Substance AbuseNCT02963948
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 3
An observational study of Substance Abuse, run by NYU Langone Health at 2 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 medical staff to offer appropriate interventions by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Meetings with implementation leader(s), the SAAS survey and Patient surveys
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 113,123 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2018to 9 Sep 2019
- 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: Number of subjects: * Approximately 40 medical staff will be enrolled for the focus groups * Approximately 100 medical staff will be surveyed using Substance Abuse Attitude Survey (SAAS) * Approximately 200 patients at a Wave 1 clinic Clinical implementation leaders Clinical implementation leaders are practicing primary care physicians (PCPs) who provide feedback to the research team and support their colleagues on implementing screening, using the CDS, and carrying out clinical interventions and referrals to address unhealthy substance use. One or two primary care providers will be identified from each participating clinic will advise the research team on implementation and to serve as a resource for their colleagues.
Who may be able to join
- English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.
Who cannot join
- Inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
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 medical staff to offer appropriate interventions by providing clinical decision support (CDS) and a mechanism for making referrals to addiction treatment. Investigators 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
SPECIFIC AIMS
- To program the NIDA CTN CDEs, the NIDA/ASAM electronic Clinical Quality Measure (eCQM), and a lean decision support module into Epic.
- To study the process of implementation of screening and referral using Epic-driven CDEs and CDS in three primary care clinics / practices, including defining potential barriers and facilitators to their adoption.
- To evaluate the impact of implementation on:
- Patient level outcomes (diagnosis, treatment referral);
- Medical staff level outcomes (screening and assessment, clinical interventions including counseling and treatment referral); and
- Systems level outcomes (logistics and costs of introducing the CDEs, feasibility).
- Conditions
- Substance Abuse
- Being tested
- Meetings with implementation leader(s), the SAAS survey, Patient surveys
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meetings with implementation leader(s)Behavioural
The perceived appropriateness of the intervention to medical staff will affect an intervention's initial adoption as well as sustainability. We will assess this through focus groups with staff, conducted approximately 1-2 months after implementation of the screening and CDS tools.
the SAAS surveyBehavioural
Medical staff will be surveyed using the Substance Abuse Attitude Survey (SAAS) to gather information about attitudes from medical staff who do not participate in the focus groups, or may be uncomfortable sharing negative attitudes in a group of their peers. The SAAS is a validated multidimensional instrument that evaluates physician attitudes toward substance-using patients. It includes specific measures of attitudes toward permissiveness, treatment intervention, stereotypes, treatment optimism, and moralism, and has been used in prior studies of primary care physicians. Collecting information on staff attitudes toward substance users and substance use interventions will be helpful to inform about any sources for low adoption of the tools, and any needs for additional provider education and training.
Patient surveysBehavioural
Patient surveys regarding attitudes toward substance use screening and interventions in the primary care clinic will be distributed to patients presenting for care, regardless of whether they completed screening, at regular time periods throughout this study phase. The survey will be conducted for 1 week at the following approximate intervals following successful implementation: 1 month, 4 months, 7 months, and 10 months
| Study group | Role | What they receive |
|---|---|---|
| Clinic A1 | Not described Receives: Behavioral: Meetings with implementation leader(s); Behavioral: the SAAS survey; Behavioral: Patient surveys | |
| Clinic A2 | Not described Receives: Behavioral: Meetings with implementation leader(s); Behavioral: the SAAS survey; Behavioral: Patient surveys | |
| Clinic B1 | Not described Receives: Behavioral: Meetings with implementation leader(s); Behavioral: the SAAS survey; Behavioral: Patient surveys | |
| Clinic B2 | Not described Receives: Behavioral: Meetings with implementation leader(s); Behavioral: the SAAS survey; Behavioral: Patient surveys | |
| Clinic B3 | Not described Receives: Behavioral: Meetings with implementation leader(s); Behavioral: the SAAS survey; Behavioral: Patient surveys | |
| Clinic B4 | Not described Receives: Behavioral: Meetings with implementation leader(s); Behavioral: the SAAS survey; Behavioral: Patient surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of screening
% patients presenting for primary care visits who were screened in the past 12 months
Measured: 12 Months
Provider adoption of CDS
% patients with positive screens for which CDS was launched and completed
Measured: 12 Months
Referral of high risk patients
% patients with high risk use who received referral to specialty care
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start28 Feb 2018
- Primary completion9 Sep 2019
- Study completion9 Sep 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 Substance AbuseStudies 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
- Prospective
- Enrolment
- 113,123 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jennifer McNeely, PhD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963948
- Sponsor's protocol ID
- 16-01373
- Other IDs
- CTN-0062Ot
- 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, Adam A, Rotrosen J, Wakeman SE, Wilens TE, Kannry J, Rosenthal RN, Wahle A, Pitts S, Farkas S, Rosa C, Peccoralo L, Waite E, Vega A, Kent J, Craven CK, Kaminski TA, Firmin E, Isenberg B, Harris M, Kushniruk A, Hamilton L. Comparison of Methods for Alcohol and Drug Screening in Primary Care Clinics. JAMA Netw Open. 2021 May 3;4(5):e2110721. doi: 10.1001/jamanetworkopen.2021.10721.
PubMed 34014326
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 3
- ClinicalTrials.gov ID
- NCT02963948
- Acronym / sponsor ID
- 16-01373
- Conditions
- Substance Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113,123 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, National Institute on Drug Abuse (NIDA)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 15 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 medical staff to offer appropriate interventions by providing clinical decision support (CDS) and a mechanism for making referrals to addiction treatment. Investigators 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
SPECIFIC AIMS
- To program the NIDA CTN CDEs, the NIDA/ASAM electronic Clinical Quality Measure (eCQM), and a lean decision support module into Epic.
- To study the process of implementation of screening and referral using Epic-driven CDEs and CDS in three primary care clinics / practices, including defining potential barriers and facilitators to their adoption.
- To evaluate the impact of implementation on:
- Patient level outcomes (diagnosis, treatment referral);
- Medical staff level outcomes (screening and assessment, clinical interventions including counseling and treatment referral); and
- Systems level outcomes (logistics and costs of introducing the CDEs, feasibility).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Clinic A1 | – | Behavioral: Meetings with implementation leader(s), Behavioral: the SAAS survey, Behavioral: Patient surveys |
| Clinic A2 | – | Behavioral: Meetings with implementation leader(s), Behavioral: the SAAS survey, Behavioral: Patient surveys |
| Clinic B1 | – | Behavioral: Meetings with implementation leader(s), Behavioral: the SAAS survey, Behavioral: Patient surveys |
| Clinic B2 | – | Behavioral: Meetings with implementation leader(s), Behavioral: the SAAS survey, Behavioral: Patient surveys |
| Clinic B3 | – | Behavioral: Meetings with implementation leader(s), Behavioral: the SAAS survey, Behavioral: Patient surveys |
| Clinic B4 | – | Behavioral: Meetings with implementation leader(s), Behavioral: the SAAS survey, Behavioral: Patient surveys |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Number of subjects: * Approximately 40 medical staff will be enrolled for the focus groups * Approximately 100 medical staff will be surveyed using Substance Abuse Attitude Survey (SAAS) * Approximately 200 patients at a Wave 1 clinic Clinical implementation leaders Clinical implementation leaders are practicing primary care physicians (PCPs) who provide feedback to the research team and support their colleagues on implementing screening, using the CDS, and carrying out clinical interventions and referrals to address unhealthy substance use. One or two primary care providers will be identified from each participating clinic will advise the research team on implementation and to serve as a resource for their colleagues.
Key inclusion criteria (1 listed)
- English speaking adult individuals age 18 years or older, and current employee or patient at a Wave 1 clinic with direct patient contact.
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 |
|---|---|---|
| Meetings with implementation leader(s)The perceived appropriateness of the intervention to medical staff will affect an intervention's initial adoption as well as sustainability. We will assess this through focus groups with staff, conducted approximately 1-2 months after implementation of the screening and CDS tools. | Behavioural | Clinic A1, Clinic A2, Clinic B1, Clinic B2, Clinic B3, Clinic B4 |
| the SAAS surveyMedical staff will be surveyed using the Substance Abuse Attitude Survey (SAAS) to gather information about attitudes from medical staff who do not participate in the focus groups, or may be uncomfortable sharing negative attitudes in a group of their peers. The SAAS is a validated multidimensional instrument that evaluates physician attitudes toward substance-using patients. It includes specific measures of attitudes toward permissiveness, treatment intervention, stereotypes, treatment optimism, and moralism, and has been used in prior studies of primary care physicians. Collecting information on staff attitudes toward substance users and substance use interventions will be helpful to inform about any sources for low adoption of the tools, and any needs for additional provider education and training. | Behavioural | Clinic A1, Clinic A2, Clinic B1, Clinic B2, Clinic B3, Clinic B4 |
| Patient surveysPatient surveys regarding attitudes toward substance use screening and interventions in the primary care clinic will be distributed to patients presenting for care, regardless of whether they completed screening, at regular time periods throughout this study phase. The survey will be conducted for 1 week at the following approximate intervals following successful implementation: 1 month, 4 months, 7 months, and 10 months | Behavioural | Clinic A1, Clinic A2, Clinic B1, Clinic B2, Clinic B3, Clinic B4 |
Primary outcome
Adoption of screening
Time frame: 12 Months
% patients presenting for primary care visits who were screened in the past 12 months
Provider adoption of CDS
Time frame: 12 Months
% patients with positive screens for which CDS was launched and completed
Referral of high risk patients
Time frame: 12 Months
% patients with high risk use who received referral to specialty care
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 34014326McNeely J, Adam A, Rotrosen J, Wakeman SE, Wilens TE, Kannry J, Rosenthal RN, Wahle A, Pitts S, Farkas S, Rosa C, Peccoralo L, Waite E, Vega A, Kent J, Craven CK, Kaminski TA, Firmin E, Isenberg B, Harris M, Kushniruk A, Hamilton L. Comparison of Methods for Alcohol and Drug Screening in Primary Care Clinics. JAMA Netw Open. 2021 May 3;4(5):e2110721. doi: 10.1001/jamanetworkopen.2021.10721.
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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.
Jennifer McNeely, PhD principal investigator
New York University Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse, run by NYU Langone Health at 2 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 2 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?
Adoption of screening (time frame: 12 Months). 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 NCT02963948, 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.