review of prescription medications to avoid therapeutic duplication and to discontinue unnecessary drugs; advising patients to frequent one community pharmacy and to discuss self-selection of over-the-counter (OTC) and herbal therapy with a pharmacist or physician [9]–[11]. Enhanced patient monitoring is also frequently suggested.…”

Covariates that influence the quality of a medication review: Table 1

“…Previous studies have shown that adverse drug events are a common cause for hospitalisations and how medication reviews might have an impact on such hospitalisations 1 8 9 24 25. In the HARM (Hospital Admissions Related to Medication) study, Leendertse et al 8 found that up to 46% of the drug-related hospital admissions were preventable; based on their findings, they recommended the performance of regular medication reviews to improve that outcome.…”