Conversational IT for Better, Safer Pediatric Primary Care (PHP)

November 16, 2015 updated by: Bill Adams, Boston Medical Center

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

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

475

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Safety Training
IT intervention focuses on safety in the home.
Experimental: 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.

What is the study measuring?

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
Time Frame: 2 week -1day before doctor's appointment and 1 week after appointment
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
Time Frame: 2 week-1day before doctor's appointment and 1 week after appointment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • H-26670
  • R18HS017248-01 (U.S. AHRQ Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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