Conversational IT for Better, Safer Pediatric Primary Care

Preventive Care Clinical Trial

— PHP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188629
• Other study ID #: H-26670
• Secondary ID: R18HS017248-01
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2010
• Last updated: November 16, 2015
• Start date: July 2007
• Est. completion date: August 2011

Study information

• Verified date: November 2015
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 11 Years

Eligibility

Inclusion Criteria:

• Parents of children will be enrolled in the study if they meet a set of eligibility criteria which includes:

1. Age 0 - 11 years old

2. A primary care patient at Boston Medical Center

3. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Medication Management
• Preventive Care

Intervention

Behavioral:
• Safety Training
IT intervention focuses on safety in the home.
• Personal Health Partner and Counseling (PHP+C)
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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No