|- candidate number||8746|
|- NTR Number||NTR2647|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-dec-2010|
|- Secondary IDs||M253 / NL20582.028.07 ; METOPP / CCMO|
|- Public Title||Preventing hospital admissions by reviewing medication in primary care.|
|- Scientific Title||Preventing hospital admissions by reviewing medication in primary care: A cluster randomised, controlled, multi-centre study.|
|- hypothesis||Medication review in patients at risk for hospital admissions related to medication may prevent these admissions.|
|- Healt Condition(s) or Problem(s) studied||Medication related hospital admission|
|- Inclusion criteria||1. 65 years of age or older;|
2. Using at least five medicines;
3. Using at least one medicine from ATC group A or B;
4. Being non-adherent to at least one medicine.
|- Exclusion criteria||1. Resident in nursing home;|
2. Life expectancy of less than 3 months;
3. No informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2008|
|- planned closingdate||1-apr-2011|
|- Target number of participants||14200|
|- Interventions||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 patientís 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 patientís own pharmacist and GP carry out the intervention.
The control group receives usual care.
|- Primary outcome||Hospital admissions related to medication.|
|- Secondary outcome||1. Adverse drug events;|
3. Quality of life;
4. Severe adverse drug events.
|- Timepoints||12 months after inclusion: Final measurements.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.M.L.A. Bemt, van den|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.M.L.A. Bemt, van den|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Utrecht Institute for Pharmaceutical Sciences, Utrecht University|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background:|
Medication 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.
The PHARM-study is designed as a cluster randomised, controlled, multi-centre study in an integrated primary care setting. Patients with a high risk on 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 occurred over multiple encounters of patients and clinicians. The steps of this pharmaceutical care process are a pharmaceutical anamnesis, a review of the patientís 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 patientís 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.
The 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 the entire pharmaceutical care process should be implemented in the primary care setting.
|- Main changes (audit trail)|
|- RECORD||7-dec-2010 - 17-dec-2010|