AddictionNCT02974335
A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings ("CDE-EHR-PC" Study), Phase 1
An observational study of Addiction, run by NYU Langone Health at 3 sites in United States.
Trial summary
This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and utilizing the CDEs in clinical practice requires a strategy for implementing screening to collect substance use information that populates the CDEs, and assisting primary care providers to offer appropriate interventions by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction
- What is being tested?
- Interviews with Stakeholders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 67 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jul 2017to 5 Apr 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the three clinics where we plan to implement study Phases 2-4. Clinic staff will give recruitment flyers to all patients registering for appointments in the week prior to each focus group. Potential participants who are interested in participating will call the Research Coordinator, who will assess eligibility and schedule them for the appropriate group. Groups will be divided based on age; one group will include participants under age 50, and a second group will include those age 50 and over. This grouping strategy is chosen because individuals in these age groups are anticipated to differ in their substance use patterns, medical needs, and concerns about screening procedures.
Who may be able to join
- Must be a current primary care clinic patient
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusettes General Hospital
Boston, Massachusetts, 02114
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Oregon Health and Science University
Portland, Oregon, 97239
About this study
This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and utilizing the CDEs in clinical practice requires a strategy for implementing screening to collect substance use information that populates the CDEs, and assisting primary care providers to offer appropriate interventions by providing clinical decision support (CDS) and a mechanism for making referrals to addiction treatment. We aim to maximize the efficient adoption of screening, CDS, and treatment referrals by integrating all of these activities into the electronic health record (EHR).
The study will be conducted at three sites, representing three large health systems. Each phase will include deliverables essential to move to the next phase, and an independent Advisory Committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase. Based on progress during earlier phases, the Advisory Committee may recommend expansion to additional clinics or health systems during the second part of Phase 4.
Read the detailed description
Phase 1 involves identifying the optimal screening tools and approaches for capturing CDE data, programming the screening tools and CDEs into the Epic EHR, and soliciting stakeholder input regarding implementation strategies for screening and clinical interventions (including treatment referrals) to address substance use.
In the KTA framework, Phase 1 addresses the first steps in the action cycle, which are to identify, review, and select the tools that are to be implemented; adapt tools to the local context; assess barriers to use of the tools; and begin the process of implementation by programming these tools into the Epic EHR. We will accomplish these steps primarily through interviews and focus groups with key stakeholders. The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3.
Research Questions and Aims
The research questions that Phase 1 seeks to address are:
- Where should screening and initial assessment occur, and who should administer the screening and assessment questionnaires?
- Is it better to screen for drugs only, or for drugs and alcohol, or for drugs, alcohol and tobacco? Should screening also include depression (e.g., PHQ2 and PHQ9)? Should screening be embedded in a broad behavioral health screen (e.g., a comprehensive health risk assessment such as My Own Health Report (30))?
The specific aim that corresponds to Phase 1 is Aim 1: To program the NIDA CTN CDEs and a lean decision support module into Epic. This phase will also define potential barriers and facilitators to the adoption of the CDEs and CDS, which is a component of Specific Aim 2.
- Conditions
- Addiction
- Being tested
- Interviews with Stakeholders
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews with StakeholdersBehavioural
The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Providers (PCPs) | Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems. Receives: Behavioral: Interviews with Stakeholders | |
| Medical Assistants (MAs) + Registered Nurses (RNs) | Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems. Receives: Behavioral: Interviews with Stakeholders | |
| Patients | Key stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems. Receives: Behavioral: Interviews with Stakeholders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient level outcomes: diagnosis, and treatment referral
Measured: 1 Year
Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.
Measured: 1 year
Systems level outcomes: logistics and costs of introducing the CDEs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start25 Jul 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 67 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Oregon Health and Science University, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Jennifer McNeely, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974335
- Sponsor's protocol ID
- 14-01948
- Status last verified
- Aug 2022
- First submitted
- 10 Nov 2016
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McNeely J, Kumar PC, Rieckmann T, Sedlander E, Farkas S, Chollak C, Kannry JL, Vega A, Waite EA, Peccoralo LA, Rosenthal RN, McCarty D, Rotrosen J. Barriers and facilitators affecting the implementation of substance use screening in primary care clinics: a qualitative study of patients, providers, and staff. Addict Sci Clin Pract. 2018 Apr 9;13(1):8. doi: 10.1186/s13722-018-0110-8.
PubMed 29628018
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phased-Implementation Feasibility and Proof-of-Concept Study to Assess Incorporating the NIDA CTN Common Data Elements (CDEs) Into the Electronic Health Record (EHR) in Large Primary Care Settings ("CDE-EHR-PC" Study), Phase 1
- ClinicalTrials.gov ID
- NCT02974335
- Acronym / sponsor ID
- 14-01948
- Conditions
- Addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Oregon Health and Science University, Massachusetts General Hospital
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 28 Nov 2016 (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.
This is a 4-phase study to implement the NIDA CDEs in primary care settings. Collecting and utilizing the CDEs in clinical practice requires a strategy for implementing screening to collect substance use information that populates the CDEs, and assisting primary care providers to offer appropriate interventions by providing clinical decision support (CDS) and a mechanism for making referrals to addiction treatment. We aim to maximize the efficient adoption of screening, CDS, and treatment referrals by integrating all of these activities into the electronic health record (EHR).
The study will be conducted at three sites, representing three large health systems. Each phase will include deliverables essential to move to the next phase, and an independent Advisory Committee will review progress and make recommendations at each transition about how best to progress to each subsequent phase. Based on progress during earlier phases, the Advisory Committee may recommend expansion to additional clinics or health systems during the second part of Phase 4.
Detailed description
Phase 1 involves identifying the optimal screening tools and approaches for capturing CDE data, programming the screening tools and CDEs into the Epic EHR, and soliciting stakeholder input regarding implementation strategies for screening and clinical interventions (including treatment referrals) to address substance use.
In the KTA framework, Phase 1 addresses the first steps in the action cycle, which are to identify, review, and select the tools that are to be implemented; adapt tools to the local context; assess barriers to use of the tools; and begin the process of implementation by programming these tools into the Epic EHR. We will accomplish these steps primarily through interviews and focus groups with key stakeholders. The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3.
Research Questions and Aims
The research questions that Phase 1 seeks to address are:
- Where should screening and initial assessment occur, and who should administer the screening and assessment questionnaires?
- Is it better to screen for drugs only, or for drugs and alcohol, or for drugs, alcohol and tobacco? Should screening also include depression (e.g., PHQ2 and PHQ9)? Should screening be embedded in a broad behavioral health screen (e.g., a comprehensive health risk assessment such as My Own Health Report (30))?
The specific aim that corresponds to Phase 1 is Aim 1: To program the NIDA CTN CDEs and a lean decision support module into Epic. This phase will also define potential barriers and facilitators to the adoption of the CDEs and CDS, which is a component of Specific Aim 2.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Care Providers (PCPs) | – | Behavioral: Interviews with StakeholdersKey stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems. |
| Medical Assistants (MAs) + Registered Nurses (RNs) | – | Behavioral: Interviews with StakeholdersKey stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems. |
| Patients | – | Behavioral: Interviews with StakeholdersKey stakeholders including: informatics/Epic leaders, medical providers, and patients from the two health systems that will be involved in the study, as well as national health information technology leaders from other large health systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the three clinics where we plan to implement study Phases 2-4. Clinic staff will give recruitment flyers to all patients registering for appointments in the week prior to each focus group. Potential participants who are interested in participating will call the Research Coordinator, who will assess eligibility and schedule them for the appropriate group. Groups will be divided based on age; one group will include participants under age 50, and a second group will include those age 50 and over. This grouping strategy is chosen because individuals in these age groups are anticipated to differ in their substance use patterns, medical needs, and concerns about screening procedures.
Key inclusion criteria (1 listed)
- Must be a current primary care clinic patient
Key exclusion criteria (1 listed)
- Inability to provide informed consent
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 |
|---|---|---|
| Interviews with StakeholdersThe information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3. | Behavioural | Medical Assistants (MAs) + Registered Nurses (RNs), Patients, Primary Care Providers (PCPs) |
Primary outcome
Patient level outcomes: diagnosis, and treatment referral
Time frame: 1 Year
Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.
Time frame: 1 year
Systems level outcomes: logistics and costs of introducing the CDEs.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Results publication: PubMed 29628018McNeely J, Kumar PC, Rieckmann T, Sedlander E, Farkas S, Chollak C, Kannry JL, Vega A, Waite EA, Peccoralo LA, Rosenthal RN, McCarty D, Rotrosen J. Barriers and facilitators affecting the implementation of substance use screening in primary care clinics: a qualitative study of patients, providers, and staff. Addict Sci Clin Pract. 2018 Apr 9;13(1):8. doi: 10.1186/s13722-018-0110-8.
Related trials for Addiction
Enrolling by invitationObservational study
Addictions Neuroclinical Assessment (ANA)
Normal Physiology, Alcohol Use Disorder
Active, not recruiting
Pain Self-Management and Treatment Engagement for Patients Taking Opioids
Chronic Pain, Opioid Use Disorder
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
Not yet recruiting
The Impact of Equine-Assisted Therapy on Mental Health and Addictive Behaviors in Patients Receiving Addiction Treatment
Equine-assisted Therapy, Addiction
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.
Jennifer McNeely principal investigator
New York University Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, run by NYU Langone Health at 3 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient level outcomes: diagnosis, and treatment referral (time frame: 1 Year). The study lists 3 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 NCT02974335, 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 29 Aug 2022.