NCT01188629

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

3.6 years

First QC Date

August 24, 2010

Last Update Submit

November 16, 2015

Conditions

Preventive CareMedication Management

Keywords

Preventive CareMedication ManagementElectronic Medical RecordsAutomated Telephone System

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Personal Health Partner (PHP) pre-visit counseling with post-visit reinforcement

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

Study Arms (2)

Safety Training

PLACEBO COMPARATOR
Behavioral: Safety Training

Personal Health Partner and Counseling (PHP+C)

EXPERIMENTAL
Behavioral: Personal Health Partner and Counseling (PHP+C)

Interventions

Safety TrainingBEHAVIORAL

IT intervention focuses on safety in the home.

Safety Training
Personal Health Partner and Counseling (PHP+C)BEHAVIORAL

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.

Personal Health Partner and Counseling (PHP+C)

Eligibility Criteria

AgeUp to 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

  • Walsh KE, Bacic J, Phillips BD, Adams WG. Misuse of Pediatric Medications and Parent-Physician Communication: An Interactive Voice Response Intervention. J Patient Saf. 2021 Apr 1;17(3):e207-e213. doi: 10.1097/PTS.0000000000000375.

    PMID: 28333698DERIVED

  • Adams WG, Phillips BD, Bacic JD, Walsh KE, Shanahan CW, Paasche-Orlow MK. Automated conversation system before pediatric primary care visits: a randomized trial. Pediatrics. 2014 Sep;134(3):e691-9. doi: 10.1542/peds.2013-3759. Epub 2014 Aug 4.

    PMID: 25092938DERIVED

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • William Adams, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics, Principle Investigator

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 25, 2010

Study Start

July 1, 2007

Primary Completion

February 1, 2011

Study Completion

August 1, 2011

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

US(1)