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

Primary Purpose

Polypharmacy, Adverse Drug Reaction

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polypharmacy focused on measuring Drug Utilization Review, Aged, Aged, 80 and over, Primary Health Care

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational intervention

Delayed educational intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Composite outcome: Unplanned hospitalisation or emergency department visit

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2012
Last Updated
October 18, 2013
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01732302
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypharmacy, Adverse Drug Reaction
Keywords
Drug Utilization Review, Aged, Aged, 80 and over, Primary Health Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed educational intervention
Arm Type
No Intervention
Arm Description
Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite outcome: Unplanned hospitalisation or emergency department visit
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Unplanned hospitalisation
Time Frame
9 months
Title
Emergency department visit
Time Frame
9 months
Title
Length of hospital stay
Time Frame
9 months
Title
All cause mortality
Time Frame
9 months
Title
Number of drug utilization reviews
Time Frame
9 months
Title
Number of patients with polypharmacy
Description
polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient
Time Frame
9 months
Title
Inappropriate drug use according to national guidelines
Description
see link
Time Frame
9 months
Title
Number of patients with contraindicated drugs regarding renal function
Time Frame
9 months
Title
Number of drugs with inappropriate drug dose regarding renal function
Time Frame
9 months
Title
Number of drug interactions
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hasselström, MD, PhD
Organizational Affiliation
Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
City
Huddinge
ZIP/Postal Code
14183
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
12061133
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.
Results Reference
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PubMed Identifier
17630041
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.
Results Reference
background
PubMed Identifier
9475445
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.
Results Reference
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Educational Intervention to Reduce Drug-related Hospitalizations in Elderly Primary Health Care Patients

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