Clinical trial NCT02894814: My Health - My Medication. Patient Involvement in Administration of Medication
Official title: My Health - My Medication. A Controlled Investigation of Patient Involvement in Administration of Medication in Hospitalized Medical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Patients
Keywords: Self administration
Medication
Inpatient
Self-care
Self-management
Medical patients
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in adherence to medical treatment
timeFrame: From baseline (admission) to one month after discharge
Secondary outcomes:
measure: Patient satisfaction
timeFrame: The day at discharge, after admission of an average of 3 days
measure: Time spent per patient
timeFrame: Days admitted, an average of 3 days
measure: Cost per patient
timeFrame: Days admitted, an average of 3 days
measure: Knowledge of own medication
timeFrame: Days admitted, an average of 3 days
measure: Change in patient's perception of security and safety regarding medication
timeFrame: From baseline (admission) to one month after discharge
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Diagnostic Centre, Regional Hospital Silkeborg
Study officials:
affiliation: Diagnostic Centre, Regional Hospital Silkeborg, Denmark
name: Charlotte W Appel, PhD
role: PRINCIPAL_INVESTIGATOR
References: