Heart Failure, CongestivePhase 4NCT00351676
Capturing Outcomes of Clinical Activities Performed by a Rounding Pharmacist Practising in a Team Environment
A Phase 4 study testing Integration of a team based clinical pharmacist, Optimizing therapeutic treatments and Optimizing processes of care in people with Heart Failure, Congestive and Pulmonary Disease, Chronic Obstructive, run by University of Alberta at 3 sites in Canada.
Trial summary
We, the researchers, propose to link a clinical pharmacist with an internal medicine or family medicine team to provide pharmaceutical care to all patients assigned to the team. The hypothesis is that through this team based approach, pharmacists will act as a resource for providing pharmacotherapeutic advice during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Pulmonary Disease, Chronic Obstructive, Pneumonia
- What is being tested?
- Integration of a team based clinical pharmacist, Optimizing therapeutic treatments and Optimizing processes of care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 452 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2006to Jul 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients > 18 years of age admitted to participating internal and family medicine teams during the 1 year study period will be eligible to receive the pharmacist intervention. For the purposes of data analysis, patients with a most responsible or primary diagnosis of HF, COPD, CAP, T2DM, and CAD will be included.
Who cannot join
- Residence outside the Capital Health catchment
- Admitted for ≤ 2 days
- Palliative care
- Transferred to another team
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
About this study
Official title: Capturing Outcomes of Clinical Activities Performed by a Rounding Pharmacist Practising in a Team Environment (COLLABORATE)
We, the researchers, propose to link a clinical pharmacist with an internal medicine or family medicine team to provide pharmaceutical care to all patients assigned to the team. The hypothesis is that through this team based approach, pharmacists will act as a resource for providing pharmacotherapeutic advice during the drug therapy decision making process and promote optimal drug use by identifying and resolving actual and potential drug related problems. This study is designed to test this hypothesis, by assessing the impact of this intervention on evidence based, quality of drug therapy indicators, for patients admitted with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).
Read the detailed description
The overall goal of the COLLABORATE study is to improve processes of care and patient outcomes by optimizing drug therapy via a hospital pharmacy practice model that integrates clinical pharmacists into the patient care team.
The intervention consists of a clinical pharmacist assigned to the patient care team for the purpose of providing proactive clinical pharmacy services. The study pharmacist will be available during normal office hours 5 days per week to provide clarification of the patient's medication history, identify and resolve actual and potential patient specific drug related problems/issues, participate in patient care rounds, provide drug information to the patient care team, provide patient education and discharge medication counselling, and provide physician and/or nursing staff education. The anticipated pharmacist to patient ratio is approximately 1:20.
Control patients will receive usual care. Usual care consists of reactive clinical pharmacy services (i.e. drug related issues identified as orders are received, or by patient profile review) provided by a ward based, not team based, clinical pharmacist.
- Conditions
- Heart Failure, Congestive, Pulmonary Disease, Chronic Obstructive, Pneumonia, Diabetes Mellitus, Type 2, Coronary Arteriosclerosis
- Being tested
- Integration of a team based clinical pharmacist, Optimizing therapeutic treatments, Optimizing processes of care
- Keywords
- Drug Therapy, Hospitals, Teaching, Hospitals, Community, Interprofessional relations, Patient Care Team, Pharmacists, Pharmacy Service, Hospital, Comparative Study, Hospitalization
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive, Pneumonia, Diabetes Mellitus, Type 2, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integration of a team based clinical pharmacistBehavioural
Optimizing therapeutic treatmentsDrug
Optimizing processes of careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups.
Measured: in hospital
Secondary outcomes (4)
Differences in condition-specific achievement of drug therapy quality indicators;
Measured: in hospital
Differences in 6 month hospital readmission rate;
Measured: 6 months
Differences in number, type, acceptance rate, and expected impact of all pharmacist interventions;
Measured: in hospital
Qualitative evaluation of the impact of the intervention via interviews with the participating pharmacists and physicians.
Measured: in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startFeb 2006
- Study completionJul 2007
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 Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Health, Canada
- Investigators
- Ross T. Tsuyuki, PharmD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351676
- Sponsor's protocol ID
- EPICORE-2006-001
- Status last verified
- Feb 2006
- First submitted
- 12 Jul 2006
- Last updated
- 11 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Makowsky MJ, Koshman SL, Midodzi WK, Tsuyuki RT. Capturing outcomes of clinical activities performed by a rounding pharmacist practicing in a team environment: the COLLABORATE study [NCT00351676]. Med Care. 2009 Jun;47(6):642-50. doi: 10.1097/MLR.0b013e3181926032.
PubMed 19433997Makowsky MJ, Schindel TJ, Rosenthal M, Campbell K, Tsuyuki RT, Madill HM. Collaboration between pharmacists, physicians and nurse practitioners: a qualitative investigation of working relationships in the inpatient medical setting. J Interprof Care. 2009 Mar;23(2):169-84. doi: 10.1080/13561820802602552.
PubMed 19234987
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capturing Outcomes of Clinical Activities Performed by a Rounding Pharmacist Practising in a Team Environment (COLLABORATE)
- ClinicalTrials.gov ID
- NCT00351676
- Acronym / sponsor ID
- EPICORE-2006-001
- Conditions
- Heart Failure, Congestive, Pulmonary Disease, Chronic Obstructive, Pneumonia, Diabetes Mellitus, Type 2, Coronary Arteriosclerosis
- Keywords
- Drug Therapy, Hospitals, Teaching, Hospitals, Community, Interprofessional relations, Patient Care Team, Pharmacists, Pharmacy Service, Hospital, Comparative Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Capital Health, Canada
- Study start
- Feb 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 13 Jul 2006 (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.
We, the researchers, propose to link a clinical pharmacist with an internal medicine or family medicine team to provide pharmaceutical care to all patients assigned to the team. The hypothesis is that through this team based approach, pharmacists will act as a resource for providing pharmacotherapeutic advice during the drug therapy decision making process and promote optimal drug use by identifying and resolving actual and potential drug related problems. This study is designed to test this hypothesis, by assessing the impact of this intervention on evidence based, quality of drug therapy indicators, for patients admitted with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).
Detailed description
The overall goal of the COLLABORATE study is to improve processes of care and patient outcomes by optimizing drug therapy via a hospital pharmacy practice model that integrates clinical pharmacists into the patient care team.
The intervention consists of a clinical pharmacist assigned to the patient care team for the purpose of providing proactive clinical pharmacy services. The study pharmacist will be available during normal office hours 5 days per week to provide clarification of the patient's medication history, identify and resolve actual and potential patient specific drug related problems/issues, participate in patient care rounds, provide drug information to the patient care team, provide patient education and discharge medication counselling, and provide physician and/or nursing staff education. The anticipated pharmacist to patient ratio is approximately 1:20.
Control patients will receive usual care. Usual care consists of reactive clinical pharmacy services (i.e. drug related issues identified as orders are received, or by patient profile review) provided by a ward based, not team based, clinical pharmacist.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients > 18 years of age admitted to participating internal and family medicine teams during the 1 year study period will be eligible to receive the pharmacist intervention. For the purposes of data analysis, patients with a most responsible or primary diagnosis of HF, COPD, CAP, T2DM, and CAD will be included.
Key exclusion criteria (4 listed)
- Residence outside the Capital Health catchment
- Admitted for ≤ 2 days
- Palliative care
- Transferred to another team
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 |
|---|---|---|
| Integration of a team based clinical pharmacist | Behavioural | – |
| Optimizing therapeutic treatments | Drug | – |
| Optimizing processes of care | Behavioural | – |
Primary outcome
Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups.
Time frame: in hospital
4 secondary outcomes
Differences in condition-specific achievement of drug therapy quality indicators;
Time frame: in hospital
Differences in 6 month hospital readmission rate;
Time frame: 6 months
Differences in number, type, acceptance rate, and expected impact of all pharmacist interventions;
Time frame: in hospital
Qualitative evaluation of the impact of the intervention via interviews with the participating pharmacists and physicians.
Time frame: in 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 11 Dec 2007.
- Derived from this study: PubMed 19433997Makowsky MJ, Koshman SL, Midodzi WK, Tsuyuki RT. Capturing outcomes of clinical activities performed by a rounding pharmacist practicing in a team environment: the COLLABORATE study [NCT00351676]. Med Care. 2009 Jun;47(6):642-50. doi: 10.1097/MLR.0b013e3181926032.
- Derived from this study: PubMed 19234987Makowsky MJ, Schindel TJ, Rosenthal M, Campbell K, Tsuyuki RT, Madill HM. Collaboration between pharmacists, physicians and nurse practitioners: a qualitative investigation of working relationships in the inpatient medical setting. J Interprof Care. 2009 Mar;23(2):169-84. doi: 10.1080/13561820802602552.
- Related InfoLink provided by the sponsor.
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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.
Ross T. Tsuyuki, PharmD, MSc principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Integration of a team based clinical pharmacist, Optimizing therapeutic treatments and Optimizing processes of care in people with Heart Failure, Congestive and Pulmonary Disease, Chronic Obstructive, run by University of Alberta at 3 sites in Canada.
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 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 11 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement in proportion of quality indicators achieved, for target diseases as a most responsible or primary diagnosis, between groups. (time frame: in hospital). 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 NCT00351676, 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 11 Dec 2007.