Clinical trial NCT04841863: Secondary Prevention of Dug-related Problems Through Digital Health
Official title: Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug-Related Problems
Keywords: DRP
Digital Health
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
timeFrame: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
measure: Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment.
timeFrame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Secondary outcomes:
measure: Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population.
timeFrame: Baseline
measure: Identify risk factors for ED visits related to DRP
timeFrame: Baseline
measure: Identify which groups of drugs are more frequently associated to DRP
timeFrame: Baseline
measure: Change in the patient therapeutic adherence
timeFrame: Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
measure: Change in the patient therapeutic adherence
timeFrame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
measure: Mesure therapeutic complexity
timeFrame: Baseline
measure: Identify predictive factors of a greater capacity for digital empowerment.
timeFrame: Baseline
measure: Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
timeFrame: 90-day after discharge (in phase I, Pilot Trial)
measure: Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool
timeFrame: 12-month after discharge (in phase II, Clinical Trial)
measure: Change in the quality of life of patients in the active group
timeFrame: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
measure: Change in the quality of life of patients in the active group
timeFrame: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Laia López Vinardell
role: PRINCIPAL_INVESTIGATOR
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