Interactive Spaced Education to Optimize Hypertension Management

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00904007
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

Online interactive spaced education (ISE) is a novel educational methodology based on the "spacing effect", the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice question. The investigators recently completed a randomized trial involving 95 VISN 1 primary care providers (PCPs) which demonstrated that an ISE intervention can significantly improve clinician's practice patterns. Those clinicians randomized to the ISE intervention on prostate cancer screening demonstrated a 26% relative reduction in inappropriate screening. The investigators propose to conduct a randomized controlled trial involving PCPs in VISN 1 to determine whether ISE can (1) increase knowledge of the appropriate treatment of hypertensive patients, (2) reduce clinical inertia in hypertension management, and (3) improve the blood pressure control in hypertensive patients.

Anticipated Impacts on Veterans' Healthcare: This study aims to demonstrate that online interactive spaced education (ISE) can improve providers' care of patients with hypertension. ISE is the type of intervention that can be deployed across the VHA with content tailored to meet specific needs and can be implemented as a tool to improve performance measures and clinical outcomes

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Other: Interactive Spaced Education (ISE) --- online education	N/A

Detailed Description

Anticipated Impacts on Veterans' Healthcare: This study aims to demonstrate that online interactive spaced education (ISE) can improve providers' care of patients with hypertension. ISE is the type of intervention that can be deployed across the VHA with content tailored to meet specific needs and can be implemented as a tool to improve performance measures and clinical outcomes.

Project Background/Rationale: ISE is a novel educational methodology based on the "spacing effect", the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice questions. We recently completed a randomized trial involving 95 VISN 1 primary care providers (PCPs) which demonstrated that an ISE intervention can significantly improve clinician's practice patterns. Those clinicians randomized to the ISE intervention on prostate cancer screening demonstrated a 26% relative reduction in inappropriate screening.

Project Objectives: Lowering blood pressure in hypertensive patients unequivocally decreases the incidence of stroke and cardiovascular events and is highly cost-effective. The majority of patients with blood pressure above the treatment target do not have their anti-hypertensive medications appropriately intensified at clinician visits. A reduced frequency of treatment intensification is alternatively termed 'clinical inertia'. Our preliminary results show that clinicians' knowledge of hypertension management guidelines is limited, and few clinicians report following the guidelines consistently. We propose to conduct a randomized controlled trial involving PCPs in VISN 1 to determine whether ISE can (1) increase knowledge of the appropriate treatment of hypertensive patients, (2) reduce clinical inertia in hypertension management, and (3) improve the blood pressure control in hypertensive patients.

Project Methods: One hundred six VISN 1 primary care practitioners (physicians, nurse practitioners, and physician assistants) will be recruited via email to participate in the study. Participants will be randomized to one of two cohorts: (1) the intervention cohort will receive ISE over year 1, and (2) the control cohort will receive no intervention and will represent the "standard of education" on hypertension management. The ISE intervention will consist of an email every 4 days containing 1 multiple-choice questions based on a curriculum derived from clinical practice guidelines on appropriate hypertension management. Providers will submit answers to the questions online and immediately receive the correct answer and an explanation of the pertinent clinical issues. Using a new adaptive methodology, the spacing and content of the educational intervention will be individualized for each clinician based on their performance. The ISE intervention will be completed in 9-11 months. Hypertension knowledge will be assessed by a post-test at the end of year 1. Providers' clinical inertia and the blood pressures of their patients will be assessed over 2 years: initial changes attributable to ISE will be identified in year 1, while the retention of these changes will be monitored in year 2. Drawing on the interdisciplinary expertise of our investigator team, the study is positioned to enrich national debates about how best to improve the ways in which clinicians can meet their lifelong learning needs.

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Interactive Spaced Education to Optimize Hypertension Management
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SE Game Cohort Will receive ISE intervention.	Other: Interactive Spaced Education (ISE) --- online education; ISE is a novel educational methodology based on the "spacing effect", the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice questions.
No Intervention: Control Cohort The control cohort will receive identical content online (with no ISE)

Outcome Measures

Primary Outcome Measures

1. Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure [Months 1-24]

   A unique hypertensive period served as the unit of analysis. A hypertensive period started on the first day during the study when a patient's BP was elevated. It ended on the first subsequent day when it was <140/90 mm Hg or on the last day BP was recorded during the study. Duration of the hypertensive period (days) was the outcome measure. BP measurements obtained in the course of routine care were used to ascertain study outcomes, whether obtained by the PCP or at other clinic visits. These measurements were obtained from structured data (ie, BP recordings in the electronic medical record) and natural language processing of provider notes as previously described. If several measurements were recorded on the same day, the lowest mean arterial BP was used.

Secondary Outcome Measures

1. Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12) [Months 1-12]

2. Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12) [Months 1-12]

3. Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24) [Months 13-24]

4. Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24) [Months 13-24]

5. Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24) [Months 1-24]

6. Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24) [Months 1-24]

7. Cross-cohort Comparison of Frequency of Treatment Intensification [Months 1-24]

8. Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure [Months 1-24]

9. Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.) [Month 1]

10. Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements) [Months 1-12]

11. Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only) [Months 1-12]

12. Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only) [Months 1-12]

13. Provider-perceived Acceptability of Spaced Education Intervention [Months 1-12]

14. Provider-perceived Effectiveness of Spaced Education Intervention [Months 1-12]

15. Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention [Months 1-12]

16. Provider-perceived Barriers and Facilitators to the Spaced Education Intervention [Months 1-12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• VA VISN 1 primary care clinicians (MD, NP, PA) who have at least a 50% (4/8 time) clinical appointment.

Exclusion Criteria:

• VA VISN 1 primary care clinicians (MD, NP, PA) who do not have at least a 50% (4/8 time) clinical appointment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Boston Healthcare System Brockton Campus, Brockton, MA	Brockton	Massachusetts	United States	02301

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: B. Price Kerfoot, MD EdM, VA Boston Healthcare System Brockton Campus, Brockton, MA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00904007
• Other Study ID Numbers: EDU 08-422
• First Posted: May 19, 2009
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by VA Office of Research and Development: Educational Technology; Hypertension; Education, Professional
• Additional relevant MeSH terms: Hypertension

Study Results

Participant Flow

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Period Title: Overall Study
STARTED	55	56
COMPLETED	55	56
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	SE Game Cohort	Control Cohort	Total
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.	Total of all reporting groups
Overall Participants	55	56	111
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.5 (9.7)	53.1 (8.5)	51.8 (9.2)
Sex: Female, Male (Count of Participants)
Female	35 63.6%	38 67.9%	73 65.8%
Male	20 36.4%	18 32.1%	38 34.2%

Outcome Measures

1. Primary Outcome

Title	Cross-cohort Comparison of the Average Time Needed to Normalize Patients' Blood Pressure
Description	A unique hypertensive period served as the unit of analysis. A hypertensive period started on the first day during the study when a patient's BP was elevated. It ended on the first subsequent day when it was <140/90 mm Hg or on the last day BP was recorded during the study. Duration of the hypertensive period (days) was the outcome measure. BP measurements obtained in the course of routine care were used to ascertain study outcomes, whether obtained by the PCP or at other clinic visits. These measurements were obtained from structured data (ie, BP recordings in the electronic medical record) and natural language processing of provider notes as previously described. If several measurements were recorded on the same day, the lowest mean arterial BP was used.
Time Frame	Months 1-24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	55	56
Median (Full Range) [days]	137	145

2. Secondary Outcome

Title	Cross-cohort Comparison of Patients' Average Blood Pressure at 12 Months After Trial Launch (Last Measured Blood Pressure in Months 1-12)
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	Will receive ISE intervention. Interactive Spaced Education (ISE) --- online education: ISE is a novel educational methodology based on the "spacing effect", the psychological finding that repeated presentations of educational material over spaced intervals increase learning efficiency and improve knowledge retention. ISE is delivered using periodic emails that contain clinical case scenarios and multiple-choice questions.	The control cohort will receive identical content online (with no ISE)
Measure Participants	0	0

3. Secondary Outcome

Title	Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-12 (Last Measured Blood Pressure in Months 1-12)
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

4. Secondary Outcome

Title	Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 13-24)
Time Frame	Months 13-24

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

5. Secondary Outcome

Title	Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 13-24 (Last Measured Blood Pressure in Months 13-24)
Time Frame	Months 13-24

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

6. Secondary Outcome

Title	Cross-cohort Comparison of Patients' Average Blood Pressure at 24 Months After Trial Launch (Last Measured Blood Pressure in Months 1-24)
Time Frame	Months 1-24

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

7. Secondary Outcome

Title	Cross-cohort Comparison of Patients' Average Change in Blood Pressure Over Months 1-24 (Last Measured Blood Pressure in Months 1-24)
Time Frame	Months 1-24

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

8. Secondary Outcome

Title	Cross-cohort Comparison of Frequency of Treatment Intensification
Time Frame	Months 1-24

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

9. Secondary Outcome

Title	Cross-cohort Comparison of Patients' Follow-up Intervals After Clinical Encounters With Elevated Blood Pressure
Time Frame	Months 1-24

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

10. Secondary Outcome

Title	Pre-test Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Etc.)
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

11. Secondary Outcome

Title	Cross-cohort Comparison of Providers' Post-test Scores (Score Improvements)
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

12. Secondary Outcome

Title	Baseline Knowledge Levels of Providers Assessed Via Their Initial Responses to Spaced Education Items (Spaced Education Cohort Only)
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

13. Secondary Outcome

Title	Performance Differences by Provider-related Variables (Site of Care, Age, Date of Recertification, Sex, Etc.) in the Spaced Education Program (Spaced Education Cohort Only)
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

14. Secondary Outcome

Title	Provider-perceived Acceptability of Spaced Education Intervention
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

15. Secondary Outcome

Title	Provider-perceived Effectiveness of Spaced Education Intervention
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

16. Secondary Outcome

Title	Providers' Perceptions of the Optimal Parameters for the Spaced Education Intervention
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

17. Secondary Outcome

Title	Provider-perceived Barriers and Facilitators to the Spaced Education Intervention
Time Frame	Months 1-12

Outcome Measure Data

Analysis Population Description

PI and project staff no longer have access to the raw data and are no longer able to generate any more data analyses.

Arm/Group Title	SE Game Cohort	Control Cohort
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.	Control clinicians received identical educational content in an online posting with email reminders.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Arm 1		Arm 2
Arm/Group Description	SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.		Control clinicians received identical educational content in an online posting with email reminders.
All Cause Mortality
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/56 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.