The purpose of this study is to evaluate the clinical impact of a program for the secondary prevention of drug-realted problems (DRP) focused on the patient empowerment through Digital Health in patients who visit the Emergency Department (ED) of the Hospital de la Santa Creu i Sant Pau (HSCiSP) for a health problem related to medication in terms of readmissions, revisits and quality of life.
After being infomed about the estudy and potential risks, all patients who meet the eligibility requirements and giving written informed consent, will be randomized. The project is structured in two consecutive phases. 1. st Phase: 3-month randomized pilot study. Patients will be randomized with a 1:1 distribution to be included in the Drug Code Active Patient or DCAP (intervention group) or to receive usual care (control group). The pilot study will confirm whether the proposed methodology is feasible to implement it on a large scale, as well as providing the information necessary to calculate the sample of patients according to the main objective of the study. 2. nd Phase: Randomized clinical trial lasting 18 months (6 of which will be recruitment and 12 months follow-up) following the methodology described for the pilot in a larger sample of patients until the calculated sample size is achieved.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions.
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
Time frame: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
Change in clinical impact during the follow-up time will be evaluated in terms of number of readmissions, number of revisits and quality of life (based on the result obtained in the EQ-5D-3L51 questionnaire)
Time frame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety)
Time frame: Baseline
Identify risk factors for ED visits related to DRP
Age, sex, social and familiar environment, blood presure (mmHg), heart frequency (bpm), Hb1Ac (%), pain (visual analog scale), weight (kg) and height (cm), chronic kidney disease, number of drugs at admission and at discharge, number of chronic health problems.
Time frame: Baseline
Identify which groups of drugs are more frequently associated to DRP
Using ATC group classification
Time frame: Baseline
Change in the patient therapeutic adherence
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Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
Time frame: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Change in the patient therapeutic adherence
Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging
Time frame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Mesure therapeutic complexity
Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire
Time frame: Baseline
Identify predictive factors of a greater capacity for digital empowerment.
Using the CAMBADOS questionnaire
Time frame: Baseline
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Using the TrilemaSalud questionnaire
Time frame: 90-day after discharge (in phase I, Pilot Trial)
Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
Using the TrilemaSalud questionnaire
Time frame: 12-month after discharge (in phase II, Clinical Trial)
Change in the quality of life of patients in the active group
Using the EQ-5D-3L51 questionnaire
Time frame: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Change in the quality of life of patients in the active group
Using the EQ-5D-3L51 questionnaire
Time frame: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)