Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388908
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2006-10-16
Brief Title:
Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Addressing Vertebral Osteoporosis Incidentally Detected to Prevent Future Fractures The AVOID FRACTURE Study
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVOID Fracture
Brief Summary:
Osteoporosis is a common and progressive condition that leads to broken bones fractures which cause pain disability deformity and even death There are new treatments available that can decrease the risk of a fracture by 50 and the people who benefit the most are those with osteoporosis who have already had a fracture like a vertebral spine fracture Vertebral fractures are usually silent and 20 of people over the age of 60 years have had one although they dont know it Many of these people have had chest x-rays done for other reasons and these x-rays can incidentally detect these silent fractures Although most people with a vertebral fracture should be tested and treated for osteoporosis studies demonstrate that less than one-quarter of older people with a vertebral fracture are ever investigated or even treated This reflects a gap between evidence-based best practice and everyday practice in the community The proposed research addresses this care-gap by using a quality improvement intervention that uses chest x-rays done in the Emergency Department to remind family physicians about osteoporosis while providing them with evidence-based treatment guidelines - with or without educating and empowering patients about osteoporosis The effectiveness of this intervention will be compared to usual care in a controlled trial The intent of this research is to improve quality of care for patients at high risk of fracture by increasing rates of testing and treatment of osteoporosis
Detailed Description:
Objective To improve the quality of care for elderly patients with osteoporosis and vertebral fractures incidentally detected by a chest radiograph in the Emergency Department
Background Osteoporosis leads to decreased bone mass skeletal fragility and fractures Osteoporosis affects at least 14 million Canadians 25 of women and 12 of men 60 years of age The most common osteoporotic fractures are vertebral spinal two-thirds of which are asymptomatic Irrespective of symptoms these silent fractures cause disability deformity and death Compared to those with normal bones and no fracture the patient with osteoporosis and vertebral fracture has a 20-fold increased risk of future fracture Guidelines recommend aggressive treatment because rate of re-fracture is 20 within 1 year and treatment reduces risk by 40-50 Guidelines do not however recommend population screening for vertebral fractures We reported Arch Intern Med 2005 that chest radiographs performed in the Emergency Department detected incidental fractures in 16 of elderly patients although only 25 of patients were treated for osteoporosis The care gap between evidence-based best practice and usual care needs to be urgently addressed
Hypothesis The proposed intervention will improve rates of diagnosis and treatment of osteoporosis in high-risk patients The intervention will be directed at physicians patient-specific reminders and opinion leader generated 1-page guidelines with or without patient-activation leaflets and telephone-based counseling
Specific Aims To determine whether exposure to a physician-directed quality improvement intervention can- Aim 1 Increase rates of osteoporosis treatment in patients with newly recognized vertebral fractures Aim 2 Increase patients self-reported diagnosis of osteoporosis and other related knowledge Aim 3 Be further augmented by the addition of patient-activation
Study Design A single-center prospective nonrandomized controlled trial with blinded allocation-concealed ascertainment of outcomes comparing the proposed physician-intervention to usual care controls We define usual care as notification of the patients physician of chest radiograph results Allocation will be on the basis of an alternate-week time series design with the proposed intervention on for all patients for one week followed by the intervention being off ie usual care the next week After 3 months controls will be offered the physician-intervention plus patient-activation with outcomes recollected 3 months later Eligible patients will be 60 years of age who present to the Emergency Department 1 with a chest radiograph reporting the presence of a vertebral fracture 2 are not taking prescription osteoporosis treatment and 3 are discharged home The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition secondary outcomes include BMD testing and diagnosis of osteoporosis The intervention is expected to increase the primary outcome by at least 20 absolute over usual care rates of 10 With alpha005 beta080 20 losses-to-followup and additional power to address secondary outcomes and effects of patient-activation the required sample size is 240 patients
Pilot Data and Feasibility Our pilot study AJR 2004 found institutional true-positive reporting rates for vertebral fractures were 60 with 100 specificity compared with reference standard A 1-year feasibility study of a random sample of 5000 radiographs was then undertaken Arch Intern Med 2005 Based on these data we expect to enroll 3-4 patientsweek complete recruitment in 20 months ascertain outcomes by 30 months and finish the study in 3 years The research team has generated pilot data systematically reviewed pertinent literature recruited opinion leaders to create guidelines trained research staff refined methods for outcomes ascertainment and conducted related studies of wrist Annals Intern Med 2004 and hip fractures
Significance To our knowledge there are no studies examining strategies to improve care for this vulnerable and high-risk population and we believe our results will be important regardless of findings If negative it will provide evidence that more costly and laborious interventions will be needed to overcome clinical inertia if positive however our intervention should be widely applicable In addition positive results can be easily extended to other related populations eg routine chest radiographs done for admission to nursing homes and can be adapted for implementation via other modalities eg computerized decision support telemedicine
Background Osteoporosis leads to decreased bone mass skeletal fragility and fractures Osteoporosis affects at least 14 million Canadians 25 of women and 12 of men 60 years of age The most common osteoporotic fractures are vertebral spinal two-thirds of which are asymptomatic Irrespective of symptoms these silent fractures cause disability deformity and death Compared to those with normal bones and no fracture the patient with osteoporosis and vertebral fracture has a 20-fold increased risk of future fracture Guidelines recommend aggressive treatment because rate of re-fracture is 20 within 1 year and treatment reduces risk by 40-50 Guidelines do not however recommend population screening for vertebral fractures We reported Arch Intern Med 2005 that chest radiographs performed in the Emergency Department detected incidental fractures in 16 of elderly patients although only 25 of patients were treated for osteoporosis The care gap between evidence-based best practice and usual care needs to be urgently addressed
Hypothesis The proposed intervention will improve rates of diagnosis and treatment of osteoporosis in high-risk patients The intervention will be directed at physicians patient-specific reminders and opinion leader generated 1-page guidelines with or without patient-activation leaflets and telephone-based counseling
Specific Aims To determine whether exposure to a physician-directed quality improvement intervention can- Aim 1 Increase rates of osteoporosis treatment in patients with newly recognized vertebral fractures Aim 2 Increase patients self-reported diagnosis of osteoporosis and other related knowledge Aim 3 Be further augmented by the addition of patient-activation
Study Design A single-center prospective nonrandomized controlled trial with blinded allocation-concealed ascertainment of outcomes comparing the proposed physician-intervention to usual care controls We define usual care as notification of the patients physician of chest radiograph results Allocation will be on the basis of an alternate-week time series design with the proposed intervention on for all patients for one week followed by the intervention being off ie usual care the next week After 3 months controls will be offered the physician-intervention plus patient-activation with outcomes recollected 3 months later Eligible patients will be 60 years of age who present to the Emergency Department 1 with a chest radiograph reporting the presence of a vertebral fracture 2 are not taking prescription osteoporosis treatment and 3 are discharged home The primary outcome is the proportion of patients starting prescription osteoporosis treatment within 3 months of fracture recognition secondary outcomes include BMD testing and diagnosis of osteoporosis The intervention is expected to increase the primary outcome by at least 20 absolute over usual care rates of 10 With alpha005 beta080 20 losses-to-followup and additional power to address secondary outcomes and effects of patient-activation the required sample size is 240 patients
Pilot Data and Feasibility Our pilot study AJR 2004 found institutional true-positive reporting rates for vertebral fractures were 60 with 100 specificity compared with reference standard A 1-year feasibility study of a random sample of 5000 radiographs was then undertaken Arch Intern Med 2005 Based on these data we expect to enroll 3-4 patientsweek complete recruitment in 20 months ascertain outcomes by 30 months and finish the study in 3 years The research team has generated pilot data systematically reviewed pertinent literature recruited opinion leaders to create guidelines trained research staff refined methods for outcomes ascertainment and conducted related studies of wrist Annals Intern Med 2004 and hip fractures
Significance To our knowledge there are no studies examining strategies to improve care for this vulnerable and high-risk population and we believe our results will be important regardless of findings If negative it will provide evidence that more costly and laborious interventions will be needed to overcome clinical inertia if positive however our intervention should be widely applicable In addition positive results can be easily extended to other related populations eg routine chest radiographs done for admission to nursing homes and can be adapted for implementation via other modalities eg computerized decision support telemedicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None