DiabetesPhase 4NCT00157638
Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics
A Phase 4 study testing integration of pharmacist into primary care, optimizing therapeutic treatments and optimizing processes of care in people with Diabetes and Hypertension, run by Hamilton Health Sciences Corporation at 3 sites in Canada.
Trial summary
Recent health policy documents have endorsed an integrated model of collaboration between pharmacists and physicians in primary care. The integration of pharmacists into primary care has been identified as a priority for primary health care reform in Canada. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes, Hypertension, Hyperlipidemia
- What is being tested?
- integration of pharmacist into primary care, optimizing therapeutic treatments and optimizing processes of care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,400 participants
- Where
- 3 sitesCanada
- Study dates
- Feb 2004to Jul 2006
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 + years and any two of the following:
- Elevated blood pressure
- Elevated hemoglobin A1C
- Elevated LDL-C
- Diagnosis of hypertension and no blood pressure readings in past 12 months
- Diagnosis of diabetes and no hemoglobin A1C readings in past 12 months
Show all 13Show fewer
- Diagnosis of hyperlipidemia and no cholesterol readings in past 12 months
- Diagnosis of osteoarthritis or rheumatoid arthritis
- Using narcotics
- Diagnosis of hypertension, diagnosis of diabetes and not using an ACE inhibitor
- Diagnosis of hypertension, elevated blood pressure and using an NSAID
- Diagnosis of hyperlipidemia, elevate dLDL-C and not using a lipid lowering agent
- Diagnosis of hypertension, high blood pressure and not using a potassium wasting diuretic
Who cannot join
- Less than one visit to family physician in past 12 months
- More than 20 visits to family physician in past 12 months
- Awaiting placement to a nursing home or long-term care facility
- Alcoholism
- Palliative care patient
- Family physician only sees patient as a home visit
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University
Hamilton, Ontario, L8N 1G6
University of Ottawa
Ottawa, Ontario, K1N 5C8
University of Toronto
Toronto, Ontario, M5S 2S2
About this study
Official title: Optimizing Drug Therapy in Primary Care: Integrating Pharmacists With Ontario Family Physician Group Practices.
Recent health policy documents have endorsed an integrated model of collaboration between pharmacists and physicians in primary care. The integration of pharmacists into primary care has been identified as a priority for primary health care reform in Canada. However, the best way to do this has not been demonstrated or evaluated. This demonstration project shows the various ways in which pharmacists can be trained and integrated into different family practice settings, the processes and costs associated with doing this, and the outcomes observed. The main hypothesis is that pharmacist integration into family practice will optimize medication use, clinical care and clinical outcomes. This information provides policy makers with necessary information about collaboration between pharmacists and family physicians for their overall goal of reforming the delivery of primary health care to the population.
Read the detailed description
The overall goal of IMPACT was to improve patient outcomes by optimizing drug therapy through a community practice model that integrates pharmacists into family practices.
This multi-site demonstration project involved 7 pharmacists, approximately 70 physicians and approximately 150,000 patients. Within each practice site, a pharmacist with special clinical training worked 2.5 days per week for 2 years and coordinated a multifaceted intervention aimed at optimizing drug therapy to improve patient outcomes (blood pressure, cholesterol, diabetes, pain control, constipation, etc.) The integrated pharmacist conducted patient assessments for medication problems, optimized office system medication management (e.g. develop process for handling of medication samples), and provided education (academic detailing ) focussed on key therapeutic areas. Pharmacists were provided with ongoing support from a training and mentorship program and the services of the Ontario Pharmacists' Association Drug Information Centre.
The family physicians and other members of the practice worked closely with the pharmacist in implementing these strategic interventions. Family physicians from a range of practice models (Ontario Family Health Networks, Primary Care Networks, and other types of family physician group practices) participated in this project.
Quantitative and qualitative methods were used to evaluate the process of integration, pharmacist service uptake, drug-related patient outcomes, and the costs associated with program implementation for sustainability. The integration of the physicians and pharmacists at the practice sites were evaluated with the aim of generating a practical and transferable practice model. The main hypothesis was that pharmacist integration into family practice will optimize medication use, clinical care and clinical outcomes.
- Conditions
- Diabetes, Hypertension, Hyperlipidemia, Constipation, Pain
- Being tested
- integration of pharmacist into primary care, optimizing therapeutic treatments, optimizing processes of care
- Keywords
- pharmacist, physician, primary care, collaboration, therapeutics
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias, Constipation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integration of pharmacist into primary careBehavioural
optimizing therapeutic treatmentsDrug
optimizing processes of careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of patients referred and assessed
Characterization and quantification of pharmacist activities
Numbers and types of drug-related problems identified and resolved
Medication changes made
Number of recommendations implemented
Process indicators (measurement of blood pressure, Cholesterol, hemoglobin A1C)
Surrogate clinical outcomes (values of blood pressure, Cholesterol, hemoglobin A1C)
Symptom improvement (constipation, pain)
Secondary outcomes (12)
Health resource utilization
Satisfaction with service
Uptake of pharmacist recommendations
Extent of knowledge translation
Extent of collaboration
Satisfaction with integrated pharmacist program
Set up costs
Pharmacist and physician time costs
Travel cost
Space requirements
Medication costs
Health services utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 4
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Lisa Dolovich, PharmD, MSc, Principal investigator, McMaster UniversityKevin Pottie, MD, Principal investigator, University of Ottawa, Ottawa ONJanusz Kaczorowski, PhD, Principal investigator, McMaster UniversityBarbara Farrell, PharmD, Principal investigator, Elisabeth Bruyere Research Institute, Ottawa, ON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157638
- Sponsor's protocol ID
- G03-02671
- Status last verified
- Sep 2006
- First submitted
- 8 Sep 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Drug Therapy in Primary Care: Integrating Pharmacists With Ontario Family Physician Group Practices.
- ClinicalTrials.gov ID
- NCT00157638
- Acronym / sponsor ID
- G03-02671
- Conditions
- Diabetes, Hypertension, Hyperlipidemia, Constipation, Pain
- Keywords
- pharmacist, physician, primary care, collaboration, therapeutics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Jul 2006
- First posted
- 12 Sep 2005 (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.
Recent health policy documents have endorsed an integrated model of collaboration between pharmacists and physicians in primary care. The integration of pharmacists into primary care has been identified as a priority for primary health care reform in Canada. However, the best way to do this has not been demonstrated or evaluated. This demonstration project shows the various ways in which pharmacists can be trained and integrated into different family practice settings, the processes and costs associated with doing this, and the outcomes observed. The main hypothesis is that pharmacist integration into family practice will optimize medication use, clinical care and clinical outcomes. This information provides policy makers with necessary information about collaboration between pharmacists and family physicians for their overall goal of reforming the delivery of primary health care to the population.
Detailed description
The overall goal of IMPACT was to improve patient outcomes by optimizing drug therapy through a community practice model that integrates pharmacists into family practices.
This multi-site demonstration project involved 7 pharmacists, approximately 70 physicians and approximately 150,000 patients. Within each practice site, a pharmacist with special clinical training worked 2.5 days per week for 2 years and coordinated a multifaceted intervention aimed at optimizing drug therapy to improve patient outcomes (blood pressure, cholesterol, diabetes, pain control, constipation, etc.) The integrated pharmacist conducted patient assessments for medication problems, optimized office system medication management (e.g. develop process for handling of medication samples), and provided education (academic detailing ) focussed on key therapeutic areas. Pharmacists were provided with ongoing support from a training and mentorship program and the services of the Ontario Pharmacists' Association Drug Information Centre.
The family physicians and other members of the practice worked closely with the pharmacist in implementing these strategic interventions. Family physicians from a range of practice models (Ontario Family Health Networks, Primary Care Networks, and other types of family physician group practices) participated in this project.
Quantitative and qualitative methods were used to evaluate the process of integration, pharmacist service uptake, drug-related patient outcomes, and the costs associated with program implementation for sustainability. The integration of the physicians and pharmacists at the practice sites were evaluated with the aim of generating a practical and transferable practice model. The main hypothesis was that pharmacist integration into family practice will optimize medication use, clinical care and clinical outcomes.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- Elevated blood pressure
- Elevated hemoglobin A1C
- Elevated LDL-C
- Diagnosis of hypertension and no blood pressure readings in past 12 months
- Diagnosis of diabetes and no hemoglobin A1C readings in past 12 months
Key exclusion criteria (6 listed)
- Less than one visit to family physician in past 12 months
- More than 20 visits to family physician in past 12 months
- Awaiting placement to a nursing home or long-term care facility
- Alcoholism
- Palliative care patient
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 pharmacist into primary care | Behavioural | – |
| optimizing therapeutic treatments | Drug | – |
| optimizing processes of care | Behavioural | – |
Primary outcome
Number and types of patients referred and assessed
Characterization and quantification of pharmacist activities
Numbers and types of drug-related problems identified and resolved
Medication changes made
Number of recommendations implemented
Process indicators (measurement of blood pressure, Cholesterol, hemoglobin A1C)
Surrogate clinical outcomes (values of blood pressure, Cholesterol, hemoglobin A1C)
Symptom improvement (constipation, pain)
12 secondary outcomes
Health resource utilization
Satisfaction with service
Uptake of pharmacist recommendations
Extent of knowledge translation
Extent of collaboration
Satisfaction with integrated pharmacist program
Set up costs
Pharmacist and physician time costs
Travel cost
Space requirements
Medication costs
Health services utilization
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 Sep 2006.
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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.
Lisa Dolovich, PharmD, MSc principal investigator
McMaster University
Kevin Pottie, MD principal investigator
University of Ottawa, Ottawa ON
Janusz Kaczorowski, PhD principal investigator
McMaster University
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 pharmacist into primary care, optimizing therapeutic treatments and optimizing processes of care in people with Diabetes and Hypertension, run by Hamilton Health Sciences Corporation 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 13 inclusion and 6 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 Sep 2006. 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?
Number and types of patients referred and assessed. The study lists 8 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 11 Sep 2006.