PILOT-EBM: Study of an Intervention to Improve Use of Life-saving Medications for Heart Disease

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00323258
• Collaborator: Pfizer (Industry), Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 143
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Behavioral: oral education & written tips for remembering medications; Device: pill box; Device: pocket medication card; Behavioral: sharing information with community pharmacist; Behavioral: Medication use evaluations by community pharmacist; Behavioral: informing physician if patient has stopped a medication; Behavioral: Routine discharge counseling; Other: Letter to physician/discharge summary	N/A

Detailed Description

Heart disease is the leading cause of death for men and women in the United States. For patients with documented coronary artery disease (CAD), anti-platelet agents, beta-blockers and statins have all been shown to improve survival and reduce the frequency of myocardial infarction. Yet, previous research by the Duke CERTs has shown that in a population of over 28,000 patients with documented CAD, only 21% reported consistent use of triple therapy with aspirin, beta-blockers and lipid lowering therapy. These results stimulated the Duke CERTs to devise an intervention to improve adherence to these life-saving medications.

Comparisons: Patients admitted to Duke University Hospital or Southeastern Regional Medical Center (SRMC) with CAD or CAD plus heart failure who agree to participate, will be randomized to an intervention or control arm. The control group will receive usual care, which consists of routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the Duke physician to the community physician. In addition to usual care, the intervention group will receive focused medication counseling in the hospital by the clinical pharmacist-investigator, who will identify and address potential barriers to medication adherence and will reinforce the importance of taking evidence-based medications long term. Discharge medications will be shared with the community pharmacist. The community pharmacist will monitor for problems with adherence and communicate issues back to the patient and the patient's care team.

Study Design

• Study Type: Interventional
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications
• Study Start Date: Jun 1, 2006
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.	Behavioral: oral education & written tips for remembering medications; Clinical pharmacist will review purpose of medications of interest (beta-blockers, statins, Angiotensin Converting Enzyme Inhibitor (ACEI)/Angiotensin Receptor Blocker (ARB), aspirin, and other anti-platelets) with the subject. A written list of tips for remembering medications will be provided and reviewed.; Other Names: Cue-dose training ; Device: pill box; Subject is provided a pill box and briefly instructed on how to use the box.; Other Names: Pill box organizer pillbox ; Device: pocket medication card; Subject is provided with a card that contains space for prescription and non-prescription medications. If desired the clinical pharmacist-investigator will complete the card for the subject.; Other Names: Medication List List of Medications ; Behavioral: sharing information with community pharmacist; A fax is sent to the designated community pharmacy at the time of the subject's discharge from the hospital. The fax contains the subject's medications of interest, barriers to medication adherence, and physicians' contact information.; Other Names: increased communication with community pharmacist ; Behavioral: Medication use evaluations by community pharmacist; The community pharmacist will assess use of medications of interest at time of first medication fill and by reviewing the subject's computerized medication profile at the pharmacy. Assessments occur at first visit to pharmacy, 6-weeks, 12-weeks, 18-weeks, and 24-weeks. If there are issues with any medications of interest the subject will be called. If needed, the subject's health care team will be notified.; Other Names: medcation adherence verification ; Behavioral: informing physician if patient has stopped a medication; The community pharmacist or clinical pharmacist-investigator will fax the subject's physician to notify that a medication has been stopped.; Other Names: Communication with physician about patient's medication use ; Behavioral: Routine discharge counseling; Both groups received routine discharge counseling performed by the patient-care nurse.; Other Names: Discharge instructions ; Other: Letter to physician/discharge summary; A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations.; Other Names: Communication to physician about hospital course.
Active Comparator: Usual Care The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.	Behavioral: Routine discharge counseling; Both groups received routine discharge counseling performed by the patient-care nurse.; Other Names: Discharge instructions ; Other: Letter to physician/discharge summary; A letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations.; Other Names: Communication to physician about hospital course.

Outcome Measures

Primary Outcome Measures

1. Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months [6 months]

   Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist

Secondary Outcome Measures

1. Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records [6 months]

   Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy

2. Percent of Patients Adherent to Beta-blocker Via Refill Records [6 months]

   According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes

3. Percent of Patients Adherent to Statin Via Refill Records [6 months]

   According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes

4. Death in Intervention Patients Compared to Usual Care [6 months]

   Number of patients who died in each treatment group prior to the 6 month follow-up time point.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 18 years of age or older

• Utilize a pharmacy in Durham, Robeson, Person, Granville, or Vance County, NC

• Have coronary artery disease (CAD) documented in the medical record by one of the following:

1. A diagnosis of unstable angina or acute myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction)

2. A cardiac catheterization demonstrating CAD greater than or equal to 50 narrowing of artery)

3. Prior angioplasty

4. Prior coronary artery stent

5. Prior coronary artery bypass graft surgery (CABG)

• Plan to have their prescription medications filled and refilled by one of the participating pharmacies

• Prescribed aspirin or another antiplatelet, a beta-blocker and statin agent (referred to as triple therapy for this study) at discharge. If a patient has a true contraindication to any of the three medication groups in triple therapy, they will still be eligible for the study

Exclusion Criteria:

• Providers predict an anticipated hospital stay of less than 48 hours

• Patient plans to use a pharmacy outside of Durham, Robeson, Person, Granville, or Vance County, NC

• Patient is unable to give consent (cognitively impaired, does not speak English, or has altered mental status)

• Patient transferred to Cardiothoracic Surgery service for CABG

• Patient has terminal condition and may not survive until 6-month follow-up

• Patient lives in a correctional or long-term care facility

• Patient will be unable to participate in follow-up phone call (hearing impaired without caregiver who can help or does not have a phone)

• Patient is a known participant in the Duke Heart Failure Program

• Patient does not agree to use only the one Durham, Robeson, Person, Granville, or Vance County pharmacy throughout the study period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27704

Sponsors and Collaborators

• Duke University
• Pfizer
• Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Judith M. Kramer, MD,MS, Duke University
• Principal Investigator: Nancy Allen LaPointe, PharmD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Newby LK, LaPointe NM, Chen AY, Kramer JM, Hammill BG, DeLong ER, Muhlbaier LH, Califf RM. Long-term adherence to evidence-based secondary prevention therapies in coronary artery disease. Circulation. 2006 Jan 17;113(2):203-12. Epub 2006 Jan 9.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00323258
• Other Study ID Numbers: Pro00005018; U18HS010548
• First Posted: May 9, 2006
• Last Update Posted: Jan 18, 2013
• Last Verified: May 1, 2012

• Keywords provided by Duke University: Heart disease; Coronary disease; Patient compliance; Treatment refusal; Pharmacists; Continuity of patient care; Evidence-based medicine; Patient education; Adherence
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

Participant Flow

Recruitment Details	Patients hospitalized at Duke University Hospital (Durham, NC) were screened for study enrollment from July 5, 2006, through July 2, 2009. To increase enrollment, the study was opened to enrollment at Southeastern Regional Medical Center (Lumberton, NC) on May 27, 2008.
Pre-assignment Detail	After patients provided written informed consent, the study pharmacist collected baseline demographics, medical history, medication history, potential barriers to medication adherence, pharmacy name, physicians' contact information, and the Beliefs about Medicines Questionnaire (BMQ).

Arm/Group Title	Intervention Arm	Usual Care
Arm/Group Description	Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified. The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.	The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested. The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.
Period Title: Primary Outcome (Phone Call at 6 Months)
STARTED	71	72
COMPLETED	55	53
NOT COMPLETED	16	19
Period Title: Primary Outcome (Phone Call at 6 Months)
STARTED	71	72
COMPLETED	57	58
NOT COMPLETED	14	14

Baseline Characteristics

Arm/Group Title	Intervention Arm	Usual Care	Total
Arm/Group Description	Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified. The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.	The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested. The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available.	Total of all reporting groups
Overall Participants	71	72	143
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	63	62	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.0 (11.5)	61.5 (12.0)	62.3 (11.7)
Sex: Female, Male (Count of Participants)
Female	24 33.8%	28 38.9%	52 36.4%
Male	47 66.2%	44 61.1%	91 63.6%

Outcome Measures

1. Primary Outcome

Title	Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months
Description	Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Those participants alive and able to speak to pharmacist on 6 month follow up phone call. Missing (n=35)- Could not be reached: 12 intervention and 11 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Died during call period: 2 intervention and 1 usual care, refused to participate in call: 1 intervention and 5 usual care.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.	Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
Measure Participants	55	53
Number [percentage of participants]	91 128.2%	94 130.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments	Sample size of 286 patients(143 patients per group).Based on an estimated absolute improvement in medication adherence of 15% in the intervention group (eg, 85% in the intervention group, 70% in the control group), a 2-sided test with α level of .05, a 15% dropout rate, and power of 0.80.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence analysis. Null hypothesis: The will be no difference in proportion of participants adherent to triple therapy in the "treatment" arm compared to those who receive "usual care."
Statistical Test of Hypothesis	p-Value	.50
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records
Description	Percent of patients in each group adherent to beta-blocker and statin for 6 months after discharge as assessed by refill records from the patient's pharmacy
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.	Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
Measure Participants	57	58
Number [percentage of participants]	53 74.6%	38 52.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments	Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to combined beta-blocker and statin therapy in the "treatment" arm compared to those who receive "usual care."
Statistical Test of Hypothesis	p-Value	=0.11
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Percent of Patients Adherent to Beta-blocker Via Refill Records
Description	According to the local pharmacy records, the patient has had a supply of beta-blocker for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.	Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
Measure Participants	57	58
Number [percentage of patients with PDC >or=75%]	71	49

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments	Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to beta-blockers in the "treatment" arm compared to those who receive "usual care."
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Percent of Patients Adherent to Statin Via Refill Records
Description	According to the local pharmacy records, the patient has had a supply of statin for at least 75% of the days from the day of discharge to 180 days after the discharge date. Refill records from 90 days prior to index admission will be taken into account. % adherence = (days of available drug supply in the first 180 days/180)*100 If % adherence = or > 75, then adherence = yes
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Those participants who were living, did not withdraw, and refill records were available from their pharmacy. Missing (n=28)- Refill records not available: 12 intervention and 10 usual care, Died between 0-6 months: 1 intervention and 2 usual care, Withdrew: 1 intervention and 2 usual care.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.	Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
Measure Participants	57	58
Number [percentage of patients with >or=75%]	58	49

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments	Sample Size calculated as 286 total or 143 patient per treatment group. Based on a baseline adherence rate of 70%, an estimated absolute improvement in medication adherence of 15.0% in the intervention group, we would require 122 patients per group assuming a 2-sided test with alpha-level of .05 and power of .80. To sustain a 15% dropout/ loss to follow-up rate, about 143 patients per group (286 patients total) would need to be consented.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence analysis. Null hypothesis: The will be no difference in the proportion of participants who are >/= 75% adherent to statins in the "treatment" arm compared to those who receive "usual care."
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	Chi-squared
	Comments

5. Secondary Outcome

Title	Death in Intervention Patients Compared to Usual Care
Description	Number of patients who died in each treatment group prior to the 6 month follow-up time point.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.	Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
Measure Participants	71	72
Number [participants]	1 1.4%	2 2.8%

Adverse Events

Adverse Event Reporting Description	This was a behavioral and educational intervention. It was minimal risk and all patients (both groups) were taking the same medication classes. Adverse Events were not collected for this study. Death was not considered an event but collected only as a reason for not being available for follow-up with a participant.
Arm/Group Title	Intervention		Usual Care
Arm/Group Description	Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.		Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
All Cause Mortality
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.