Dataset Information

A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.

ABSTRACT:

Introduction

Sequential multiple assignment randomized trials (SMART) inform the design of adaptive treatment interventions. We tested the feasibility of a SMART to deliver a stepped-care intervention among primary care patients who smoked daily.

Methods

In a 12-week pilot SMART (NCT04020718), we tested the feasibility of recruiting and retaining (>80 %) participants to an adaptive intervention starting with cessation text messages (SMS). The study randomly assigned participants (R1) to assessment of quit status, the tailoring variable, after either 4 or 8 weeks of SMS. The study offered continued SMS alone to those reporting abstinence. Those reporting smoking were randomized (R2) to SMS + mailed NRT or SMS + NRT + brief telephone coaching.

Results

During Jan-March and July-Aug 2020, we enrolled 35 patients (>18 years) from a primary care network in Massachusetts. Two (6 %) of 31 participants reported seven-day point prevalence abstinence at their tailoring variable assessment. The 29 participants who continued to smoke at 4 or 8 weeks were randomized (R2) to SMS + NRT (n = 16) or SMS + NRT + coaching (n = 13). Thirty of 35 participants (86 %) completed 12-weeks; 13 % (2/15) of those in 4-week group and 27 % (4/15) of those in 8-week group had CO < 6 ppm at 12-weeks (p = 0.65). Among 29 participants in R2, one was lost to follow-up, 19 % (3/16) of the SMS + NRT group had CO < 6 ppm vs. 17 % (2/12) of SMS + NRT + coaching (p = 1.00). Treatment satisfaction was high (93 %, 28 of 30 who completed 12-weeks).

Conclusions

A SMART exploring a stepped-care adaptive intervention combining SMS, NRT, and coaching for primary care patients was feasible. Retention and satisfaction were high and quit rates were promising.

SUBMITTER: Kruse GR

PROVIDER: S-EPMC10016234 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.

Kruse G R GR Joyce A A Yu L L Park E R ER Neil J J Chang Y Y Rigotti N A NA

Journal of substance use and addiction treatment 20230106

<h4>Introduction</h4>Sequential multiple assignment randomized trials (SMART) inform the design of adaptive treatment interventions. We tested the feasibility of a SMART to deliver a stepped-care intervention among primary care patients who smoked daily.<h4>Methods</h4>In a 12-week pilot SMART (NCT04020718), we tested the feasibility of recruiting and retaining (>80 %) participants to an adaptive intervention starting with cessation text messages (SMS). The study randomly assigned participants ( ...[more]

PMID: 36880910

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Project description:IntroductionProactive, population health cessation programs can guide efforts to reach smokers outside of the clinic to encourage quit attempts and treatment use.Aims and methodsThis study aimed to measure trial feasibility and preliminary effects of a proactive intervention offering text messages (TM) and/or mailed nicotine replacement therapy (NRT) to smokers in primary care clinics. From 2017 to 2019 we performed a pilot randomized trial comparing brief telephone advice (control: BA), TM, 2 weeks of mailed NRT, or both interventions (TM + NRT). Patients were identified using electronic health records and contacted proactively by telephone to assess interest in the study. We compared quit attempts, treatment use, and cessation in the intervention arms with BA.ResultsOf 986 patients contacted, 153 (16%) enrolled (mean age 53 years, 57% female, 76% white, 11% black, 8% Hispanic, 52% insured by Medicaid) and 144 (94%) completed the 12-week assessment. On average, patients in the TM arms received 159 messages (99.4% sent, 0.6% failed), sent 19 messages, and stayed in the program for 61 days. In all groups, a majority of patients reported quit attempts (BA 67% vs. TM 86% [p = .07], NRT 81% [p = .18], TM + NRT 79% [p = .21]) and NRT use (BA 51% vs. NRT 83% [p = .007], TM 65% [p = .25], TM + NRT 76% [p = .03]). Effect estimates for reported 7-day abstinence were BA 10% versus TM 26% (p = .09), NRT 28% (p = .06), and TM + NRT 23% (p = .14).ConclusionsProactively offering TM or mailed nicotine medications was feasible among primary care smokers and a promising approach to promote quit attempts and short-term abstinence.ImplicationsProactive intervention programs to promote quit attempts outside of office visits among smokers enrolled in primary care practices are needed. TM have potential to engage smokers not planning to quit or to support smokers to make a planned quit attempt. This pilot study demonstrates the feasibility of testing a proactive treatment model including TM and/or mailed NRT to promote quit attempts, treatment use, and cessation among nontreatment-seeking smokers in primary care.Clinicaltrials.gov identifierNCT03174158.

Project description:Considerable public health efforts are ongoing Canada-wide to reduce the prevalence of smoking in the general population. From 1985 to 2005, smoking rates among adults decreased from 35% to 19%, however, since that time, the prevalence has plateaued at around 18-19%. To continue to reduce the number of smokers at the population level, one option has been to translate interventions that have demonstrated clinical efficacy into population level initiatives. Nicotine Replacement Therapy (NRT) has a considerable clinical research base demonstrating its efficacy and safety and thus public health initiatives in Canada and other countries are distributing NRT widely through the mail. However, one important question remains unanswered--do smoking cessation programs that involve mailed distribution of free NRT work? To answer this question, a randomized controlled trial is required.A single blinded, panel survey design with random assignment to an experimental and a control condition will be used in this study. A two-stage recruitment process will be employed, in the context of a general population survey with two follow-ups (8 weeks and 6 months). Random digit dialing of Canadian home telephone numbers will identify households with adult smokers (aged 18+ years) who are willing to take part in a smoking study that involves three interviews, with saliva collection for 3-HC/cotinine ratio measurement at baseline and saliva cotinine verification at 8-week and 6-month follow-ups (N = 3,000). Eligible subjects interested in free NRT will be determined at baseline (N = 1,000) and subsequently randomized into experimental and control conditions to receive versus not receive nicotine patches. The primary hypothesis is that subjects who receive nicotine patches will display significantly higher quit rates (as assessed by 30 day point prevalence of abstinence from tobacco) at 6-month follow-up as compared to subjects who do not receive nicotine patches at baseline.The findings from the proposed trial are timely and highly relevant as mailed distribution of NRT require considerable resources and there are limited public health dollars available to combat this substantial health concern. In addition, findings from this randomized controlled trial will inform the development of models to engage smokers to quit, incorporating proactive recruitment and the offer of evidence based treatment.ClinicalTrials.gov: NCT01429129.

Project description:BackgroundColorectal cancer (CRC) is currently the second leading cause of cancer-related deaths in the United States; however, it is mostly preventable with appropriate screening and is often treatable when detected at early stages. Many patients enrolled in an urban Federally Qualified Health Center (FQHC) clinic were found to be past due for CRC screening.ObjectiveThis study described a quality improvement (QI) project to improve CRC screening rates. This project used bidirectional texting with fotonovela comics and natural language understanding (NLU) to encourage patients to mail fecal immunochemical test (FIT) kits back to the FQHC.MethodsThe FQHC mailed FIT kits to 11,000 unscreened patients in July 2021. Consistent with the usual care, all patients received 2 text messages and a patient navigator call within the first month of mailing. As part of a QI project, 5241 patients who did not return their FIT kit within 3 months, aged 50-75 years, and spoke either English or Spanish were randomized to either usual care (no further intervention) or intervention (4-week texting campaign with a fotonovela comic and remailing kits if requested) groups. The fotonovela was developed to address known barriers to CRC screening. The texting campaign used NLU to respond to patients' texts. A mixed methods evaluation used data from SMS text messages and electronic medical records to understand the impact of the QI project on CRC screening rates. Open-ended text messages were analyzed for themes, and interviews were completed with a convenience sample of patients to understand barriers to screening and impact of the fotonovela.ResultsOf the 2597 participants, 1026 (39.5%) in the intervention group engaged with bidirectional texting. Participating in bidirectional texting was related to language preference (χ22=11.0; P=.004) and age group (χ22=19.0; P<.001). Of the 1026 participants who engaged bidirectionally, 318 (31%) clicked on the fotonovela. Furthermore, 54% (32/59) of the patients clicked on the fotonovela and responded that they loved it, and 36% (21/59) of patients responded that they liked it. The intervention group was more likely to get screened (487/2597, 18.75%) than those in usual care (308/2644, 11.65%; P<.001), and this pattern held, regardless of demographic subgroup (sex, age, screening history, preferred language, and payer type). Interview data (n=16) indicated that the text messages, navigator calls, and fotonovelas were well received and not unduly invasive. Interviewees noted several important barriers to CRC screening and offered suggestions for reducing barriers and increasing screening.ConclusionsTexting using NLU and fotonovela is valuable in increasing CRC screening as observed by the FIT return rate for patients in the intervention group. There were patterns in which patients did not engage bidirectionally; future work should investigate how to ensure that populations are not left out of screening campaigns.

Project description:ObjectiveTo assess whether offering free mailed nicotine replacement therapy (NRT) and telephone counselling to smokers on elective surgery waiting lists increases quitting before surgery.Design, settingRandomised, controlled trial at Frankston Hospital, a public tertiary referral hospital in Melbourne.ParticipantsAdult smokers added to elective surgery waiting lists for operations at least ten days in the future, 1 April 2019 - 3 April 2020.InterventionIn addition to normal care, intervention participants received a brochure on the risks of low frequency smoking, an offer of Quitline call-back registration, and an offer of mailed NRT according to reported daily smoking: 1-9 cigarettes/day, 2 mg lozenges; 10-15/day, 7-14 mg patches [three weeks] and 2 mg lozenges; > 15/day, 7-21 mg patches [five weeks] and 2 mg lozenges.Main outcome measuresPrimary outcome: quitting at least 24 hours before surgery, verified by exhaled carbon monoxide testing.Secondary outcomesquitting at least four weeks before surgery, adverse events, and (for those who had quit before surgery) abstinence three months after surgery.ResultsOf 748 eligible participants (control, 363; intervention, 385), 516 (69%) had undergone elective surgery when the trial was terminated early (for COVID-19-related reasons) (intervention group, 274; control group, 242). 122 of the 385 intervention participants (32%) had accepted the offer of cessation support. The proportions of intervention participants who quit at least 24 hours before surgery (18% v 9%; odds ratio [OR], 1.97; 95% CI, 1.22-3.15) or at least four weeks before surgery (9% v 4%; OR, 2.20; 95% CI, 1.08-4.50) were larger than for the control group. Three months after surgery, 27 of 58 intervention (47%) and 12 of 25 control participants (48%) who quit before surgery reported not smoking in the preceding seven days. No major adverse events were reported.ConclusionUptake of free mailed NRT and Quitline support by smokers on elective surgery waiting lists was good, and offering additional support was associated with higher proportions of smokers quitting before surgery.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12619000032156 (prospective).

Project description:BackgroundIncreasingly, public health interventions are delivered via telephone and/or text messages. Recent systematic reviews of early childhood obesity prevention interventions have not adequately reported on the way interventions are delivered and the experiences/perceptions of stakeholders. We aimed to summarise the literature in early childhood obesity prevention interventions delivered via telephone or text messages for evidence of application of process evaluation primarily to evaluate stakeholders' acceptability of interventions.MethodsA systematic search of major electronic databases was carried out using the Population, Intervention, Comparison, Outcomes framework. Studies were included if interventions were delivered via telephone/text messages; aimed at changing caregivers' behaviours to prevent early childhood obesity; with one or more outcomes related to early obesity risk factors such as breastfeeding, solid feeding, tummy time, sleep and settling, physical activity and screen time; published from inception to May 2020. All eligible studies were independently assessed by two reviewers using the Cochrane Collaboration tool for assessing risk of bias. Qualitative studies were assessed using the Consolidated Criteria for Reporting Qualitative Research and Standards for Reporting Qualitative Research tools.ResultsTwenty-four studies were eligible, and the overall risk of bias was low. Eight studies (33%) had evidence of process evaluation that examined participants' perceptions of interventions. Participants appreciated the convenience of receiving interventions via telephone or text messages. 63% of all studies in this review showed improvement in one or more behaviours related to childhood obesity prevention. Participants were likely to modify behaviours if they received information from a credible source such as from health professionals.ConclusionThere is limited reporting of stakeholders' experiences in early obesity prevention studies delivered by telephone or text messages. Only one-third of studies examined participants' acceptability and the potential for delivery of childhood obesity prevention interventions conveniently using this mode of delivery. Interventions delivered remotely via telephone or text messages have the potential to reach equal or a greater number of participants than those delivered via face-to-face methods. Future research should build in process evaluation alongside effectiveness measurements to provide important insight into intervention reach, acceptability and to inform scale up.Trial registrationPROSPERO registration: CRD42019108658.

Dataset Information

A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.

Introduction

Methods

Results

Conclusions

Publications

A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.

Similar Datasets

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