Implementation of a Diabetic Foot Prevention Strategy in Primary Care: Study Protocol for Two-arm Cluster Randomised Controlled Trial (iMplanta Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,520
- 试验地点
- 2
- 主要终点
- Reach
研究概览
简要总结
The goal of this two-arm cluster randomised controlled trial (RCT) is to evaluate the effectiveness of a new implementation strategy based on the ImM model for the Protocol of assistance to the person with diabetic foot (PAPDF) of the Balearic Islands Health Service in reducing complications of diabetic foot, compared to the current implementation strategy, in the primary care centers of Majorca. As secondary objectives we aim 1. To determine the reach of the implementation strategy in the GAPM primary care centers, 2.To compare the effectiveness of the PAPDF versus usual care in preventing diabetic foot complications, 3. To identify the number of healthcare professionals adhering to the implementation strategy and 4. To assess the sustainability of the implementation strategy over time.
详细描述
A two-arm, cluster-randomized clinical trial will be conducted. The unit of randomization will be the primary care centers (PCCs) within the Mallorca Primary Care Management (GAPM). The PCCs will be randomly assigned to the intervention group, that will apply an implementation strategy based on the Implementation Mapping (ImM) model and the control group, that will receive no specific intervention, and the implementation of the PAPDF will continue as currently practiced in the participating PCCs.
Data collection will be carried out at baseline (visit 0), at six months (visit 1), and 12 months (visit 2) for follow-up.
Four primary care centers (PCCs) will be included in the study. Since the implementation of the PAPDF intervention will be integrated into the routine care of the participating PCCs, all healthcare professionals working in the selected centers will be automatically included in the study. Patients from the PCCs meeting the following criteria will be eligible for participation: Diagnosis of type 1 or type 2 diabetes mellitus (DM), aged 18 years or older, attending nursing consultations at participating PCCs during the study period. To assess the occurrence of complications associated with PD, cross-sectional samples of patients with DM in the selected health centres will be selected at different time points: before implementation (baseline), which will correspond to data from the 12 months prior to the start of the study, and at 6 and 12 months after the start of the study.
Eligible participants will be patients with a diagnosis of type 1 and 2 DM, over 18 years of age, who belong to the Public Health Service of the Balearic Islands of one of the selected centres. Will be excluded individuals with gestational diabetes, patients with DF ulcers or lower limb amputations prior to the start of the study.
The selected health centres will be randomly distributed into the control or intervention group using a computerised randomisation tool. Due to the characteristics of the implementation intervention, blinding will not be possible. However, there will be blinding for the team responsible for data analysis, as they will not know to which randomisation group (control/intervention) the data will belong.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 or type 2 diabetes mellitus.
- •Aged 18 years or older.
- •Attending nursing consultations at participating primary care centers during the study period.
排除标准
- •Patients with gestational diabetes.
- •Patients with diabetic foot ulcers prior to the start of the study.
- •Patients with lower limb amputations prior to the start of the study.
结局指标
主要结局
Reach
时间窗: At baseline, 6 months and 12 months.
Percentage of patients with diabetes mellitus over 18 years of age who have the "Diabetic Foot Protocol" open in the electronic medical record divided by the total number of patients with DM over 18 years of age in the health centers of both groups.
次要结局
- Effectiveness(At baseline, 6 months and 12 months.)
- Adoption(At baseline, 6 months and 12 months.)
- Implementation fidelity(At baseline, 6 months and 12 months.)
- Maintenance(At baseline, 6 months and 12 months.)