Conversational IT for Better, Safer Pediatric Primary Care

NCT ID: NCT01188629

Last Updated: 2015-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-08-31

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.

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.

Conditions

Preventive Care; Medication Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Safety Training

Group Type: PLACEBO_COMPARATOR

Safety Training

Intervention Type: BEHAVIORAL

IT intervention focuses on safety in the home.

Personal Health Partner and Counseling (PHP+C)

Group Type: EXPERIMENTAL

Personal Health Partner and Counseling (PHP+C)

Intervention Type: 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.

Interventions

Safety Training

IT intervention focuses on safety in the home.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Bill Adams

Professor of Pediatrics, Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Adams, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28333698 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25092938 (View on PubMed)

Other Identifiers

R18HS017248-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

H-26670

Identifier Type: -

Identifier Source: org_study_id