Evidence map›Paper›PMID 40418742›Full record

Trial reportJournal of primary care & community health

From Trials to Practice: Implementing a Clinical Intervention in Community Settings.

Elizabeth M Vaughan, Xiaoying Yu, Victor J Cardenas, Craig A Johnston, Salim S Virani, Ashok Balasubramanyam, Christie M Ballantyne, Aanand D Naik

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of primary care & community health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

8 authors.

Elizabeth M VaughanUniversity of Texas Medical Branch, Galveston, USA.ORCID 0000-0001-9565-0134
Xiaoying YuUniversity of Texas Medical Branch, Galveston, USA.
Victor J CardenasUniversity of Texas Medical Branch, Galveston, USA.
Craig A JohnstonUniversity of Houston, TX, USA.
Salim S ViraniBaylor College of Medicine, Houston, TX, USA.
Ashok BalasubramanyamBaylor College of Medicine, Houston, TX, USA.
Christie M BallantyneBaylor College of Medicine, Houston, TX, USA.
Aanand D NaikUniversity of Texas School of Public Health, Houston, USA.

Funding

Implementing Sustainable Type 2 Diabetes Care: A Hybrid Type 1 RCT to Test a Community Health Worker-Led Evidence-Based InterventionR01DK129474 · NIDDK · UNIVERSITY OF TEXAS MED BR GALVESTON · PI Elizabeth M Vaughan · 2021 to 2026
$4.1M
NIDDK NIH HHS R01 DK129474
6 · The paper itself

Abstract

INTRODUCTION/

objectivesDiabetes increases the risk of complications, especially for vulnerable populations. Our previous randomized clinical trial (RCT), TIME (

methodsWe conducted a 12-month RCT at a nonprofit community clinic using the Consolidated Framework for Implementation Research (CFIR). Participants, Hispanic adults without insurance and with type 2 diabetes (N = 58; 29/arm), were randomized to TIME (intervention) or usual care (control). The intervention included monthly group visits and weekly CHW mHealth contact (6 months, Action Phase), followed by quarterly visits and bi-monthly mHealth contact (6 months, Maintenance Phase). The research team provided tele-mentoring to the clinic team throughout the intervention. Outcomes included implementation measures including acceptability, adoption, appropriateness, cost, feasibility, fidelity, satisfaction, and effectiveness. KEY

resultsThe program showed high levels of fidelity (direct observation), adoption (CHW-participant contact: 844 successes of 957 attempts [88.2%]), and feasibility (3.4% attrition). The intervention's net savings was $16,435 ($566/participant). At 6 months, intervention participants had greater HbA1c reductions (-0.85% vs 0.35% [δ = 1.2%];

conclusionsTIME met key early implementation measures, including strong engagement at both clinic and participant levels, while demonstrating cost savings and significant clinical improvements. These results support the transition of TIME from efficacy trials to practical, community-based diabetes care. Larger studies are needed to further evaluate these findings.

Indexed as

Community Health WorkersDiabetes Mellitus, Type 2TelemedicineAdultAgedFemaleHispanic or LatinoHumansMaleMiddle AgedPatient Satisfactioncommunity clinicdiabetesdiabetes group visits or shared medical appointmentsHispanic or Latino(a)implementationpatient navigators or community health workerstelehealth

Identifiers

PMID40418742
PMCPMC12106995

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.