Drug UseNCT03671629
Clinical Pharmacist Intervention to Reduce Drug-related Readmissions Among Older People
A study testing Enhanced clinical pharmacist service in people with Drug Use, run by Umeå University at 1 site in Sweden.
Trial summary
This randomized controlled trial primarily investigates if a clinical pharmacist intervention can reduce drug-related readmissions among patients >75 years. The intervention targets the transfer between hospital and primary care. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Use
- What is being tested?
- Enhanced clinical pharmacist service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSweden
- Study dates
- 19 Sep 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Living at home
- Acutely admitted
- Registered at one of ten pre-specified primary care health centers
Who cannot join
- Patients unable to communicate or who do not speak Swedish
- Patients scheduled for palliative care
- Patients admitted due to intoxication by alcohol or drug (non prescription)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Medical Centre, University Hospital of Umeå
Umeå, 901 85
Matsson, +4690-785 84 02, cecilia.mattsson@vll.se
About this study
Official title: Involving Clinical Pharmacists in Transitional Care to Reduce Drug-related Readmissions Among the Elderly - a Randomized Controlled Trial
This randomized controlled trial primarily investigates if a clinical pharmacist intervention can reduce drug-related readmissions among patients >75 years. The intervention targets the transfer between hospital and primary care. In brief, the intervention includes medical chart reviews and patient interviews during a period of 180 days.
Read the detailed description
At discharge from the hospital, patients that meet the inclusion criteria are offered to participate in the study. At this point the investigators will also gather baseline data through questionnaires on self-reported adherence (MARS-5) and quality of life (EQ-5D). The participants are randomized to the different study arms according to a stratified procedure based on their cognitive function.
The intervention group will have their charts reviewed every second week and be contacted by the clinical pharmacist through phone within 7 and after 30 and 60 days respectively to discuss their medications. If possible drug-related problems are suspected during the interviews that cannot be solved immediately, the physician is contacted.
Both groups have a follow-up time of 30 and 180 days. After 30 and 180 days, the patients will once again report adherence and quality of life. All other data can be gathered from the medical charts.
- Conditions
- Drug Use
- Being tested
- Enhanced clinical pharmacist service
- Keywords
- Clinical pharmacist, Elderly, Adherence, Drug-related readmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced clinical pharmacist serviceOther
The intervention includes regular medical chart reviews, multiple patient interviews and, if needed, collaboration with the primary care physician.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition to a standard medication review at the hospital, this group also receives an enhanced clinical pharmacist service during 180 days after discharge from the hospital. Receives: Other: Enhanced clinical pharmacist service |
| Control group | No intervention | This group receives standard care, which might include a medication review at the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from discharge to first drug-related readmission
Survival analysis with drug-related readmission as endpoint
Measured: 180 days
Secondary outcomes (13)
Time from discharge to first drug-related readmission
Survival analysis with drug-related readmission as endpoint
Measured: 30 days
Frequency of drug-related readmissions
Difference in total number of drug-related readmissions
Measured: 30 and 180 days
Time from discharge to first drug-related readmission - subgroups with/without heart failure
Survival analysis among patients with/without heart failure
Measured: 30 and 180 days
Time from discharge to first drug-related readmission - subgroups with/without cognitive impairment
Survival analysis among patients with/without cognitive impairment
Measured: 30 and 180 days
Frequency of drug-related readmissions - subgroups with/without cognitive impairment
Subgroup analysis among patients with/without cognitive impairment
Measured: 30 and 180 days
Frequency of drug-related readmissions - subgroups with/without heart failure
Subgroup analysis among patients with/without heart failure
Measured: 30 and 180 days
Time from discharge to first all-cause hospital visit
Survival analysis with readmission or visit to the emergency department as endpoint
Measured: 30 and 180 days
Frequency of all-cause hospital visits
Difference in total number of readmissions and visits to the emergency department
Measured: 30 and 180 days
Self-reported adherence
Adherence to medications reported through MARS-5 ( Medication Adherence Rating Scale) and Swedish Prescribed Drug Register
Measured: 30 and 180 days
Self assessed quality of life: EQ-5D-questionnaire
Health-related quality of life reported through the EQ-5D-questionnaire
Measured: 30 and 180 days
Health economics
Cost for visits for (drug-related) readmissions and to visits to the Emergency Department compared between patients in the control group and intervention group.
Measured: 180 days
Medication appropriateness
Medication appropriateness using the implicit Medication Appropriateness Index (MAI) and explicit tools in the form of the quality indicators published by the Swedish National Board of Health and Welfare and The European Union (EU)(7)-PIM list
Measured: 180 days
Mortality
Survival analysis with death as endpoint
Measured: 30 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start19 Sep 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 UseStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Gustafsson, Umeå University
- Investigators
- Maria Gustafsson, Ph.D, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671629
- Sponsor's protocol ID
- UmU-2018-700
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2018
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kindstedt J, Svahn S, Sjolander M, Glader EL, Lovheim H, Gustafsson M. Investigating the effect of clinical pharmacist intervention in transitions of care on drug-related hospital readmissions among the elderly: study protocol for a randomised controlled trial. BMJ Open. 2020 Apr 27;10(4):e036650. doi: 10.1136/bmjopen-2019-036650.
PubMed 32345700
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involving Clinical Pharmacists in Transitional Care to Reduce Drug-related Readmissions Among the Elderly - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03671629
- Acronym / sponsor ID
- UmU-2018-700
- Conditions
- Drug Use
- Keywords
- Clinical pharmacist, Elderly, Adherence, Drug-related readmission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Sep 2018 (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.
This randomized controlled trial primarily investigates if a clinical pharmacist intervention can reduce drug-related readmissions among patients >75 years. The intervention targets the transfer between hospital and primary care. In brief, the intervention includes medical chart reviews and patient interviews during a period of 180 days.
Detailed description
At discharge from the hospital, patients that meet the inclusion criteria are offered to participate in the study. At this point the investigators will also gather baseline data through questionnaires on self-reported adherence (MARS-5) and quality of life (EQ-5D). The participants are randomized to the different study arms according to a stratified procedure based on their cognitive function.
The intervention group will have their charts reviewed every second week and be contacted by the clinical pharmacist through phone within 7 and after 30 and 60 days respectively to discuss their medications. If possible drug-related problems are suspected during the interviews that cannot be solved immediately, the physician is contacted.
Both groups have a follow-up time of 30 and 180 days. After 30 and 180 days, the patients will once again report adherence and quality of life. All other data can be gathered from the medical charts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Enhanced clinical pharmacist serviceIn addition to a standard medication review at the hospital, this group also receives an enhanced clinical pharmacist service during 180 days after discharge from the hospital. |
| Control group | No intervention | –This group receives standard care, which might include a medication review at the hospital. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Living at home
- Acutely admitted
- Registered at one of ten pre-specified primary care health centers
Key exclusion criteria (3 listed)
- Patients unable to communicate or who do not speak Swedish
- Patients scheduled for palliative care
- Patients admitted due to intoxication by alcohol or drug (non prescription)
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 |
|---|---|---|
| Enhanced clinical pharmacist serviceThe intervention includes regular medical chart reviews, multiple patient interviews and, if needed, collaboration with the primary care physician. | Other | Intervention group |
Primary outcome
Time from discharge to first drug-related readmission
Time frame: 180 days
Survival analysis with drug-related readmission as endpoint
13 secondary outcomes
Time from discharge to first drug-related readmission
Time frame: 30 days
Frequency of drug-related readmissions
Time frame: 30 and 180 days
Time from discharge to first drug-related readmission - subgroups with/without heart failure
Time frame: 30 and 180 days
Time from discharge to first drug-related readmission - subgroups with/without cognitive impairment
Time frame: 30 and 180 days
Frequency of drug-related readmissions - subgroups with/without cognitive impairment
Time frame: 30 and 180 days
Frequency of drug-related readmissions - subgroups with/without heart failure
Time frame: 30 and 180 days
Time from discharge to first all-cause hospital visit
Time frame: 30 and 180 days
Frequency of all-cause hospital visits
Time frame: 30 and 180 days
Self-reported adherence
Time frame: 30 and 180 days
Self assessed quality of life: EQ-5D-questionnaire
Time frame: 30 and 180 days
Health economics
Time frame: 180 days
Medication appropriateness
Time frame: 180 days
Mortality
Time frame: 30 and 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Derived from this study: PubMed 32345700Kindstedt J, Svahn S, Sjolander M, Glader EL, Lovheim H, Gustafsson M. Investigating the effect of clinical pharmacist intervention in transitions of care on drug-related hospital readmissions among the elderly: study protocol for a randomised controlled trial. BMJ Open. 2020 Apr 27;10(4):e036650. doi: 10.1136/bmjopen-2019-036650.
- Individual participant dataSharing planned: No
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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.
Maria Gustafsson, Ph.D principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced clinical pharmacist service in people with Drug Use, run by Umeå University at 1 site in Sweden.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Dec 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kindstedt (+46706572422, jonas.kindstedt@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from discharge to first drug-related readmission (time frame: 180 days). 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 NCT03671629, 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 20 Dec 2024.