Secondary Prevention of Dug-related Problems Through Digital Health

Drug-Related Problems Clinical Trial

Official title:

Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04841863
• Other study ID #: IIBSP-COD-2019-46
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: April 2023

Study information

• Verified date: April 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Ana Juanes Borrego, Doctor
• Phone: 932 91 90 00
• Email: ajuanes[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2023
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug-Related Problems

Intervention

Device:
• MyPlan 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.

Other:
• Satndard care
Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Primary	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)	Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Secondary	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)	Baseline
Secondary	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.	Baseline
Secondary	Identify which groups of drugs are more frequently associated to DRP	Using ATC group classification	Baseline
Secondary	Change in the patient therapeutic adherence	Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging	Baseline, 48h after discharge, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Secondary	Change in the patient therapeutic adherence	Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging	Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial)
Secondary	Mesure therapeutic complexity	Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire	Baseline
Secondary	Identify predictive factors of a greater capacity for digital empowerment.	Using the CAMBADOS questionnaire	Baseline
Secondary	Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool	Using the TrilemaSalud questionnaire	90-day after discharge (in phase I, Pilot Trial)
Secondary	Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool	Using the TrilemaSalud questionnaire	12-month after discharge (in phase II, Clinical Trial)
Secondary	Change in the quality of life of patients in the active group	Using the EQ-5D-3L51 questionnaire	Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial)
Secondary	Change in the quality of life of patients in the active group	Using the EQ-5D-3L51 questionnaire	Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial)