Educational Intervention to Reduce Drug-related Hospitalizations in Elderly Primary Health Care Patients

Educational Intervention to Reduce Drug-related Hospitalizations and Visits in Emergency Departments in Elderly Primary Health Care Patients - a Cluster-randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Polypharmacy; Adverse Drug Reaction
• Intervention / Treatment: Other: Educational intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 14183
    • Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational intervention; Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.	Other: Educational intervention; Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.
No Intervention: Delayed educational intervention; Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite outcome: Unplanned hospitalisation or emergency department visit	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality		9 months
Unplanned hospitalisation		9 months
Emergency department visit		9 months
Length of hospital stay		9 months
Number of drug utilization reviews		9 months
Number of patients with polypharmacy	polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient	9 months
Inappropriate drug use according to national guidelines	see link	9 months
Number of patients with contraindicated drugs regarding renal function		9 months
Number of drugs with inappropriate drug dose regarding renal function		9 months
Number of drug interactions		9 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Jan Hasselström, MD, PhD, Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: November 19, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (Estimate): November 22, 2012

Study Record Updates

• Last Update Posted (Estimate): October 21, 2013
• Last Update Submitted That Met QC Criteria: October 18, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Primary Health Care; Aged; Aged, 80 and over; Drug Utilization Review
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 2012 1266-31