Diabetes Mellitus, Type 2NCT03134170
Effect of Pharmacists Treating Diabetes in a FQHC
A study testing Pharmacist review of therapy in people with Diabetes Mellitus, Type 2, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study is a randomized controlled cross-over trial, in the form of a proof of concept study that is designed to evaluate the health outcomes resulting from incorporating a licensed clinical pharmacist in a health care team to provide case management for diabetic patients at the Henry J Austin Health Clinic. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Pharmacist review of therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 31 Dec 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and 74
- Medicaid insurance
- HbA1c of 8% or greater
Who cannot join
- HbA1C greater than 15% because the finger stick device can not accurately read values greater than this unless the HbA1C can be confirmed with a value drawn in the laboratory.
- Age < 18 years old or age ≥ 75 years old
- HbA1c < 8.5% PLUS presence of one or more of the following regardless of age:
- Limited life expectancy
- History of severe hypoglycemia
- HbA1c < 8.5% PLUS presence of one or more of the following if age ≥ 65 years old:
Show all 10Show fewer
- Residency in a long-term care facility (e.g. nursing home, adult family home, etc.)
- ≥ 3 co-existing chronic illnesses c
- Impairments in ability to perform two or more instrumental activities of daily living d
- Mild, moderate, or severe cognitive impairment as determined by the patient's provider and Mini-Cog test
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry J Austin Health Clinic
Trenton, New Jersey, 08618
About this study
Official title: Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center
This study is a randomized controlled cross-over trial, in the form of a proof of concept study that is designed to evaluate the health outcomes resulting from incorporating a licensed clinical pharmacist in a health care team to provide case management for diabetic patients at the Henry J Austin Health Clinic. The study uses a control group design and will feature both an experimental group and a control group. The control group, of 80 patients, will receive the standard treatment at the clinic. The experimental group, of 80 patients, will receive the standard treatment as well as Medication Therapy Management and counseling from a pharmacist. After one year the patients in the control group can cross-over to the intervention group and receive care from the pharmacist.
Read the detailed description
We will put all patients into one of two groups by chance (like flipping a coin). One group of 80 patients will get the regular care at the clinic (control group). The other group of 80 patients will get their regular care at the clinic plus care by a pharmacist. The pharmacist and the regular provider will work as a team to manage the patient's drug therapy (Intervention group).
We will test the status of the patient's diabetes at each visit. Tests may include:
- Measuring weight, heart rate, and blood pressure
- Finger stick with a small needle to check lipid (fat) concentrations, fasting blood sugar or HbA1c
- Examining feet, skin, and eyes
- Reviewing the patient's diary of blood sugars, diet, and exercise history
- Filling out a survey that measures quality of life and problems that make it hard to control your diabetes
- Referral to other specialists such as a podiatrist (foot doctor), optometrist (eye doctor), nutritionist, and dentist
Patients will have appointments with their current provider and possibly with the pharmacist at least every 3 months. However, the total number of appointments is based on the patient's health needs. The first appointment with the pharmacist will take about one hour. Additional appointments will take about 30 minutes.
The group without the pharmacist will have regular appointment times. After 12 months in the study if the patients glucose is not well controlled they can be treated by the pharmacist for 6 months.
Final measures will be made after 12 mont
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Pharmacist review of therapy
- Keywords
- pharmacist, diabetes, Preventative Care, Quality of Life
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist review of therapyOther
Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | The no intervention group will serve as control group. This group will receive standard care and will be an active comparator. At the end of the study they may join the intervention group |
| Intervention group | Other | The intervention group will be seen by a pharmacist iin addition to their normal provider. The pharmacist will provide medication therapy review of the patient's therapy. The pharmacist will make recommendations to make revisions in the patient's therapy. Receives: Other: Pharmacist review of therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Plasma glucose control
Measured: every 3 months for one year
Secondary outcomes (1)
Preventative care
How frequent does the patient see a dentist, podiatris, optomitrist,
Measured: Baseline 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Aug 2015
- Primary completion1 Nov 2018
- Study completion31 Dec 2019 (estimated)
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients are randomized to the control or intervention group. After 12 months patients in the control group who do not have well controlled diabetes may be crossed over to the interventiobn gorup
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Louise Wagner, Rutgers, The State University of New Jersey
- Investigators
- Caitlin McCarthy, PharmD, Study chair, Rutgers, Earnest Mario School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134170
- Sponsor's protocol ID
- 14-805
- Status last verified
- Nov 2018
- First submitted
- 26 Apr 2017
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition, the pharacists at the clinic who are treating the have access to the patient data
Publications
Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421.
PubMed 18363526Wallack MC, Loafman M, Sorensen TD. The Patient Safety and Clinical Pharmacy Collaborative: improving medication use systems for the underserved. J Health Care Poor Underserved. 2012 Aug;23(3 Suppl):96-102. doi: 10.1353/hpu.2012.0143.
PubMed 22864490
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding a Pharmacist to the Health Care Team in a Federally Qualified Health Center
- ClinicalTrials.gov ID
- NCT03134170
- Acronym / sponsor ID
- 14-805
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- pharmacist, diabetes, Preventative Care, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 28 Apr 2017 (actual)
- 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.
This study is a randomized controlled cross-over trial, in the form of a proof of concept study that is designed to evaluate the health outcomes resulting from incorporating a licensed clinical pharmacist in a health care team to provide case management for diabetic patients at the Henry J Austin Health Clinic. The study uses a control group design and will feature both an experimental group and a control group. The control group, of 80 patients, will receive the standard treatment at the clinic. The experimental group, of 80 patients, will receive the standard treatment as well as Medication Therapy Management and counseling from a pharmacist. After one year the patients in the control group can cross-over to the intervention group and receive care from the pharmacist.
Detailed description
We will put all patients into one of two groups by chance (like flipping a coin). One group of 80 patients will get the regular care at the clinic (control group). The other group of 80 patients will get their regular care at the clinic plus care by a pharmacist. The pharmacist and the regular provider will work as a team to manage the patient's drug therapy (Intervention group).
We will test the status of the patient's diabetes at each visit. Tests may include:
- Measuring weight, heart rate, and blood pressure
- Finger stick with a small needle to check lipid (fat) concentrations, fasting blood sugar or HbA1c
- Examining feet, skin, and eyes
- Reviewing the patient's diary of blood sugars, diet, and exercise history
- Filling out a survey that measures quality of life and problems that make it hard to control your diabetes
- Referral to other specialists such as a podiatrist (foot doctor), optometrist (eye doctor), nutritionist, and dentist
Patients will have appointments with their current provider and possibly with the pharmacist at least every 3 months. However, the total number of appointments is based on the patient's health needs. The first appointment with the pharmacist will take about one hour. Additional appointments will take about 30 minutes.
The group without the pharmacist will have regular appointment times. After 12 months in the study if the patients glucose is not well controlled they can be treated by the pharmacist for 6 months.
Final measures will be made after 12 mont
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomized to the control or intervention group. After 12 months patients in the control group who do not have well controlled diabetes may be crossed over to the interventiobn gorup
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –The no intervention group will serve as control group. This group will receive standard care and will be an active comparator. At the end of the study they may join the intervention group |
| Intervention group | Other | Other: Pharmacist review of therapyThe intervention group will be seen by a pharmacist iin addition to their normal provider. The pharmacist will provide medication therapy review of the patient's therapy. The pharmacist will make recommendations to make revisions in the patient's therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and 74
- Medicaid insurance
- HbA1c of 8% or greater
Key exclusion criteria (10 listed)
- HbA1C greater than 15% because the finger stick device can not accurately read values greater than this unless the HbA1C can be confirmed with a value drawn in the laboratory.
- Age < 18 years old or age ≥ 75 years old
- HbA1c < 8.5% PLUS presence of one or more of the following regardless of age:
- HbA1c < 8.5% PLUS presence of one or more of the following if age ≥ 65 years old:
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 review of therapyPatients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist | Other | Intervention group |
Primary outcome
Hemoglobin A1C
Time frame: every 3 months for one year
Plasma glucose control
1 secondary outcome
Preventative care
Time frame: Baseline 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Results publication: PubMed 18363526Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36. doi: 10.1592/phco.28.4.421.
- Results publication: PubMed 22864490Wallack MC, Loafman M, Sorensen TD. The Patient Safety and Clinical Pharmacy Collaborative: improving medication use systems for the underserved. J Health Care Poor Underserved. 2012 Aug;23(3 Suppl):96-102. doi: 10.1353/hpu.2012.0143.
- Individual participant dataSharing planned: Yes. In addition, the pharacists at the clinic who are treating the have access to the patient data
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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.
Caitlin McCarthy, PharmD study chair
Rutgers, Earnest Mario School of Pharmacy
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 review of therapy in people with Diabetes Mellitus, Type 2, run by Rutgers, The State University of New Jersey 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Nov 2018. 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?
Results are not available in the source record.
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?
Hemoglobin A1C (time frame: every 3 months for one year). 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 NCT03134170, 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 16 Nov 2018.