Quality of LifeNCT01016301
Effects of a Clinical Pharmacist Service on Health-related Quality of Life
A study testing Pharmacist service in people with Quality of Life, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life
- What is being tested?
- Pharmacist service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Jul 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the wards during week days after decision of a ward physician or nurse if the medical condition allows inclusion
Who cannot join
- Exclusion criteria are poor Swedish language and planned discharge before the intervention can be performed.
- Patients transferred to wards not belonging to the department of medicine or other hospitals during the hospital stay are also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.
Read the detailed description
A randomized controlled trial is performed in two internal medicine wards at Sahlgrenska University Hospital, Göteborg, Sweden.
- Conditions
- Quality of Life
- Being tested
- Pharmacist service
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist serviceOther
Medication Review, medication report
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist service, | Active comparator | The pharmacist service consists of medication review, drug treatment discussion with the patient, and a medication report. Receives: Other: Pharmacist service |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Measured: 6 months
Secondary outcomes (1)
Prescribing of drugs
Measured: Discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startSep 2007
- Primary completionDec 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Sahlgrenska 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
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna Wallerstedt, Sahlgrenska University Hospital
- Investigators
- Susanna Wallerstedt, MD, Ass Prof, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016301
- Sponsor's protocol ID
- CPS1
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2009
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bladh L, Ottosson E, Karlsson J, Klintberg L, Wallerstedt SM. Effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs: a randomised controlled trial. BMJ Qual Saf. 2011 Sep;20(9):738-46. doi: 10.1136/bmjqs.2009.039693. Epub 2011 Jan 5.
PubMed 21209140Wallerstedt SM, Bladh L, Ramsberg J. A cost-effectiveness analysis of an in-hospital clinical pharmacist service. BMJ Open. 2012 Jan 5;2(1):e000329. doi: 10.1136/bmjopen-2011-000329. Print 2012.
PubMed 22223840
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Clinical Pharmacist Service on Health-related Quality of Life
- ClinicalTrials.gov ID
- NCT01016301
- Acronym / sponsor ID
- CPS1
- Conditions
- Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Nov 2009 (estimated)
- 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.
The aim of the present study is to evaluate effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs.
Detailed description
A randomized controlled trial is performed in two internal medicine wards at Sahlgrenska University Hospital, Göteborg, Sweden.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist service, | Active comparator | Other: Pharmacist serviceThe pharmacist service consists of medication review, drug treatment discussion with the patient, and a medication report. |
| Control | No intervention | –Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to the wards during week days after decision of a ward physician or nurse if the medical condition allows inclusion
Key exclusion criteria (2 listed)
- Exclusion criteria are poor Swedish language and planned discharge before the intervention can be performed.
- Patients transferred to wards not belonging to the department of medicine or other hospitals during the hospital stay are also excluded.
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 |
|---|---|---|
| Pharmacist serviceMedication Review, medication report | Other | Pharmacist service, |
Primary outcome
Health-related quality of life
Time frame: 6 months
1 secondary outcome
Prescribing of drugs
Time frame: Discharge from hospital
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 18 Nov 2015.
- Results publication: PubMed 21209140Bladh L, Ottosson E, Karlsson J, Klintberg L, Wallerstedt SM. Effects of a clinical pharmacist service on health-related quality of life and prescribing of drugs: a randomised controlled trial. BMJ Qual Saf. 2011 Sep;20(9):738-46. doi: 10.1136/bmjqs.2009.039693. Epub 2011 Jan 5.
- Results publication: PubMed 22223840Wallerstedt SM, Bladh L, Ramsberg J. A cost-effectiveness analysis of an in-hospital clinical pharmacist service. BMJ Open. 2012 Jan 5;2(1):e000329. doi: 10.1136/bmjopen-2011-000329. Print 2012.
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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.
Susanna Wallerstedt, MD, Ass Prof principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist service in people with Quality of Life, run by Sahlgrenska University Hospital 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 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 18 Nov 2015. 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?
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?
Health-related quality of life (time frame: 6 months). 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 NCT01016301, which also lists 2 linked publications.
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 18 Nov 2015.