- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01188629
Conversational IT for Better, Safer Pediatric Primary Care (PHP)
The Personal Health Care Partner Project, Conversational IT for Better, Safer Pediatric Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
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
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.
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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
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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