Clinical trial NCT02306122: Pharmacy Home Adherence Reporting and Monitoring Outcomes Study
Official title: Nudging Doctors to Collaborate With Pharmacists to Improve Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Hypercholesterolemia
Keywords: medication adherence
choice architecture
pharmacy home
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Tufts Medical Center
name: Harvard University
name: Johns Hopkins University
First posted: 2014-12-03
Enrollment: 2697
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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: 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Probability of Resolution of Nonadherence Within 30 Days
timeFrame: Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.
measure: Duration of Nonadherence Event
timeFrame: Participants were followed over a total of 6 months
Secondary outcomes:
measure: Probability of Physician Viewing Nonadherence Event Information
timeFrame: Participants were followed over a total of 6 months
measure: Probability of Pharmacist Action Triggered
timeFrame: Participants were followed over a total of 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Ira B Wilson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.