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RCT·emergency medicine, public health, clinical trial, family medicine, internal medicine·PMC10399826

Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania

PLOS ONE · 15 authors, 9 centres

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TL;DR

This feasibility study evaluated a pragmatic randomized adaptive trial design for a culturally adapted brief negotiational interview (PPKAY) to reduce harmful alcohol use among injury patients in a Tanzanian emergency department. The trial design, intervention, and use of text message boosters were found to be feasible and acceptable, with good recruitment, retention, and intervention fidelity.

Full summary

1,029 CHARS

This single-blind, parallel, adaptive, multi-stage, block-randomized controlled trial evaluated the feasibility of conducting a pragmatic randomized adaptive clinical trial (PRACT) for a nurse-driven brief negotiational interview (PPKAY) to reduce harmful alcohol use among injury patients in a low-income country emergency department. The study used the RE-AIM framework. From 181 screened patients, 75 were enrolled. The trial demonstrated feasible recruitment and retention, with 80% follow-up at 6 weeks, 82.7% at 3 months, and 84% at 6 months. Implementation showed high PPKAY fidelity (76%) and SMS delivery (74%). Patient acceptance was positive, with 100% perceiving a positive behavioral impact. The study concludes the trial design and intervention are feasible and acceptable, supporting a full-scale effectiveness trial. Limitations include the small sample size not powered for effect size, potential generalizability issues due to requiring mobile phone access, and possible response bias in acceptability measures.

STUDY TYPE

RCT

SPECIALTY

emergency medicine

SUMMARISED BY

AI pipeline

FIDELITY CHECK

100% · A

ORIGINAL PAPER

PMC10399826

Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania

PLOS ONE

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ABSTRACT

Abstract Introduction Low-resourced settings often lack personnel and infrastructure for alcohol use disorder treatment. We culturally adapted a Brief Negotiational Interview (BNI) for Emergency Department injury patients, the “Punguza Pombe Kwa Afya Yako (PPKAY)” (“Reduce Alcohol For Your Health”) in Tanzania. This study aimed to evaluate the feasibility of a pragmatic randomized adaptive controlled trial of the PPKAY intervention. Materials and methods This feasibility trial piloted a single-blind, parallel, adaptive, and multi-stage, block-randomized controlled trial, which will subsequently be used to determine the most effective intervention, with or without text message booster, to reduce alcohol use among injury patients. We reported our feasibility pilot study using the Reach , Effectiveness , Adoption , Implementation , Maintenance (RE-AIM) framework, with recruitment and retention rates being our primary and secondary outcomes. We enrolled adult patients seeking care for an acute injury at the Kilimanjaro Christian Medical Center in Tanzania if they (1) exhibited an Alcohol Use Disorder Identification Test (AUDIT) ≥8, (2) disclosed alcohol use prior to injury, or (3) had a breathalyzer ≥0.0 on arrival. Intervention arms were usual care (UC), PPKAY, PPKAY with standard text booster, or a PPKAY with a personalized text booster. Results Overall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention. Adoption measures showed an overwhelmingly positive patient acceptance with 100% of patients perceiving a positive impact on their behavior. The Implementation and trial processes were performed with high rates of PPKAY fidelity (76%) and SMS delivery (74%). Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible. Conclusions Our intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol. Results suggest support for undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country. Trial registration Trial registration number NCT02828267 . https://classic.clinicaltrials.gov/ct2/show/NCT02828267 .

CITATION EXPORT

Catherine A Staton, Kaitlyn Friedman, Ashley J Phillips et al.. Feasibility of a pragmatic randomized adaptive clinical trial to evaluate a brief negotiational interview for harmful and hazardous alcohol use in Moshi, Tanzania. PLOS ONE. (2023). https://doi.org/10.1371/journal.pone.0288458

AUTHORS

15 · 9 CENTRES

Catherine A Staton, Kaitlyn Friedman, Ashley J Phillips, Mary Catherine Minnig, Francis M Sakita, Kennedy M Ngowi, Brian Suffoletto, Jon Mark Hirshon, Monica Swahn, Blandina T Mmbaga, Joao Ricardo Nickenig Vissoci, Renee Hoch, Steve Zimmerman, James Mockridge, James Mockridge

1Division of Emergency Medicine, Duke University School of Medicine, Durham, NC, United States of America
2Duke Global Health Institute, Duke University, Durham, NC, United States of America
3Kilimanjaro Christian Medical Centre, Moshi, Tanzania
4Kilimanjaro Clinical Research Institute, Moshi, Tanzania
5Department of Emergency Medicine, University of Pittsburgh School of Medicine, Pittbsurgh, PA, United States of America
6Department of Emergency Medicine, University of Maryland School of Medicine, Baltimore MD, United States of America
7Department of Epidemiology, Georgia State University School of Public Health, Atlanta, GA, United States of America
8Kilimanjaro Christian Medical University College, Moshi, Tanzania
9PLOS: Public Library of Science, UNITED KINGDOM