Pharmacy Home Adherence Reporting and Monitoring Outcomes Study

NCT ID: NCT02306122

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2697 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-02-28

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.

Conditions

Diabetes; Hypertension; Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Default patient default doctor

Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call

Group Type: EXPERIMENTAL

Pharmacist calls patient unless physician cancels call

Intervention Type: BEHAVIORAL

Patient nonadherence information sent to physician

Intervention Type: BEHAVIORAL

Information patient default doctor

Patient nonadherence information sent to physician

Group Type: EXPERIMENTAL

Patient nonadherence information sent to physician

Intervention Type: BEHAVIORAL

Control patient default doctor

Control - no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Choice patient choice doctor

Patient nonadherence information sent to physician; Pharmacist calls patient if physician requests call

Group Type: EXPERIMENTAL

Patient nonadherence information sent to physician

Intervention Type: BEHAVIORAL

Pharmacist calls patient if physician requests call

Intervention Type: BEHAVIORAL

Information patient choice doctor

Patient nonadherence information sent to physician

Group Type: EXPERIMENTAL

Patient nonadherence information sent to physician

Intervention Type: BEHAVIORAL

Control patient choice doctor

Control - no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Information patient information doctor

Patient nonadherence information sent to physician

Group Type: EXPERIMENTAL

Patient nonadherence information sent to physician

Intervention Type: BEHAVIORAL

Control patient information doctor

Control - no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Information doctor

Physician receives nonadherence information, but there is no opportunity for pharmacist action

Group Type: EXPERIMENTAL

Doctor receives information and may be allowed certain actions

Intervention Type: BEHAVIORAL

Choice doctor

Physician receives nonadherence information, and can choose to request pharmacist action

Group Type: EXPERIMENTAL

Doctor receives information and may be allowed certain actions

Intervention Type: BEHAVIORAL

Default doctor

Physician receives nonadherence information; pharmacist action will be triggered unless physician cancels action

Group Type: EXPERIMENTAL

Doctor receives information and may be allowed certain actions

Intervention Type: BEHAVIORAL

Interventions

Pharmacist calls patient unless physician cancels call

Intervention Type: BEHAVIORAL

Patient nonadherence information sent to physician

Intervention Type: BEHAVIORAL

Pharmacist calls patient if physician requests call

Intervention Type: BEHAVIORAL

Doctor receives information and may be allowed certain actions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ira B Wilson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31835278 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

7RC4AG039072-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1010000295

Identifier Type: -

Identifier Source: org_study_id