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Controlled Trial to Increase Detection and Treatment of Osteoporosis in Older Patients With a Wrist Fracture

10 september 2005 uppdaterad av: University of Alberta

The primary objective of this proposed research is to improve the quality of care for patients who present to the Emergency Department with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

The study hypothesis is that a quality improvement intervention (with multiple components that include a notification system for primary care physicians, patient-specific reminders, locally generated treatment guidelines endorsed by opinion leaders, and patient education and counseling) will lead to increased use of proven efficacious osteoporosis treatments in patients eligible for secondary prevention. This hypothesis will be tested by comparing the intervention with usual care controls, in a prospective nonrandomized controlled trial.

Studieöversikt

Detaljerad beskrivning

BACKGROUND: Osteoporosis is a progressive condition that causes a loss of bone mass, skeletal fragility, and fractures. Fractures result in pain, disability, deformity, and death. Osteoporosis is a major population health problem affecting 1.4 million Canadians, 25% of women and 12% of men over the age of 50 years. Current guidelines recommend aggressive secondary prevention in patients with osteoporosis who have suffered a fracture, because these patients have as high as a 20% risk of fracture in the following year, and because there are now proven efficacious treatments that can reduce this risk by 40-60%. Nevertheless, recent studies have shown that these patients are under-recognized and under-treated, demonstrating a care gap between evidence-based best practice and usual care. All patients with osteoporotic fractures (i.e., of the hip, vertebrae, or wrist) benefit from treatment. However, patients who present with a wrist fracture may be best suited to an intervention to improve secondary prevention practices, because wrist fractures are "sentinel events" in the natural history of osteoporosis: they are common, easily diagnosed, always present to medical attention, and occur years before the more devastating and costly fractures of the hip and vertebrae.

OBJECTIVES: The primary objective of this study is to improve the quality of care for patients who present to the ED with osteoporosis and a fracture of the wrist, by increasing the use of proven efficacious osteoporosis treatment. This is the primary study outcome, and it is defined as starting any one of hormone replacement therapy, a bisphosphonate, raloxifene, or calcitonin within 6 months of a fracture of the wrist.

HYPOTHESIS: A quality improvement intervention directed at patients and their primary care physicians will increase the use of proven efficacious osteoporosis treatment. The intervention itself has multiple components that include: a notification system and patient-specific reminders for primary care physicians, locally developed treatment guidelines endorsed by opinion leaders, and patient education and counseling. The study hypothesis will be tested by comparing the intervention to usual care controls, in a prospective nonrandomized controlled trial.

SPECIFIC AIMS: To determine whether the proposed intervention can-

  • 1. Increase the use of proven efficacious osteoporosis treatment in patients with a fracture of the wrist,
  • 2. Increase appropriate use of bone mineral density testing,
  • 3. Increase patients' knowledge of osteoporosis and satisfaction.

Studietyp

Interventionell

Inskrivning

160

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2B7
        • University Of Alberta Hospitals

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • age > 50 years
  • any closed distal forearm fracture
  • discharged home

Exclusion Criteria:

  • unwilling or unable to provide consent
  • admitted to hospital
  • long term care resident
  • residence outside Edmonton, Alberta
  • unable to read and converse in English
  • currently taking prescription osteoporosis treatment

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vad mäter studien?

Primära resultatmått

Resultatmått
Increased use of proven efficacious osteoporosis treatment within six months of study enrollment, defined as: hormone therapy, a bisphosphonate, raloxifene, or calcitonin.

Sekundära resultatmått

Resultatmått
1. BMD testing
2. Osteoporosis diagnosis
3. Osteoporosis related knowledge
4. Satisfaction
5. Generic, Disease Specific, and Function-related QOL
6. Falls, falls-related injuries, and fall interventions
7. Persistence of effects and generalizability of effects
8. 1, 2, 3 year outcomes

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Sumit R Majumdar, MD, MPH, University of Alberta

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2001

Avslutad studie

1 januari 2005

Studieregistreringsdatum

Först inskickad

10 september 2005

Först inskickad som uppfyllde QC-kriterierna

10 september 2005

Första postat (Uppskatta)

15 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

15 september 2005

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2005

Senast verifierad

1 september 2005

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Multifaceted intervention (patient education, physician guidelines, reminders)

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