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
  Purpose

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.


Condition Intervention
Hip Fracture
Other: Medication review

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medication review
Assessment of risks of falls and fractures, medication review
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.
No Intervention: Controll 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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627483

Locations
Sweden
Sahlgrenska University Hospital/Mölndal
Mölndal, Region Västra Götaland, Sweden, 431 80
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
The Swedish National Board of Health and Welfare
Investigators
Study Director: Susanna M Wallerstedt, Assprofessor Department of Clinical Pharmacology, Sahlgrenska University Hospital, Bruna stråket 21, S-413 45 Gothenburg, Sweden
  More Information

Publications:
Responsible Party: Christina Sjoberg, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01627483     History of Changes
Other Study ID Numbers: SUCPGMHip-09, 095-09
Study First Received: June 21, 2012
Last Updated: June 21, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
elderly
hip fracture
osteoporosis
fall risk
medication review

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 14, 2014