Randomized Controlled Trial of Effects of Physician's Medication Reviews on Prescribing in Older Hip Fracture Patients
Primary Purpose
Hip Fracture
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Medication review
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring elderly, hip fracture, osteoporosis, fall risk, medication review
Eligibility Criteria
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
Sites / Locations
- Sahlgrenska University Hospital/Mölndal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Medication review
Controll
Arm Description
Assessment of risks of falls and fractures, medication review
Outcomes
Primary Outcome Measures
Treatment with fall-risk-increasing drugs
Drug treatment is estimated from the Swedish Register of Dispensed Drugs
Treatment with fracture-preventing drugs
Drug treatment is estimated from the Swedish Register of Dispensed Drugs
Secondary Outcome Measures
Attitudes towards the intervention among physicians
Attitudes towards the oral and written parts of the intervention are investigated by a short questionnaire sent to the involved physicians and answered anonymously.
Fall-related injuries in need of medical care
Contact with a physician due to an injury caused by a fall
Death
Full Information
NCT ID
NCT01627483
First Posted
June 21, 2012
Last Updated
June 21, 2012
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Ministry of Health and Social Affairs, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT01627483
Brief Title
Randomized Controlled Trial of Effects of Physician's Medication Reviews on Prescribing in Older Hip Fracture Patients
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Ministry of Health and Social Affairs, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate if prescribing of fall-risk increasing and fracture-preventing drugs can be improved in older hip fracture patients by assessments of risks of falls and fractures and medication reviews performed by a physician and forwarded to prescribing physicians.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
elderly, hip fracture, osteoporosis, fall risk, medication review
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medication review
Arm Type
Experimental
Arm Description
Assessment of risks of falls and fractures, medication review
Arm Title
Controll
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Medication review
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment with fall-risk-increasing drugs
Description
Drug treatment is estimated from the Swedish Register of Dispensed Drugs
Time Frame
One year
Title
Treatment with fracture-preventing drugs
Description
Drug treatment is estimated from the Swedish Register of Dispensed Drugs
Time Frame
One year
Secondary Outcome Measure Information:
Title
Attitudes towards the intervention among physicians
Description
Attitudes towards the oral and written parts of the intervention are investigated by a short questionnaire sent to the involved physicians and answered anonymously.
Time Frame
Ten months
Title
Fall-related injuries in need of medical care
Description
Contact with a physician due to an injury caused by a fall
Time Frame
One year
Title
Death
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna M Wallerstedt, Assprofessor
Organizational Affiliation
Department of Clinical Pharmacology, Sahlgrenska University Hospital, Bruna stråket 21, S-413 45 Gothenburg, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Sahlgrenska University Hospital/Mölndal
City
Mölndal
State/Province
Region Västra Götaland
ZIP/Postal Code
431 80
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
20658793
Citation
Sjoberg C, Bladh L, Klintberg L, Mellstrom D, Ohlsson C, Wallerstedt SM. Treatment with fall-risk-increasing and fracture-preventing drugs before and after a hip fracture: an observational study. Drugs Aging. 2010 Aug 1;27(8):653-61. doi: 10.2165/11538200-000000000-00000.
Results Reference
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Randomized Controlled Trial of Effects of Physician's Medication Reviews on Prescribing in Older Hip Fracture Patients
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