Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03541421
Other study ID # SAMRR2016_2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2017
Est. completion date May 1, 2019

Study information

Verified date December 2019
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background Medication administration errors occur in around 20% of administrations. Patient involvement (PI) is recommended and self-management support e.g. as self-administration of patient's own drugs during hospital stay is a central component of practising PI.

Aim To investigate whether PI in administering drugs in hospital affects the number of medication errors, medication adherence and patient satisfaction and whether it is economically advantageously.

Materials and methods The PhD Study is performed at the Department of Cardiology, Randers Regional Hospital.

The study design is "complex intervention" and the PhD study therefore consists of three studies. In study 1 the intervention is developed, investigated for feasibility and pilot-tested in small scale. In study 2 and 3 the intervention is evaluated within a RCT with outcomes as medication errors, medication adherence, patient satisfaction and cost-effectiveness.


Description:

Background When patients are admitted to Danish hospitals, the responsibility for their medication is taken over by the hospital staff.

Medication administration errors occur in approximately 20% of the total opportunities for error.

Patient involvement (PI) is recommended and self-management support is a central component of PI aiming to improve patients' knowledge, skills and confidence into managing their health condition. "Self-administration of patient's own drugs" during hospital stay is considered a central part of self-management support.

Self-administration of patient's own drugs has been tested in the Capital Region of Denmark. Conclusions were that self-administration increase PI, prepare patients to manage their medication after discharge and release resources within the care group. The occurrence of medication errors compared to traditional medication system was not investigated.

Aim The aim is to investigate whether PI in administering drugs during hospital stay affects the number of medication errors, medication adherence and patient satisfaction and whether it is economically advantageously.

Materials and methods The study design is "complex intervention" and a stepwise process is recommended by the UK Medical Research Council. In study 1 the intervention will therefore be developed, investigated for feasibility and pilot-tested in small scale. In study 2 and 3 the intervention will be evaluated within a RCT.

Intervention If the patient is assessed able to self-administer own drugs at admission, the patient will be asked if he has brought (or can get someone to bring) his usual drugs to hospital. The drugs and an updated medication list will be placed in a lockable bedside table. During hospitalization the patient is responsible for taking his own medication. If a new drug is prescribed, the patient will be involved and instructed about it. Furthermore the smallest package will be delivered so that the patient can begin self-administration of the new drug during hospitalization. After discharge, the patient can bring the package and an updated medication list back home to ensure continuity in the medical treatment.

Study 1: Feasibility and pilot study The PhD study is performed at the Department of Cardiology, Randers Regional Hospital. By visits in the department it is assessed how many eligible patients there are, how many patients change ability to self-administer own drugs during hospital stay (risk of withdrawal), how many drugs do they receive and how many opportunities for error are there? These numbers will be used to assess the inclusion period and to calculate the sample size for the RCT. The intervention and workflows will be developed in collaboration with nurses, physicians and patients to ensure acceptability, feasibility and high patient safety.

In the pilot study the intervention and tools for study 2 is tested.

Study 2: RCT The study is a randomized controlled trial where patients are randomized for either intervention or control. The intervention group consists of patients who self-administer own drugs at home and are able to self-administer own drugs during hospital stay. The control group consists of patients who self-administer own drugs at home, who is able to self-administer own drugs during hospital stay, but where standard care is used (not self-administration).

Study 3: Health economic evaluation The cost effectiveness of the intervention is assessed from the perspectives of the hospital and the health system. Relevant resource use will be identified and detailed in study 1 and measured alongside the RCT.

The costs incurred in the intervention group will be compared to the control group based on an intention to treat principle. If the intervention costs in the intervention group exceed those in the control group, the costs will be related to an effect measure such as number of medication errors avoided.

Perspectives When the patient plays an active role in their own medication, it is expected that they will have a more comprehensive and adequate understanding of their situation and will be better to manage their own medication. The number of medication errors during the processes of dispensing and administering drugs at the wards is expected to decrease when patients administers their own drugs. PI and the use of patient's own drugs during admission are expected to contribute to a better utilization of the resources of the Health Care System.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date May 1, 2019
Est. primary completion date September 26, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients admitted to the department "Medicinsk sengeafsnit 1", at Randers Regional Hospital Monday to Friday from 8.00 am to 6.00 pm

- Patients who are self-administering own drugs at home

Exclusion Criteria:

- Patients under 18 years old

- Patients who are not able to self-administer own drugs during hospital stay

- Patients who do not speak Danish

- Patients who can not or will not give informed consent

Study Design


Intervention

Other:
Patient involvement in administration of drugs
The patient´s own drugs and an updated medication list will be placed in a lockable bedside table. During hospitalization the patient is responsible for taking his own medication. If a new drug is prescribed, the patient will be involved and instructed about it. Furthermore the smallest package will be delivered so that the patient can begin self-administration of the new drug during hospitalization.

Locations

Country Name City State
Denmark Medicinsk Sengeafsnit 1, Regionshospitalet Randers Randers

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Hospital Pharmacy Central Denmark Region, Randers Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Medication administration errors The total number of medication administration errors observed compared to the total opportunities for error. Direct observation of nurses (control group) and patients (intervention group) dispensing drugs. on the day of inclusion and the following day. 1-2 days.
Secondary Medication errors after discharge Discrepancies in medicationlists 14 days after discharge through interviews 14 days after discharge
Secondary Medication Adherence The patients medication adherence is assessed through interviews at hospitalization and 14 days after discharge
Secondary Patient satisfaction The patients satisfaction with the hospital stay is assessed through interviews 14 days after discharge
Secondary Health economics The cost effectiveness of the intervention is assessed. The costs incurred in the intervention group will be compared to the control group based on an intention to treat principle. If the intervention costs in the intervention group exceed those in the control group, the costs will be related to an effect measure such as number of medication errors avoided. from day of inclusion to day of discharge (1-31 days).
See also
  Status Clinical Trial Phase
Completed NCT04709640 - Pilot Study to Improve Medication Management in Older Adults N/A
Completed NCT03257579 - Myocardial Infarction Prescription Duration Adherence Study N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Withdrawn NCT03427008 - A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Kidney Transplant Recipients N/A
Completed NCT03805451 - Life Steps for PrEP for Youth N/A
Withdrawn NCT03292393 - Social Norms and Antihypertensive Medication Adherence N/A
Completed NCT02914730 - Insulin Dosing Practices in Persons With Diabetes on Multiple Daily Injections
Not yet recruiting NCT02876848 - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study) N/A
Completed NCT02823795 - The Supporting Patient Activation in Transition to Home Intervention N/A
Completed NCT02066935 - Non-adherence to Immunosuppressives in Kidney Transplantation in Brazil Multicenter Study
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT01934608 - The Effect of Synching Prescription Refills on Adherence N/A
Completed NCT01741311 - Secondary HIV Prevention and Adherence Among HIV-infected Drug Users N/A
Completed NCT01770314 - Study to Test the Efficacy of Online Education to Increase Safe Use of Opioid Medication. Phase 2
Recruiting NCT01105104 - An Enhanced Medication Monitoring Program Phase 1
Completed NCT01859273 - Adherence Enhancement for Renal Transplant Patients N/A
Withdrawn NCT01430702 - Feasibility of Using a Telemedicine Medication Delivery Unit for Older Adults N/A
Completed NCT01118208 - Blister Packaging Medication to Increase Treatment Adherence and Clinical Response N/A
Completed NCT00848224 - Improving Adherence to Pharmacological Treatment N/A
Completed NCT06034301 - Pill Bottle vs Reminder App N/A