Pharmacy Home Adherence Reporting and Monitoring Outcomes Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nudging Doctors to Collaborate With Pharmacists to Improve Medication Adherence

Conditions
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Diabetes, Hypertension, Hypercholesterolemia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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. | Participants were followed over a total of 6 months | 
| 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. | Participants were followed over a total of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication adherence, choice architecture, pharmacy home