Drug CounselingNCT03829995
Effect of Pharmacist Provided Drug Information Services After Hospital Discharge
A study testing Drug counseling in people with Drug Counseling, run by Region Hovedstadens Apotek at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Counseling
- What is being tested?
- Drug counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jul 2018to 3 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Capital Regions Hospital Pharmacy
Copenhagen, København NV, 2400
About this study
Official title: 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.
Read the 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
- Being tested
- Drug counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug counselingOther
Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Participants in the control group received the normal care following the Danish standard procedure. |
| Intervention group | Active comparator | 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. Receives: Other: Drug counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 weeks after discharge.
Secondary outcomes (7)
Number of medications by admission.
Number of medications will be read in admission report.
Measured: Within one week after discharge.
Number of medications by discharge.
Number of medications will be read in discharge report..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Directly after the patient received drug counseling.
Cause of hospitalization.
The patient's journal will be searched for cause of hospitalization.
Measured: Within one week after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start12 Jul 2018
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug CounselingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group is compared with the control group.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Hovedstadens Apotek
- Sponsor type
- Other government
- Collaborators
- The Hospitals Pharmacies' and Amgros' Research Development Foundation
- Responsible party
- Principal investigator, Tim Emil Vejborg, Region Hovedstadens Apotek
- Investigators
- Tim E Vejborg, M.Sc.Pharm, Principal investigator, Region Hovedstadens Apotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829995
- Sponsor's protocol ID
- H-18003889
- Status last verified
- Jun 2019
- First submitted
- 22 Jan 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37883413
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pharmacist Provided Drug Information Services After Hospital Discharge: Patient Satisfaction and Sense Of Security Regarding Drug Treatment.
- ClinicalTrials.gov ID
- NCT03829995
- Acronym / sponsor ID
- H-18003889
- Conditions
- Drug Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Region Hovedstadens ApotekOther government
- Collaborators
- The Hospitals Pharmacies' and Amgros' Research Development Foundation
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group is compared with the control group.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Participants in the control group received the normal care following the Danish standard procedure. |
| Intervention group | Active comparator | Other: Drug counselingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug counselingParticipants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues. | Other | Intervention group |
Primary outcome
Sense of security regarding drug treatment and satisfaction with drug counseling.
Time frame: 2-4 weeks after discharge.
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.
7 secondary outcomes
Number of medications by admission.
Time frame: Within one week after discharge.
Number of medications by discharge.
Time frame: Within one week after discharge.
Number of patients that received medication review by pharmacist during admission.
Time frame: Within one week after discharge.
Number of patients that received help with medication at home after discharge.
Time frame: Within one week after discharge.
Number of enquiries.
Time frame: Directly after the patient received drug counseling.
Number of potentially prevented drug-related problems.
Time frame: Directly after the patient received drug counseling.
Cause of hospitalization.
Time frame: Within one week after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Derived from this study: PubMed 37883413Fjaere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim E Vejborg, M.Sc.Pharm principal investigator
Region Hovedstadens Apotek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug counseling in people with Drug Counseling, run by Region Hovedstadens Apotek at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sense of security regarding drug treatment and satisfaction with drug counseling. (time frame: 2-4 weeks after discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.