Nellis Air Force Base - Clinical Investigation Facility

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Nellis Clinical Investigation Facility

MISSION:
The primary mission of the Nellis Air Force Base Clinical Investigation Facility (CIF) is to support Graduate Medical Education (GME) research. We also have the desire to develop and test alternative treatments for pain and other conditions.

ABOUT US:
The Mike O'Callaghan Federal Medical Center at Nellis Air Force base was selected as a new CIF for FY12. Nellis AFB is the first CIF within the Air Combat Command.

We are also part of the new Air Force Diabetes and Obesity Research Working Group (DORWG). As part of this group, we helped develop the Research Development Document for diabetes and have about 8 research protocols underway.

We are participating in the Military Primary Care Research Network, a network of Family Medicine research sites coordinated by USUHS.

We are funded through a variety of mechanisms-AFMSA SG9, American Academy of Family Physicians Foundation, The Diabetes Action Research and Education Foundation, several industry contacts and the Geneva Foundation.

Clinical Investigation Facility (CIF) personnel conversing

CURRENT RESEARCH PROJECTS:

Complimentary & Alternative Medicine:

Title: Aromatherapy with lavender oil to reduce pain and anxiety during cervical colposcopy: A randomized, controlled trial.
Purpose: To determine if aromatherapy with lavender oil lowers 1) pain or 2) anxiety levels in women during colposcopy.
Recruitment: All women at least 18 yrs of age undergoing colposcopy who have not previously participated in this protocol.
Title: Ear acupuncture for acute sore throat in patients unable to take non-steroidal anti-inflammatory agents (NSAIDs).
Purpose: The purpose of this study is to assess the effect of ear acupuncture alone in subjects with a contraindication to anti-inflammatory medications in the reduction of pain and hours lost from work in acute sore throat.
Recruitment: Male and female subjects, 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat and an allergy to Allergy to Non-Steroidal Anti-inflammatory agents (NSAIDs).
Title: Ear acupuncture for acute sore throat. A randomized controlled trial.
Purpose: The purpose of this study is to compare ear acupuncture plus standard of care versus standard therapy (anti-inflammatory medications) in the reduction of pain, reduction in oral anti inflammatory medication use, hours lost from work in acute sore throat.
Recruitment: Male and female subject, 18 years or older, with upper respiratory complaints and their primary symptom being acute sore throat.
Title: Ear acupuncture for post-operative pain associated with ambulatory arthroscopic knee surgery. A randomized controlled trial.
Purpose: The purpose of this study is to compare ear acupuncture plus standard therapy versus standard therapy alone (narcotic and non-narcotic analgesia) in reduction of intravenous (IV) and oral pain medication use, time to ambulation without assistance, time to discharge from Post-Anesthesia Care Unit (PACU) and Same-Day Surgery Unit (SDSU) and return to duty time following ambulatory arthroscopic knee surgery.
Recruitment: Male and female subjects, 18 years or older scheduled for ambulatory unilateral arthroscopic knee surgery.

Diabetes:

Title: Qi Gong Effect on Serum Blood Sugar.
Purpose: The purpose of this study is to utilize the practice of Qi Gong in lowering serum blood sugar over 90 days.
Recruitment: Male and female DoD beneficiaries ages ≥18 to ≤65. Diagnosed as having either Type 1 or Type 2 Diabetes Mellitus. Have been prescribed oral therapy such as Metformin or insulin for at least 6 weeks prior to being offered the opportunity to participate in the study.
Title: The Prevalence of Metabolic Syndrome in Recent Air Force Retirees.
Purpose: The purpose of this study is to be able to provide information regarding the risk of developing metabolic syndrome and specific metabolic syndrome defining criteria after Air Force retirement. This information will be vital for recommendations regarding screening and prevention interventions at the time of military retirement and the first few years after retirement targeted to lowering long-term cardiovascular disease risk.
Recruitment: Retired Air Force members (20 or more years of active-duty service and not retired for medical reasons) who have retired up to 6 years prior to enrollment.
Title: Cinnamon bark, water-soluble cinnamon extract, and Metformin as initial treatment for Type 2 diabetes mellitus: A randomized, controlled trial.
Purpose: The purpose of this study is to assess whether Cinnamon bark or water-soluble cinnamon is an effective nutraceutical for the initial treatment of diabetes when compared to standard therapy of Metformin.
Recruitment: Patients over the age of 18 with newly diagnosed type 2 diabetes mellitus within the last month.
Title: Cinnamon Trial--assessment of the effeCt of lIfestyle iNtervention plus water-soluble ciNnAMon extract in delaying the ONset of diabetes: A randomized, double-blind, multicenter, placebo controlled trial.
Purpose: The purpose of this study is to assess whether water-soluble cinnamon extract plus aggressive lifestyle intervention is effective in delaying the onset of diabetes in pre-diabetic patients when compared to aggressive lifestyle therapy plus placebo.
Recruitment: Patients over age 18. Diagnosis of pre-diabetes (defined as a fasting plasma glucose (FPG) 100-125mg/dl or hemoglobin A1C 5.7-6.4% or a 2-hour oral glucose tolerance test (OGTT) 140-199).
Title: Survey of military adult beneficiaries to determine patients' explanation for successful (>3.0) Hemoglobin A1C reduction.
Purpose: The purpose of this study is to identify motivational behavior factors within military adult beneficiaries to determine patients' explanation for highly successful (>3.0) Hemoglobin A1C reduction.
Recruitment: Retrospective review of patients' records.
Title: Assessing the Risk of Developing Type II Diabetes Using Serum Biomarkers in Patients Diagnosed with Obstructive Sleep Apnea.
Purpose: The purpose of this small exploratory study is to ascertain if a seven serum biomarker panel that predicts the 5-year risk of developing type II diabetes mellitus (DM2) is affected by continuous positive airway pressure (CPAP) therapy in patients with obstructive sleep apnea. Furthermore, we hope to show that a patient's knowledge of his DM2 risk score affects his compliance with CPAP.
Recruitment: Male or Female > 18 years old. Groups 1 and 2: newly diagnosed with OSA and determined to need CPAP therapy by their treating physician. Group 4: known diagnosis of OSA treated with CPAP therapy for 12-24 months with demonstrated compliance after review of SD card.
Title: An Epidemiological Study of the Prevalence of Pre-diabetes and Diabetes among Air Force personnel who fail the Air Force Physical Fitness Test at Nellis AFB, NV in 2011.
Purpose: The purpose of this study is to evaluate the prevalence of pre-diabetes and diabetes among those Air Force personnel who fail the Air Force physical fitness test (AFPT) and to evaluate the usefulness of the AFPT as a prescreening tool for these disease processes.
Recruitment: Over the age of 18 and took their AFPT within the past 1 month.
Title: Impact of a Diabetes Risk Score on Lifestyle Education and Patient Adherence (IDEA Trial).
Purpose: The purpose of this study is to decrease incidence of progression from prediabetes to diabetes by evaluating the impact of knowing a personalized diabetes risk score on prediabetic patients' adherence to a lifestyle education program and resultant weight loss compared with usual care.
Recruitment: Men and women of all ethnic groups, ≥30-75 years of age, Pre-diabetic defined as follows: fasting plasma glucose (FPG) 100-125mg/dL, HbA1c 5.7% to 6.4%, Body Mass Index ≥ 25 kg/m².

Women's Health:

Title: A Pilot Study for a Non-Inferiority Trial of Clinician-Collected Versus Patient-Collected Cervical Papanicolaou Smears. (SoloPap).
Purpose: The purpose of this study is to 1. Determine whether it is feasible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is non-inferior to the clinician performed Pap test in detecting precancerous cervical lesions in females. 2. Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.
Recruitment: All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding.

Quality Improvement Research:

Title: Comparison of methods to improve abdominal aortic aneurysm (AAA) screening rates in the primary care setting.
Purpose: Standard of care dictates that eligible patients should receive an abdominal aortic aneurysm (AAA) screening ultrasound. At present, different military primary care physicians utilize different methods at their discretion to ensure their patients get screened--telephone contact; mail-out reminders; referring patients for ultrasound directly from an office visit; as well as other methods--which we will refer to as "usual care". The purpose of this study is to improve screening rates for AAA and determine what notification methods are best at improving screening rates.
Recruitment: Male patients between the ages of 65-75 years old.

FUTURE RESEARCH PROJECTS:

Title: The effect of high dose folic acid versus placebo on the rate of gestational diabetes or gestational hypertension in Pregnant Women: a randomized controlled trial.
Purpose: The purpose of this study is to determine if higher-than usual doses of daily folic acid has an effect on the rate of gestational diabetes mellitus (GDM) or gestational hypertension in pregnant women while determining status of folic acid, vitamin B12, homocysteine and vitamin D in pregnancy.
Title: Short-Term Impact of Tobacco Cessation on Glycemic Control in Diabetes Mellitus, Type 2.
Purpose: The objective is to determine whether significant changes in glycemic control occur in those with diabetes mellitus, type 2 during the first 2-3 weeks and/or first 3-4 months after enrollment in a tobacco cessation program and if so, what determinants may predict a higher likelihood of worsened glycemic control. The long-term goal is to be able to provide those that care for patients with diabetes with either reassurance that changes in diabetes treatment are not generally required prior to or during tobacco cessation or a mechanism to predict who likely will need changes in their treatment prior to or during tobacco cessation and some guidance as to what those required changes in treatment are likely to be.
Title: The influence of Proton Pump Inhibitors (PPI's) on blood levels of 25-Hydroxyvitamin D.
Purpose: The purpose of this study is to demonstrate if Proton Pump Inhibitors (PPI's) decrease blood levels of 25-Hydroxyvitamin D (25-OH Vitamin D).
Title: The effects of normobaric hypoxia on blood glucose levels.
Purpose: The purpose of this research study is to observe whether there is a change in blood glucose levels in response to a 2 hour oral glucose tolerance tests (OGTT) during acute normobaric hypoxia (short term low oxygen levels at normal ambient air pressure).

COMPLETED RESEARCH PROJECTS:

Title: Survey of Military Family Physicians and Physician Assistants regarding knowledge of Diabetes Screening, Diagnosis and Treatment.
Purpose: The purpose of this research study is to utilize a web based survey to assess the knowledge of Military Family Physicians and Physician Assistants regarding the screening, diagnosis and treatment of diabetes, which will aid in the development of comprehensive educational programs.
Title: Efficacy of Residency Training in Preparing Air Force Physicians to Effectively Respond in Time of Disaster or in Support of Humanitarian Response.
Purpose: The purpose of this study is to assess the adequacy of graduate medical education in preparing Air Force physicians emotionally, logistically, and competently to respond to times of crisis such as regional disasters or humanitarian operations.
Title: Using the Communication Assessment Tool in Family Medicine Residency Programs: Expanding the Data.
Purpose: The objective of this study is to expand upon the initial benchmarking data for the use of the CAT (Communication Assessment Tool; Makoul [1]) in Family Medicine residency programs. The Communication Assessment Tool (CAT) is a 15 item paper and pencil survey that was developed to assess patients' perceptions of the interpersonal and communication skills of Family Medicine residents. In this study we plan to examine differences in patient ratings of Family Medicine residents based on the resident's year in training, gender of the resident, native language of the resident (including duration of living in an English speaking country), and location of medical school training (US graduate vs. International Medical Graduate). The data gathered from the CAT will be aggregated for the purpose of this research project (i.e. data analyzed and reported only for groups of residents such as by training year, gender, etc).
Title: A retrospective case-control study to compare group education with the "Journey to Life" Conversation Map to Diabetes Education in Type 2 diabetic patients.
Purpose: Retrospective review of Patients' records.
Title: Knowledge, Concerns and Myths Regarding Diabetes: A Survey of the US Air Force.
Purpose: The purpose of this study is to survey non-medical Air Force personnel to determine baseline knowledge of diabetes in order to identify deficiencies and allow the Air Force to develop ways to focus on prevention efforts and elucidate concerns and myths regarding diabetes.