Drug-Related Problems
Conditions
Keywords
DRP, Digital Health
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMyPlan digital health platform
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.
OTHERSatndard care
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than or equal to 18 years. * Visit ED for a DRP caused bu a drug of the ATC groups A, B, C or N. * Be independent for activities of daily living (equivalent to Barthel 100). * Have a Chalson Comorbidity Index 2 \<= 3. * Not present cognitive impairment. * Be directly responsible for pharmacotherapy. * Have a mobile device compatible with the MyPlan mobile application and access to Wi-Fi or mobile data, enabling the use of the technology platform from home.
Exclusion criteria
* Important language barrier. * Impossibility of carrying out the necessary questionnaires or interviews defined in the methods of this study. * Mental pathology that makes the autonomous use of technology impossible or that represents a safety problem for the patient according to clinical criteria. * Patients not residing in the territory who cannot be followed-up later.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment. | Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population. | Baseline | Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety) |
| Identify risk factors for ED visits related to DRP | Baseline | 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. |
| Identify which groups of drugs are more frequently associated to DRP | Baseline | Using ATC group classification |
| Identify predictive factors of a greater capacity for digital empowerment. | Baseline | Using the CAMBADOS questionnaire |
| Mesure therapeutic complexity | Baseline | Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire |
| Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool | 90-day after discharge (in phase I, Pilot Trial) | Using the TrilemaSalud questionnaire |
| Change in the quality of life of patients in the active group | Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial) | Using the EQ-5D-3L51 questionnaire |
| Change in the patient therapeutic adherence | Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial) | Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging |
Countries
Spain
Contacts
Primary ContactAna Juanes Borrego, Doctor
Backup ContactJesús Ruiz Ramos, Doctor
Outcome results
None listed