PHARxMOS: Pharmacy Home Adherence Reporting and Monitoring Outcomes Study

• Sponsor: Brown University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02306122
• Collaborator: National Institute on Aging (NIA) (NIH), Tufts Medical Center (Other), Harvard University (Other), Johns Hopkins University (Other)
• Enrollment: 2,697
• Location: 1
• Arms: 11
• Duration (Months): 35.1
• Patients Per Site Per Month: 76.9

Study Details

Study Description

Brief Summary

This study is a pilot test of an intervention that delivers timely diagnostic information about medication nonadherence to doctors, and then offers the services of clinical pharmacists to treat these nonadherence problems. Participating doctors will be notified when a patient is 10 days late refilling a medication for diabetes, hypertension, or hypercholesterolemia. In one randomization arm the pharmacist will contact the patient as the default option (with no action required by the doctor), and in the other the pharmacist will contact the patient only if the doctor actively chooses that the pharmacist take action. Patients of participating doctors will be randomized to 1) one of these two pharmacist options, 2) an information only control arm in which the doctor gets adherence information but does not have access to a pharmacist for that patient, and 3) a no information control arm. The investigators' central hypothesis is that the pharmacist will be consulted more often when intervention by the pharmacist is the default outcome and that the default pharmacist intervention will be the most beneficial for adherence outcomes.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Hypertension; Hypercholesterolemia	Behavioral: Pharmacist calls patient unless physician cancels call; Behavioral: Patient nonadherence information sent to physician; Behavioral: Pharmacist calls patient if physician requests call; Behavioral: Doctor receives information and may be allowed certain actions	N/A

Detailed Description

Poor adherence with prescription medications is ubiquitous, regardless of the disease, medication, patient population, or country studied. It is also expensive - annual costs of poor adherence in the United States were recently estimated at $290 billion. This problem has two components: diagnosis and treatment. Regarding diagnosis, doctors' assessments of patients' adherence are inaccurate, and doctors often do not discuss adherence problems with their patients. This makes it attractive to use pharmacy claims to identify nonadherence. While diagnostic data is necessary to solve the non-adherence problem, it is not sufficient. Once diagnosed, doctors must take action to treat nonadherence. Research shows that simply giving doctors claims data about nonadherence is ineffective, probably because it is not clear what action to take, and because the costs in time and energy of taking action are too great. What is currently lacking is a practical way to effectively integrate this diagnostic information and treatment expertise into work flows in primary care doctors' offices, and an effective method of inducing doctors to act on it. Behavioral economics suggests that barriers to doctors' action may be overcome in a cost effective way by altering the architecture of choices doctors face.

The long term goal of this research is to develop systems that effectively connect pharmacy benefits managers (PBMs), primary care doctors, clinical pharmacists, and patients in ways that improve medication adherence and patients' health outcomes. The overall objective of this application, which is the next step toward attainment of the investigators long term goal, is to conduct a pilot test of an intervention that delivers timely diagnostic information about nonadherence to doctors, and then offers the services of clinical pharmacists to treat these nonadherence problems. Participating doctors will be notified when a patient is 10 days late refilling a medication for diabetes, hypertension, or hypercholesterolemia. Taking advantage of the principle of intelligent choice architecture from behavioral economics, in one arm the pharmacist will contact the patient as the default option (with no action required by the doctor), and in the other the pharmacist will contact the patient only if the doctor actively chooses that the pharmacist take action. Patients of participating doctors will be randomized to 1) one of these two pharmacist options, 2) an information only control arm in which the doctor gets adherence information but does not have access to a pharmacist for that patient, and 3) a no information control arm. The investigators central hypothesis, which is strongly supported by work in other fields, is that the pharmacist will be consulted more often when intervention by the pharmacist is the default outcome and that the default pharmacist intervention will be the most beneficial for adherence outcomes.

This study is a collaboration between researchers at Brown University, Tufts University, Harvard University, and Johns Hopkins University; Express Scripts; a large regional commercial insurer; and a network of primary care doctors in Eastern Massachusetts. The team is led by Dr. Ira Wilson, an experienced adherence researcher, and includes behavioral and health economists, and a statistician experienced in adherence issues. The investigators will accomplish the investigators overall objectives by pursuing the following Specific Aims:

1. Establish and test the technical and communications infrastructure required for the conduct of this clinical trial. The following steps must occur in a secure environment:

1. Express Scripts notifies the study that a patient is late filling a prescription, b) the study notifies the doctor, c) the doctor makes a choice about how to respond, and d) a pharmacist, in some cases, contacts the patient.

1. Conduct and evaluate a clinical trial of an intervention comparing methods of offering pharmacist services to primary care doctors. Eligible doctors and patients will be randomized to a) pharmacist services under one of two choice architecture conditions (default or choice), b) adherence information only, or c) no information; further randomization for patients in the experimental arms will occur where the patient's HMO/PPO status will be revealed to the physician, or not. Outcomes include medication adherence, duration of nonadherence event, and physician participant behavioral outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2697 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Nudging Doctors to Collaborate With Pharmacists to Improve Medication Adherence
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Default patient default doctor Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Behavioral: Pharmacist calls patient unless physician cancels call; Behavioral: Patient nonadherence information sent to physician
Experimental: Information patient default doctor Patient nonadherence information sent to physician	Behavioral: Patient nonadherence information sent to physician
No Intervention: Control patient default doctor Control - no intervention
Experimental: Choice patient choice doctor Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Behavioral: Patient nonadherence information sent to physician; Behavioral: Pharmacist calls patient if physician requests call
Experimental: Information patient choice doctor Patient nonadherence information sent to physician	Behavioral: Patient nonadherence information sent to physician
No Intervention: Control patient choice doctor Control - no intervention
Experimental: Information patient information doctor Patient nonadherence information sent to physician	Behavioral: Patient nonadherence information sent to physician
No Intervention: Control patient information doctor Control - no intervention
Experimental: Information doctor Physician receives nonadherence information, but there is no opportunity for pharmacist action	Behavioral: Doctor receives information and may be allowed certain actions
Experimental: Choice doctor Physician receives nonadherence information, and can choose to request pharmacist action	Behavioral: Doctor receives information and may be allowed certain actions
Experimental: Default doctor Physician receives nonadherence information; pharmacist action will be triggered unless physician cancels action	Behavioral: Doctor receives information and may be allowed certain actions

Outcome Measures

Primary Outcome Measures

1. Probability of Resolution of Nonadherence Within 30 Days [Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.]

   Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which these patients have filled a prescription by 30 days. Outcome is 1 if the patient fills the prescription by 30 days (considered resolution of nonadherence); otherwise it is 0. Outcome measures reported are the means of the per-person proportions of nonadherence (NAE) events resolved within 30 days across all patients in each particular arm.

2. Duration of Nonadherence Event [Participants were followed over a total of 6 months]

   Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the duration of nonadherence event (the length of time the patient took to refill a prescription if the refill had been late), in days.

Secondary Outcome Measures

1. Probability of Physician Viewing Nonadherence Event Information [Participants were followed over a total of 6 months]

   Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which physicians viewed nonadherence event information. Outcome measures reported are the means of the per-person proportions of NAE event notices viewed by the physician across all patients in each particular arm.

2. Probability of Pharmacist Action Triggered [Participants were followed over a total of 6 months]

   Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which pharmacist action was triggered to resolve nonadherence. Outcome measures reported are the means of the per-person proportions of NAE events which triggered pharmacist action across all patients in each particular arm.

Eligibility Criteria

Criteria

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

Physician Inclusion Criteria:

• New England Quality Care Alliance (NEQCA) primary care physicians of adult patients insured through large commercial insurer partner

Patient Inclusion Criteria:

• Adult patients of consented New England Quality Care Alliance (NEQCA) primary care physicians

• Insured through large commercial insurer partner

• Prescribed chronic medications for one or more of the three study conditions in the past six months

Patient Exclusion Criterion:

• On the insurer's "do not contact" list

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brown University	Providence	Rhode Island	United States	02913

Sponsors and Collaborators

• Brown University
• National Institute on Aging (NIA)
• Tufts Medical Center
• Harvard University
• Johns Hopkins University

Investigators

• Principal Investigator: Ira B Wilson, MD, MSc, Brown University

Study Documents (Full-Text)

• Informed Consent Form - Aug 4, 2011

More Information

Publications

None provided.

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT02306122
• Other Study ID Numbers: 1010000295; 7RC4AG039072-02
• First Posted: Dec 3, 2014
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brown University: medication adherence; choice architecture; pharmacy home
• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

Participant Flow

Recruitment Details

Physician recruitment with signed consent forms was in-person. 91 physicians were consented and enrolled at launch. All eligible patients were automatically enrolled, and mailed an opt-out card to be returned if participation was refused.

Pre-assignment Detail

Both patients and doctors were enrolled in the study. Separate Periods represent the sequential nature of the study design: Period 1 includes physicians only. Only those patients with a nonadherence event were randomized to a control or intervention arm, so the number consented at launch (2,606) is higher than the number included in the study results (1,474). Patients were removed if insurance coverage expired or if their enrolled physician withdrew.

Arm/Group Title	Default Patient Default Doctor	Information Patient Default Doctor	Control Patient Default Doctor	Choice Patient Choice Doctor	Information Patient Choice Doctor	Control Patient Choice Doctor	Information Patient Information Doctor	Control Patient Information Doctor	Information Doctor	Default Doctor	Choice Doctor
Arm/Group Description	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Patient nonadherence information sent to physician	Control - no intervention	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Patient nonadherence information sent to physician	Control - no intervention	Patient nonadherence information sent to physician	Control - no intervention	Physician randomized to Information Only arm	Physician randomized to Default arm	Physician randomized to Choice arm
Period Title: Initial Physician Randomization
STARTED	0	0	0	0	0	0	0	0	29	31	31
COMPLETED	0	0	0	0	0	0	0	0	28	31	31
NOT COMPLETED	0	0	0	0	0	0	0	0	1	0	0
Period Title: Initial Physician Randomization
STARTED	244	123	121	274	134	137	220	221	28	31	31
COMPLETED	244	123	121	274	134	137	220	221	28	31	31
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Default Patient	Information Patient	Control Patient	Choice Patient	Information Doctor	Choice Doctor	Default Doctor	Total
Arm/Group Description	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Patient nonadherence information sent to physician	Control - no intervention	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Physician randomized to information only arm	Physician randomized to choice arm	Physician randomized to default arm	Total of all reporting groups
Overall Participants	244	477	479	274	29	31	31	1565
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.80 (0.49)	55.99 (0.51)	56.58 (0.47)	56.29 (0.68)	53.86 (1.67)	56.87 (1.53)	56.16 (1.78)	56.33 (0.45)
Sex: Female, Male (Count of Participants)
Female	78 32%	167 35%	163 34%	107 39.1%	16 55.2%	11 35.5%	12 38.7%	554 35.4%
Male	166 68%	310 65%	316 66%	167 60.9%	13 44.8%	20 64.5%	19 61.3%	1011 64.6%
Region of Enrollment (participants) [Number]
United States	244 100%	477 100%	479 100%	274 100%	29 100%	31 100%	31 100%	1565 100%

Outcome Measures

1. Primary Outcome

Title	Probability of Resolution of Nonadherence Within 30 Days
Description	Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which these patients have filled a prescription by 30 days. Outcome is 1 if the patient fills the prescription by 30 days (considered resolution of nonadherence); otherwise it is 0. Outcome measures reported are the means of the per-person proportions of nonadherence (NAE) events resolved within 30 days across all patients in each particular arm.
Time Frame	Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.

Outcome Measure Data

Analysis Population Description

All Information Only patients are grouped together in these results (regardless of physician arm), because the treatment for all Information Only patients is identical across all physician arms.

Arm/Group Title	Default Patient	Choice Patient	Information Patient	Control Patient
Arm/Group Description	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Patient nonadherence information sent to physician	No information sent to physician, no opportunity for pharmacist intervention
Measure Participants	244	274	477	479
Mean (Standard Deviation) [Proportion of resolved NAEs within 30]	.4286 (.4953)	.4290 (.4953)	.4554 (.4982)	.4437 (.4971)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Default Patient, Control Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.034
	Estimation Comments	Comparator is control arm

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Choice Patient, Control Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.041
	Estimation Comments	Comparator is control arm

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Information Patient, Control Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.012
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.029
	Estimation Comments	Comparator is control arm

2. Primary Outcome

Title	Duration of Nonadherence Event
Description	Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the duration of nonadherence event (the length of time the patient took to refill a prescription if the refill had been late), in days.
Time Frame	Participants were followed over a total of 6 months

Outcome Measure Data

Analysis Population Description

All Information Only patients are grouped together in these results (regardless of physician arm), because the treatment for all Information Only patients is identical across all physician arms.

Arm/Group Title	Default Patient	Choice Patient	Information Patient	Control Patient
Arm/Group Description	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Patient nonadherence information sent to physician	No information sent to physician, no opportunity for pharmacist intervention
Measure Participants	244	274	477	479
Mean (Standard Deviation) [Days]	40.91 (37.89)	39.46 (35.02)	41.35 (43.51)	41.04 (41.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Default Patient, Control Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.128
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.523
	Estimation Comments	Comparator is the control arm

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Choice Patient, Control Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.582
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.997
	Estimation Comments	Comparator is the control arm

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Information Patient, Control Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.308
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.38
	Estimation Comments	Comparator is the control arm

3. Secondary Outcome

Title	Probability of Physician Viewing Nonadherence Event Information
Description	Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which physicians viewed nonadherence event information. Outcome measures reported are the means of the per-person proportions of NAE event notices viewed by the physician across all patients in each particular arm.
Time Frame	Participants were followed over a total of 6 months

Outcome Measure Data

Analysis Population Description

We excluded the Control group because we considered only claims where physicians assigned to a treatment arm would have been notified by email of nonadherence.

Arm/Group Title	Default Patient	Choice Patient	Information Only Patient
Arm/Group Description	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call	Patient nonadherence information sent to physician
Measure Participants	244	274	477
Mean (Standard Deviation) [Proportion of NAEs viewed]	0.2822 (0.4505)	0.3856 (0.4872)	0.3257 (0.4688)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Default Patient, Information Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-0.043
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.068
	Estimation Comments	Comparator is the information arm

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Choice Patient, Information Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.063
	Estimation Comments	Comparator is the information arm

4. Secondary Outcome

Title	Probability of Pharmacist Action Triggered
Description	Patients who were more than 10 days late refilling a chronic medication prescription were in the analytic sample frame and were targeted for intervention according to how they were randomized. This outcome is the rate at which pharmacist action was triggered to resolve nonadherence. Outcome measures reported are the means of the per-person proportions of NAE events which triggered pharmacist action across all patients in each particular arm.
Time Frame	Participants were followed over a total of 6 months

Outcome Measure Data

Analysis Population Description

We considered only claims for patients who had been randomly assigned to intervention arms where the pharmacist was available - Default and Choice.

Arm/Group Title	Default Patient	Choice Patient
Arm/Group Description	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
Measure Participants	244	274
Mean (Standard Deviation) [Proportion with pharmacist calls]	0.6102 (0.4881)	0.1903 (0.3929)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Default Patient, Choice Patient
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.42
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.071
	Estimation Comments	Comparator is the choice arm

Adverse Events

Time Frame	From launch of study to end of study (6 months)
Arm/Group Title	Default Patient Default Doctor		Information Patient Default Doctor		Control Patient Default Doctor		Choice Patient Choice Doctor		Information Patient Choice Doctor		Control Patient Choice Doctor		Information Patient Information Doctor		Control Patient Information Doctor		Information Doctor		Choice Doctor		Default Doctor
Arm/Group Description	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call Pharmacist calls patient unless physician cancels call Patient nonadherence information sent to physician		Patient nonadherence information sent to physician Patient nonadherence information sent to physician		Control - no intervention		Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call Patient nonadherence information sent to physician Pharmacist calls patient if physician requests call		Patient nonadherence information sent to physician Patient nonadherence information sent to physician		Control - no intervention		Patient nonadherence information sent to physician Patient nonadherence information sent to physician		Control - no intervention		Doctor receives information and may be allowed certain actions		Doctor receives information and may be allowed certain actions		Doctor receives information and may be allowed certain actions
All Cause Mortality
	Default Patient Default Doctor		Information Patient Default Doctor		Control Patient Default Doctor		Choice Patient Choice Doctor		Information Patient Choice Doctor		Control Patient Choice Doctor		Information Patient Information Doctor		Control Patient Information Doctor		Information Doctor		Choice Doctor		Default Doctor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/244 (0%)		0/123 (0%)		0/121 (0%)		0/274 (0%)		0/134 (0%)		0/137 (0%)		0/220 (0%)		0/221 (0%)		0/29 (0%)		0/31 (0%)		0/31 (0%)
Serious Adverse Events
	Default Patient Default Doctor		Information Patient Default Doctor		Control Patient Default Doctor		Choice Patient Choice Doctor		Information Patient Choice Doctor		Control Patient Choice Doctor		Information Patient Information Doctor		Control Patient Information Doctor		Information Doctor		Choice Doctor		Default Doctor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/244 (0%)		0/123 (0%)		0/121 (0%)		0/274 (0%)		0/134 (0%)		0/137 (0%)		0/220 (0%)		0/221 (0%)		0/29 (0%)		0/31 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Default Patient Default Doctor		Information Patient Default Doctor		Control Patient Default Doctor		Choice Patient Choice Doctor		Information Patient Choice Doctor		Control Patient Choice Doctor		Information Patient Information Doctor		Control Patient Information Doctor		Information Doctor		Choice Doctor		Default Doctor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/244 (0%)		0/123 (0%)		0/121 (0%)		0/274 (0%)		0/134 (0%)		0/137 (0%)		0/220 (0%)		0/221 (0%)		0/29 (0%)		0/31 (0%)		0/31 (0%)

Limitations/Caveats

We partnered with only one insurer and pharmacy benefit manager and therefore had information on adherence for a subset of any physician's patients. We only had information on selected medications. We could only track patient outcomes related to adherence. Few patients actually received the pharmacist intervention. A relatively high share of patients opted out of the research. Our multilevel experimental design, with randomization occurring at both patient and physician levels, was complex.

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.