Secondary Prevention of Dug-related Problems Through Digital Health

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Unknown

Conditions: Drug-Related Problems

Treatments: Device: MyPlan digital health platform; Other: Satndard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04841863

IIBSP-COD-2019-46

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Drug Code Active Patient o DCAP

Active Comparator group

Description:

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. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge.

Treatment:

Device: MyPlan digital health platform

Standard care

Placebo Comparator group

Description:

Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care. Patients will receive follow-up by videoconference 48 hours after discharge and in the phase II, at 6 and 12 months after discharge.

Treatment:

Other: Satndard care