Clinical trial NCT01732302: Educational Intervention to Reduce Drug-related Hospitalizations in Elderly Primary Health Care Patients
Official title: Educational Intervention to Reduce Drug-related Hospitalizations and Visits in Emergency Departments in Elderly Primary Health Care Patients - a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy
Adverse Drug Reaction
Keywords: Drug Utilization Review
Aged
Aged, 80 and over
Primary Health Care
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2012-11-22
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether an educational intervention given towards health care providers working in primary health care centers can reduce inappropriate prescribing in the elderly patient and thus reduce number and length of drug-related hospitalizations as well as number of emergency department visits in this patient group.

Detailed description: Inappropriate medication in the elderly patient leads to substantial morbidity, possibly causing up to 20% of hospitalizations in this patient group (1). To improve prescribing and thus reduce undesired drug effects is a great challenge for doctors and nurses in primary health care.

Performance of drug utilization reviews is recommended in order to reduce the negative impact of inappropriate prescribing in the elderly. However, scientific evidence on their efficacy is lacking, especially regarding patient-related health outcomes (2,3). Most studies are carried out in inpatient care, making it difficult to draw conclusions regarding primary health care (2). Moreover, studies in this scientific field diverge regarding the content and structure of drug utilization reviews, which implies that comparison between studies becomes challenging, if not impossible.

This trial aims at educating health care providers in how to perform drug utilization reviews, and to help them implement theory into practice.

Eligibility criteria: Inclusion Criteria:

* primary health care center in Stockholm County
* authorized by Stockholm County Council since at least 3 years
* at least 5% of patients attributed to primary health care center are 65 years and older
* primary health care center takes care of at least 10 home care patients

Exclusion Criteria:

* less than 3000 patients listed in primary health care center
* primary health care centers where researchers carrying out the present study work

Primary outcomes:
measure: Composite outcome: Unplanned hospitalisation or emergency department visit
timeFrame: 9 months
Secondary outcomes:
measure: Unplanned hospitalisation
timeFrame: 9 months
measure: Emergency department visit
timeFrame: 9 months
measure: Length of hospital stay
timeFrame: 9 months
measure: All cause mortality
timeFrame: 9 months
measure: Number of drug utilization reviews
timeFrame: 9 months
measure: Number of patients with polypharmacy
timeFrame: 9 months
measure: Inappropriate drug use according to national guidelines
timeFrame: 9 months
measure: Number of patients with contraindicated drugs regarding renal function
timeFrame: 9 months
measure: Number of drugs with inappropriate drug dose regarding renal function
timeFrame: 9 months
measure: Number of drug interactions
timeFrame: 9 months
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
Study officials:
affiliation: Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
name: Jan Hasselström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54. doi: 10.1023/a:1015570104121.
citation: Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.
citation: Stewart S, Pearson S, Luke CG, Horowitz JD. Effects of home-based intervention on unplanned readmissions and out-of-hospital deaths. J Am Geriatr Soc. 1998 Feb;46(2):174-80. doi: 10.1111/j.1532-5415.1998.tb02535.x.