Effect of Pharmacist Provided Drug Information Services After Hospital Discharge

NCT ID: NCT03829995

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-06-03

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.

Conditions

Drug Counseling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

Participants in the control group received the normal care following the Danish standard procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Drug counseling

Intervention Type: OTHER

Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Interventions

Drug counseling

Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hospitals Pharmacies' and Amgros' Research Development Foundation

UNKNOWN

Sponsor Role: collaborator

Region Hovedstadens Apotek

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tim Emil Vejborg

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tim E Vejborg, M.Sc.Pharm

Role: PRINCIPAL_INVESTIGATOR

Region Hovedstadens Apotek

Locations

Capital Regions Hospital Pharmacy

Copenhagen, København NV, Denmark

Countries

Denmark

References

Fjaere KW, Vejborg TE, Colberg L, Ulrich CS, Pedersen L, Demeny AK, Poulsen JH, Armandi HB, Clemmensen MH. Medicine information helpline after hospitalization-a randomized trial: Impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safety. PLoS One. 2023 Oct 26;18(10):e0293523. doi: 10.1371/journal.pone.0293523. eCollection 2023.

Reference Type: DERIVED

PMID: 37883413 (View on PubMed)

Other Identifiers

H-18003889

Identifier Type: -

Identifier Source: org_study_id