NCT01732302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

10 months

First QC Date

November 19, 2012

Last Update Submit

October 18, 2013

Conditions

Keywords

Drug Utilization ReviewAgedAged, 80 and overPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Composite outcome: Unplanned hospitalisation or emergency department visit

    9 months

Secondary Outcomes (10)

  • Unplanned hospitalisation

    9 months

  • Emergency department visit

    9 months

  • Length of hospital stay

    9 months

  • All cause mortality

    9 months

  • Number of drug utilization reviews

    9 months

  • +5 more secondary outcomes

Study Arms (2)

Educational intervention

EXPERIMENTAL

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

Delayed educational intervention

NO INTERVENTION

Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay.

Interventions

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.

Educational intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet

Huddinge, 14183, Sweden

Location

Related 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. doi: 10.1023/a:1015570104121.

    PMID: 12061133BACKGROUND
  • 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.

    PMID: 17630041BACKGROUND
  • 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.

    PMID: 9475445BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Jan Hasselström, MD, PhD

    Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

November 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations