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My Health - My Medication. Patient Involvement in Administration of Medication

C

Central Jutland Regional Hospital

Status

Completed

Conditions

Medical Patients

Treatments

Behavioral: One-Stop Dispensing
Behavioral: One-Stop Dispensing and focused dialogue

Study type

Interventional

Funder types

Other

Identifiers

NCT02894814
6300002A
1-16-02-124-16 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to investigate if patient involvement in the medication procedures through elements of the medication system One-Stop Dispensing (use of own medication, placed in bedside locker, partly or self-administration of medication) and focused dialogue about medication can maintain or improve the patients' health literacy to perform the prescribed medical treatment during and after hospitalization.

The hypothesis is, that involving the patient in the medication procedure and focused dialogue about the medicine during hospitalization will improve the patients' health literacy measured by patient adherence, patient knowledge and perceptions of safety about the medication. It is further expected that more time will be spent together with the patient, and that the new medication procedures will be cost-neutral.

Full description

More people live with chronic diseases and therefore it is important for the healthcare system to develop and organize initiatives that involve patients in their treatment.

In Denmark dispensing and administration of medication during hospitalization is a process where the health staff has completely taken the responsibility from the patient, leaving unused resources among patients and their relatives.

In general non-adherence to medication in patients with chronic medical diseases is a common problem, which contributes to adverse health outcomes, increase healthcare expenditures and reduce quality of life.

One-Stop Dispensing (use of own medication, placed in bedside locker, partly or self-administration of medication during hospitalization), which is a medication system developed in United Kingdom in the 1990s, could be an important part of a shift in the healthcare system toward increasing patient involvement. Use of own medication and self-administration aims, among other things, to increase adherence and the patient's knowledge and understanding of their medication. One-Stop Dispensing has so far only been tested on elective surgical patients in Denmark, which is why this study set out to investigate acute hospitalized medical patients.

To investigate the effect of the medication system One-Stop Dispensing in Danish medical patients the investigators planned a study including two designs. An observational before and after implementing One-Stop Dispensing study and a randomized controlled study for the intervention period.

Enrolment for an observational part of the study will begin in April 2016 with data collection on patients under the traditional medication system.

In October 2016 enrolment will then begin for the intervention period including randomization to a basic intervention including the elements of One-Stop Dispensing or an extended intervention which besides One-Stop Dispensing also include a dialogue with the patients about their medication during the hospitalization and at discharge. The data collection will end in March 2017.

The research team will identify and verify patient eligibility. All participants will need to provide informed written consent. For recruitment and informed consent, project information will be discussed with the participants.

Baseline variables will be collected at admission and in the intervention period prior to randomization. This includes questionnaire and baseline characteristics such as age, sex and diagnosis. The primary measure is adherence measured at baseline and 1 month after discharge. Knowledge of the patients' own medication will assessed by a health professional also at baseline and again at discharge.

The study will end after one month follow up is completed for all the included patients.

Enrollment

329 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hospitalized patients at Diagnostic Center, Regional Hospital Silkeborg, Denmark ≥ age 18 years, who understand, speak and are able to read Danish.

Exclusion criteria

  • Patients admitted for elective procedures, where admission is expected to be <24 hours
  • Patients with significant cognitive problems (dementia, dying, psychotic etc.)
  • Patients who abuse medicine or narcotics.
  • Patients who have participated in the project during a previous admission.
  • Patients who do not use prescribed medicine.
  • Patients admitted in the period monday from 8 a.m. until friday 3 p.m.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

329 participants in 3 patient groups

Basic intervention
Active Comparator group
Description:
Elements of One-Stop Dispensing (use of own medication, placed in bedside locker, partly or self-administration of medication during hospitalization)
Treatment:
Behavioral: One-Stop Dispensing
Extended intervention
Active Comparator group
Description:
Elements of One-Stop Dispensing and focused dialogue with the patients about their medication during the hospitalization.
Treatment:
Behavioral: One-Stop Dispensing and focused dialogue
Observational part of the study
No Intervention group
Description:
Data collection on patients under the traditional medication system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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