Pharmacy Home Adherence Reporting and Monitoring Outcomes Study

NCT02306122 | Completed Results

• 2 other identifiers: 10100002957RC4AG039072-02
• Study Type: interventional
• Target: 2,697
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Hypertension; Hypercholesterolemia

Keywords

medication adherence; choice architecture; pharmacy home

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Probability of Physician Viewing Nonadherence Event Information

  Participants were followed over a total of 6 months

• Probability of Pharmacist Action Triggered

  Participants were followed over a total of 6 months

Study Arms (11)

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

Control patient choice doctor

NO INTERVENTION

Control - no intervention

Information patient information doctor

EXPERIMENTAL

Patient nonadherence information sent to physician

Behavioral: Patient nonadherence information sent to physician

Control patient information doctor

NO INTERVENTION

Control - no intervention

Information doctor

EXPERIMENTAL

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

Behavioral: Doctor receives information and may be allowed certain actions

Choice doctor

EXPERIMENTAL

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

Behavioral: Doctor receives information and may be allowed certain actions

Default doctor

EXPERIMENTAL

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

Behavioral: Doctor receives information and may be allowed certain actions

Interventions

Pharmacist calls patient unless physician cancels call BEHAVIORAL

Default patient default doctor

Patient nonadherence information sent to physician BEHAVIORAL

Choice patient choice doctor; Default patient default doctor; Information patient choice doctor; Information patient default doctor; Information patient information doctor

Pharmacist calls patient if physician requests call BEHAVIORAL

Choice patient choice doctor

Doctor receives information and may be allowed certain actions BEHAVIORAL

Choice doctor; Default doctor; Information doctor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Brown University

Providence, Rhode Island, 02913, United States

Location

Related Publications (1)

• 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.

  PMID: 31835278 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hypercholesterolemia; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and 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.

Results Point of Contact

• Title: Joanne Michaud
• Organization: Brown University

joanne_michaud@brown.edu

401-863-9317

Study Officials

• Ira B Wilson, MD, MSc

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: December 3, 2014
• Study Start: March 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)