- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01627483
Randomized Controlled Trial of Effects of Physician's Medication Reviews on Prescribing in Older Hip Fracture Patients
Improving Treatment With Fracture-preventing and Fall-risk-increasing Drugs in Older Hip Fracture Patients: Effects of Medication Reviews Performed by a Physician - a Randomized Controlled Trial
Study Overview
Detailed Description
The patients will be recruited postsurgery. They will be randomly allocated to an intervention or a control group (1:1). Sequentially numbered, opaque, sealed envelopes will be opened sequentially after participant details are written on the envelope. Carbon paper inside the envelope will transfer the information to the assignment card. Two persons not involved in the study and without knowledge about the study protocol will perform the randomization procedure. The patient will not be informed about the result of randomization.
Intervention By a short interview and/or extraction of information from the medical records comprehensive assessments of the risk of falls and the risk of fractures. Thereafter a medication review focusing on fall-risk-increasing and fracture-preventing drugs will be performed. The results of the assessments and the medication review will be forwarded orally and in written to the prescribing physicians. The recipients will be the physician at the ward during inhospital care and the general practitioner at three and six months after the surgery.
Data collection Prescribing of drugs Data will be obtained from the medical records of Sahlgrenska University Hospital, the medical records of the general practitioner, the multi-dose drug dispensing list, if any, and the Swedish Prescribed Drugs Register (Läkemedelsförteckningen).
Patient data Information on the patients during the hospital stay and the follow-up period will be obtained from the medical records of the hospital, the medical records of the general practitioner, the Swedish National Hip Fracture Register (RIKSHÖFT), and from the health care database in the Region of Västra Götaland. Data on other medical care contacts due to a fall accident will be obtained from the care database in the Western Region (VEGA database). Additionally, data on diagnoses will be obtained from the National Patient Register (Patientregistret). For deceased patients, data from the Cause of Death Register (Dödsorsaksregistret) will be obtained.
Physicians attitudes A short questionnaire will be administered to the physicians at the hospital and the general practitioners. The questionnaire will be answered anonymously and will include questions on attitudes towards the intervention and its usefulness. A reminder will be administered two weeks later.
Power calculation The study has a power of >80% to detect a 50% rise in the prescribing of fracture-preventing drugs in the intervention group, a doubling in bisphosphonates or other bone specific drugs and a reduction of 15% in the mean (SD) number of fall-risk increasing drugs. Power calculations were based on the assumption that drug treatment in the control group was improved by 30% for all fracture-preventing drugs and 60% for bisphosphonates when compared with the study performed in 2008.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Region Västra Götaland
-
Mölndal, Region Västra Götaland, Sweden, 431 80
- Sahlgrenska University Hospital/Mölndal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hip fracture surgery at Sahlgrenska University Hospital/Mölndal
- aged 65 years and over
- residing in the Gothenburg area
Exclusion Criteria:
- own opposition to participation
- if not able to give informed consent, opposition to participation by next of kin
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Medication review
Assessment of risks of falls and fractures, medication review
|
Assessment of risks of falls and fractures; medication review concerning fall-risk-increasing and fracture-preventing drugs; oral and written feed back of the results of the assessments and medication reviews to the hospital physician during the hospital stay and to the general practitioner 3 and 6 months after the hip fracture surgery.
|
No Intervention: Controll
|
Assessment of risks of falls and fractures; medication review concerning fall-risk-increasing and fracture-preventing drugs; oral and written feed back of the results of the assessments and medication reviews to the hospital physician during the hospital stay and to the general practitioner 3 and 6 months after the hip fracture surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment with fall-risk-increasing drugs
Time Frame: One year
|
Drug treatment is estimated from the Swedish Register of Dispensed Drugs
|
One year
|
Treatment with fracture-preventing drugs
Time Frame: One year
|
Drug treatment is estimated from the Swedish Register of Dispensed Drugs
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attitudes towards the intervention among physicians
Time Frame: Ten months
|
Attitudes towards the oral and written parts of the intervention are investigated by a short questionnaire sent to the involved physicians and answered anonymously.
|
Ten months
|
Fall-related injuries in need of medical care
Time Frame: One year
|
Contact with a physician due to an injury caused by a fall
|
One year
|
Death
Time Frame: One year
|
One year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Susanna M Wallerstedt, Assprofessor, Department of Clinical Pharmacology, Sahlgrenska University Hospital, Bruna stråket 21, S-413 45 Gothenburg, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUCPGMHip-09
- 095-09 (Other Identifier: Regional Ethical Review Board in Gothenburg)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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