ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01732302
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : October 21, 2013
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Lars Agreus, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Polypharmacy Adverse Drug Reaction Other: Educational intervention Not Applicable

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  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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.



Primary Outcome Measures :
  1. Composite outcome: Unplanned hospitalisation or emergency department visit [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Unplanned hospitalisation [ Time Frame: 9 months ]
  2. Emergency department visit [ Time Frame: 9 months ]
  3. Length of hospital stay [ Time Frame: 9 months ]
  4. All cause mortality [ Time Frame: 9 months ]
  5. Number of drug utilization reviews [ Time Frame: 9 months ]
  6. Number of patients with polypharmacy [ Time Frame: 9 months ]
    polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient

  7. Inappropriate drug use according to national guidelines [ Time Frame: 9 months ]
    see link

  8. Number of patients with contraindicated drugs regarding renal function [ Time Frame: 9 months ]
  9. Number of drugs with inappropriate drug dose regarding renal function [ Time Frame: 9 months ]
  10. Number of drug interactions [ Time Frame: 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732302


Locations
Sweden
Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
Huddinge, Sweden, 14183
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Jan Hasselström, MD, PhD Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet

Additional Information:
Publications:
Responsible Party: Lars Agreus, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01732302     History of Changes
Other Study ID Numbers: 2012 1266-31
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by Lars Agreus, Karolinska Institutet:
Drug Utilization Review
Aged
Aged, 80 and over
Primary Health Care

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders