Treatment Trials

16 Clinical Trials for Various Conditions

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COMPLETED
Increasing Patient Engagement in the Annual Well Visits Program
Description

NYU Langone Health calls patients to remind them to schedule their annual well-health appointments (including annual well visit, mammograms, etc.). The proposed study will test different iterations of the call script with the goal of increasing call completion rate and the number of scheduled appointments within an appropriate timeframe.

COMPLETED
Precision Nudging Drives Wellness Visit Attendance at Scale
Description

The purpose of the present randomized controlled trial is to explore the effectiveness of a 12-month well woman digital health intervention leveraging Precision Nudging - the application of behavioral science and reinforcement learning to create individualized, tailored health messaging at scale that matches the right message to the right person at the right time - in promoting behavior change. Specifically, it is hypothesized that scaling behavioral science through reinforcement learning will be more effective at motivating participants to engage with well woman messages and to schedule and to attend a well woman visit compared to a standard of care message.

ENROLLING_BY_INVITATION
A Trial of Text-Message-Based Engagement for Well-Child Visits
Description

The goal of this clinical trial is to evaluate the effectiveness of different outreach strategies in closing HEDIS gaps for Well-Child Visits (WCV) in children aged 0-21 years. The main questions it aims to answer are: Does automated SMS outreach improve the rate of completed Well-Child Visits compared to traditional passive outreach? Does the combination of automated SMS and appointment scheduling assistance lead to higher completion rates than automated SMS alone? Researchers will compare three groups to see if the different outreach strategies have varying effects on WCV completion rates: Control Group: Participants will receive traditional passive outreach (current standard practice). Automated SMS Group: Participants will receive standardized SMS messages to remind them of their Well-Child Visits. Automated SMS + Scheduling Assistance Group: Participants will receive SMS messages along with proactive assistance in scheduling their appointments. Participants will: Be randomized into one of the three study groups. Receive outreach according to their group assignment. Have their appointment scheduling and attendance tracked. Contribute data that will help evaluate the effectiveness of each outreach strategy in closing HEDIS gaps for Well-Child Visits. This study aims to optimize outreach methods to improve healthcare delivery and preventive care adherence for pediatric populations.

ENROLLING_BY_INVITATION
Comparing Technological and Relational Approaches to Support Families After a Missed Well Child Visit
Description

The overall goal of this study is to compare the effectiveness of different follow up protocols for scheduled but not attended ("no-show") Well-Child Visits, relative to care-as-usual (no standardized or typical follow up procedure). The main goals are to: * Demonstrate feasibility of merging a new referral protocol following Well-Child visit no-show into existing health system Community Health Worker resources. * Compare Well-Child Visit attendance following no-show between patients randomized to care-as-usual (comparison), text message only (low-touch intervention), and community health worker outreach (high-touch intervention) groups. * Define the costs and cost-effectiveness of different follow-up protocols.

COMPLETED
Twilio Well-Child Visit Pilot Open Trial
Description

This project will use Twilio as a platform for a text messaging campaign to implement timely follow up with parents/guardians of children ages 0 to 17 years who have no-showed for WCVs. The first phase of the study will be an open trial to assess feasibility and acceptability of three different reminder messages, analyze preliminary data, and collect feedback from participants using interviews to identify the top one or two performing messages. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal. These findings will be used to conduct the second phase of the study, a randomized controlled trial.

COMPLETED
Well-Child Visit Trial
Description

This project will use Twilio as a platform for a text messaging campaign to implement timely follow up with parents/guardians of children ages 0 to 17 years who have missed Well Child Visits (WCVs). The first phase of this project was an open trial. This second phase of the study will be a randomized controlled trial (RCT) to randomly assign parents/guardians of children who missed a WCV to an intervention condition or no intervention, and assess reasons for missed visits and experiences at last visit. Parents/guardians will receive text messages notifying them of missed visits and prompting them to reschedule, as well as inviting them to complete an online survey. Each reminder message will at minimum direct parents/guardians to reschedule by phone or by the patient portal. Outcomes of the follow-up campaign will be evaluated, including rescheduled visits within 6 weeks of missed visit and attendance at rescheduled visit. This aim will incorporate patient Electronic Health Record (EHR) data into mixed effects logistic regressions for the primary study outcomes.

COMPLETED
Well-child Visit Video Project
Description

The purpose of this study is to determine if incorporating videos on the importance of minimizing infant sugar-containing beverage (SCB) consumption into well-child visit protocols increases parents' SCB-related knowledge and their compliance with related early feeding recommendations. The study also aims to determine whether these videos increase the frequency and quality of the SCB-related reduction education and counseling provided to parents during well-child visits.

Conditions
COMPLETED
Use of a Reproductive Life Planning Tool at the Pediatric Well-Baby Visit With Postpartum Women
Description

Improved access to timely health care and contraception in the postpartum (PP) period is needed to reduce unintended pregnancies and help women achieve desired birth spacing. While the routine 6-week visit has historically been considered the place for women to discuss and receive contraception, many women, particularly low-income women, do not attend the postpartum visit. A novel approach to increasing receipt of PP care and contraception is the adoption of a reproductive life planning tool. Explorations of the use of a self-administered Reproductive Life Plan Tool (RLPT) by pediatricians in the context of the Well-Baby Visit (WBV) with postpartum mothers, holds great promise. The objective of this study is to determine whether use of a simple self-administered Reproductive Life Plan Tool at the 2-month WBV increases the proportion of postpartum women receiving woman's health care and contraception at 6-months PP, compared to women not exposed to such an intervention. The two specific aims of the project are: 1) To determine if introducing a self-administered Reproductive Life Planning Tool (RLPT) with postpartum mothers during the 2-month WBV will increase the proportion of women receiving a well-woman primary care health visit by 6 months postpartum; and if introducing a self-administered Reproductive Life Planning Tool (RLPT) will increase utilization rates of contraception by 6 months postpartum. 2) To assess patient-, provider-, and systems-level barriers and facilitators to integrating a self-administered Reproductive Life Planning Tool (RLPT) designed to facilitate referral of postpartum women for primary well-woman care in the context of a pediatric clinic. The investigators hypothesize that exposure to a self-administered RLPT combined with a conversation with a pediatrician during a 2-month WBV will increase use of well-woman primary health care during the postpartum period as well as receipt of contraception, by 6-months postpartum. If successful, the results of this study have great potential to inform clinical and public health practice to increase women's use of health care and contraception in the postpartum period.

COMPLETED
Family Nutrition Physical Activity Tool Use During Well Child Visits
Description

The main aim of the study would be to examine the effect of using a health behavior screening tool and a brief patient centered conversation on health behavior goal setting during well-child visits.

Conditions
RECRUITING
Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement
Description

The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.

WITHDRAWN
Diaper Distribution in Low-Income Infants
Description

The adverse effects of poverty at the individual, family, and community level on health outcomes for children are well-established. Material hardship, defined as difficulty meeting basic needs such as food, housing, and consumer goods, has been shown to have negative physical and emotional effects on both children and their parents. Diaper need, defined as a lack of sufficient supply of clean and dry diapers, is an example of a material hardship. Community-based studies of low-income families have demonstrated that between 30-50% of caregivers of young children expressed diaper need. Some of these caregivers with diaper need reported reducing diaper changes, a practice that is associated with diaper dermatitis and urinary tract infections (UTIs). These community-based studies have also shown that diaper need is associated with maternal depression and parental stress, even after adjusting for demographic factors and food insecurity. Diaper need may be a specific modifiable marker of caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot, randomized controlled trial of low-income newborns and their caregivers the investigators will test the feasibility of supplying diapers as an intervention to infants in low-income families and assess if it can improve both a child's health and their caregiver's overall health.

COMPLETED
Anticipatory Guidance to Prevent Childhood Obesity
Description

The purpose of this pilot project is to test anticipatory guidance, which is information given to families during a well child visit to prevent obesity during childhood. The objectives were to compare two styles of anticipatory guidance during the first year of life, maternal focused and infant focused, versus usual care and determine which style, if any, showed the most ideal infant feeding behaviors at age 1 year and to see if there were any differences in infant weight for height at one year of age. The investigators hypothesized that mothers who received the maternal focused anticipatory guidance (which gave information on eating family meals, not having tv on during meals, and maternal nutrition) would actually have the best infant feeding behaviors and weight for height of infants at one year.

COMPLETED
Assisting Low-Income Families at Pediatric Well-Child Care Visits
Description

The objective of this study is to evaluate the impact and feasibility of a practice-based intervention on the discussion and referral of family psychosocial topics at well-child care visits at a medical home for low-income children.

COMPLETED
Reducing Socioeconomic Disparities in Health at Pediatric Visits
Description

This research project is aimed to assess the effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the English language ) on child health.

COMPLETED
Addressing Low-Income Families' Basic Social Needs at Pediatric Visits
Description

This research project is aimed to address low-income families' basic social needs (housing, food, employment, education, childcare, utilities) within the context of pediatric primary care. This project builds upon the PI's prior study at Hopkins which demonstrated a positive impact of a similar intervention on pediatric residents' screening and referral to community agencies. This study will specifically test whether a further strengthened intervention--Basic Needs Surveillance (BNS) protocol-- can lead to greater maternal enrollment in community resources and receipt of eligible benefits. In addition, we will measure the intervention's impact on maternal well-being, and compliance with well-child care (WCC) visits. The project will take place at eight community health centers in the Greater Boston Area. The centers will be randomized to either an intervention or control site. Mothers who bring their infant in for a WCC visit from birth to 6 months will be eligible. They will be followed until their child is one year of age. Study subjects will complete two self-administered surveys (baseline, follow-up), and one brief telephone interview (when their infant is 9 months old). Pediatric providers will also be subjects; and will fill out a demographic questionnaire at the time of enrollment. The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers. Families attending the control health centers will receive standard of care. Enrolled mothers will be offered the intervention at the end of the 12-month follow-up interview. When follow-up data collection is complete, the PI will offer the control sites the opportunity to implement the BNS protocol.

COMPLETED
Northwell Health Visits: A Family Connects Pilot Implementation at Northwell Health
Description

Northwell Health Visits (NHV) is a three year pilot replication of the evidence-based model, Family Connects, which is a brief universal Nurse Practitioner home visiting program for new mothers and their infants. We seek to compare outcomes among mothers and infants enrolled in the NHV enhanced intervention arm, those enrolled in the NHV screening-only arm, and those in the control arm. NHV will follow a three- armed randomized control trial design.