DiabetesCEDARNCT02087293
e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse Reactions
A study testing Intervention arm - automated call and phone-based pharmacist counseling in people with Diabetes and Depression, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the safety and effectiveness of treatment for patients taking FDA-approved medications for one of four common chronic conditions (diabetes, hypertension, insomnia, depression), with integrated management support by a pharmacist. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes, Depression, Insomnia
- What is being tested?
- Intervention arm - automated call and phone-based pharmacist counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38,400 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receives primary care at one of the Brigham-affiliated ambulatory care clinics
- has received a new prescription for an oral agent to treat diabetes, hypertension, depression, or insomnia
- prescribed new target drug within last month by a provider at one of the participating clinics
Who cannot join
- not a true "new start," i.e. patient new to clinic/health system
- patient prescribed the drug for short term use, i.e. less than a week's dose
- patient prescribed same drug less than 2 years prior
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the safety and effectiveness of treatment for patients taking FDA-approved medications for one of four common chronic conditions (diabetes, hypertension, insomnia, depression), with integrated management support by a pharmacist.
Specific Aim 2: To measure the reach, effectiveness, adoption and implementation of this integrated module for adult primary care patients in the Brigham and Women's Primary Care Practice-Based Research Network.
Read the detailed description
The study team has wide experience surveying primary care patients about medication problems, and has established that this is an important component of detecting and understanding ADEs among ambulatory patients. In the first study, 18% of primary care patients reported a problem due to a medication during the previous year, but this was documented in only 3% of medical records. A subsequent study found that 27% of patients reported a medication-related symptom, but that only 69% of patients discussed this symptom with their physician. Upon being notified via this automated pharmacovigilance, physicians changed therapy in response to 76% of these symptoms, and 21% symptoms that had not been previously discussed resulted in a preventable ADE and 2% resulted in a preventable ADE.
During the prior CERT, the investigators developed an interactive voice response system (IVRS) that interoperates with the health system EHR, and demonstrated that IVRS can be used to monitor ambulatory patients to assess adherence, medication related symptoms, and ADEs. This study builds on that initial work.
The safety of prescription drugs represents an ongoing public health concern. A study by the US General Accounting Office (GAO) found that 51% of all approved drugs have at least one serious ADE that was not recognized during the approval process, reflecting the careful selection and limited number of patients who participate in pre-approval trials. While pre-market studies detect commonly occurring ADEs and efficacy in rigorously selected participants, they are not designed to assess safety and effectiveness in the broader population of eventual users. While the FDA maintains a passive adverse event reporting system, it is estimated that only about 1% of all ADEs and 10% of serious ADEs are reported, and these case reports lack accurate denominators to estimate incidence. While efforts are underway to substantially expand capacity for active surveillance using electronic health records and claims data, these data may not fully capture the patient experience, as clinicians often do not fully document patients' symptoms.
Accurate ascertainment of ADEs and effectiveness in clinical practice requires real-time systems that integrate patient-reported information with clinician decision-making. Telephonic IVRS are a low-cost, sustainable way of reaching out to primary care populations, independent of a visit. In addition to monitoring for ADEs, this technology could be used to systematically assess treatment outcomes that are not commonly documented in the medical chart such as functional status, sleep, and mood.
This 5 year project will have three phases: (1) development and pilot testing of the integrated pharmacovigilance system; (2) implementation; and (3) assessment of the translation and dissemination of the system, including data collection from both patients and providers. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) conceptual model provides a framework to examine the success of translation and dissemination of this system, and will be used for the third phase of the project.
- Conditions
- Diabetes, Depression, Insomnia, Hypertension
- Being tested
- Intervention arm - automated call and phone-based pharmacist counseling
- Medical subject headings
- Diabetes Mellitus, Depression, Sleep Initiation and Maintenance Disorders, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm - automated call and phone-based pharmacist counselingBehavioural
patients receive automated phone call with questions about side effects and an opportunity to speak with a pharmacist
| Study group | Role | What they receive |
|---|---|---|
| Intervention group, IVR call, RPh counseling | Experimental | Group receives interactive voice response automated call asking about side effects of newly prescribed medications; has opportunity to speak with study pharmacist via phone about medication Receives: Behavioral: Intervention arm - automated call and phone-based pharmacist counseling |
| Control | No intervention | Intervention patients are matched with control patients; control patients have only chart review completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation of mediation
Was medication thought to be associated with adverse drug reaction discontinued in the patient chart?
Measured: 6-8 months after initial recruitment
Secondary outcomes (1)
Adverse drug reaction awareness
evidence of adverse drug reaction awareness in patient chart - ADR discussed with provider, dose changed, medication switched.
Measured: 6-8 months following recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2015
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- None (open label)
- Enrolment
- 38,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elissa Klinger, Brigham and Women's Hospital
- Investigators
- Gordon Schiff, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087293
- Sponsor's protocol ID
- 2012-P000210
- Acronym
- CEDAR
- Status last verified
- Aug 2015
- First submitted
- 11 Mar 2014
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Haas JS, Klinger E, Marinacci LX, Brawarsky P, Orav EJ, Schiff GD, Bates DW. Active pharmacovigilance and healthcare utilization. Am J Manag Care. 2012 Nov 1;18(11):e423-8.
PubMed 23198749Haas JS, Amato M, Marinacci L, Orav EJ, Schiff GD, Bates DW. Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting. Drug Saf. 2012 Aug 1;35(8):623-8. doi: 10.2165/11630650-000000000-00000.
PubMed 22764754Linder JA, Haas JS, Iyer A, Labuzetta MA, Ibara M, Celeste M, Getty G, Bates DW. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf. 2010 Dec;19(12):1211-5. doi: 10.1002/pds.2027.
PubMed 21155192Haas JS, Iyer A, Orav EJ, Schiff GD, Bates DW. Participation in an ambulatory e-pharmacovigilance system. Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):961-9. doi: 10.1002/pds.2006.
PubMed 20623512Schiff GD, Klinger E, Salazar A, Medoff J, Amato MG, John Orav E, Shaykevich S, Seoane EV, Walsh L, Fuller TE, Dykes PC, Bates DW, Haas JS. Screening for Adverse Drug Events: a Randomized Trial of Automated Calls Coupled with Phone-Based Pharmacist Counseling. J Gen Intern Med. 2019 Feb;34(2):285-292. doi: 10.1007/s11606-018-4672-7. Epub 2018 Oct 5.
PubMed 30291602
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse Reactions
- ClinicalTrials.gov ID
- NCT02087293
- Acronym / sponsor ID
- CEDAR / 2012-P000210
- Conditions
- Diabetes, Depression, Insomnia, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38,400 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 14 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aim 1: To develop a patient-reported, EHR-integrated system to actively monitor the safety and effectiveness of treatment for patients taking FDA-approved medications for one of four common chronic conditions (diabetes, hypertension, insomnia, depression), with integrated management support by a pharmacist.
Specific Aim 2: To measure the reach, effectiveness, adoption and implementation of this integrated module for adult primary care patients in the Brigham and Women's Primary Care Practice-Based Research Network.
Detailed description
The study team has wide experience surveying primary care patients about medication problems, and has established that this is an important component of detecting and understanding ADEs among ambulatory patients. In the first study, 18% of primary care patients reported a problem due to a medication during the previous year, but this was documented in only 3% of medical records. A subsequent study found that 27% of patients reported a medication-related symptom, but that only 69% of patients discussed this symptom with their physician. Upon being notified via this automated pharmacovigilance, physicians changed therapy in response to 76% of these symptoms, and 21% symptoms that had not been previously discussed resulted in a preventable ADE and 2% resulted in a preventable ADE.
During the prior CERT, the investigators developed an interactive voice response system (IVRS) that interoperates with the health system EHR, and demonstrated that IVRS can be used to monitor ambulatory patients to assess adherence, medication related symptoms, and ADEs. This study builds on that initial work.
The safety of prescription drugs represents an ongoing public health concern. A study by the US General Accounting Office (GAO) found that 51% of all approved drugs have at least one serious ADE that was not recognized during the approval process, reflecting the careful selection and limited number of patients who participate in pre-approval trials. While pre-market studies detect commonly occurring ADEs and efficacy in rigorously selected participants, they are not designed to assess safety and effectiveness in the broader population of eventual users. While the FDA maintains a passive adverse event reporting system, it is estimated that only about 1% of all ADEs and 10% of serious ADEs are reported, and these case reports lack accurate denominators to estimate incidence. While efforts are underway to substantially expand capacity for active surveillance using electronic health records and claims data, these data may not fully capture the patient experience, as clinicians often do not fully document patients' symptoms.
Accurate ascertainment of ADEs and effectiveness in clinical practice requires real-time systems that integrate patient-reported information with clinician decision-making. Telephonic IVRS are a low-cost, sustainable way of reaching out to primary care populations, independent of a visit. In addition to monitoring for ADEs, this technology could be used to systematically assess treatment outcomes that are not commonly documented in the medical chart such as functional status, sleep, and mood.
This 5 year project will have three phases: (1) development and pilot testing of the integrated pharmacovigilance system; (2) implementation; and (3) assessment of the translation and dissemination of the system, including data collection from both patients and providers. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) conceptual model provides a framework to examine the success of translation and dissemination of this system, and will be used for the third phase of the project.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group, IVR call, RPh counseling | Experimental | Behavioral: Intervention arm - automated call and phone-based pharmacist counselingGroup receives interactive voice response automated call asking about side effects of newly prescribed medications; has opportunity to speak with study pharmacist via phone about medication |
| Control | No intervention | –Intervention patients are matched with control patients; control patients have only chart review completed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- receives primary care at one of the Brigham-affiliated ambulatory care clinics
- has received a new prescription for an oral agent to treat diabetes, hypertension, depression, or insomnia
- prescribed new target drug within last month by a provider at one of the participating clinics
Key exclusion criteria (3 listed)
- not a true "new start," i.e. patient new to clinic/health system
- patient prescribed the drug for short term use, i.e. less than a week's dose
- patient prescribed same drug less than 2 years prior
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 |
|---|---|---|
| Intervention arm - automated call and phone-based pharmacist counselingpatients receive automated phone call with questions about side effects and an opportunity to speak with a pharmacist | Behavioural | Intervention group, IVR call, RPh counseling |
Primary outcome
Discontinuation of mediation
Time frame: 6-8 months after initial recruitment
Was medication thought to be associated with adverse drug reaction discontinued in the patient chart?
1 secondary outcome
Adverse drug reaction awareness
Time frame: 6-8 months following recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Background: PubMed 23198749Haas JS, Klinger E, Marinacci LX, Brawarsky P, Orav EJ, Schiff GD, Bates DW. Active pharmacovigilance and healthcare utilization. Am J Manag Care. 2012 Nov 1;18(11):e423-8.
- Background: PubMed 22764754Haas JS, Amato M, Marinacci L, Orav EJ, Schiff GD, Bates DW. Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting. Drug Saf. 2012 Aug 1;35(8):623-8. doi: 10.2165/11630650-000000000-00000.
- Background: PubMed 21155192Linder JA, Haas JS, Iyer A, Labuzetta MA, Ibara M, Celeste M, Getty G, Bates DW. Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting. Pharmacoepidemiol Drug Saf. 2010 Dec;19(12):1211-5. doi: 10.1002/pds.2027.
- Background: PubMed 20623512Haas JS, Iyer A, Orav EJ, Schiff GD, Bates DW. Participation in an ambulatory e-pharmacovigilance system. Pharmacoepidemiol Drug Saf. 2010 Sep;19(9):961-9. doi: 10.1002/pds.2006.
- Derived from this study: PubMed 30291602Schiff GD, Klinger E, Salazar A, Medoff J, Amato MG, John Orav E, Shaykevich S, Seoane EV, Walsh L, Fuller TE, Dykes PC, Bates DW, Haas JS. Screening for Adverse Drug Events: a Randomized Trial of Automated Calls Coupled with Phone-Based Pharmacist Counseling. J Gen Intern Med. 2019 Feb;34(2):285-292. doi: 10.1007/s11606-018-4672-7. Epub 2018 Oct 5.
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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.
Gordon Schiff, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm - automated call and phone-based pharmacist counseling in people with Diabetes and Depression, run by Brigham and Women's Hospital 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 4 Aug 2015. 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?
Results are not available in the source record.
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?
Discontinuation of mediation (time frame: 6-8 months after initial recruitment). 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 NCT02087293, which also lists 5 linked publications.
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 4 Aug 2015.