Secondary Prevention of Dug-related Problems Through Digital Health

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug-Related Problems
• Intervention / Treatment: Device: MyPlan digital health platform; Other: Satndard care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Juanes Borrego, Doctor; Phone Number: 7459 932 91 90 00; Email: ajuanes@santpau.cat
• Study Contact Backup: Name: Jesús Ruiz Ramos, Doctor; Phone Number: 7459 932 91 90 00; Email: jruiz@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital De La Santa Creu I Sant Pau
    • Contact: Ana Juanes, Doctor; Email: ajuanes@santpau.cat
    • Contact: Jesús Ruiz, Doctor; Email: jruiz@santpau.cat
    • Principal Investigator: Laia López

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drug Code Active Patient o DCAP; 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.	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.
Placebo Comparator: Standard care; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Identify which groups of drugs are more frequently associated to DRP	Using ATC group classification	Baseline
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)
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)
Mesure therapeutic complexity	Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire	Baseline
Identify predictive factors of a greater capacity for digital empowerment.	Using the CAMBADOS questionnaire	Baseline
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Laia López Vinardell, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Digital Health; DRP
• Other Study ID Numbers: IIBSP-COD-2019-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Monitor clinical trial will have access to all study data
• IPD Sharing Time Frame: Data will be avaliable for monitor during the whole study period
• IPD Sharing Access Criteria: All data may be analysed and revised during the whole study period by the monitor and investigators
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No