scholarly journals Promoting the adoption of local governmental policy on the reimbursement of chronic disease medicines (PAPMed): study protocol of a field-based cluster randomized trial in rural Nantong, China

Author(s):  
Zhengting He ◽  
Xin Cao ◽  
Duan Zhao ◽  
Zemin Tang ◽  
Jiayu Zhao ◽  
...  

Abstract Background Among rural Chinese patients with non-communicable diseases (NCDs), low socioeconomic status increases the risk of developing NCDs and associated financial burdens in paying for medicines and treatments. Despite the chronic disease medicine reimbursement policy of the local government in Nantong City, China, various barriers prevent patients from registering for and benefitting from the policy. This study aims to develop a behavior-science based intervention program for promoting the adoption of the policy and to evaluate the effectiveness of the program compared with usual practices. Methods Barriers and opportunities affecting stakeholders in adopting the policy were identified through contextual research and summarized through behavior mapping. The intervention targets these barriers and opportunities through behavior science theories and will be evaluated through a 6-month cluster randomized controlled trial in Tongzhou District, Nantong, China. A total of 30 villages from two townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual practices). Village doctors in the intervention arm (1) receive systematic training on policy details, registration procedures, and intervention protocol, (2) promote the policy and encourage registration, (3) follow-up with patients in the first, third and sixth month after the intervention, and (4) receive financial incentives based on performance. The primary outcome is policy registration rate and the secondary outcomes include the number of patients registering for the policy, medical costs saved, frequency of village doctor visits, and health conditions such as blood pressure and glucose levels. Discussion This study is one of very few that aims to promote adoption of NCDs outpatient medication reimbursement policies, and the first study to evaluate the impact of these policies on patients’ financial and physical wellbeing in China. The simple, feasible, and scalable intervention is designed based on the theories of behavior science and are applicable to similar low-income regions nationwide where outpatient medical costs remain a financial burden for patients. Trial registration: ClinicalTrials.gov, NCT04731194, registered on 29 January 2021, https://clinicaltrials.gov/ct2/show/NCT04731194?term=PAPMed&draw=2&rank=1; Chinese Clinical Trial Registry, ChiCTR2100042152, registered on 14 January 14 2021, http://www.chictr.org.cn/showproj.aspx?proj=65987.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18567-e18567
Author(s):  
Ahmad Hamad ◽  
Mariam Eskander ◽  
Yaming Li ◽  
Oindrila Bhattacharyya ◽  
James L Fisher ◽  
...  

e18567 Background: The Affordable Care Act (ACA) increased insurance coverage for low-income individuals, which should potentially lead to better access to care and improved oncological outcomes. This study seeks to evaluate the impact of Medicaid expansion (ME) on care for pancreatic ductal adenocarcinoma (PDAC). Methods: Patients who were uninsured or on Medicaid and diagnosed with PDAC between 2004 and 2017 were queried from the National Cancer Database (NCDB). Two different expansion cohorts were included: early expansion states and 2014 expansion states. For early expansion states, the time period of pre-expansion was 2004-2009 and post-expansion was 2010-2017. As for the 2014 expansion states, the pre-expansion period was from 2004-2013 and post-expansion period was from 2014-2017. Patients in non-expansion states formed the control group. A difference-in-difference (DID) analysis was used to assess the association of ME with stage of diagnosis, treatment and survival for each expansion cohort. Results: In both early and January 2014 expansion states, there was an increase in overall Medicaid coverage (Early: DID = 0.29, 2014: DID = 0.37; P < 0.001), in particular for non-Hispanic Black and Hispanic Black patients (Non-Hispanic Black: Early: DID = 0.11, 2014: DID = 0.11; P < 0.001, Hispanic-Black: 2014: DID = 0.20; P = 0.003). There were no differences in early stage diagnosis (Early: DID = 0.02, 2014: DID = -0.02; P > 0.05). There was an increase in the number of patients receiving surgery (Early: DID = 0.05; P = 0.001, 2014: DID = 0.03; P = 0.029) but no difference in time to surgery among patients receiving surgery upfront (Early: DID = 1.75, 2014: DID = 0.38; P > 0.05). There was no difference in 30-day readmission post-surgery (Early: DID = 0.003; 2014: DID = -0.00007; P > 0.05) or 90-day mortality (Early: DID = -0.007, 2014: DID = -0.035; P > 0.05). Moreover, there was no difference in receipt of chemotherapy (Early: DID = 0.01, 2014: DID = 0.005; P > 0.05) or time to chemotherapy for patients receiving neoadjuvant chemotherapy (Early: Early: DID = 9.62, 2014: DID = 0.01; P > 0.05). Finally, there was no difference in receipt of palliative care among stage IV patients in both cohorts (Early: DID = -0.004, 2014: DID = 0.004; P > 0.05). Conclusions: This study suggests that after ME, PDAC patients were more likely to be insured and had increased access to surgical care. Future, studies should evaluate the implications of improved surgical access on clinical outcomes such as mortality.


Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G. Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  

AbstractIntroductionInconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norms-centric behavior change interventions to increase toilet use in low-income settings. This protocol details the rationale and design of an ex-ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norms-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India.Methods and AnalysisFollowing two years of formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “Our wellbeing”). The multi-level intervention aims to shift collective beliefs by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to build, consistently use and maintain their toilets. This trial includes 76 wards in Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining serve as counterfactuals. During baseline and endline (conducted one year after the initiation of intervention) assessments, we collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, wellbeing outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We will also conduct a process evaluation to understand the extent to which the intervention was implemented, as designed.Ethics and DisseminationThe study protocol has been reviewed and approved by the ethics board at the University of Pennsylvania, USA and the Catalyst Foundation, India. Research findings will be disseminated through open access peer reviewed publications and presentations to stakeholders, government officials and conferences.Trial registrationNCT04269824.Strengths and limitations of this studyThis ex-ante, parallel cluster randomized trial assesses the impact of a norm-centric behavior change intervention strategy to improve sanitation practices. These behavior change techniques are novel to the sanitation sector but has been effective in changing a variety of behaviors, such as water use, drinking behavior, and energy consumption.The study outcomes include health, wellbeing outcomes, and a careful assessment of changes in social beliefs, expectations, and social determinants of collective sanitation behaviors.This study is being rolled out during the ongoing COVID-19 pandemic. This can potentially impact the effectiveness of this intervention package that uses community and network-based group activities. However, through a detailed process monitoring and evaluation we will be able to assess the impact on delivery, and subsequent behavior change in this unique setting.


2020 ◽  
Author(s):  
Sania Ashraf ◽  
Cristina Bicchieri ◽  
Maryann G Delea ◽  
Upasak Das ◽  
Kavita Chauhan ◽  
...  

BACKGROUND Inconsistent toilet usage is a continuing challenge in India. Despite the impact of social expectations on toilet usage, few programs and studies have developed theoretically grounded norm-centric behavior change interventions to increase toilet use in low-income settings. OBJECTIVE The objective of this paper is to detail the rationale and design of an ex ante, parallel cluster-randomized trial evaluating the impact of a demand-side, norm-centric behavior change intervention on exclusive toilet use and maintenance in peri-urban Tamil Nadu, India. METHODS Following formative research, we developed an evidence-based norm-centric behavior change intervention called Nam Nalavazhvu (Tamil for “our well-being”). The multilevel intervention aims to improve toilet usage by shifting empirical expectations or beliefs about other relevant people’s sanitation practices. It also provides action-oriented information to aid individuals to set goals and overcome barriers to own, consistently use, and maintain their toilets. This trial includes 76 wards in the Pudukkottai and Karur districts, where half were randomly assigned to receive the intervention and the remaining served as counterfactuals. RESULTS We enrolled wards and conducted a baseline survey among randomly selected individuals in all 76 wards. The 1-year behavior change intervention is currently ongoing. At the endline, we will collect relevant data and compare results between study arms to determine the impacts of the Nam Nalavazhvu intervention on sanitation-related behavioral, health, and well-being outcomes and potential moderators. This study is powered to detect differences in the prevalence of exclusive toilet use between study arms. We are also conducting a process evaluation to understand the extent to which the intervention was implemented as designed, given the special pandemic context. CONCLUSIONS Findings from this trial will inform norm-centric behavior change strategies to improve exclusive toilet usage. CLINICALTRIAL ClinicalTrials.gov NCT04269824; https://www.clinicaltrials.gov/ct2/show/NCT04269824 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24407


2019 ◽  
pp. 1-13
Author(s):  
Lydia E. Pace ◽  
Jean Marie Vianney Dusengimana ◽  
Lawrence N. Shulman ◽  
Lauren E. Schleimer ◽  
Cyprien Shyirambere ◽  
...  

PURPOSE Feasible and effective strategies are needed to facilitate earlier diagnosis of breast cancer in low-income countries. The goal of this study was to examine the impact of health worker breast health training on health care utilization, patient diagnoses, and cancer stage in a rural Rwandan district. METHODS We conducted a cluster randomized trial of a training intervention at 12 of the 19 health centers (HCs) in Burera District, Rwanda, in 2 phases. We evaluated the trainings’ impact on the volume of patient visits for breast concerns using difference-in-difference models. We used generalized estimating equations to evaluate incidence of HC and hospital visits for breast concerns, biopsies, benign breast diagnoses, breast cancer, and early-stage disease in catchment areas served by intervention versus control HCs. RESULTS From April 2015 to April 2017, 1,484 patients visited intervention HCs, and 308 visited control HCs for breast concerns. The intervention led to an increase of 4.7 visits/month for phase 1 HCs ( P = .001) and 7.9 visits/month for phase 2 HCs ( P = .007) compared with control HCs. The population served by intervention HCs had more hospital visits (115.1 v 20.5/100,000 person-years, P < .001) and biopsies (36.6 v 8.9/100,000 person-years, P < .001) and higher breast cancer incidence (6.9 v 3.3/100,000 person-years; P = .28). The incidence of early-stage breast cancer was 3.3 per 100,000 in intervention areas and 0.7 per 100,000 in control areas ( P = .048). CONCLUSION In this cluster randomized trial in rural Rwanda, the training of health workers and establishment of regular breast clinics were associated with increased numbers of patients who presented with breast concerns at health facilities, more breast biopsies, and a higher incidence of benign breast diagnoses and early-stage breast cancers.


2021 ◽  
Author(s):  
Rachel Hurst ◽  
Kendra Liljenquist ◽  
Sarah J Lowry ◽  
Peter Szilagyi ◽  
Kevin A. Fiscella ◽  
...  

BACKGROUND The Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) intervention was created as a team-based approach to well-child care (WCC) that relies on a health educator ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services. OBJECTIVE To evaluate the impact of PARENT using a cluster randomized controlled trial (RCT). METHODS This study will test the effectiveness of PARENT at 10 clinical sites of two federally-qualified health centers (FQHCs) in Tacoma, WA and Los Angeles, CA. We are conducting a cluster RCT that includes 940 families with a child ≤ 12 months old at the time of the baseline survey. Parents will be followed up at 6 months and 12 months post-enrollment. The Parent Coach, the main element of PARENT, provides anticipatory guidance, psychosocial screening/referral, and developmental and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by parent-focused pre-visit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical exam and any concerns that require a clinician’s attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health–related information recommended by Bright Futures national guidelines. We will examine parent-reported quality of care (receipt of nationally-recommended WCC services, family-centeredness of care, and parent experiences of care) and healthcare utilization (WCC, urgent care, emergency department [ED], and hospitalizations), conduct a cost/cost-offset analysis, and conduct a separate Time Motion Study to assess clinician time allocation to assess efficiency. We will also collect data on exploratory measures of parent and parenting-focused outcomes. Our primary outcomes are receipt of anticipatory guidance and ED utilization. RESULTS Participant recruitment began in March 2019 and will continue through June 2021. After recruitment concludes, 6 and 12 month follow up surveys will be completed. Thus far, over 500 participants have been enrolled. CONCLUSIONS This large pragmatic trial of PARENT in partnership with FQHCs will assess its utility as an evidence-based and financially sustainable model for the delivery of preventive care services to children in low-income communities. CLINICALTRIAL ClinicalTrials.gov NCT03797898


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Jane Mumma ◽  
Sheillah Simiyu ◽  
Evalyne Aseyo ◽  
John Anderson ◽  
Alexandra Czerniewska ◽  
...  

Abstract Background Symptomatic and asymptomatic enteric infections in early childhood are associated with negative effects on childhood growth and development, especially in low and middle-income countries, and food may be an important transmission route. Although basic food hygiene practices might reduce exposure to faecal pathogens and resulting infections, there have been few rigorous interventions studies to assess this, and no studies in low income urban settings where risks are plausibly very high. The aim of this study is to evaluate the impact of a novel infant food hygiene intervention on infant enteric infections and diarrhoea in peri-urban settlements of Kisumu, Kenya. Methods This is a cluster randomized control trial with 50 clusters, representing the catchment areas of Community Health Volunteers (CHVs), randomly assigned to intervention or control, and a total of 750 infants recruited on a rolling basis at 22 weeks of age and then followed for 15 weeks. The intervention targeted four key caregiver behaviours related to food hygiene: 1) hand washing with soap before infant food preparation and feeding; 2) bringing all infant food to the boil before feeding, including when reheating or reserving; 3) storing all infant food in sealed containers; and, 4) using only specific utensils for infant feeding which are kept separate and clean. Results The primary outcome of interest is the prevalence of one or more of 23 pre-specified enteric infections, determined using quantitative real-time polymerase chain reaction for enteric pathogen gene targets. In addition, infant food samples were collected at 33 weeks, and faecal indicator bacteria (Enterococcus) isolated and enumerated to assess the impact of the intervention on infant food contamination. Conclusion To our knowledge this is the first randomized controlled trial to assess the effect of an infant food hygiene intervention on enteric infections in a high burden, low income urban setting. Our trial responds to growing evidence that food may be a key pathway for early childhood enteric infection and disease and that basic food hygiene behaviours may be able to mitigate these risks. The Safe Start trial seeks to provide new evidence as to whether a locally appropriate infant food hygiene intervention delivered through the local health extension system can improve the health of young children. Trial registration The trial was registered at clinicaltrial.gov on March 16th 2018 before enrolment of any participants (https://clinicaltrials.gov/ct2/show/NCT03468114).


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
A. K. Lofters ◽  
M. A. O’Brien ◽  
R. Sutradhar ◽  
A. D. Pinto ◽  
N. N. Baxter ◽  
...  

Abstract Background The BETTER (Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Primary Care) intervention was designed to integrate the approach to chronic disease prevention and screening in primary care and demonstrated effective in a previous randomized trial. Methods We tested the effectiveness of the BETTER HEALTH intervention, a public health adaptation of BETTER, at improving participation in chronic disease prevention and screening actions for residents of low-income neighbourhoods in a cluster randomized trial, with ten low-income neighbourhoods in Durham Region Ontario randomized to immediate intervention vs. wait-list. The unit of analysis was the individual, and eligible participants were adults age 40–64 years residing in the neighbourhoods. Public health nurses trained as “prevention practitioners” held one prevention-focused visit with each participant. They provided participants with a tailored prevention prescription and supported them to set health-related goals. The primary outcome was a composite index: the number of evidence-based actions achieved at six months as a proportion of those for which participants were eligible at baseline. Results Of 126 participants (60 in immediate arm; 66 in wait-list arm), 125 were included in analyses (1 participant withdrew consent). In both arms, participants were eligible for a mean of 8.6 actions at baseline. At follow-up, participants in the immediate intervention arm met 64.5% of actions for which they were eligible versus 42.1% in the wait-list arm (rate ratio 1.53 [95% confidence interval 1.22–1.84]). Conclusion Public health nurses using the BETTER HEALTH intervention led to a higher proportion of identified evidence-based prevention and screening actions achieved at six months for people living with socioeconomic disadvantage. Trial registration NCT03052959, registered February 10, 2017.


2018 ◽  
Vol 68 (10) ◽  
pp. 1665-1674 ◽  
Author(s):  
Richard E Sanya ◽  
Gyaviira Nkurunungi ◽  
Remy Hoek Spaans ◽  
Margaret Nampijja ◽  
Geraldine O’Hara ◽  
...  

Abstract Background The prevalence of allergy-related diseases is increasing in low-income countries. Parasitic helminths, common in these settings, may be protective. We hypothesized that intensive, community-wide, anthelminthic mass drug administration (MDA) would increase allergy-related diseases, while reducing helminth-related morbidity. Methods In an open, cluster-randomized trial (ISRCTN47196031), we randomized 26 high-schistosomiasis-transmission fishing villages in Lake Victoria, Uganda, in a 1:1 ratio to receive community-wide intensive (quarterly single-dose praziquantel plus albendazole daily for 3 days) or standard (annual praziquantel plus 6 monthly single-dose albendazole) MDA. Primary outcomes were recent wheezing, skin prick test positivity (SPT), and allergen-specific immunoglobulin E (asIgE) after 3 years of intervention. Secondary outcomes included helminths, haemoglobin, and hepatosplenomegaly. Results The outcome survey comprised 3350 individuals. Intensive MDA had no effect on wheezing (risk ratio [RR] 1.11, 95% confidence interval [CI] 0.64–1.93), SPT (RR 1.10, 95% CI 0.85–1.42), or asIgE (RR 0.96, 95% CI 0.82–1.12). Intensive MDA reduced Schistosoma mansoni infection intensity: the prevalence from Kato Katz examinations of single stool samples from each patient was 23% versus 39% (RR 0.70, 95% CI 0.55–0.88), but the urine circulating cathodic antigen test remained positive in 85% participants in both trial arms. Hookworm prevalence was 8% versus 11% (RR 0.55, 95% CI 0.31–1.00). There were no differences in anemia or hepatospenomegaly between trial arms. Conclusions Despite reductions in S. mansoni intensity and hookworm prevalence, intensive MDA had no effect on atopy, allergy-related diseases, or helminth-related pathology. This could be due to sustained low-intensity infections; thus, a causal link between helminths and allergy outcomes cannot be discounted. Intensive community-based MDA has a limited impact in high-schistosomiasis-transmission fishing communities, in the absence of other interventions. Clinical Trials Registration ISRCTN47196031.


PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242407
Author(s):  
Nadereh Pourat ◽  
Brenna O’Masta ◽  
Xiao Chen ◽  
Connie Lu ◽  
Weihao Zhou ◽  
...  

Background The opioid epidemic and subsequent mortality is a national concern in the U.S. The burden of this problem is disproportionately high among low-income and uninsured populations who are more likely to experience unmet need for substance use services. We assessed the impact of two Health Resources and Services Administration (HRSA) substance use disorder (SUD) service capacity grants on SUD staffing and service use in HRSA -funded health centers (HCs). Methods and findings We conducted cross-sectional analyses of the Uniform Data System (UDS) from 2010 to 2017 to assess HC (n = 1,341) trends in capacity measured by supply of SUD and medication-assisted treatment (MAT) providers, utilization of SUD and MAT services, and panel size and visit ratio measured by the number of patients seen and visits delivered by SUD and MAT providers. We merged mortality and national survey data to incorporate SUD mortality and SUD treatment services availability, respectively. From 2010 to 2015, 20% of HC organizations had any SUD staff, had an average of one full-time equivalent SUD employee, and did not report an increase in SUD patients or SUD services. SUD capacity grew significantly in 2016 (43%) and 2017 (22%). MAT capacity growth was measured only in 2016 and 2017 and grew by 29% between those years. Receipt of both supplementary grants increased the probability of any SUD capacity by 35% (95% CI: 26%, 44%) and service use, but decreased the probability of SUD visit ratio by 680 visits (95% CI: -1,013, -347), compared to not receiving grants. Conclusions The significant growth in HC specialized SUD capacity is likely due to supplemental SUD-specific HRSA grants and may vary by structure of grants. Expanding SUD capacity in HCs is an important step in increasing SUD access for low income and uninsured populations broadly and for patients of these organizations.


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