Randomized Controlled Trial of Effects of Physician's Medication Reviews on Prescribing in Older Hip Fracture Patients

This study has been completed.
Sponsor:
Collaborator:
The Swedish National Board of Health and Welfare
Information provided by (Responsible Party):
Christina Sjoberg, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01627483
First received: June 21, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted

June 21, 2012
June 21, 2012
April 2009
April 2010   (final data collection date for primary outcome measure)
  • Treatment with fall-risk-increasing drugs [ Time Frame: One year ] [ Designated as safety issue: No ]
    Drug treatment is estimated from the Swedish Register of Dispensed Drugs
  • Treatment with fracture-preventing drugs [ Time Frame: One year ] [ Designated as safety issue: No ]
    Drug treatment is estimated from the Swedish Register of Dispensed Drugs
Same as current
No Changes Posted
  • Attitudes towards the intervention among physicians [ Time Frame: Ten months ] [ Designated as safety issue: No ]
    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 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Contact with a physician due to an injury caused by a fall
  • Death [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hip Fracture
Other: 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.
  • Experimental: Medication review
    Assessment of risks of falls and fractures, medication review
    Intervention: Other: Medication review
  • No Intervention: Controll
    Intervention: Other: Medication review
Sjöberg C, Bladh L, Klintberg L, Mellström 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01627483
SUCPGMHip-09, 095-09
No
Christina Sjoberg, Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
The Swedish National Board of Health and Welfare
Study Director: Susanna M Wallerstedt, Assprofessor Department of Clinical Pharmacology, Sahlgrenska University Hospital, Bruna stråket 21, S-413 45 Gothenburg, Sweden
Sahlgrenska University Hospital, Sweden
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP