Innovation Fund Project Proposal SIF191

Helen Keller International- Bangladesh Innovation Fund Project Proposal Innovation Fund Project Proposal SIF191

1. Background information

1.1. Organisation Name Helen Keller International

1.2. Organisation Address 352 Park Avenue South, Suite 1200

Non-Governmental Organisation (NGO) Blind Peoples’ Organisation (BPO) 1.3. Type of Organisation Which of the following best Disabled Peoples’ Organisation (DPO) describes your organisation? Organisation working with Disabled People (Select a maximum of two Academic Institution categories) Ethnic Minority Group or Organisation Other... [please specify] Name: Nick Kourgialis 1.4. Main contact person Email:[email protected] Phone:646-472-0323 1.5. Country(ies)/ area(s) & Chittagong Division of Bangladesh districts of planned project

A randomized controlled trial of an intensive case 1.6. Project name management model in improving compliance with care for people with diabetic retinopathy in Bangladesh

Erica Khetran, Bangladesh Country Director, HKI David Friedman, MD, MPH, PhD, Senior 1.7. Authors of Proposal Ophthalmologist, HKI Nick Kourgialis, Vice President for Eye Health, HKI Innovation Fund Project Proposal

2. Core Innovation Project Information Eye Health Challenges Challenge No. 1 Challenge No. 2 Challenge No. 3 Challenge No. 4

Inclusive Education Challenges 2.1. Implementation Challenge No. 1 Challenge the project addresses Challenge No. 2 (Please tick the relevant Challenge No. 3 box) Challenge No. 4

Social Inclusion Challenges Challenge No. 1 Challenge No. 2 Challenge No. 3 Challenge No. 4 Innovation Fund Project Proposal

2. Core Innovation Project Information Bangladesh has among the world’s largest number of diabetics1 but its health care system lacks effective models for managing the disease, including identification and treatment of diabetic retinopathy (DR). HKI has established a comprehensive, high- quality DR grading and treatment facility, with two screening centers, in the Chittagong Division of Bangladesh, which has already reached over 12,000 patients with DR screening and provided over 2,500 of them with laser or Avastin injection treatment. However, HKI and other agencies working to reduce preventable blindness due to DR in Bangladesh face continuous challenges in overcoming the social and economic barriers to patient compliance with recommended treatment plans. Since early detection and treatment of DR can reduce the risk of severe vision loss by more than 90 percent2, it is imperative that steps are taken to ensure that people with diabetes are educated about DR and, when appropriate, seek treatment. However, our initial DR work in Bangladesh has demonstrated that despite educational efforts to inform those with diabetes of the need to follow up with screening recommendations, a significant percentage of those requiring a 2.3.Background full retinal evaluation and likely treatment fail to return to the information and clinic. The rates of follow up are particularly low for women, who project rationale face additional social and economic barriers in seeking care.

HKI now seeks to incorporate an intensive case management (ICM) system, incorporating tailored, consistent follow up with patients and their families alongside comprehensive patient education, and to rigorously evaluate this model and its impact on patient knowledge and behaviour (particularly care-seeking). As HKI has learned through its experiences in Bangladesh, it is not enough to provide access to DR treatment services; it also is necessary to improve knowledge, promote care-seeking behaviour and work with patients and their families to overcome real and perceived barriers to seeking care. Evidence indicates that ICM represents an important component of any comprehensive DR prevention and treatment program; however, questions remain as to which aspects of ICM are the most effective for DR treatment, for whom and why. With diabetes representing a growing global public health crisis with especially dire consequences for populations in resource-poor settings, this model could provide an effective, replicable and sustainable approach to preventing unnecessary vision loss due to DR worldwide. The project will be implemented over an 18-month period, from 2.4 Project Duration September 1, 2012 to February 29, 2014. Innovation Fund Project Proposal

2. Core Innovation Project Information HKI has a longstanding relationship with the Chittagong Eye Infirmary and Training Complex (CEITC), one of Bangladesh’s leading eye health service and training facilities. HKI established a DR screening and referral system at CEITC in 2009, with the goal of doubling its laser treatment capacity. HKI has worked with CEITC to increase awareness among diabetics and their caregivers regarding the eye health impact of diabetes and the availability of DR treatment, including roll out of a state- of the-art patient education package with information about DR and tools to better manage diabetes including a recipe book and exercise log. HKI has strengthened local capacity for early detection of DR by training general health practitioners and medical specialists in participating diabetic clinics to routinely refer patients for photographic screening for DR and to assist 2.5. Organisations them to obtain further treatment at CEITC if disease is detected. targeted for In addition, HKI has begun training counselors and health replication, and educators to provide detailed information about diabetes and strategy to achieve the ways in which it can harm vision. We would now like to scale expand this work to provide ICM to patients referred for retinal examination in order to increase attendance, knowledge and ultimately provision of vision-saving treatments. We expect that the RCT conducted through this project will demonstrate the cost effectiveness and impact of ICM in improving DR treatment compliance. A further benefit of this program is the fact that as the demand for DR treatment increases following the implementation of ICM, hospitals will generate more revenue from providing treatment, and this will increase the availability of resources needed to further expand, enhance and sustain the program over the long term. HKI has also established a DR screening and referral system at Feni Diabetes Hospital (FDH), which is located 100 km away, and where the project also will be implemented. The Diabetes Association of Bangladesh (DAB) and Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) 2.6. Other support diabetic hospitals throughout Bangladesh, including the organisations working Chittagong Division. HKI has established a close partnership on related issues in with these organizations in order to support cross-learning and the project area opportunities for collaboration. It is anticipated that, along with CEITC, the BIRDEM network will be a key partner in identifying other diabetes centers that can adopt and build upon the ICM model. 2.7. What is the total The total cost of the project is £74,538. cost of the project? 2.8. Total funding to be requested from Total funding requested from Sightsavers for this project is Sightsavers for this £74,538. project Innovation Fund Project Proposal

2.9 Summary of proposed Goal, Purpose, Expected Outcomes, Outputs and activities

Goal The goal of this project is to increase the coverage of diabetic retinopathy (DR) treatment among (What is the overall, higher-level objective to referred patients and assess the effectiveness and costs of intensive case management (ICM) in which the project/programme will contribute?) DR photographic screening programs.

Purpose (Overall Objective) Expected outcomes (5 max) Expected outputs Main activities (What is the positive developmental (What are the expected short and medium term (What are the deliverables achieved as a (Examples of top line activities) change that the project will produce if effects of the interventions outputs?) result of implementing project activities?) successful?) Number of DR examinations by Patient recruitment and Improved attendance for referral ophthalmologists baseline exam Objective 1: Assess the visits Outreach with doctors and effectiveness of the intervention general patient population by examining differences between groups in: attending Number of DR treatments of Follow up visits, treatment exams based on DR referral screened positive patients and close-out exam after photographic screening Improved patient receipt of needed ICM, including tailored and obtaining treatment as DR treatments counselling and patient recommended (primary education for patients and outcome) and knowledge about family members DR (secondary outcome). Project findings published and Meetings with key endorsed by MoHFW, BIRDEM stakeholders (e.g., MoHFW, Objective 2: Evaluate the and other partners BIRDEM) incremental cost-effectiveness IRB-approved RCT of the intervention by assessing ICM model’s effectiveness comparing ICM to standard the cost per additional eye exam documented and accepted by key referral protocol completed and the cost per stakeholders in Bangladesh Data compilation/cleaning, additional treatment provided in endline survey with the intervention group. treatment and control groups, analysis and results dissemination Innovation Fund Project Proposal

3. Detailed Innovation Project Information 3.1. Why is this project needed at this time in this location? Bangladesh has among the world’s largest number of diabetics, but the health care system lacks appropriate screening models for diabetic retinopathy (DR). HKI has established a DR grading and treatment facility, with two screening centers, in Bangladesh’s Chittagong Region, but many patients identified by photographic screening for DR never follow-up for care. Barriers to care-seeking include perceptions that the cost of DR treatment outweighs the benefits, inability or unwillingness to devote the time needed for treatment, and a lack of family support. The issue of family support has a particularly profound impact on female patients, who were twice as likely to report in an HKI-conducted survey that lack of a family member to accompany them for treatment was the primary reason they did not seek care. To address this challenge, HKI will develop and test an ICM intervention to improve compliance with examination and treatment recommended after DR screening and to document the costs and outcomes of this more intensive approach.

A total of 2,000 patients with diabetes will be recruited to participate in the RCT from HKI’s DR screening programs at Chittagong Eye Institute Training Center (CEITC) and Feni Diabetes Hospital (FDH). Of this total, 1,000 will benefit from a traditional system of screening and referral, while 1,000 will benefit from ICM. HKI currently screens an average of 400 persons per month at CEITC and an average of 400 persons at hospital satellite clinic in FDH which is about a two-hour drive to CEITC. Patients at FDH typically encounter higher barriers to accessing care compared to patients at CEITC. Thus, the study design will allow us to compare the impact of ICM among populations with low versus comparatively high barriers to care. Patients to be included in the study will be consenting persons aged 18 years and older who have been diagnosed with Type I or Type II diabetes and who have screened positive for having DR. Patients to be excluded will include those unable to communicate due to dementia or language problems, and those blind from any cause.

Though DR is one of the most common and devastating consequences of diabetes, high- quality trial data have demonstrated that significant reductions in risk may be achieved with tight glucose control3-4, treatment of hypertension5,6,7 and hypercholesterolemia8, and timely laser treatment9. Laser treatment for DR is highly cost-effective and even cost- Innovation Fund Project Proposal

3. Detailed Innovation Project Information 3.2. What specific change is this initiative intended to achieve? This project will assess through an RCT the cost and effectiveness of ICM in improving patient compliance with DR treatment. Based on previously published studies it is assumed that ICM will increase patient compliance with DR treatment, as ICM has been demonstrated to improve other diabetic outcomes, including HbA1c, total cholesterol, blood pressure, hospital admissions, all-cause mortality, and compliance with diabetic and other medications. HKI’s own experience reflects this, with the number of patients seeking DR screening and treatment increasing as patient education strategies have been rolled out. HKI’s experience also suggests that the impact will be greatest for women, who face more social and familial barriers to seeking care. An estimated 2,800 people will directly benefit from this project. Innovation Fund Project Proposal

3. Detailed Innovation Project Information 3.3. What is the methodology and approach to be used by the project to achieve the changes described? This RCT will recruit 2,000 diabetic patients from Chittagong Eye Institute Training Center (CEITC) and Feni Diabetes Hospital (FDH). Patients who screen positive for diabetic retinopathy (DR) will be randomly assigned to a control group receiving routine referrals (information about the need to seek treatment provided immediately after screening and a single reminder phone call) or to a more comprehensive program of intensive case management (ICM). ICM will consist of health educators actively pursuing avenues to facilitate follow-up and treatment including education for patients and their family members, assistance with appointments and direct communication of screening results. ICM will be provided by a team of three project staff (two health educators and a project coordinator) and will involve the following elements: • Group teaching about diabetes and the benefits of screening and treatment for DR, and of good blood pressure and blood sugar control. • Assistance in scheduling appointments for eye examinations and treatment as recommended based on photo-screening. Each subject with DR will be assigned to one member of the team who will serve as their “case manager.” This individual will schedule follow up appointments, identify barriers to obtaining care, and help to overcome those barriers for the patient. • The designated case manager will be the “point person” for the dissemination of photo screening results to the patient and physician. This team member will then schedule detailed retinal examinations by a physician (in the event of positive or un-gradable results) and laser or Avastin treatments (for positive screening results confirmed by examination) as needed. • The case manager will work with patients to overcome barriers to treatment, including financial issues, should these arise, or the need to convince family members to facilitate treatment by providing transport or someone to accompany the patient. The case managers will be trained in gender-related barriers to care- seeking and will work with female patients and their families to overcome them. • The assigned team member will also be the point person in the clinic for feedback on any missed appointments for physician ocular examination or laser treatment. Patients will be contacted by telephone (if available), mail or (in the event of two failed contacts by other means) home visit to re-schedule appointments. Innovation Fund Project Proposal

3. Detailed Innovation Project Information 3.4. Who will be carrying out the project activities? HKI will carry out project activities in partnership with the Chittagong Eye Infirmary and Training Complex (CEITC), one of Bangladesh’s leading eye health service and training facilities, and Feni Diabetes Hospital (FDH). CEITC and FDH staff will be responsible for actual screening and treatment services, while HKI-hired project staff will conduct ICM, engaging CEITC and FDH counsellors whenever possible. HKI established a DR screening and referral system at CEITC and FDH in 2009. HKI chose CEITC as an implementation site in collaboration with the Diabetes Association of Bangladesh (DAB) and Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM), due to the need for DR treatment services among CEITC’s patient population as well its ability to incorporate and scale up such services. 3.5. Innovation: Why is this approach considered to be innovative? As discussed, published studies have demonstrated the effectiveness of ICM in improving selected diabetic outcomes. However, there is a lack of research that specifically demonstrates ICM’s impact and costs on DR treatment compliance, especially among patients in resource-poor settings. HKI’s initial assessments in this area have demonstrated the efficacy of ICM, but it is necessary to more rigorously evaluate this model and its impact on patient behavior and knowledge. This project is innovative since it seeks to identify and define the specific details that make ICM an effective approach for this population so that a replicable model can be successfully brought to scale in order to prevent unnecessary vision loss due to DR. Innovation Fund Project Proposal

3. Detailed Innovation Project Information 3.6. Planning for sustainability Screening for and treating DR is highly cost-effective. However, individuals rarely notice an immediate benefit from DR treatments since they are aimed at preserving vision, not improving it. This poses important obstacles to sustainability as patients may not be motivated to seek repeated treatment and poorer patients may not be willing to expend scarce resources for ongoing care in order to stop further vision loss. To address this issue, HKI has developed an educational model that seeks to improve patient adherence to DR treatment. Through this project, HKI will further establish an ICM to help patients overcome barriers to receiving needed exams and treatments once they have screened positive. We will evaluate the model’s cost-effectiveness and impact in improving patient compliance to DR treatment. It is expected that by increasing the number of patients who receive (and pay for) DR treatment, health facilities will ultimately see the financial benefit of initial investment in ICM.

Importantly, primary management and financial support for the DR screening and treatment program in CEITC and Feni will transition to the facilities themselves six months into the project (March 2013). As facilities themselves will already be managing screening and treatment services, they will be well-positioned to adopt the ICM component at the end of the project once its benefit for both patients and the facilities is demonstrated. Additionally, HKI’s strong partnerships with the Ministry of Health and Family Welfare (MoHFW) and national organizations (DAB and BIRDEM) offer opportunities to promote the impact of the ICM model. These partners will be engaged in the project from the outset, and we anticipate that the model, once supported with rigorous data on the effectiveness of ICM and the potential for cost recovery, will be of interest to other organizations involved in DR treatment and screening services. Innovation Fund Project Proposal

4. Project Management & Required Resources The project requires a total of £74,538 (approximately £47,426 in year one and £27,110 in year two, which slightly differs from the total due to a currency conversion). This 4.1. Financial investment is in addition to costs (salaries and equipment) requirements paid by an existing HKI project in the first six months, and CEITC and FDH staff who will conduct screening and treatment services throughout the project.

Six months into the project (March 2013), management of the DR screening, referral and treatment services will transition to full management by CEITC and FDH. This not only increases 4.2. Partner resources the project’s overall cost-effectiveness, it also bodes well for available sustainability as ICM will be the only external “add on” to a fully localized, but highly innovative, strategy to identify and treat DR.

The project will be directly managed by a project coordinator based at CEITC and hired by HKI. The project coordinator will directly oversee two health educators engaged in ICM and will be the primary point person for data collection and liaison with the project partners. The project coordinator will report to 4.3. Management of HKI’s program manager, based in Dhaka and directly the project overseen by HKI’s country director. The country director will liaise with partners, including the MoHFW, to garner interest in the project and support for scaling up results. Research activities will be managed by HKI’s senior ophthalmologist, based at Johns Hopkins University, and supported by HKI staff in Bangladesh, including the Senior Manager, M&E. Innovation Fund Project Proposal

4. Project Management & Required Resources

4.4. Implementation See attached implementation worksheet. plan

4.5. M&E plan The following data will be collected at baseline: contact information of the study subject and a second contact, age, gender, educational level, type of diabetes, years since diagnosis, presenting visual acuity, history of any laser or other treatment for DR, status of DR based on two-field retinal photographs, and knowledge of diabetes and DR from a standard questionnaire that has already been used in previous research. DR examinations by ophthalmologists and DR treatments of screened positive patients will be the main outcome measure. Knowledge of diabetes/DR will be measured using forms that have already been pilot-tested on the proposed study population.

For Objective 1 (Effectiveness), we will analyze group differences in attaining follow-up with an ophthalmologist after a positive DR screening and obtaining treatment when recommended. We will also determine knowledge of the subjects about DR over time. The groups will be compared for baseline differences in the following parameters potentially important in compliance with DR screening: age, gender, educational level, type of diabetes, baseline severity of diabetes (represented by years since diagnosis and severity of DR), presenting vision in the better eye and knowledge of DR at baseline. Logistic regression modelling in SAS will be used to adjust the primary outcome of attending DR examinations for any baseline differences as noted above. For secondary outcomes with continuous distribution, linear Innovation Fund Project Proposal

4. Project Management & Required Resources regression models will be used in similar fashion to adjust for relevant baseline differences between groups. Analyses will be carried out by a statistician at Johns Hopkins University familiar with analysis of ophthalmic data. At endline, an additional survey will be conducted among randomly selected patients from the treatment and control groups to identify supplemental information which may help explain variations in ICM’s effectiveness (for example the distance from patients’ residence to the treatment center, perceived barriers to care and family support). The survey will also identify additional positive outcomes from ICM as reported by patients, such as improvements in diet, exercise and foot care.

For Objective 2 (Cost of intervention per completed exam and completed treatment), we will analyze cost per additional eye exam attended and cost per additional treatment received. 1 Wild SH, e al. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030, Diabetes Care 2004;27:1047-1153. 2 Garg S, Davis R. Diabetic Retinopathy Screening Update. Clinical Diabetes 2009;27(4):140-145. 3 The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993;329:977-986. 4 UK Prospective Diabetes Study Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853. 5 Stratton IM,et al. UKPDS 50: risk factors for incidence and progression of retinopathy in type II diabetes over 6 years from diagnosis. Diabetologia. 2001;44:156-163. 6 Adler AI,et al. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36). BMJ. 2000;321:412-419. 7 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317:703-713. 8 Chew EY,.et al. Association of elevated serum lipid levels with retinal hard exudate in diabetic retinopathy. Arch Ophthalmol. 1996;114:1079-1084. 9 ETDRS Research Group. Early photocoagulation for diabetic retinopathy. Ophthalmology 1991;98:766-85. 10 Javitt JC, et al. Cost-effectiveness of detecting and treating diabetic retinopathy. Ann Intern Med. 1996;124:164-169. 11 Vijan S, et al. Cost-utility analysis of screening intervals for diabetic retinopathy in patients with type 2 diabetes mellitus. JAMA. 2000;283:889-896. 12 Taylor CB, et al. Evaluation of a nurse-care management system to improve outcomes in patients with complicated diabetes. DiabetesCare. 2003;26(4):1058–1063. 13 Yong A, Power E, Gill G. Improving glycaemic control of insulin-treated diabetic patients—a structured audit of specialist nurse intervention. J Clin Nurs. 2002;11(6):773–776. 14 Ingersoll S, et al. Nurse care coordination for diabetes: a literature review and synthesis. J Nurse Care Qual 2005;20:208-214. 15 Svoren B, et al. Reducing adverse outcomes in youths with Type I Diabetes: A randomized controlled trial. Pediatrics 2003;112;914-922. 16 Mullen BA, et al. Diabetes nurse management: an effective tool. J Am Acad Nurse Pract 2006;18:22-30. 17 New JP, et al. Specialist nurse-led intervention to treat and control hypertension and hyperlipidemia in diabetes (SPLINT): a randomized controlled trial. Diabetes Care. 2003;26(8):2250–2255. 18 Gary TL, et al. Randomized controlled trial of the effects of nurse case manager and community health worker interventions on risk factors for diabetes-related complications in urban African Americans. Prev Med. 2003;37(1):23– 32. 19 Kobb R, Hoffman N, Lodge R, et al. Enhancing elder chronic care through technology and care coordination: report from a pilot. Telemed J E Health. 2003;9(2):189–195. 20 Thiebaud P, et al. Impact of disease management on utilization and adherence with drugs and tests. Diabetes Care 2008;31:1717-1722. 21 Schoenfeld ER, et al. Baseline findings from the diabetic retinopathy awareness program. Ophthalmology 2001;108:563–571. 22 Paz SH, et al. Noncompliance with vision care guidelines in Latinos with Type 2 diabetes mellitus. Ophthalmology 2006;113:1372–1377 23 Lewis K, et al. A qualitative study in the United Kingdom of factors influencing attendance by patients with diabetes at ophthalmic outpatient clinics. Ophthalmic Epidemiol 2007;14:375-80. 24 Walker EA et al. Incentives and barriers to retinopathy screening among African Americans with diabetes. J Diabetes Complications 1997;11:298-306. 25 Helen Keller International. Diabetic retinopathy education treatment and training (DRETT) knowledge attitudes and practices survey results. Available at: http://www.hki.org/research/HKI%20Bulletin %20Bangladesh%20June%2010%20Diabetic%20Retinopathy%20Education.pdf. Accessed June 18, 2012.