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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Boston Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01188629
First received: August 24, 2010
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Preventive Care
Medication Management
Behavioral: Safety Training
Behavioral: Personal Health Partner and Counseling (PHP+C)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: The Personal Health Care Partner Project, Conversational IT for Better, Safer Pediatric Primary Care

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1300
Study Start Date: July 2007
Estimated Study Completion Date: August 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Safety Training Behavioral: Safety Training
IT intervention focuses on safety in the home.
Experimental: Personal Health Partner and Counseling (PHP+C) Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   up to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01188629

Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: William Adams, MD Boston Medical Center
  More Information

No publications provided

Responsible Party: William Adams, MD, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01188629     History of Changes
Other Study ID Numbers: H-26670, R18HS017248-01
Study First Received: August 24, 2010
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Preventive Care
Medication Management
Electronic Medical Records
Automated Telephone System

ClinicalTrials.gov processed this record on September 29, 2014