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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01188629
First Posted: August 25, 2010
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Bill Adams, Boston Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Bill Adams, 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 ]
    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 ]
    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.


Enrollment: 475
Study Start Date: July 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 11 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188629


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: William Adams, MD Boston Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bill Adams, Professor of Pediatrics, Principle Investigator, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01188629     History of Changes
Other Study ID Numbers: H-26670
R18HS017248-01 ( U.S. AHRQ Grant/Contract )
First Submitted: August 24, 2010
First Posted: August 25, 2010
Last Update Posted: November 18, 2015
Last Verified: November 2015

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