Safe Use of Medication at Home by Caregivers. Experimental Study

Study Overview
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Brief Summary
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Experimental study to test the effectiveness of a psychoeducational intervention using virtual reality, aimed at caregivers of multi-pathological and polypharmacy persons to promote safer medication use at home. Experimental design with two groups (experimental and control), pre-post measures, and participants assignment to groups by simple randomization. Null hypothesis. There will be no differences in the frequency of medication errors at home, the severity of the consequences of medication errors, perceived self-efficacy, and health literacy between caregivers using a dosing device (control group) and caregivers using a dosing device with the reinforcement of a psychoeducational intervention designed ad hoc (experimental group).

Detailed Description
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Background. Population aging is leading to an increase in the number of multi-pathological and polymedicated patients. These patients are at increased risk of suffering adverse events due to medication errors (ME), especially if Barthel≤55. The management of their medication places an added burden of stress on those who assume responsibility for their care. This task, due to the existing gender gap, falls more often on women. Objective. To promote the safe use of medication in the home by those who assume the role of caregivers of these patients. Method. Mixed research study. First: Nominal groups (N=128) and survey (N=1255) to design a psychoeducational intervention aimed at caregivers based on the identification of ME, its causes and consequences, and risk factors that contribute to ME. Second: Single-subject experimental design (two groups, experimental and control, with pre-post measures) to determine the effectiveness of the psycho-educational intervention (n=432). Setting. Primary care centers and caregivers' associations and training schools in Alicante, Granada, Madrid, Pamplona, Seville, and Zaragoza. Expected results. Identify critical elements for medication risk management in the home by caregivers. Low-cost psycho-educational intervention for safer use of medication adjusted to the possible different needs of male and female caregivers. The transfer of results will be mainly oriented to reinforce the action carried out by nursing and caregivers' training schools.

Official Title
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Safe Use of Medication at Home by Caregivers. Experimental Study

Conditions
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Caregivers of Multi-pathological and Polypharmacy Adults

Intervention / Treatment
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* Behavioral: Psychoeducational intervention for safe medication use at home + Medication dosing device
* Device: Medication dosing device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caregivers of multi-pathological and polypharmacy patients (Barthel equal to or less than 55). Residence in Alicante, Granada, Madrid, Pamplona, Seville, or Zaragoza (in the patient's home or the family member's home). At patient's charge for at least six months during the year. Exclusion Criteria: Caregivers of patients who are institutionalized a minimum of 3 months per year. Caregivers with experience of more than six months in the use of medication dosing devices. Health education/profession. Filing of a property claim in the last 5 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants. Caregivers of multi-pathological and polypharmacy patients (Barthel equal to or lower than 55). Recruitment will be carried out by simple randomization based on the diaries of patients seen in the last 18 months in the collaborating centers. Intervention. Psychoeducational intervention based on virtual reality aimed at increasing self-efficacy and health literacy in medication use. Procedure. By simple randomization, participants will be assigned to one of the two groups (control or experimental) after giving their informed consent. They will not know to which group they belong. Treatments. The subjects in the control group will use a dosing device and will receive information on how to use it to avoid medication errors. The experimental group will receive the psychoeducational intervention and the same medication device. The experimental group will receive the psychoeducational intervention. Intervention period: 15 days. Follow-up: 12 months.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group (Psychoeducational Intervention)<br>Two hundred and sixteen caregivers of multi-pathological and polypharmacy patients will receive psychoeducational intervention based on virtual reality and a dosing device for safer medication use at home. The intervention will be developed in a previous project phase using a mixed methodology (observational study and qualitative techniques). The intervention will be group-based and consist of motivational discussions and a review of audiovisual materials to promote self-efficacy and health literacy on the safe use of medication at home (most frequent errors, preventive strategies, etc.). Study period: 15 days intervention and follow-up 12 months. | Behavioral: Psychoeducational intervention for safe medication use at home + Medication dosing device<br>* The intervention is yet to be defined. Psychoeducational intervention based on virtual reality, demonstrations, and psychoeducational content using virtual reality. Contents: Most frequent medication errors at home. Approaches to risk management in the home. Correct use of the most common medications in different patient profiles. Strategies to avoid medication errors. Guidance to alleviate the burden of responsibility suffered by women as a result of the gender bias derived from assuming the caregiver role. Other.<br>|
| Active Comparator: Control Group (Dosing Device)<br>The 216 subjects assigned to the control group will use a medication dosing device and will receive information on how to use it for medication errors. Study period: 15 days intervention and follow-up 12 months. | Device: Medication dosing device<br>* Use of medication dosing device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Frequency of Medication Errors after the intervention (12 months later). | The number of medication errors, type, and consequences (adverse events and consumption of healthcare resources to mitigate the effect of the error). Self-reported measure. Pre-intervention measure (5 years prior). Post-intervention measure (last 12 months). | Pre-intervention measure (5 years prior). Post-intervention measure (last 12 months). | 
| Change from Baseline Health Literacy after the intervention (12 months later). | Health Literacy validated questionnaire. | Pre- and post-intervention measurement (12 months time lapse). | 
| Change from Baseline Therapeutic Adherence after the intervention (12 months later). | Therapeutic Adherence validated questionnaire. | Pre- and post-intervention measurement (12 months time lapse). | 
| Change from Baseline Locus of Control after the intervention (12 months later). | Locus of Control Test - Abridged. | Pre- and post-intervention measurement (12 months time lapse). | 
| Change from Baseline Self-efficacy after the intervention (12 months later). | Adaptation of the Family Caregiver Activation in Transitions (FCAT) Tool (Coleman et al., 2015). | Pre- and post-intervention measurement (12 months time lapse). | 
| Perceived usefulness of the information provided at the time of intervention completion. | Ad hoc survey | Post-intervention measure (15 days after the start of the intervention). | 
| Perceived usefulness of the information provided after 3 months from the end of the intervention. | Ad hoc survey | Post-intervention measure (after 3 months). | 
| Perceived usefulness of the information provided after 6 months from the end of the intervention. | Ad hoc survey | Post-intervention measure (after 6 months). | 
| Perceived usefulness of the information provided after 12 months from the end of the intervention. | Ad hoc survey | Post-intervention measure (after12 months). | 
| Family Caregivers' Experience at the time of intervention completion. | The Measure of the Family Caregivers' Experience (Guilabert et al., 2018). | Post-intervention measure (15 days after the start of the intervention). | 
| Family Caregivers' Experience after 3 months from the end of the intervention. | The Measure of the Family Caregivers' Experience (Guilabert et al., 2018). | Post-intervention measure (after 3 months). | 
| Family Caregivers' Experience after 6 months from the end of the intervention. | The Measure of the Family Caregivers' Experience (Guilabert et al., 2018). | Post-intervention measure (after 6 months). | 
| Family Caregivers' Experience after 12 months from the end of the intervention. | The Measure of the Family Caregivers' Experience (Guilabert et al., 2018). | Post-intervention measure (after 12 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication Errors, Patient Safety, Psychoeducational Intervention, Risk Management, Health Literacy