Osteoporosis Coordinator for Low Volume Community Hospitals (ROCKET)
Regional Osteoporosis Coordinator Knowledge Exchange Trial
調査の概要
詳細な説明
A. Background and Rationale. Despite the availability of proven safe and effective treatment options, the majority of patients with low trauma fracture are under-investigated and under-treated, indicating that treatment for osteoporosis after fracture is less than optimal. Most of the published studies on interventions using a coordinator recruited patients from one or a few academic centres or health maintenance organization. However, in Ontario, one-third of fracture patients are treated in non-academic centres and hospitals which have no dedicated osteoporosis fracture clinic coordinator and are underserviced for osteoporosis specialists. It remains unclear whether the impact will be as great for smaller centres where the coordinator function is centralized across multiple centres; hence the need for this trial.
B. Objectives 1. The primary objective is to evaluate if a quality improvement program including physician and patient osteoporosis recommendations from a regional osteoporosis coordinator will increase the proportion of individuals with a low trauma fracture who receive appropriate management for osteoporosis compared to those who receive only falls prevention advice.
2. A secondary objective is to determine if the above program will result in changes in perceived susceptibility, osteoporosis knowledge and use of supplements compared to those who receive only falls prevention advice.
C. Methods. Design: cluster randomized controlled trial (hospitals=cluster site) with the outcome assessors and data analyst blinded to group allocation.
Patient population: patients 40 years old and over (men and women) presenting with a low trauma fracture of the hip, forearm/wrist, rib(s), sternum, thoracic and lumbar spine, shoulder, upper arm, pelvis, lower leg and ankle. Hospitals that treat more than 40 patients/year and have no dedicated fracture clinic coordinator in their Emergency Department/Fracture Clinic will be considered.
Hospital recruitment: out of 63 hospitals 30 will be recruited (15 as intervention and 15 control); 20 patients from each hospital will be identified with the expectation that 10 will consent to the study, for a total sample size of 300 patients.
Intervention: provide evidenced-based recommendations and having a centralized osteoporosis coordinator follow-up with fracture patients and their physicians to provide information about fracture risk and osteoporosis treatment as part of educational outreach, assist with ordering BMD test and arranging consultation to Multidisciplinary Osteoporosis Program (MOP) via telehealth if required. For the control sites the same process will be followed for identifying fracture patients. They will receive educational material and telephone counseling regarding fall prevention and home safety and will be encouraged to visit their family physician.
Data collection. Patients will be identified from NACRS database. Baseline data will be collected by the osteoporosis coordinator. The questionnaire will be similar to "Fracture Clinic OP Screening Program". Follow-up data will be collected by a research assistant who will call consenting patients.
Data Analysis. The analysis of primary and secondary outcome measures will compare the intervention and control groups and will be carried out at the level of the cluster (hospital), based on the standard two-sample t-test with 2(k-1) degrees of freedom, where k is the number of sites in each group (α= 0.05, power=1-β).
D. Future implications. This trial will increase our understanding of how to implement care delivery models in communities in terms of resources, services and patient and provider preferences. At the health system level this trial will have direct relevance to Ontario's Osteoporosis Strategy. The findings will be used by decision-makers to determine if hospitals with no dedicated osteoporosis coordinator should be provided access to a centralized fracture coordinator. At the provider and patient level the trial will increase access to osteoporosis care and treatment utilization, along with awareness and knowledge regarding osteoporosis treatment.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ、M5G 2A2
- 募集
- Toronto Rehabilitation Institute
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コンタクト：
- Oana S Donescu, MD PhD
- 電話番号：7884 416 597-3422
- メール：Donescu.Smaranda@TorontoRehab.on.ca
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コンタクト：
- Susan B Jaglal, PhD
- 電話番号：416 978 0315
- メール：susan.jaglal@utoronto.ca
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副調査官：
- Gillian Hawker, MD MSc
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副調査官：
- Sumit Majumdar, MD
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副調査官：
- Dorcas Beaton, PhD
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副調査官：
- Suzanne Cadarette, PhD
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副調査官：
- Lynn Meadows, PhD
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副調査官：
- Alexandra Papaioannou
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副調査官：
- Earl Bogoch, MD
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副調査官：
- Merrick Zwarenstein, PhD
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副調査官：
- Kevin Thorpe, PhD
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副調査官：
- Marita Kloseck, PhD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Cluster site (hospital) level: Hospitals with no dedicated osteoporosis coordinator that treat more than 60 patients/year in their Emergency Department and who have a Telehealth studio.
- Patient level: Patients 40 years old and over (men and women) presenting with a low trauma fracture of the hip, forearm and wrist, rib(s), sternum, thoracic and lumbar spine, shoulder and upper arm, pelvis, lower leg and ankle. Subjects without previous medication as well as subjects on osteoporosis medication and presenting with a fracture will be included.
Exclusion Criteria:
- Hospitals that have an Osteoporosis Strategy fracture clinic coordinator
- Fractures associated with major trauma; fractures due to malignancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
hospitals randomly allocated to receive physician and patient osteoporosis recommendations from the regional coordinator
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The regional osteoporosis coordinator will phone fracture patients and counsel them about their risk of osteoporosis, reiterating messages in the print material.
The coordinator will also follow-up with family physicians by phone and send them a patient-specific reminder that informs them that their patient has experienced a fracture and they are at high risk for future fracture.
As part of the reminder, a set of evidence-based recommendations about appropriate BMD testing and treatment based on the recent Canadian guidelines will be included.
If the patient does not have a family physician, the regional osteoporosis coordinator will facilitate referral to the MOP.
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アクティブコンパレータ：2
hospitals randomly allocated to receive falls prevention advice
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Fracture patients from hospitals receiving falls prevention advice will also be called by the osteoporosis regional coordinator.
The patient will receive educational material and telephone counseling regarding fall prevention.
During the call, patients will be encouraged to visit their family physician for fracture follow-up.
They will not receive counseling or educational materials about osteoporosis at this time.
Patients in the falls prevention group will receive the physician and patient osteoporosis program six months post-fracture.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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proportion of patients from the intervention group as compared to the control group that had "appropriate management" based on a composite of undergoing a BMD test and starting therapy within 6 months of fracture.
時間枠：1.5 years
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1.5 years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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osteoporosis knowledge, perceived susceptibility, self-efficacy, preventive behaviors
時間枠：1.5 years
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1.5 years
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participants' experience and perceptions of future fracture risk; their understanding of the educational materials and acceptance of recommended treatment plans.
時間枠：1.5 years
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1.5 years
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協力者と研究者
捜査官
- 主任研究者：Susan B Jaglal PhD、Toronto Rehabilitation Institute, University of Toronto
- スタディディレクター：Oana S Donescu MD PhD、Toronto Rehabilitation Institute, University of Toronto
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- TRI REB 07-029
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