Effect of Pharmacist Provided Drug Information Services After Hospital Discharge

Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.

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.

Study Overview

• Status: Completed
• Conditions: Drug Counseling
• Intervention / Treatment: Other: Drug counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • København NV
    • Copenhagen, København NV, Denmark, 2400
      • Capital Regions Hospital Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Participants in the control group received the normal care following the Danish standard procedure.
Active Comparator: Intervention group; Participants in the intervention group received the normal care following the Danish stadard procedure. Additionally the participants was also offered the possibility to contact a hospital pharmacy department by phone or mail for drug counseling.	Other: Drug counseling; Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sense of security regarding drug treatment and satisfaction with drug counseling.	The questionnaire comprised closed-ended questions, open-ended questions and questions or statements where the respondents were asked to rate the questions or statements on a five-point scale. The scale used is a attitude measurement scale that assess attitudes by presenting respondents with sentences that state beliefs about the particular attitude being measured. The respondents then decide to what extent he or she agrees with the statement. The responses are divided numerically into a series of ordered responses. Ratings: 1 = not at all, 2 = to a small extent, 3 = to some extent, 4 = to a great extent, 5 = to a very great extent.	2-4 weeks after discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of medications by admission.	Number of medications will be read in admission report.	Within one week after discharge.
Number of medications by discharge.	Number of medications will be read in discharge report..	Within one week after discharge.
Number of patients that received medication review by pharmacist during admission.	The patient's journal will be searched for a medication review.	Within one week after discharge.
Number of patients that received help with medication at home after discharge.	The patient's journal will be searched for information regarding help with medication at home.	Within one week after discharge.
Number of enquiries.	Patient enquiries will be classified to one of the predefined categories: adverse effects, choice of therapy, dosage and administration, interactions, product information, storage and handling, indication or other.	Directly after the patient received drug counseling.
Number of potentially prevented drug-related problems.	The pharmacist that performed the drug counseling assessed whether the drug counseling had potentially prevented a drug-related problem.	Directly after the patient received drug counseling.
Cause of hospitalization.	The patient's journal will be searched for cause of hospitalization.	Within one week after discharge.

Collaborators and Investigators

• Sponsor: Region Hovedstadens Apotek
• Collaborators: The Hospitals Pharmacies' and Amgros' Research Development Foundation
• Investigators: Principal Investigator: Tim E Vejborg, M.Sc.Pharm, Region Hovedstadens Apotek

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): June 3, 2019
• Study Completion (Actual): June 3, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: H-18003889

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No