Pharmacy Home Adherence Reporting and Monitoring Outcomes... | NCT02306122

ID	Type	Description	Link
7RC4AG039072-02	U.S. NIH Grant/Contract		View source

Name	Class
National Institute on Aging (NIA)	NIH
Tufts Medical Center	OTHER
Harvard University	OTHER
Johns Hopkins University

Description Module

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:

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: a) 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.
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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Default patient default doctor	Experimental	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
Information patient default doctor	Experimental	Patient nonadherence information sent to physician	Behavioral: Patient nonadherence information sent to physician
Control patient default doctor	No Intervention	Control - no intervention
Choice patient choice doctor	Experimental	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
Information patient choice doctor	Experimental	Patient nonadherence information sent to physician	Behavioral: Patient nonadherence information sent to physician

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmacist calls patient unless physician cancels call	Behavioral		Default patient default doctor
Patient nonadherence information sent to physician

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Probability of Resolution of Nonadherence Within 30 Days	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.	Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.
Duration of Nonadherence Event	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.	Participants were followed over a total of 6 months

Secondary Outcomes

Measure	Description	Time Frame
Probability of Physician Viewing Nonadherence Event Information	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.

Name	Affiliation	Role
Ira B Wilson, MD, MSc	Brown University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Brown University		Providence	Rhode Island	02913	United States

PubMed Identifier	Type	Citation	Retractions
31835278	Derived	McConnell M, Rogers W, Simeonova E, Wilson IB. Architecting Process of Care: A randomized controlled study evaluating the impact of providing nonadherence information and pharmacist assistance to physicians. Health Serv Res. 2020 Feb;55(1):136-145. doi: 10.1111/1475-6773.13243. Epub 2019 Dec 13.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Default Patient Default Doctor	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
FG001	Information Patient Default Doctor

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Aug 4, 2011	Dec 13, 2021

ID	Title	Description
BG000	Default Patient	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
BG001	Information Patient	Patient nonadherence information sent to physician
BG002	Control Patient	Control - no intervention
BG003	Choice Patient	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
BG004	Information Doctor	Physician randomized to information only arm
BG005	Choice Doctor	Physician randomized to choice arm
BG006	Default Doctor	Physician randomized to default arm
BG007	Total	Total of all reporting groups

Units	Counts
Participants	BG000244 BG001477 BG002479 BG003274 BG00429 BG00531 BG00631 BG0071565

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Probability of Resolution of Nonadherence Within 30 Days

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.

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.

Posted

Mean

Standard Deviation

Proportion of resolved NAEs within 30

Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.

ID	Title	Description
OG000	Default Patient	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
OG001	Choice Patient	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
OG002	Information Patient	Patient nonadherence information sent to physician
OG003	Control Patient	No information sent to physician, no opportunity for pharmacist intervention

Units	Counts
Participants	OG000244 OG001274 OG002477 OG003

Title

Denominators

Categories

Title	Measurements
	OG000.4286± .4953 OG001.4290± .4953 OG002.4554± .4982 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		Regression, Logistic		<0.01		Risk Difference (RD)	-0.015	Standard Error of the Mean	0.034	2-Sided						Comparator is control arm		Superiority
OG001 OG003		Regression, Logistic

Primary

Duration of Nonadherence Event

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.

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.

Posted

Mean

Standard Deviation

Days

Participants were followed over a total of 6 months

ID	Title	Description
OG000	Default Patient	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
OG001	Choice Patient	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
OG002	Information Patient	Patient nonadherence information sent to physician
OG003	Control Patient

Secondary

Probability of Physician Viewing Nonadherence Event Information

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.

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.

Posted

Mean

Standard Deviation

Proportion of NAEs viewed

Participants were followed over a total of 6 months

ID	Title	Description
OG000	Default Patient	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
OG001	Choice Patient	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call
OG002	Information Only Patient	Patient nonadherence information sent to physician

Secondary

Probability of Pharmacist Action Triggered

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.

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

Posted

Mean

Standard Deviation

Proportion with pharmacist calls

Participants were followed over a total of 6 months

ID	Title	Description
OG000	Default Patient	Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call
OG001	Choice Patient	Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Default Patient Default Doctor	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	244	244	244
EG001	Information Patient Default Doctor	Patient nonadherence information sent to physician Patient nonadherence information sent to physician	123	123	123
EG002	Control Patient Default Doctor	Control - no intervention	121	121	121
EG003	Choice Patient Choice Doctor	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	274	274	274
EG004	Information Patient Choice Doctor	Patient nonadherence information sent to physician Patient nonadherence information sent to physician	134	134	134
EG005	Control Patient Choice Doctor	Control - no intervention	137	137	137
EG006	Information Patient Information Doctor	Patient nonadherence information sent to physician Patient nonadherence information sent to physician	220	220	220
EG007	Control Patient Information Doctor	Control - no intervention	221	221	221
EG008	Information Doctor	Doctor receives information and may be allowed certain actions	29	29	29
EG009	Choice Doctor	Doctor receives information and may be allowed certain actions	31	31	31
EG010	Default Doctor	Doctor receives information and may be allowed certain actions	31	31	31

ID	Term
D003920	Diabetes Mellitus
D006973	Hypertension
D006937	Hypercholesterolemia
D055118	Medication Adherence

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D010349	Patient Compliance
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior