NCT02894814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 2, 2017

Status Verified

June 1, 2017

Enrollment Period

11 months

First QC Date

May 30, 2016

Last Update Submit

June 1, 2017

Conditions

Keywords

Self administrationMedicationInpatientSelf-careSelf-managementMedical patients

Outcome Measures

Primary Outcomes (1)

  • Change in adherence to medical treatment

    Ability to adhere to medical recommendations in general, assessed by questionnaire at baseline (admission to hospital) and 1 month after discharge.

    From baseline (admission) to one month after discharge

Secondary Outcomes (5)

  • Patient satisfaction

    The day at discharge, after admission of an average of 3 days

  • Time spent per patient

    Days admitted, an average of 3 days

  • Cost per patient

    Days admitted, an average of 3 days

  • Knowledge of own medication

    Days admitted, an average of 3 days

  • Change in patient's perception of security and safety regarding medication

    From baseline (admission) to one month after discharge

Study Arms (3)

Basic intervention

ACTIVE COMPARATOR

Elements of One-Stop Dispensing (use of own medication, placed in bedside locker, partly or self-administration of medication during hospitalization)

Behavioral: One-Stop Dispensing

Extended intervention

ACTIVE COMPARATOR

Elements of One-Stop Dispensing and focused dialogue with the patients about their medication during the hospitalization.

Behavioral: One-Stop Dispensing and focused dialogue

Observational part of the study

NO INTERVENTION

Data collection on patients under the traditional medication system

Interventions

Use of own medication, review of the patient's medication, partly or self-administration of medication during hospitalization under support from the health personnel to improve adherence, knowledge and feeling safe about the medication.

Basic intervention

Besides the elements of One-Stop Dispensing focused dialogue about the patient's medicine during hospitalization and at discharge to improve adherence, knowledge and feeling safe about the medication

Extended intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diagnostic Centre, Regional Hospital Silkeborg

Silkeborg, 8600, Denmark

Location

Study Officials

  • Charlotte W Appel, PhD

    Diagnostic Centre, Regional Hospital Silkeborg, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Nurse

Study Record Dates

First Submitted

May 30, 2016

First Posted

September 9, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 2, 2017

Record last verified: 2017-06

Locations