Older PatientsNCT03369652
Telephone Contact Between Hospital and General Practitioner About Medication Review for Older Patients
A study testing Medication review in people with Older Patients and Medication Review, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
In this trial, the feasibility of cooperation between clinical pharmacists and physicians by conducting a telephone follow-up conversation between the hospital geriatrician, the general practitioner and the clinical pharmacist is evaluated. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older Patients, Medication Review, Cross-sectional Communication
- What is being tested?
- Medication review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 2 sitesDenmark
- Study dates
- 24 Nov 2017to 30 Nov 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 5 drugs or more
Who cannot join
- Terminal illness
- Not able to speak and understand Danish
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Odense University Hospital
Odense, 5000
Svendborg Sygehus
Svendborg
About this study
Official title: Can Telephone Contact After Discharge Between Geriatrician, Clinical Pharmacist and General Practitioner About Medication Review in Hospital Improve the Medication in Older Patients? A Feasibility Study.
In this trial, the feasibility of cooperation between clinical pharmacists and physicians by conducting a telephone follow-up conversation between the hospital geriatrician, the general practitioner and the clinical pharmacist is evaluated. During hospital stay the clinical pharmacist and the geriatrician will review older patients' medication and discuss the future treatment with the general practitioner after discharge by telephone or medico-technology.
The first part of the feasibility study will be a qualitative baseline measure of characteristics of the participants and work flow. The second part will be a pilot randomized controlled study where participants will be allocated to either usual care or medication review and follow up contact
- Being tested
- Medication review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewBehavioural
Conducted by the pharmacist and discussed with hospital physician
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Medication history by pharmaconomist. Medication review by pharmacist, patient interview, and conference with physician in hospital, telephone contact to general practitioner after discharge, medication report sent to primary care. Receives: Behavioral: Medication review |
| Control | No intervention | Medication history by pharmaconomist. Usual care by physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in number of medications
Increase or decrease in number of medications from admission to discharge
Measured: At admission and at discharge
Parts of the intervention completed
In the intervention Group only, it is measured, how many of the elements of the intervention the patient actually have received
Measured: Day 1 after discharge
Changes in the Electronic Medication Profile (FMK)
How many changes have been Applied to the Electronic Medication Profile
Measured: 14 days after discharge
Secondary outcomes (6)
Number of readmissions
Data from registers
Measured: within 30 days after discharge
Number of emergency visits
Data from registers
Measured: within 30 days after discharge
Number of visits at general practitioner
Data from registers
Measured: within 30 days after discharge
Patient satisfaction with the discharge
Measured by telephone interview
Measured: 14 days after discharge
Changes in patient-experienced quality of life
Measured by telephone interview using the 5-item questionnaire EQ-5D, where each question can be answered on a 5-point Likert Scale ranging from "very high degree of problems" to "very low degree of problems"
Measured: At admission and 14 days after discharge
Health care professionals satisfaction
Measured by a questionnaire
Measured: 3 months after implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start24 Nov 2017
- Primary completion1 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PatientsStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene V. Ravn-Nielsen, Odense University Hospital
- Investigators
- Anton Pottegård, phd, Study chair, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369652
- Sponsor's protocol ID
- OP_468
- Other IDs
- 1704197
- Status last verified
- Mar 2019
- First submitted
- 21 Nov 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD are planned sharing
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Telephone Contact After Discharge Between Geriatrician, Clinical Pharmacist and General Practitioner About Medication Review in Hospital Improve the Medication in Older Patients? A Feasibility Study.
- ClinicalTrials.gov ID
- NCT03369652
- Acronym / sponsor ID
- OP_468
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 12 Dec 2017 (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.
In this trial, the feasibility of cooperation between clinical pharmacists and physicians by conducting a telephone follow-up conversation between the hospital geriatrician, the general practitioner and the clinical pharmacist is evaluated. During hospital stay the clinical pharmacist and the geriatrician will review older patients' medication and discuss the future treatment with the general practitioner after discharge by telephone or medico-technology.
The first part of the feasibility study will be a qualitative baseline measure of characteristics of the participants and work flow. The second part will be a pilot randomized controlled study where participants will be allocated to either usual care or medication review and follow up contact
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Medication reviewMedication history by pharmaconomist. Medication review by pharmacist, patient interview, and conference with physician in hospital, telephone contact to general practitioner after discharge, medication report sent to primary care. |
| Control | No intervention | –Medication history by pharmaconomist. Usual care by physicians. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 5 drugs or more
Key exclusion criteria (2 listed)
- Terminal illness
- Not able to speak and understand Danish
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 |
|---|---|---|
| Medication reviewConducted by the pharmacist and discussed with hospital physician | Behavioural | Intervention |
Primary outcome
Changes in number of medications
Time frame: At admission and at discharge
Increase or decrease in number of medications from admission to discharge
Parts of the intervention completed
Time frame: Day 1 after discharge
In the intervention Group only, it is measured, how many of the elements of the intervention the patient actually have received
Changes in the Electronic Medication Profile (FMK)
Time frame: 14 days after discharge
How many changes have been Applied to the Electronic Medication Profile
6 secondary outcomes
Number of readmissions
Time frame: within 30 days after discharge
Number of emergency visits
Time frame: within 30 days after discharge
Number of visits at general practitioner
Time frame: within 30 days after discharge
Patient satisfaction with the discharge
Time frame: 14 days after discharge
Changes in patient-experienced quality of life
Time frame: At admission and 14 days after discharge
Health care professionals satisfaction
Time frame: 3 months after implementation
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 19 Mar 2019.
- Individual participant dataSharing planned: No. No IPD are planned sharing
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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.
Anton Pottegård, phd study chair
University of Southern Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication review in people with Older Patients and Medication Review, run by Odense University Hospital at 2 sites 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 1 inclusion and 2 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 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Changes in number of medications (time frame: At admission and at discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2019.