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

Polypharmacy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732302
• Other study ID #: 2012 1266-31
• Status: Completed
• Phase: N/A
• First received: November 19, 2012
• Last updated: October 18, 2013
• Start date: November 2012
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Drug-Related Side Effects and Adverse Reactions
• Polypharmacy

Intervention

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.

Locations

Country	Name	City	State
Sweden	Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View 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):173-84. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome: Unplanned hospitalisation or emergency department visit		9 months	No
Secondary	Unplanned hospitalisation		9 months	No
Secondary	Emergency department visit		9 months	No
Secondary	Length of hospital stay		9 months	No
Secondary	All cause mortality		9 months	No
Secondary	Number of drug utilization reviews		9 months	No
Secondary	Number of patients with polypharmacy	polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient	9 months	No
Secondary	Inappropriate drug use according to national guidelines	see link	9 months	No
Secondary	Number of patients with contraindicated drugs regarding renal function		9 months	No
Secondary	Number of drugs with inappropriate drug dose regarding renal function		9 months	No
Secondary	Number of drug interactions		9 months	No

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