Clinical trial NCT03829995: Effect of Pharmacist Provided Drug Information Services After Hospital Discharge
Official title: Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Counseling
Lead sponsor: Region Hovedstadens Apotek
Sponsor class: OTHER_GOV
Collaborators: name: The Hospitals Pharmacies' and Amgros' Research Development Foundation
First posted: 2019-02-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group is compared with the control group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective:

The aim of this study is to evaluate if offering drug counseling from a hospital pharmacy increases patient satisfaction and sense of security regarding drug treatment after hospital discharge.

Detailed description: Method and design:

This study was estimated to include 250 participants in a clinical randomized controlled trial. The participants were included from the Acute Medical Ward and the Department of Respiratory Medicine at Bispebjerg Hospital when discharged. The participants were randomized to one of two groups with unequal sizes: the control (50 participants) or intervention group (200 participants). This study used blocked randomization with block sizes of 5/10/15/20/25. The control group received the normal care following the Danish standard procedure. Participants in the intervention group also received the normal care but was also offered the possibility to contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Data for the primary outcome measures was collected 14 days after discharge through structured phone interviews. An interview guide with a semi-structured questionnaire and already validated questions were developed, pre-tested and optimized. The participants were asked to answer open-ended questions, closed-ended question and rate statements or questions on a five-point scale.

The participants in the control group were asked to answer 13 items (seven questions or statements on a five-point scale, four closed-ended questions and two open-ended questions).

The participants in the intervention group who did not make any queries were asked the same questions as the participants in the control group and additionally three closed-ended questions. A total of 16 items.

The participants in the intervention group who made queries were asked the same questions as the participants in the intervention group who did not make any queries and additionally five questions on a five-point scale, four closed-ended and one open-ended question. A total of 27 items.

The effect of the drug counseling regarding patient safety was evaluated by a pharmaceutical assessment in which it was assessed whether the drug counseling had potentially prevented a drug-related problem.

Quantitative data from the phone interviews will be analyzed in Microsoft excel with descriptive statistics and simple parametric statistics. An analysis will determine whether there is a difference in the primary outcome measures.

Eligibility criteria: Inclusion Criteria:

* Patients discharged from the acute medical ward and department of respiratory medicine at Bispebjerg Hospital.
* Patients discharged to own home.
* Can speak the danish language.
* ≥18 years old.
* Can be contacted by phone.

Exclusion Criteria:

* Cognitive and communicative problems (e.g. dementia, aphasia, suicidal) or other barriers that unable the participant to use the intervention service.
* Patient does not answer phone within five attempts on five different days, when trying to conduct patient interview.
* Cognitive and communicative problems that unable the participant to answer questions in the patient interview.
* Deceased or readmitted before patient interview.

Primary outcomes:
measure: Sense of security regarding drug treatment and satisfaction with drug counseling.
timeFrame: 2-4 weeks after discharge.
Secondary outcomes:
measure: Number of medications by admission.
timeFrame: Within one week after discharge.
measure: Number of medications by discharge.
timeFrame: Within one week after discharge.
measure: Number of patients that received medication review by pharmacist during admission.
timeFrame: Within one week after discharge.
measure: Number of patients that received help with medication at home after discharge.
timeFrame: Within one week after discharge.
measure: Number of enquiries.
timeFrame: Directly after the patient received drug counseling.
measure: Number of potentially prevented drug-related problems.
timeFrame: Directly after the patient received drug counseling.
measure: Cause of hospitalization.
timeFrame: Within one week after discharge.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Capital Regions Hospital Pharmacy
state: København NV
Study officials:
affiliation: Region Hovedstadens Apotek
name: Tim E Vejborg, M.Sc.Pharm
role: PRINCIPAL_INVESTIGATOR
References: