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Secondary Prevention of Dug-related Problems Through Digital Health

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ClinicalTrials.gov Identifier: NCT04841863
Recruitment Status : Not yet recruiting
First Posted : April 12, 2021
Last Update Posted : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description
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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.

Condition or disease Intervention/treatment Phase
Drug-Related Problems Device: MyPlan digital health platform Other: Satndard care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Prevention of Dug-related Problems Through Patient Empowerment Through Digital Health
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment. [ Time Frame: 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)

  2. Clinical impact of a digitial health tool for secondary prevention of DRP focused on patient empowerment. [ Time Frame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical 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 Outcome Measures :
  1. Identify, classify, and quantify DRP that cause urgent care in a tertiary hospital in this patient population. [ Time Frame: Baseline ]
    Type of DRP that promotes ED visits characterized according to the three dimensions of the Third Consensus of Granada (Need, Effectiveness and Safety)

  2. Identify risk factors for ED visits related to DRP [ Time Frame: 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.

  3. Identify which groups of drugs are more frequently associated to DRP [ Time Frame: Baseline ]
    Using ATC group classification

  4. Change in the patient therapeutic adherence [ Time Frame: 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

  5. Change in the patient therapeutic adherence [ Time Frame: Baseline, 48h after discharge, 6-month and 12-month after discharge (in phase II, Clinical Trial) ]
    Active days on the MyPlan platform, functionalities used, number of queries made through platform messaging

  6. Mesure therapeutic complexity [ Time Frame: Baseline ]
    Using patient Medication Regimen Complexity Index (pMRCI-S) questionnaire

  7. Identify predictive factors of a greater capacity for digital empowerment. [ Time Frame: Baseline ]
    Using the CAMBADOS questionnaire

  8. Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool [ Time Frame: 90-day after discharge (in phase I, Pilot Trial) ]
    Using the TrilemaSalud questionnaire

  9. Measure the usability and satisfaction of patients, caregivers and professionals of the MyPlan digital health tool [ Time Frame: 12-month after discharge (in phase II, Clinical Trial) ]
    Using the TrilemaSalud questionnaire

  10. Change in the quality of life of patients in the active group [ Time Frame: Baseline, 30-day and 90-day after discharge (in phase I, Pilot Trial) ]
    Using the EQ-5D-3L51 questionnaire

  11. Change in the quality of life of patients in the active group [ Time Frame: Baseline, 6-month and 12-month after discharge (in phase II, Clinical Trial) ]
    Using the EQ-5D-3L51 questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841863


Contacts
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Contact: Ana Juanes Borrego, Doctor 932 91 90 00 ext 7459 ajuanes@santpau.cat
Contact: Jesús Ruiz Ramos, Doctor 932 91 90 00 ext 7459 jruiz@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Contact: Ana Juanes, Doctor       ajuanes@santpau.cat   
Contact: Jesús Ruiz, Doctor       jruiz@santpau.cat   
Principal Investigator: Laia López         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Laia López Vinardell Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
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Publications:

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Responsible Party: Ana Juanes, Doctor, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT04841863    
Other Study ID Numbers: IIBSP-COD-2019-46
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Monitor clinical trial will have access to all study data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be avaliable for monitor during the whole study period
Access Criteria: All data may be analysed and revised during the whole study period by the monitor and investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Juanes, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
DRP
Digital Health