Osteoporosis and Peripheral Fractures: Treatment and Investigation Multidisciplinary at the chUS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,410
- 试验地点
- 2
- 主要终点
- Percentage of patients pursuing an effective osteoporosis treatment
研究概览
简要总结
Osteoporosis is a very frequent and easily treatable disease. Rates of treatment of affected patients is very low, as few high risk patients initiate treatment and only a minority of those pursue treatment for long enough time to prevent fractures. Patients presenting a fragility fracture after 50 years of age are at high risk of osteoporosis and may represent the ideal group of patients in which intervention aimed at improving initiation and persistence on treatment will be most effective.
Our first hypothesis is that the availability of a dedicated nurse practitioner to identify patients with fragility fractures among patients presenting at fracture clinics of orthopedic surgeons will increase markedly the rate of identification of osteoporosis.
Our second hypothesis is that giving to both the patient and its primary health practitioner (PHP) the patient's clinical, biological and radiological data along with individualized care suggestions will yield significantly better results than giving to the patient and its PHP generic information on osteoporosis risk, investigation and treatment.
详细描述
3- The OPTIMUS INTERVENTIONS
3.1. PROGRAM GOALS and OBJECTIVES
The OPTIMUS program is a health intervention whose aim is to increase the rate of long-term treatment of osteoporosis in patients with incident fragility fractures by addressing both initiation of treatment and persistence on treatment. Participation to the program will be voluntary.
Specifically, the goals of OPTIMUS are:
- To increase the rate of initiation of treatment of osteoporosis following a fragility fracture in patients presenting to the CHUS. This rate is currently of about 30% in the Province of Quebec, according to the Recognizing Osteoporosis and its Consequences in Quebec (ROCQ) survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 50 years of age
- •Fragility fracture
- •Consulting an orthopedic surgeon at the CHUS for treatment of the fracture
排除标准
- •No Primary Care Practitioner
- •Severe co-morbidity requiring specialized care
- •Failure to consent
研究组 & 干预措施
Group 1
CONTROL GROUP (first year only; maximum 300 patients): patients seen by CHUS orthopedists at the Hotel-Dieu site, where no nurse coordinator is available for inclusion. This is random but not randomized.
干预措施: Control group (Behavioral)
Group 2
MINIMAL INTERVENTION GROUP: 1/2 of patients, randomly selected.
INTERVENTION: A nurse coordinator will identify patients with fragility fractures and inform the patient about osteoporosis as the cause of the fracture, the benefit of treatment, and the options of treatment adapted to the individual patient. Written information will be sent to his/her family physician containing a presumed osteoporosis diagnosis, investigation to be performed, correct interpretation of any osteodensitometry results in the context of a fragility fracture, the options of treatment, and alternatives if the first prescriptions are not tolerated or stopped. Intervention
干预措施: Minimal Intervention (Behavioral)
Group 3
INTENSIVE INTERVENTION GROUP: 1/2 of patients, randomly selected Multiple layers of intervention will be added: results of the basic blood investigation for osteoporosis will be transmitted to the family physician with a personal letter explaining the importance of seeing the patient rapidly and indicating the urgency of initiating a treatment and indicating detailed instructions of treatment. The patient will be called at 4, 8, 12,16 and 24 months to monitor drug adherence, correct inadequate intake, and try to improve adherence. If the patient is not taking an adequate treatment at 4, 8 or 12 months, a letter will be sent again to the family physician asking to treat the patient according to recommendations.
干预措施: Intensive Intervention (Behavioral)
结局指标
主要结局
Percentage of patients pursuing an effective osteoporosis treatment
时间窗: At one year after the clinical fracture
Patients with fragility fracture seeing an orthopedic surgeon for care of the fracture are included. Patients are then followed up by phone to assess new fragility fractures and initiation and persistence on osteoporosis treatments
次要结局
- Rate of recurrent fragility fractures according to the site of the inclusion fracture(Up to 4 years after clinical fracture)
研究者
Gilles Boire
MD
Université de Sherbrooke