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

ConditionsDiabetic Foot Disease Diabetic Foot Ulcer (DFU)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of the Balearic Islands

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Implementation strategy developed using the Implementation Mapping model to enhance the effective integration of the Protocol for Assistance to People with Diabetic Foot
Behavioral
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
Other intervention
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.

Treatment groups

1,520 Participants

are divided into 2 treatment groups

Group A: Implementation Mapping strategyExperimental treatment 0 interventions

Group B: Current implementation strategy for diabetic foot preventionSham comparator 1 intervention

Trial outcomes

Primary outcomes

Reach

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.

Time frame