Preventive CarePhase 2PHPNCT01188629
Conversational IT for Better, Safer Pediatric Primary Care
A Phase 2 study testing Safety Training and Personal Health Partner and Counseling (PHP+C) in people with Preventive Care and Medication Management, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 11 years
- Conditions the study is for
- Preventive Care, Medication Management
- What is being tested?
- Safety Training and Personal Health Partner and Counseling (PHP+C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 475 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Personal Health Care Partner Project, Conversational IT for Better, Safer Pediatric Primary Care
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.
Read the 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
- Being tested
- Safety Training, Personal Health Partner and Counseling (PHP+C)
- Keywords
- Preventive Care, Medication Management, Electronic Medical Records, Automated Telephone System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety TrainingBehavioural
IT intervention focuses on safety in the home.
Personal Health Partner and Counseling (PHP+C)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Safety Training | Placebo comparator | Not described Receives: Behavioral: Safety Training |
| Personal Health Partner and Counseling (PHP+C) | Experimental | Not described Receives: Behavioral: Personal Health Partner and Counseling (PHP+C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 2 week-1day before doctor's appointment and 1 week after appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJul 2007
- Primary completionFeb 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preventive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Bill Adams, Boston Medical Center
- Investigators
- William Adams, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188629
- Sponsor's protocol ID
- H-26670
- Other IDs
- R18HS017248-01
- Acronym
- PHP
- Status last verified
- Nov 2015
- First submitted
- 24 Aug 2010
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 28333698Adams 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.
PubMed 25092938
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Personal Health Care Partner Project, Conversational IT for Better, Safer Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT01188629
- Acronym / sponsor ID
- PHP / H-26670
- Conditions
- Preventive Care, Medication Management
- Keywords
- Preventive Care, Medication Management, Electronic Medical Records, Automated Telephone System
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jul 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Training | Placebo comparator | Behavioral: Safety Training |
| Personal Health Partner and Counseling (PHP+C) | Experimental | Behavioral: Personal Health Partner and Counseling (PHP+C) |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parents of children will be enrolled in the study if they meet a set of eligibility criteria which includes:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety TrainingIT intervention focuses on safety in the home. | Behavioural | Safety Training |
| 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. | Behavioural | Personal Health Partner and Counseling (PHP+C) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Derived from this study: PubMed 28333698Walsh 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.
- Derived from this study: PubMed 25092938Adams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Adams, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Safety Training and Personal Health Partner and Counseling (PHP+C) in people with Preventive Care and Medication Management, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188629, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.