The Effectiveness of an Integrated Osteoporosis Care Programme in Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- Medication Possession Ratio (MPR)
研究概览
简要总结
The researchers will evaluate the effectiveness of a complex intervention composed of multiple actions targeting primary care healthcare workers and postmenopausal women with osteoporosis by means of a quasi-experimental design in the form of a cluster-controlled trial with clustering at family physician level. The study has 2 study arms. In one arm, osteoporosis stakeholders receive a complex intervention (Integrated Osteoporosis Care(IOC)). The second study arm serves as control and receives care as usual.
The complex intervention is composed of
- education and provision of educational material for all stakeholders in primary osteoporosis care (patients, family physicians, nurse-educators, physiotherapists, dietitians, pharmacists and if present patient's informal caregivers)
- patient self-management support by primary care osteoporosis stakeholders
- the construction of a primary care osteoporosis treatment guideline and care pathway Effectiveness will be measured by questionnaires and data from the (Electronic Medical Record)EMR and IMA-database, in patients and family physicians.
Effects measured in family physicians are:
- Identification failure rate
- Percentage of family physicians correctly implementing the osteoporosis treatment guideline
- Proportion of patients treated correctly as stated in the osteoporosis treatment guideline
- Proportion of family physicians correctly registering osteoporosis related information in the EMR
- Intensity of collaborative practices
- Knowledge of osteoporosis management and treatment
Effects measured in patients are:
- Medication Possession Ratio(MPR) (Primary outcome)
- Health literacy
- Self-management efficacy
- Self-reported treatment adherence
- Self-reported nutritional intake
- Intensity of integrated osteoporosis care
- Patient satisfaction with integrated osteoporosis care
- HRQoL
- Functional independence (Activities of Daily Living - ADL)
- Patient resource use The study elapse time is 18 months. Participating family physicians will receive postgraduate education and start to include patients during consultations in their doctor's office. The inclusion period is 6 months, patients eligible for participation are non-institutionalized postmenopausal women with a diagnosis of osteoporosis who are able to give informed consent.
The follow-up period for patients is 12 months. Follow-up period for family physicians is 18 months.
详细描述
Study design:
A quasi-experimental cluster-controlled trial will be conducted with 2 study arms - intervention vs. control - with clustering at GP-level. The cluster design is imperative because the intervention is implemented within the community, and data will be collected at the physician and patient levels. Trial implementation will last 18 months. GPs will be included prior to the study and will enroll patients during a 6-month period; patients will be followed for 12 months. In the IOC-arm, multiple interventions, representing an integrated approach to postmenopausal osteoporosis (PO) management, are offered for implementation. In the control arm, no intervention will take place and patients will receive CAU. The IOC-programme will be offered within the greater region of Ghent (GRG), GPs and patients from the CAU-group will be located outside this region.
Participants:
Participants will be GPs and their patients. For GPs, the only exclusion criterion will be planned retirement during the study period. For GPs in the IOC-arm, willingness to adhere to the newly developed PO management guideline is an extra inclusion criterion. In both arms, GPs engage to enroll 8-12 patients, with requests for participation made to all patients meeting inclusion criteria. Eligible patients are:
- Postmenopausal women
- With (newly) diagnosis of osteoporosis (BMD T-scores ≤ -2.5) OR eligible for anti-osteoporosis treatment because of (previous) fragility fracture after the age of 50 years
- Without terminal illness
- Who are able to speak and understand Dutch
- Who are able to give informed consent Patient eligibility will be judged and patients included by the participating GPs.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients Postmenopausal women with osteoporosis Non-institutionalized Able to give informed consent
- •Family physicians All family physicians willing to participate
排除标准
- •Patients Suffering from a terminal illness
- •Family physicians No exclusion criteria
结局指标
主要结局
Medication Possession Ratio (MPR)
时间窗: 12 months
Medication Possession Ratio is the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period.
次要结局
- Proportion of patients treated correctly(18 months)
- Percentage of family physicians who correctly register osteoporosis management in the EMR(18 months)
- Identification Failure rate(18 months)
- Intensity of collaborative practices(18 months)
- Knowledge of osteoporosis management and treatment(18 months)
- Resource use(12 months)
- Health-related competencies(12 months)
- Correct use of the osteoporosis treatment guideline(18 months)
- Self-reported medication intake(12 months)
- Patient satisfaction with osteoporosis care(12 months)
- Patient functional independence(12 months)
- Self-reported treatment adherence(12 months)
- Self-reported nutritional intake(12 months)
- Intensity of integrated osteoporosis care(12 months)
- Patient Health Related Quality of Life (HRQoL)(12 months)