HypertensionNCT01973556
Pharmacist-Physician Collaborative Medication Therapy Management Services (MTMS) Demonstration Project
A study testing Pharmacist-Physician Collaborative Medication Therapy Management in people with Hypertension, run by University of California, San Diego at 1 site in United States.
Trial summary
Patients managed by a newly formed pharmacist-physician medication therapy management team in a university primary care clinic will have better blood pressure control than patients receiving usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Pharmacist-Physician Collaborative Medication Therapy Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or over
- diagnosis of hypertension with most recent blood pressure >140/90 mmHg or blood pressure >130/80 mmHg if patients also had diabetes mellitus
- treated with at least one anti-hypertensive medication
- continuous active patient (at least one visit) of the clinic for at least the past 6 months (1/1/2010-6/31/2010)
- English speaking
- Able to complete questionnaires in English.
Who cannot join
- -do not meet provisions of the clinical collaborative agreement protocol in the judgment of the patient's physician or the clinical pharmacist
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
La Jolla, California, 92093
About this study
Patients managed by a newly formed pharmacist-physician medication therapy management team in a university primary care clinic will have better blood pressure control than patients receiving usual care.
- Conditions
- Hypertension
- Being tested
- Pharmacist-Physician Collaborative Medication Therapy Management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Physician Collaborative Medication Therapy ManagementOther
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist-Physician Collaborative Medication Management | Experimental | Pharmacist-Physician Collaborative Medication Management Receives: Other: Pharmacist-Physician Collaborative Medication Therapy Management |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startJul 2010
- Primary completionJun 2012
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 HypertensionStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Hirsch, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973556
- Sponsor's protocol ID
- 20095191
- Other IDs
- 100492
- Status last verified
- Oct 2013
- First submitted
- 25 Oct 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hirsch JD, Steers N, Adler DS, Kuo GM, Morello CM, Lang M, Singh RF, Wood Y, Kaplan RM, Mangione CM. Primary care-based, pharmacist-physician collaborative medication-therapy management of hypertension: a randomized, pragmatic trial. Clin Ther. 2014 Sep 1;36(9):1244-54. doi: 10.1016/j.clinthera.2014.06.030. Epub 2014 Jul 30.
PubMed 25085406
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-Physician Collaborative Medication Therapy Management Services (MTMS) Demonstration Project
- ClinicalTrials.gov ID
- NCT01973556
- Acronym / sponsor ID
- 20095191
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- First posted
- 31 Oct 2013 (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.
Patients managed by a newly formed pharmacist-physician medication therapy management team in a university primary care clinic will have better blood pressure control than patients receiving usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-Physician Collaborative Medication Management | Experimental | Other: Pharmacist-Physician Collaborative Medication Therapy ManagementPharmacist-Physician Collaborative Medication Management |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or over
- diagnosis of hypertension with most recent blood pressure >140/90 mmHg or blood pressure >130/80 mmHg if patients also had diabetes mellitus
- treated with at least one anti-hypertensive medication
- continuous active patient (at least one visit) of the clinic for at least the past 6 months (1/1/2010-6/31/2010)
- English speaking
Key exclusion criteria (1 listed)
- -do not meet provisions of the clinical collaborative agreement protocol in the judgment of the patient's physician or the clinical pharmacist
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-Physician Collaborative Medication Therapy Management | Other | Pharmacist-Physician Collaborative Medication Management |
Primary outcome
systolic blood pressure
Time frame: 6 months
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 31 Oct 2013.
- Derived from this study: PubMed 25085406Hirsch JD, Steers N, Adler DS, Kuo GM, Morello CM, Lang M, Singh RF, Wood Y, Kaplan RM, Mangione CM. Primary care-based, pharmacist-physician collaborative medication-therapy management of hypertension: a randomized, pragmatic trial. Clin Ther. 2014 Sep 1;36(9):1244-54. doi: 10.1016/j.clinthera.2014.06.030. Epub 2014 Jul 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-Physician Collaborative Medication Therapy Management in people with Hypertension, run by University of California, San Diego at 1 site in United States.
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 6 inclusion and 1 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 31 Oct 2013. 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 United States. 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?
systolic blood pressure (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 NCT01973556, 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 31 Oct 2013.