Wills Eye Health System Annual Progress Report: 2009 Nonformula Grant

Transcription

1 Wills Eye Health System Annual Progress Report: 2009 Nonformula Grant Reporting Period July 1, 2012 June 30, 2013 Nonformula Grant Overview The Wills Eye Health System received $3,598,366 in nonformula funds for the grant award period June 1, 2010 through May 31, Accomplishments for the reporting period are described below. Research Project: Project Title and Purpose Confronting Unequal Eye Care in Pennsylvania - The purpose of the research project is to increase utilization of eye care for older African Americans with diabetes and to provide research training and mentoring for minority students. We are conducting a randomized, placebocontrolled clinical trial to test the efficacy of a culturally-relevant intervention, Behavioral Activation, to increase the rates of dilated fundus examinations in this population. We have also developed a research training and mentoring program to increase minority nursing and biomedical students vision research skills. Anticipated Duration of Project 6/1/2010-5/31/2014 Project Overview The project s overarching goals are to increase older African Americans utilization of eye care and to promote minority students interest in pursuing research careers. Older African Americans with diabetes are more likely than Caucasians to develop severe vision loss from diabetic retinopathy (DR), which is a major complication of diabetes. Early detection with annual dilated fundus exams (DFE) can prevent severe vision loss resulting from DR. However, African Americans are less likely to have DFEs than Caucasians. To reduce this health disparity, we propose the following Specific Aims: 1. To conduct a randomized, placebo-controlled clinical trial to test the efficacy of Behavior Activation (BA) to increase rates of DFEs in older African Americans with diabetes. The control treatment, Supportive Therapy (ST), is a placebo interation to control for the interpersonal attention that subjects randomized to BA will receive. Both interventions are conducted in subjects' homes. We will enroll 206 older African Americans with diabetes who have not had a DFE in the past year and randomize 50% to each treatment group in this 6 month clinical trial. We hypothesize that 60% of subjects who receive BA compared to 35% of subjects who receive Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 1

2 ST will schedule and obtain a DFE by 6 months. Secondary outcome measures include knowledge of the risk of diabetes complications, adherence to diabetes self-care recommendations, and depressive symptoms. We will also examine the long-term efficacy of BA to increase annual DFE rates. 2. To develop a Minority Research Training and Mentoring Program at the Wills Eye Health System to increase research skills and promote interest in pursuing research careers for undergraduate and graduate minority nursing and biomedical students. To accomplish Aim 2, we will create a minority training program and summer research internship for up to four minority students per year. Principal Investigator Julia A. Haller, MD Ophthalmologist-in-Chief Wills Eye Health System 840 Walnut Street, 15th Floor Philadelphia, PA Other Participating Researchers Lisa Hark, PhD, RD; Ann Murchison, MD, MPH employed by Wills Eye Health System Barry Rovner, MD; Robin Casten, PhD; Barry Ziring, MD; James Plumb; MD, MPH; Benjamin Leiby, PhD; Kathy Ashton, PhD; Laura Pizzi, PharmD- employed by Thomas Jefferson University Rickie Brawer, PhD, MPH; Neva White, MSN, CRNP, CDE- employed by Thomas Jefferson University Hospital Jeffrey Henderer, MD employed by Temple University School of Medicine Expected Research Outcomes and Benefits This research project will have both immediate and long-term outcomes. The immediate outcome is two-fold. First, we will determine the efficacy of an innovative, culturally relevant home-based intervention to increase rates of diabetic eye screening in older African Americans. We know that many patients in this population do not fully understand diabetic eye disease or how to access care to identify or prevent it. Our research will test a program to increase utilization of ophthalmic care, thereby reducing African Americans risk for vision loss and blindness which is a pervasive health disparity. The research project s second immediate impact is that we will increase the research skills of a cadre of undergraduate and graduate minority nursing and biomedical students through direct participation in our research projects and research training programs. We will accomplish this via a research training program that consists of a summer research internship with didactic and hands-on training as well as individual student mentoring. The ultimate goal is to promote minority nursing and biomedical students interest in pursuing research careers as another step towards reducing health disparities. The long-term impact of our work will be to prevent unnecessary suffering and disability in an Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 2

3 underserved population at high risk for vision loss. If our efforts are successful, they will reduce costs associated with vision loss and its complications (e.g. depression, falls and fall-related injuries, and nursing home placements). Ultimately, the intervention that we are testing can serve as a broad-based, community health model for other medical conditions that disproportionately affect African-Americans such as asthma, hypertension, and prostate cancer, where treatment adherence is low. In this way, our translational research project s impact may extend well beyond the treatment of disorders of the eye. Our results have the potential to provide important new information to patients, clinicians, and policy makers about interventions that have the potential to save money using low cost, culturally relevant, community-based interventions. Summary of Research Completed This annual report covers project activities undertaken from July 1, 2012 June 30, Our activities for Aim 1 have focused on implementing the research protocol at Wills Eye, Thomas Jefferson University (TJU), and Temple University (TU). These activities include randomizing 58 subjects (206 subjects have been randomized to date), performing baseline and follow-up assessements, and administering study treatments to enrolled subjects. For Aim 2, we continued to implement the Clinical Vision Research Training and Mentoring Program for Minority Students. Protocol Amendments The following amendments were made to the protocol for the clinical trial during Year 3. All amendments have been approved by the Wills Eye IRB and TU IRB. 1. The protocol was amended to allow for remuneration for the referral of enrolled participants. 2. The recruitment protocol at TU was amended to change from opt-in to opt-out recruitment procedures to increase enrollment. Protocol Reapproval The Wills Eye IRB approved the continuation of the study on March 19, 2013, and TU IRB reapproved the study for an additional year on April 11, Recruitment A total of 2795 patients from TJU clinics and TU clinics met preliminary eligibility criteria (age 65, African American, type 2 diabetes). To date 1002 TJU and 1793 TU primary care patients were sent recruitment letters via mail. Of these, 7 TJU patients and 31 TU patients have been recruited for the past reporting year. Table 1 summarizes recruitment outcomes for both recruitment sites. As of June 30, 2012, 57 TJU patients and 83 TU patients have completed baseline assessments and have been randomized. As we began exhausting our potential patient pool from the TJU University and TU primary care clinics, we expanded recruitment efforts to other medical clinics, community centers, health fairs, and faith-based organizations. Throughout year 4, we have continued to recruit subjects Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 3

4 from these aforementioned places as well as place advertisements in local newspapers and specialty periodicals that target senior citizens. At community events, research staff informed interested attendees about the study and handed out recruitment flyers to those who were interested. We have spoken with approximately 500 people and have obtained basic demographic information for 238 people that met preliminary eligibility criteria (e.g. aged 65+, African American, type 2 diabetes). In year 4, we recruited 20 subjects from our community efforts. As of June 30, 2013, 63 subjects have completed baseline assessments and have been randomized over the past reporting year. Recruitment outcomes for community outreach efforts are summarized in Table 1. As of June 30, 2013 a total of 206 subjects have completed their baseline assessment and have been randomized to either the BA or ST intervention groups. Baseline demographic statistics for the 206 randomized subjects can be found in Table 2. Of these 206 subjects, 20 have dropped out of the study; 11 subjects from the ST group and 9 subjects from the BA group. Our current attrition rate of 12% is lower than the 20% initially anticipated. Our interventionists were unable to reach 14 participants; two participants dropped out of the study due to disinterest; one participant was hospitalized for an extended period of time; one participant was placed in hospice care; two participants died before the 6-month follow-up assessment. One hundred (153) subjects have completed four treatment sessions. Of these subjects, 148 subjects have completed 6-month follow-up assessments. Eighty-five (85) subjects have completed 1-year follow-up assessments and 48 subjects have completed 18-month follow-up assessments. Thirty-three (33) subjects are currently receiving BA or ST interventions. Study Outcomes Our primary hypothesis for Aim 1 is that a greater proportion of subjects who receive BA will have a dilated eye examination by 6 months compared to subjects who received ST. The primary outcome measure is medical documentation of a DFE. During the 6-month follow-up assessment, all subjects are asked if they obtained a DFE and verification is obtained by reviewing medical records. Subjects who dropped from the study and are missing follow-up data at 6 months will be excluded from analysis. Secondary hypotheses for Aim 1 include: a) subjects who receive BA will increase their risk perception and risk knowledge of diabetes and its complications to a greater extent compared to subjects who receive ST at 6 months; b) subjects who receive BA will increase their adherence to diabetes self-care recommendations to a greater extent compared to subjects who receive ST at 6 months; c) subjects who receive BA will have lower levels of depressive symptoms compared to subjects who receive ST at 6 months. These secondary outcomes are measured by the Risk Perception Survey for Diabetes Mellitus (RPS-DM), the Diabetes Self Care Inventory Revised (SCI-R), and the Patient Health Questionnaire (PHQ-9). The means for these secondary outcomes at baseline by treatment group can be found on Table 3. One exploratory hypothesis for Aim 1 is that subjects who receive BA will have a larger reduction in A1C levels from baseline to 6 months compared to subjects who receive ST. A Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 4

5 target A1C for individuals with diabetes is less than 7%. At baseline, 90 of the 193 (46.6%) subjects who had A1C tested had levels above 7%. Table 4 shows the mean A1C levels for all subjects and by treatment group at baseline. Additionally, we have added a cost analysis of the intervention as part of our exploratory aims in response to the Interim Performance Review. The Data Safety and Monitoring Board (DSMB) reviewed the data and study progress on October 31, 2012 and June 6, The DSMB confirmed the study is being conducted according to protocol, and that there were no issues concerning subject safety. The Clinical Vision Research Training and Mentoring Program for Minority Students Five students were selected from a pool of 20 applicants to participate in a 9-week Clinical Vision Research Training and Mentoring Program for Minority Students that began June 10, The students come from a variety of backgrounds: one African-American nursing student, one African-American public health undergraduate, one African-American master s degree in public health graduate, one Hispanic-American with a bachelor s degree in biology and anthropology, and one Pacific Islander with a bachelor s degree in public health. Based on the positive evaluations from last year s students, many elements for this year s program have remained the same. We also created a syllabus for the students, elements of which include: a lecture series (see Table 5) involving Co-Investigators on Aim 1 as well as outside faculty from TJU and copies of major grant protocols from the Wills Eye Department of Research. The program s goal is to introduce minority students to clinical vision research by providing direct exposure to community epidemiological and public health research and clinical trials. During the nine week program students are also teamed with a mentor with whom they meet at least 3 times. Disseminating Results Based on our preliminary results we have submitted seven articles for publications and abstracts for presentations. We will continue to identify topics and appropriate journals and conferences. We also have two manuscripts that are currently pending review: Depression and Risk Perceptions in Older African Americans with Diabetes and Recruiting Older African Americans for Ophthalmology Research: Opt-in Versus Opt-out Recruitment Strategies. The following is a list of poster presentations: Hark LA, Stratford S, Weiss DM, Murchison AP, White N, Plumb J, Brawer R, Casten RJ, Henderer J, Rovner B, Haller JA. Utilizing community-academic partnerships to reduce visionrelated health disparities. Poster presentation at 2012 Science of Eliminating Health Disparities Summit, Washington DC. December Collymore B, Murchison AP, Casten RJ, Hark LA, Weiss DM, Johnson D, Rovner B, Henderer JD, Haller JA. Vision risk perception in older African Americans with Diabetes. Association for Research in Vision and Ophthalmology. Poster presentation May Seattle, WA. Weiss DM, Murchison AP, Hark LA, Collymore B, Casten RJ, Brawer R, Plumb JD, Rovner B, Henderer JD, Haller JA. Comparing opt-in versus opt-out recruitment strategies for Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 5

6 ophthalmology research. Association for Research in Vision and Ophthalmology. Poster presentation May Seattle, WA. Weiss DM, Hark LA, Leiby B, Murchison AP, Haller JA. Impact of diabetes on vision-related quality of life: Findings from a clinical trial of African-Americans. APHA. Poster Presentation Nov Boston, MA. Table 1: Subject Recruitment Outcomes Recruitment Site Jefferson Temple Community Total Subjects meeting preliminary eligibility criteria* Subjects enrolled Ineligible subjects Subjects declined Subjects with outcome pending Reasons for Ineligibility Subjects report DFE Deceased Cognitive Impairment Reports they do not have diabetes Lives out of range Other (too sick, hard of hearing) Reasons for Refusal/Declining Not interested No time Other reasons Outcome Pending Have not opted-in** Not applicable 672 Not applicable 672 Wrong Address Wrong Number Wait to call Left message * Includes only persons who met preliminary eligibility criteria (age 65 y/o, African American, type 2 diabetes). **At TU 244 patients initially opted into the study. In August 2013, TU IRB allowed for opt-out recruitment. Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 6

7 Table 2: Baseline Demographic Characteristics by Treatment Group BA Subjects (n=103) ST Subjects (n=103) Total Subjects (n=206) n % n % n % Marital Status Married Widowed Divorced Other Gender Female Male Living Status Lives Alone Age Age 65 to Age 75 to Age Education* < 12 years years > 12 years * 1 BA Subject and 1 ST Subject did not provide education. Table 3: Secondary Outcomes at Baseline by Treatment Group BA Subjects (n=103) ST Subjects (n=103) Total Subjects (n=206) Missing Mean (SD) Missing Mean (SD) Missing Mean (SD) RPS-DM Risk Knowledge (1.28) (1.20) (1.24) Perceived Personal Control (0.54) (0.58) (0.56) Worry (0.72) (0.64) (0.68) Optimistic Bias (0.75) (0.72) (0.74) Personal Disease Risk (0.75) (0.80) (0.78) Environmental Risk (0.74) (0.66) (0.70) SCI-R Scaled Score (14.61) (14.60) (14.57) PHQ-9 Total Score (4.85) (5.28) (5.06) 1 Scores range from 0 to 5 with higher scores indicating greater knowledge of diabetes complications. 2 Scores range from 1 to 4 with higher scores indicating more perceived control and less perceived risk over diabetes complications. 3 Scores range from 1 to 4 with higher scores indicating more worry. 4 Scores range from 1 to 4 with higher scores indicating more optimistic bias; lower scores indicating greater realism/pessimism. 5 Scores range from 1 to 5 with higher scores indicating greater perceived personal disease risk. 6 Scores range from 1 to 4 with higher scores indicating greater perceived environmental risk. 7 Scores range from 0 to 100 with higher scores indicating greater adherence to self-care recommendations. 8 Possible scores range from 0 to 27, with higher scores indicating worse depressive symptoms. Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 7

8 Table 4: A1C Data at Baseline by Treatment Group Baseline N Missing* Mean A1C % (SD) All subjects (1.67) BA subjects (1.62) ST subjects (1.71) *13 Participants did not agree to have their A1C measured during the study. Table 5: Clinical Vision Research Training and Mentoring Program 2013 Lecture Series Topic Introduction to Ophthalmology Introduction to Clinical Research Designing Clinical Research Trials Research Ethics IRB Protocol Introduction to Diabetes Introduction to Cost Analysis What Are Populations and Samples? Community Engagement, Action Research, and Qualitative Methods Statistics in Clinical Research Measurement and Data Collection Introduction to Glaucoma Grant Writing Workshops Lecturer Dr. Ann Murchison Dr. Robin Casten Dr. Barry Rovner Dr. Kathleen Ashton Ann Larsen Dr. Neva White Dr. Laura Pizzi Dr. Kathleen Ashton Dr. Rickie Brawer Dr. Benjamin Leiby Dr. Robin Casten Dr. Michael Waisbourd Dr. Lisa Hark Wills Eye Health System 2009 Nonformula Grant on Blindness and Visual Impairment Page 8