- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974335
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusettes General Hospital
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health and Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Must be a current primary care clinic patient
Exclusion Criteria:
- Inability to provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient level outcomes: diagnosis, and treatment referral
Time Frame: 1 Year
|
1 Year
|
Provider level outcomes: screening and assessment, and clinical interventions including counseling and treatment referral.
Time Frame: 1 year
|
1 year
|
Systems level outcomes: logistics and costs of introducing the CDEs.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer McNeely, New York University Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-01948
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Addiction
-
The Hong Kong Polytechnic UniversityRecruiting
-
City University of Hong KongCompletedQuality of Life | Psychological Distress | Internet Gaming Disorder | Social Media Addiction | Smartphone AddictionChina
-
Gazi UniversityRecruitingAddiction | Physical Inactivity | Social Media AddictionTurkey
-
The Hong Kong Polytechnic UniversityRecruitingPrevalence of Internet Addiction and it's Effects on Psychological Well-being of Adults in Hong KongInternet AddictionHong Kong
-
Dr. Wang Man-PingActive, not recruiting
-
Daegu Catholic University Medical CenterCompletedInternet AddictionKorea, Republic of
-
Mustafa YumusakCumhuriyet UniversityNot yet recruitingSmartphone Addiction | Students, NursingTurkey
-
Hacettepe UniversityRecruitingPostural; Defect | Dual Task | Smartphone AddictionTurkey
-
Kutahya Health Sciences UniversityCompletedMental Fatigue | Smartphone AddictionTurkey
-
Bar-Ilan University, IsraelRecruitingInfant Behavior | Breastfeeding | Mother-Infant Interaction | Smartphone AddictionIsrael
Clinical Trials on Interviews with Stakeholders
-
Maastricht Radiation OncologyMaastricht University Medical Center; The Netherlands Cancer InstituteCompletedLarynx CancerNetherlands
-
Maastricht Radiation OncologyMaastricht University Medical Center; VieCuri Medical Centre; Zuyderland Medical... and other collaboratorsCompletedProstate CancerNetherlands
-
King's College LondonCompleted
-
University Hospital, MontpellierResearch department, unknowns, Strategic & innovation consulting, Paris (anthropologists) and other collaboratorsCompletedJuvenile Idiopathic ArthritisFrance
-
University Hospital, BordeauxCompletedFrom the Model to the Adaptation of a Therapeutic Education Program (TEP) in Cancer Research (MODAP)Health Services ResearchFrance
-
Institut Paoli-CalmettesNot yet recruiting
-
Centre Hospitalier Universitaire DijonCompletedDevelopment DisordersFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingAdolescent | Anorexia Nervosa | Psychotropic DrugsFrance
-
Memorial Sloan Kettering Cancer CenterMcMaster University; Hospital for Special Surgery, New YorkCompletedBreast CancerUnited States
-
Centre Oscar LambretUniversity Hospital, LilleUnknown