Implementation of a Diabetic Foot Prevention Strategy in Primary Care (iMplanta Study)

Condition(s) studied

Investigational drug(s) / intervention(s)

Implementation strategy developed using the Implementation Mapping model to enhance the effective integration of the Protocol for Assistance to People with Diabetic Foot: The intervention will be based on the Implementation Mapping methodology (IM). This model is based on the Intervention Mapping. IM consists of several specific tasks: 1. Conduct an assessment of needs and identification of programme adopters and implementers through a review of qualitative or mixed studies assessing the perceptions of both patients and professionals regarding DF prevention as well as individual semi-structured interviews with patients, health professionals and management staff 2. Indicate adoption and implementation outcomes and action objectives, identifying determinants and create matrices of change; this process will allow for the identification of determinants, which are those factors that influence the actions will be implemented 3. Select theoretical methods and select or design implementation strategies using the ERIC model (Expert Recommendations for Implementing Change) 4. Produce implementation protocols and materials 5. Evaluate implementation results

Sham Comparator: Usual care: No systematic implementation of the protocol based on the prevention of foot at risk, ulcer treatment and screening of the risk of diabetic foot ulcer for referral to hospital care.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Reach — 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.

Trial sites (1)

More University of the Balearic Islands trials in Spain