Conversational IT for Better, Safer Pediatric Primary Care

Study Overview
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Brief Summary
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Interactive telephony technologies offer a potentially highly effective, patient-centered communication modality by guiding parents at home through interactive discussions that can gather information and actively reinforce recommendations and treatments. Interactive telephony systems are particularly well suited for use in vulnerable populations since access to the telephone is nearly universal, and the system does not rely on reading printed text. The investigators propose to develop and evaluate an integrated patient-centered health information system, the Personal Health Partner (PHP). The PHP will use fully automated, interactive, conversations to gather personal health data and counsel parents before scheduled visits, exchange that data with the child's primary care clinician via the electronic health record (EHR), and offer personalized follow-up assessment and counseling after visits. The information technology-based approach to be evaluated in this project will link parents and children outside the clinical setting with their primary care center and will offer comprehensive assessments AND counseling to reinforce and support parental behavior change.

Detailed Description
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A large gap exists between what is recommended for effective primary care of children and what actually takes place in pediatric primary care settings, especially in the areas of preventive care. Furthermore, although medication management (safety and effectiveness) issues have emerged as an important factor for children, little is known about how medication is actually used by families at home. With growing use of the electronic health record (EHR) come new opportunities to link patient-centered information with clinical health information systems. Linkage of these systems has the potential to inform and activate parents, provide much richer data to drive decision support at the point-of-care, and to provide ongoing support for long-term behavior change following primary care visits. The use of conversational technologies as the foundation for the project offers a number of unique advantages especially the support of lower-literacy populations and near-universal access. Systems like the Personal Health Partner (PHP) represent a model for the future of ambulatory care and the sustainable, affordable delivery of higher quality and safer care by primary care clinicians in the future.

Official Title
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The Personal Health Care Partner Project, Conversational IT for Better, Safer Pediatric Primary Care

Conditions
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Preventive Care, Medication Management

Intervention / Treatment
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* Behavioral: Safety Training
* Behavioral: Personal Health Partner and Counseling (PHP+C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of children will be enrolled in the study if they meet a set of eligibility criteria which includes: Age 0 - 11 years old A primary care patient at Boston Medical Center An English speaking child and parent. Exclusion Criteria: Children will be considered ineligible for the study if they plan to move away from the Boston area in less than 3 months, or are participating in another primary care research project with content that overlaps the content within this study. Currently, there are no studies being conducted that would lead to exclusion.

Ages Eligible for Study
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Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Safety Training<br> | Behavioral: Safety Training<br>* IT intervention focuses on safety in the home.<br>|
| Experimental: Personal Health Partner and Counseling (PHP+C)<br> | Behavioral: Personal Health Partner and Counseling (PHP+C)<br>* The PHP intervention will have three primary functional areas: 1) pre-visit assessment and counseling; 2) EHR data exchange with clinician review; and 3) post-visit follow-up, re-assessment, and counseling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal Health Partner (PHP) assessment with electronic health record (EHR) data exchange before pediatric primary care visits | PHP assessment with EHR data exchange before pediatric primary care visits will be associated with more comprehensive preventive and medication management assessments when compared to usual care | 2 week -1day before doctor's appointment and 1 week after appointment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Personal Health Partner (PHP) pre-visit counseling with post-visit reinforcement | PHP pre-visit counseling with post-visit reinforcement will be associated with increased preventive and medication management counseling; healthier parental behaviors; and increased parental activation when compared to parents receiving usual care. | 2 week-1day before doctor's appointment and 1 week after appointment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive Care, Medication Management, Electronic Medical Records, Automated Telephone System