Evidence map›Paper›PMID 35927740›Full record

ArticleTrials2022

A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project.

Jennifer B Levin, Farren Briggs, Carol Blixen, Mark Bauer, Douglas Einstadter, Jeffrey M Albert, Celeste Weise, Nicole Woods, Edna Fuentes-Casiano, Kristin A Cassidy and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04622150 (Effectiveness RCT of Customized Adherence Enhancement), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04622150 nacompletednot on this map

Effectiveness RCT of Customized Adherence Enhancement

TypeinterventionalSponsorCase Western Reserve UniversityRan2022 to 2026Enrolled190ConditionsBipolar DisorderArmsCustomized Adherence Enhancement (CAE), Enhanced Treatment as Usual (eTAU)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Jennifer B LevinDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA. jennifer.levin@uhhospitals.org.ORCID http://orcid.org/0000-0003-1214-0636
Farren BriggsDepartment of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH, USA.ORCID http://orcid.org/0000-0002-4037-4731
Carol BlixenDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Mark BauerDepartment of Psychiatry, Harvard Medical School, Boston, MA, USA.
Douglas EinstadterDepartment of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Jeffrey M AlbertDepartment of Population and Quantitative Health Sciences, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Celeste WeiseDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Nicole WoodsDepartment of Psychiatry, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Edna Fuentes-CasianoDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Kristin A CassidyDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Julie RentschDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Kaylee SarnaDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
Martha SajatovicDepartment of Psychiatry, Case Western Reserve University School of Medicine, Cleveland, OH, USA.
University School · USUniversity Hospitals of Cleveland · USCase Western Reserve University · USHarvard University · USMetroHealth · US

Funding

Effectiveness RCT of Customized Adherence EnhancementR01MH119487 · NIMH · CASE WESTERN RESERVE UNIVERSITY · PI LEVIN, JENNIFER BETH, SAJATOVIC, MARTHA X · 2020 to 2024
$3.6M
Foundation for the National Institutes of Health R01MH119487NIMH NIH HHS R01 MH119487
6 · The paper itself

Abstract

backgroundMood-stabilizing medications are a cornerstone of treatment for people with bipolar disorder, though approximately half of these individuals are poorly adherent with their medication, leading to negative and even severe health consequences. While a variety of approaches can lead to some improvement in medication adherence, there is no single approach that has superior adherence enhancement and limited data on how these approaches can be implemented in clinical settings. Existing data have shown an increasing need for virtual delivery of care and interactive telemedicine interventions may be effective in improving adherence to long-term medication.

methodsCustomized adherence enhancement (CAE) is a brief, practical bipolar-specific approach that identifies and targets individual patient adherence barriers for intervention using a flexibly administered modular format that can be delivered via telehealth communications. CAE is comprised of up to four standard treatment modules including Psychoeducation, Communication with Providers, Medication Routines, and Modified Motivational Interviewing. Participants will attend assigned module sessions with an interventionist based on their reasons for non-adherence and will be assessed for adherence, functioning, bipolar symptoms, and health resource use across a 12-month period. Qualitative and quantitative data will also be collected to assess barriers and facilitators to CAE implementation and reach and adoption of CAE among clinicians in the community. DISCUSSION: The proposed study addresses the need for practical adherence interventions that are effective, flexible, and designed to adapt to different settings and patients. By focusing on a high-risk, vulnerable group of people with bipolar disorder, and refining an evidence-based approach that will integrate into workflow of public-sector care and community mental health clinics, there is substantial potential for improving bipolar medication adherence and overall health outcomes on a broad level.

trial registrationThe study was registered on ClinicalTrials.gov NCT04622150 on November 9, 2020.

Indexed as

Bipolar DisorderMotivational InterviewingHumansMedication AdherenceRandomized Controlled Trials as TopicBipolar disorderManic-depressive disorderMedication adherenceRandomized controlled trialTelehealth

Identifiers

PMID35927740
PMCPMC9351150
OpenAlexW4289754903

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.