Research, Quality Improvement, and Clinical Research Update

Jennifer Duong, MPHDepartment of Obstetrics and Gynecology

December 2, 2015

Disclosures

• I have no disclosures or conflicts of interest.

Objectives

• Understand the Program’s goals and residency program expectations

• Review the status of recent/current research and quality improvement projects, as well as opportunities to contribute to clinical trials

• Encourage resident physicians and attending physicians to participate in scholarly activity

ACGME Program Requirements

• Per the Accreditation Council for Graduate Medical Education (ACGME) Program Requirements for Graduate Medical Education in Obstetrics and Gynecology (eff. July 1, 2015)1: The faculty must establish and maintain an environment of inquiry and scholarship with an active research component (II.B.5.)

1. Accreditation Council for Graduate Medical Education. ACGME Program Requirements for Graduate Medical Education in Obstetrics and Gynecology. July 1, 2015 2015.

What is Scholarly Activity

• In summary, ACGME uses the following definition of “scholarly activity” for faculty and residents2:

Faculty ResidentsOrganized clinical discussionGrand RoundsJournal ClubsConferencesPeer-reviewed fundingPublication of original research or

articles in peer-reviewed journals or chapters in textbooks

Participation in national committees or educational organizations

Didactic sessionsPatient roundsCase conferencesSimulationsJournal ClubsScholarly activities (e.g. research,

literature search and review, participation in conferences, presentations, publication)

2. Philibert I, Lieh-Lai M, Miller R, Potts JR, Brigham T, Nasca TJ. Scholarly Activity in the Next Accreditation System: Moving From Structure and Process to Outcomes. Journal of graduate medical education. 2013;5(4):714-717.

What is Scholarly Activity

• In summary, ACGME uses the following definition of “scholarly activity” for faculty and residents2:

Faculty ResidentsOrganized clinical discussionGrand RoundsJournal ClubsConferencesPeer-reviewed fundingPublication of original research or

articles in peer-reviewed journals or chapters in textbooks

Participation in national committees or educational organizations

Didactic sessionsPatient roundsCase conferencesSimulationsJournal ClubsScholarly activities (e.g. research,

literature search and review, participation in conferences, presentations, publication)

2. Philibert I, Lieh-Lai M, Miller R, Potts JR, Brigham T, Nasca TJ. Scholarly Activity in the Next Accreditation System: Moving From Structure and Process to Outcomes. Journal of graduate medical education. 2013;5(4):714-717.

Program Goals and Residency Expectations

KUSM-W Department of Obstetrics and Gynecology Program Goals

1. Establish and maintain an environment of scholarship and scholarly activity for faculty and residents associated with the program and;

2. Provide a curriculum and guidance to residents that will advance their basic knowledge of basic research and quality improvement (QI).

Program OutcomesTo be eligible for graduation, the resident is required to do the following, at a minimum: Participate in one research project during the

residency program; and Participate in one QI project during the residency

program; andWrite an abstract summarizing project findings

from a research or QI project; and Create one poster (48x36) illustrating a research

project or QI project that is suitable for use during a poster presentation; or prepare an oral presentation, and

Program Outcomes Present findings to Program faculty, residents,

medical students, and staff (at minimum, Didactics); and

Present a research or QI project at a local, regional, or national conference (at minimum, the KUSM-W Annual Research Forum); and

Assist in the manuscript process and submit to the department a manuscript that would be suitable for submission for publication before the Daniel K. Roberts Annual Ob/Gyn Update.

How do we accomplish this?

• PGY-2 will focus on completing a QI project (process improvement)

• PGY-3 through PGY-4 will focus on completing a research project (basic research science)

Caveat: This is the goal as of…July 2015

Resident Research and QI Updates

FINISH

PGY-1• PGY-1 are not required to actively

participate in research or QI activities

PGY-2• PGY-2s are participating in the

Wesley Medical Center Quality Improvement Academy

PGY-2 Quality Improvement Project Topics

GBS compliance project follow-up

Assessing clinic staff knowledge of gravida and para

Rhogam administration for threatened abortion

Labetalol protocol compliance

PGY-2Topic Status Team

Assessing clinic staff knowledge of gravida and para

Drafting application

GBS compliance project follow-up

Data collection

Rhogam administration for

threatened abortion

Drafting application

Labetalol protocolcompliance

Drafting application

PGY-3• PGY-3s are finalizing IRB

documents or are collecting data

PGY-3 Research Project Topics

OB Trauma Level Designation

Hysterectomy and Treatment of Pelvic Organ Prolapse

Feedback and Gamification of the Ob/Gyn Clerkship

Reduction of Bladder Injection Pain RCT

PGY-3IRB Approval Data Collection

PGY-3Topic Status Team

OB Trauma Level Designation

Preparing IRB submission

Hysterectomy and Treatment of Pelvic Organ

Prolapse

Preparing IRB submission

Feedback and Gamification of

the Ob/Gyn Clerkship

Phase 3: Focus Group data collection

Reduction of Bladder Injection

Pain RCT

Enrollingand collecting data

PGY-4• PGY-4s are the last “era” of

residents, some are done and some and getting started

PGY-4 Research/QI Project Topics

Patient-Included Structured Debriefings after Cesareans

Risk of Multiple Pregnancies in Combo/Injectable vs. Injectable Alone Protocols

Assessing/Promoting Safe Sleep Practices in OB Clinic

Labetalol Protocol compliance

Prophylactic Antibiotic Use in Gynecologic Surgery

PGY-4IRB Approval Manuscripts

Presentations

PGY-4Topic Status Team

Patient-IncludedStructured Debriefings

after Cesareans

Presentationand Manuscript

Risk of MultiplePregnancies

Preparing IRB submission

Assessing/Promoting Safe Sleep Practices in

OB Clinic

Manuscript

Labetalol Protocolcompliance

Preparing IRB submission

Prophylactic Antibiotic Use in Gynecologic

Surgery

Presentation and Manuscript

Recent Accomplishments

• Dr. Uppendahl and Dr. Delmore’s research project:– Won 2nd place ($500) at the ACOG Joint District Meeting– Was awarded the District VII 2015 Daniel K. Roberts

Paper Award– Submitted for the National Donald F. Richardson Award

• Dr. Bertschy and Dr. Kuhlmann’s research project was accepted as a poster presentation at the 27th

Annual Institute for Healthcare Improvement National Forum in Orlando, FL

• Dr. Wykes and Dr. Farley’s QI project won 1st Place Best Resident Poster ($100) at the KUSM-W Quality Improvement/Patient Safety Conference

Recent Accomplishments

• Dr. Strang and Dr. Sobbing’s education QI project was accepted as a poster presentation at the 2016 CREOG APGO Annual Meeting

• Dr. Boender (gr. 2015) and Dr. Grainger’s research project was accepted as a poster presentation at the 2016 CREOG APGO Annual Meeting

• The Pioneer Baby collaborative project (KUSM-W PMPH and rural health facilities) was accepted as an oral presentation at the 37th Annual Meeting and Scientific Sessions of the Society of Behavioral Medicine in Washington, DC

Recent AccomplishmentsWe received one of the WCGME-KBA Pilot Studies Funding Program through the Office of Research: The Department was awarded $20,000 to execute “Breastfeeding-Friendly Provider's Office Protocol Pilot Study”Principal Investigator: David A. Grainger, MD, MPHCo-Investigators: Edmond Feuille, MD; Vickie Kindel, MD; Ashley Robbins, MDResident Co-Investigators: Taylor Bertschy, DO, PGY-4, Angela Strang, MD, PGY-3, Rachel Wykes, MD, PGY-3, Anna Haring, MD, PGY-2

Additional Department Projects

• OBoard, LLC will be exhibited at the 2016 CREOG APGO Annual Meeting and the company will be applying for a NIH Small Business Innovation Research Grant in 2016

• Pioneer Baby Collaborative: completed focus groups and transcription/coding will be completed mid-December

Manuscripts in the Pipeline

Products of Conception Paper (gr. 2015)

Binder Pilot Study (gr. 2014, resubmit)

Products of Conception Paper (gr. 2015)

Urinary Incontinence Paper (gr. 2015, resubmit)

Menopausal Hormone Therapy Paper

(gr. 2015)

Structured Debriefing Paper

Gyn Paper

How to Get Involved and Research Troubleshooting

• Ask!• Clinical Trials?• Start small…Tips:1. Set aside designated time for scholarly

activity and make written goals2. Check your email for KU/Dept. blitz3. Do your human subjects training early

Clinical Trials - Overview

• Clinical trials are conducted out of the Cypress Medical Research Center

• All studies are sponsored and are not conducted out of the our Department

• Contact: Bryan Baker, RN, MSM, CCRCPhone: (316) 425-6333Email: bryan@cypressmrc.com

Clinical Trials – Current StudiesEnrollment Open

Sponsor/Protocol Condition Objective(s)Bayer 15832 Endometriosis To compare the efficacy and safety of BAY 98-7196

(aromatase inhibitor and progestin IVR) versus leuprorelin/leuprolide acetate to placebo in women with symptomatic endometriosis over 12-week period

Sage 547-PPD-202 Postpartum depression To determine the efficacy and safety of SAGE-547 infused intravenously for 60 hrs. in reducing depressive symptoms in subjects with PPD compared to placebo

Duchesnay PED-301: N/V in pregnant adolescents To compare the efficacy and safety of Diclegis® for the treatment of nausea and vomiting in pregnant adolescents aged 12-17 years versus placebo

Evidera EVA-16301: Adenomyosis with or without endometriosis

1) Understand the important symptoms, impact and disease experience of patients and 2) Collect feedback on symptoms and impact in patients with adenomyosis (Study only involves patient interviews )

Clinical Trials – Current StudiesEnrollment Completed

Sponsor/Protocol Condition Objective(s)Viamet VMT-VT-1161-CL-006 Recurrent VVC To evaluate the safety and efficacy of 4 dosing regimens

of oral VT-1161 for the prevention of acute VVC episodes through 48 weeks

Palatin BMT 301 HSDD 1) To evaluate the safety and efficacy of bremelanotide SQ versus placebo when administered on as needed basis for the treatment of HSDD in premenopausal females during the 6-month double-blind core study and 2) To evaluate the safety and efficacy of long-term therapy with bremelanotide over 12 months in the open-label phase

TherapeuticsMD TXC12-05 Vasomotor Symptoms 1) To assess the mean change in frequency of moderate to severe vasomotor symptoms over 12 months and 2) Evaluate the incidence rate of endometrial hyperplasia at 12 months

Abbvie M12-671 Endometriosis To evaluate the efficacy and safety of elagolix versus placebo on dysmenorrhea and non-menstrual pelvic pain over 6 months

AbbVie M12-821 Endometriosis To evaluate the efficacy and safety of elagolix on dysmenorrhea and non-menstrual pelvic pain over 12 months

Clinical Trials – Recently Completed

Sponsor/Protocol Condition Investigator Objective(s)TherapeuticsMD TXV14-01Double-blind study to evaluate the safety and efficacy of TX-004HR (soft gel vaginal formulation containing solubilized estradiol) in postmenopausal women with moderate to severe symptoms of vulvar and vaginal atrophy

VVA David Grainger, MD, MPH

Edgar LeClaire, MD (sub-I)

Byron Cline, MD(referral physician)

Compare safety and efficacy of 4 doses of TX-004HR versus placebo on change in vaginal superficial and parabasal cells and on change in severity of dyspareunia during 12 weeks of treatment

Repros ZPV-201:

Randomized, double-blind, placebo-controlled study to evaluate 6 and 12 mg Proellex® administered vaginally to treat premenopausal women with confirmed symptomatic uterine fibroids

Uterine Fibroids

David Grainger, MD, MPH To evaluate the safety of 2 doses of Proellex® versus placebo in premenopausal women with confirmed uterine fibroids, including percentage of subjects who become amenorrheic after 1 or 2 courses of treatment and percentage change in menstrual blood loss over course of treatment.

Clinical Trials – Potential Upcoming Studies – 1

• These are studies seeking subjects AND potential co-investigators:

Sponsor/Protocol ConditionAbbvie M12-815:Study to evaluate the efficacy and safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women

(Expected start: 03/2015)

Uterine Fibroids

Abbvie M14-702:Evaluate the efficacy and safety of elagolix in combination with norethindrone acetate or estradiol/norethindrone acetate in subjects with moderate to severe endometriosis-associated pain

(Expected start: 02/2015)

Endometriosis

Starpharma SPL7013-017 & 018: Phase 3 studies evaluating treatment with SPL7013 Gel (VivaGel® ) in subjects with recurrent bacterial vaginosis.

(Expected start 02/2015)

Recurrent BV

Clinical Trials – Potential Upcoming Studies – 2

Sponsor/Protocol ConditionGlenmark GLK-1502: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study Comparing Generic Estradiol Vaginal Cream or Reference Estradiol Vaginal Cream and Both Active Treatments to a Vehicle Control in the Treatment of Symptoms of Vulvar and Vaginal Atrophy

(Expected start 02/2015)

VVA

Glenmark GLK-1502: A Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study Comparing Generic Estradiol Vaginal Tablet or Reference Estradiol Vaginal Tablet and Both Active Treatments to a Vehicle Control in the Treatment of Symptoms of Vulvar and Vaginal Atrophy

(Expected start 02/2015)

VVA

Novum/Teva 71436001:A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Teva Pharmaceuticals, USA) to Estrace® Estradiol Vaginal Cream, USP, 0.01% (Warner Chilcott) in the Treatment of Atrophic Vaginitis

(Expected start 01/2015)

VVA

Important Dates

• April 21, 2016 (8:30 AM-4:00 PM) – KUSM-W 24th Annual Research Forum

• June 10, 2016 (7:30 AM –3:00 PM) Daniel K. Roberts Annual Ob/Gyn Update

• October 2016, TBD (12:00 PM – 2:00 PM) – KUSM-W 2nd Annual Quality Improvement/Patient Safety Conference

Conclusion

• Research, quality improvement, and clinical trials are all considered “scholarly activities” that help the department maintain our accreditation

• Additional structure has been added to the residency program to ensure that residents meet Program goals and outcomes

Thank You

If you have any questions:

Phone: 316-962-3126Email: jduong@kumc.edu or jennifer.duong@wesleymc.comOffice: 551 N. Hillside, Suite 500Wichita, KS 67214