Diabetes Mellitus, Type 2PAMPEREDNCT00541606
Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes
A study testing Pharmacist collaboration in diabetes care in people with Diabetes Mellitus, Type 2, run by Lahey Clinic at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Pharmacist collaboration in diabetes care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jul 2004
- 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
- Adult, Older adult
Who may be able to join
- Patients over the age of 18
- A1c > 8% within the 6 months prior to the data acquisition date
- Primary Care physician at Lahey Clinic Burlington site
- Diagnosis of T2 DM for minimum of 6 months
Who cannot join
- Concurrently enrolled in any other pharmacist-run or diabetes study
- Receiving diabetes management by an outside provider
- A medical condition that may adversely affect compliance with the treatment protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
The purpose of this study is to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.
Read the detailed description
It is evident that a multi-disciplinary approach is key to the success in controlling the disease of diabetes and its complications. The value of pharmacists' involvement in disease state management in producing positive outcomes for patients has been well documented in the literature. There have been several studies that have shown that pharmacists' involvement in diabetes care improves glycemic control. There are also studies that look at pharmacists' management of glycemic control and adherence to the ADA guidelines. Many of these studies are retrospective, lack a randomized control group, had a small study sample, or were short term. We undertook a prospective, randomized study to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Pharmacist collaboration in diabetes care, Usual care
- Keywords
- Diabetes Mellitus, Type 2, Pharmaceutical Care, Collaborative Practice
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist collaboration in diabetes careOther
Patients attended a minimum of 3 clinic visits (month 0, 6, 12) with one of the clinical pharmacists, where targeted physical assessment, education, and medication changes and follow up were recommended. Additional visits were arranged as clinically appropriate for drug monitoring. Referrals were facilitated to other clinicians where indicated, including ophthalmology, podiatry, CDEs, nutrition, and primary care. The pharmacists' recommendations for medication adjustment, laboratory monitoring and referrals were based upon the most recent guidelines and clinical trial evidence. Any therapy adjustment, lab testing or referrals required approval by the referring physician. A1c, lipid and BP values were collected prospectively at months 0, 6 and 12.
Usual careOther
Control patients received usual care directed by their physician, and the same data were gathered from chart review during the 12-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Received collaborative care including a clinical pharmacist practitioner. Receives: Other: Pharmacist collaboration in diabetes care |
| Control | Active comparator | Patients received usual care directed by their physician. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes included the achievement of targets for A1c (< or = 7%), LDL cholesterol (< or = 100 mg/dL) and blood pressure (< or = 130/80), changes in quality of life as measured by the SF-36 Health Survey, and patient satisfaction.
Measured: 12 months
Secondary outcomes (1)
Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startSep 2000
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Gary Cushing, MD, Principal investigator, Lahey Clinic, Burlington, MAMichelle Jacobs, PharmD, Study director, Currently: Northeastern University, Boston, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541606
- Sponsor's protocol ID
- PAMPERED
- Acronym
- PAMPERED
- Status last verified
- May 2009
- First submitted
- 9 Oct 2007
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes (PAMPERED)
- ClinicalTrials.gov ID
- NCT00541606
- Acronym / sponsor ID
- PAMPERED / PAMPERED
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Pharmaceutical Care, Collaborative Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2000
- Study completion
- Jul 2004 (actual)
- First posted
- 10 Oct 2007 (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 purpose of this study is to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.
Detailed description
It is evident that a multi-disciplinary approach is key to the success in controlling the disease of diabetes and its complications. The value of pharmacists' involvement in disease state management in producing positive outcomes for patients has been well documented in the literature. There have been several studies that have shown that pharmacists' involvement in diabetes care improves glycemic control. There are also studies that look at pharmacists' management of glycemic control and adherence to the ADA guidelines. Many of these studies are retrospective, lack a randomized control group, had a small study sample, or were short term. We undertook a prospective, randomized study to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Pharmacist collaboration in diabetes careReceived collaborative care including a clinical pharmacist practitioner. |
| Control | Active comparator | Other: Usual carePatients received usual care directed by their physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18
- A1c > 8% within the 6 months prior to the data acquisition date
- Primary Care physician at Lahey Clinic Burlington site
- Diagnosis of T2 DM for minimum of 6 months
Key exclusion criteria (3 listed)
- Concurrently enrolled in any other pharmacist-run or diabetes study
- Receiving diabetes management by an outside provider
- A medical condition that may adversely affect compliance with the treatment protocol
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 collaboration in diabetes carePatients attended a minimum of 3 clinic visits (month 0, 6, 12) with one of the clinical pharmacists, where targeted physical assessment, education, and medication changes and follow up were recommended. Additional visits were arranged as clinically appropriate for drug monitoring. Referrals were facilitated to other clinicians where indicated, including ophthalmology, podiatry, CDEs, nutrition, and primary care. The pharmacists' recommendations for medication adjustment, laboratory monitoring and referrals were based upon the most recent guidelines and clinical trial evidence. Any therapy adjustment, lab testing or referrals required approval by the referring physician. A1c, lipid and BP values were collected prospectively at months 0, 6 and 12. | Other | Intervention |
| Usual careControl patients received usual care directed by their physician, and the same data were gathered from chart review during the 12-month study period. | Other | Control |
Primary outcome
Primary outcomes included the achievement of targets for A1c (< or = 7%), LDL cholesterol (< or = 100 mg/dL) and blood pressure (< or = 130/80), changes in quality of life as measured by the SF-36 Health Survey, and patient satisfaction.
Time frame: 12 months
1 secondary outcome
Secondary outcomes included diabetes-related hospitalizations and acute care visits during the study period for both the intervention and control groups.
Time frame: 12 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 19 May 2009.
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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.
Gary Cushing, MD principal investigator
Lahey Clinic, Burlington, MA
Michelle Jacobs, PharmD study director
Currently: Northeastern University, Boston, MA
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 collaboration in diabetes care in people with Diabetes Mellitus, Type 2, run by Lahey Clinic 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 4 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: finished, as of the sponsor's last update on 19 May 2009. 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?
Primary outcomes included the achievement of targets for A1c (< or = 7%), LDL cholesterol (< or = 100 mg/dL) and blood pressure (< or = 130/80), changes in quality of life as measured by the SF-36 Health Survey, and patient satisfaction. (time frame: 12 months). 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 19 May 2009.