DiabetesPHARxMOSNCT02306122
Pharmacy Home Adherence Reporting and Monitoring Outcomes Study
A study testing Pharmacist calls patient unless physician cancels call, Patient nonadherence information sent to physician and Pharmacist calls patient if physician requests call in people with Diabetes and Hypertension, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Hypertension, Hypercholesterolemia
- What is being tested?
- Pharmacist calls patient unless physician cancels call, Patient nonadherence information sent to physician and Pharmacist calls patient if physician requests call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,697 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nudging Doctors to Collaborate With Pharmacists to Improve Medication Adherence
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.
Read the 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.
- Conditions
- Diabetes, Hypertension, Hypercholesterolemia
- Being tested
- Pharmacist calls patient unless physician cancels call, Patient nonadherence information sent to physician, Pharmacist calls patient if physician requests call, Doctor receives information and may be allowed certain actions
- Keywords
- medication adherence, choice architecture, pharmacy home
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hypercholesterolemia, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist calls patient unless physician cancels callBehavioural
Patient nonadherence information sent to physicianBehavioural
Pharmacist calls patient if physician requests callBehavioural
Doctor receives information and may be allowed certain actionsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Default patient default doctor | Experimental | Patient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Doctor receives information and may be allowed certain actions |
| Choice doctor | Experimental | Physician receives nonadherence information, and can choose to request pharmacist action Receives: 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 Receives: Behavioral: Doctor receives information and may be allowed certain actions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Participants were followed over a total of 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Participants were followed over a total of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startMar 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,697 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Tufts Medical Center, Harvard University, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Ira B Wilson, MD, MSc, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306122
- Sponsor's protocol ID
- 1010000295
- Other IDs
- 7RC4AG039072-02
- Acronym
- PHARxMOS
- Status last verified
- Dec 2021
- First submitted
- 2 Nov 2014
- Last updated
- 11 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31835278
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Doctors to Collaborate With Pharmacists to Improve Medication Adherence
- ClinicalTrials.gov ID
- NCT02306122
- Acronym / sponsor ID
- PHARxMOS / 1010000295
- Conditions
- Diabetes, Hypertension, Hypercholesterolemia
- Keywords
- medication adherence, choice architecture, pharmacy home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,697 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Tufts Medical Center, Harvard University, Johns Hopkins University
- Study start
- Mar 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Default patient default doctor | Experimental | Behavioral: Pharmacist calls patient unless physician cancels call, Behavioral: Patient nonadherence information sent to physicianPatient nonadherence information sent to physician; Pharmacist calls patient unless physician cancels call |
| Information patient default doctor | Experimental | Behavioral: Patient nonadherence information sent to physicianPatient nonadherence information sent to physician |
| Control patient default doctor | No intervention | –Control - no intervention |
| Choice patient choice doctor | Experimental | Behavioral: Patient nonadherence information sent to physician, Behavioral: Pharmacist calls patient if physician requests callPatient nonadherence information sent to physician; Pharmacist calls patient if physician requests call |
| Information patient choice doctor | Experimental | Behavioral: Patient nonadherence information sent to physicianPatient nonadherence information sent to physician |
| Control patient choice doctor | No intervention | –Control - no intervention |
| Information patient information doctor | Experimental | Behavioral: Patient nonadherence information sent to physicianPatient nonadherence information sent to physician |
| Control patient information doctor | No intervention | –Control - no intervention |
| Information doctor | Experimental | Behavioral: Doctor receives information and may be allowed certain actionsPhysician receives nonadherence information, but there is no opportunity for pharmacist action |
| Choice doctor | Experimental | Behavioral: Doctor receives information and may be allowed certain actionsPhysician receives nonadherence information, and can choose to request pharmacist action |
| Default doctor | Experimental | Behavioral: Doctor receives information and may be allowed certain actionsPhysician receives nonadherence information; pharmacist action will be triggered unless physician cancels action |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist calls patient unless physician cancels call | Behavioural | Default patient default doctor |
| Patient nonadherence information sent to physician | Behavioural | 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 | Behavioural | Choice patient choice doctor |
| Doctor receives information and may be allowed certain actions | Behavioural | Choice doctor, Default doctor, Information doctor |
Primary outcome
Probability of Resolution of Nonadherence Within 30 Days
Time frame: Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.
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.
Duration of Nonadherence Event
Time frame: Participants were followed over a total of 6 months
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.
2 secondary outcomes
Probability of Physician Viewing Nonadherence Event Information
Time frame: Participants were followed over a total of 6 months
Probability of Pharmacist Action Triggered
Time frame: Participants were followed over a total of 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31835278McConnell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira B Wilson, MD, MSc principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist calls patient unless physician cancels call, Patient nonadherence information sent to physician and Pharmacist calls patient if physician requests call in people with Diabetes and Hypertension, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of Resolution of Nonadherence Within 30 Days (time frame: Outcome measure examines fills within 30 days of a nonadherence event. Participants were followed over a total of 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.