Proactive Telephone Research Articles

Proactive telephone counseling for adolescent smokers: Comparing regular smokers with infrequent and occasional smokers on treatment receptivity, engagement, and outcomes

BackgroundAdolescent smoking cessation efforts to date have tended to focus on regular smokers. Consequently, infrequent and occasional smokers’ receptivity and response to smoking cessation interventions is unknown. To address this gap, this study examines data from the Hutchinson Study of High School Smoking—a randomized trial that examined the effectiveness of a telephone-delivered smoking cessation intervention for a large, population-based cohort of adolescent smokers proactively recruited in an educational setting. MethodsThe study population included 1837 proactively identified high school smokers. Intervention receptivity, engagement, and outcomes were examined among adolescent infrequent (1-4days/month) and occasional (5-19days/month) smokers and compared with regular smokers (20 or more days/month). ResultsWith regard to treatment receptivity, intervention recruitment did not differ by smoking frequency. For engagement, intervention completion rates were higher for infrequent smokers (80.5%) compared with occasional (63.8%) and regular smokers (61.5%, p<0.01). Intervention effect sizes were not statistically different across groups. ConclusionsAdolescent infrequent and occasional smokers are at least as receptive to a proactively delivered smoking cessation intervention as regular smokers and can benefit just as much from it. Including these adolescent smokers in cessation programs and research—with the goal of interrupting progression of smoking before young adulthood—should help reduce the high smoking prevalence among young adults.

Depression Trajectories during the First Year after Traumatic Brain Injury.

Major depression is prevalent after traumatic brain injury (TBI) and associated with poor outcomes. Little is known about the course of depression after TBI. Participants were 559 consecutively admitted patients with mild to severe TBI recruited from inpatient units at Harborview Medical Center, a Level I trauma center in Seattle, WA. Participants were assessed with the Patient Health Questionnaire-9 (PHQ-9) depression measure at months 1-6, 8, 10, and 12 post-injury. We used linear latent class growth mixture modeling (LCGMM) of PHQ-9 total scores to identify homogeneous subgroups with distinct longitudinal trajectories. A four-class LCGMM had good fit indices and clinical interpretability. Trajectory groups were: low depression (70.1%), delayed depression (13.2%), depression recovery (10.4%), and persistent depression (6.3%). Multinomial logistic regression analyses were used to distinguish trajectory classes based on baseline demographic, psychiatric history, and clinical variables. Relative to the low depression group, the other three groups were consistently more likely to have a pre-injury history of other mental health disorders or major depressive disorder, a positive toxicology screen for cocaine or amphetamines at the time of injury, and a history of alcohol dependence. They were less likely to be on Medicare versus commercial insurance. Trajectories based on LCGMM are an empirical and clinically meaningful way to characterize distinct courses of depression after TBI. When combined with baseline predictors, this line of research may improve our ability to predict prognosis and target groups who may benefit from treatment or secondary prevention efforts (e.g., proactive telephone counseling).

The effectiveness of telephone counselling and internet- and text-message-based support for smoking cessation: results from a randomized controlled trial.

To compare the effectiveness of proactive telephone counselling, reactive telephone counselling and an internet- and text-message-based intervention with a self-help booklet for smoking cessation. A randomized controlled trial with equal allocation to four conditions: (1) proactive telephone counselling (n=452), (2) reactive telephone counselling (n=453), (3) internet- and text-message-based intervention (n=453) and (4) self-help booklet (control) (n=452). Denmark. Smokers who had participated previously in two national health surveys were invited. Eligibility criteria were daily cigarette smoking, age≥16years, having a mobile phone and e-mail address. Primary outcome was prolonged abstinence to 12months from the end of the intervention period. At 12-month follow-up, higher prolonged abstinence was found in the proactive telephone counselling group compared with the booklet group [7.3 versus 3.6%, odds ratio (OR)=2.2, 95% confidence interval (CI)=1.2-4.0]. There was no clear evidence of a difference in prolonged abstinence between the reactive telephone counselling group or the internet-based smoking cessation program and the booklet group: 1.8 versus 3.6%, OR=0.8, 95% CI=0.6-1.2 and 5.3 versus 3.6%, OR=1.6, 95% CI=0.8-3.0, respectively. In the proactive telephone counselling group, the cost per additional 12-month quitter compared with the booklet group was £644. Proactive telephone counselling was more effective than a self-help booklet in achieving prolonged abstinence for 12months. No clear evidence of an effect of reactive telephone counselling or the internet- and text-message-based intervention was found compared with the self-help booklet.

Feasibility, acceptability, and efficacy of a proactive telephone intervention to improve toxicity management during chemotherapy.

105 Background: Chemotherapy (chemo) is associated with a significant risk of toxicity, which often peaks between ambulatory visits. Consequently, effective remote symptom management support is essential to optimize self-management and resource use, including emergency department visits and hospitalizations (ED+H) during chemo. The aim of this study was to examine the feasibility, acceptability and effects of a telephone management intervention on symptomatic toxicity and resource use during chemo for early stage breast cancer (EBC). Methods: A prospective study of telephone-based toxicity management among women receiving neo-adjuvant or adjuvant chemo for EBC was undertaken at one urban and one rural site in Ontario, Canada. The intervention consisted of two standardized calls by nurses assessing common toxicities after each chemo (call 1 within 3 days and call 2 within 8-10 days). Primary outcome measures were feasibility and acceptability based on patient (pt) and clinician feedback. Efficacy was evaluated by self-reported ED+H. Results: Between 09/2013 and 12/2014, 77 women with EBC were enrolled (mean age 55 years). Most commonly used regimens were AC-paclitaxel (58%) and FEC-docetaxel (16%). 78% of pts received primary GCSF prophylaxis. Adherence with calls was 82%; mean call duration was 9 minutes. The intervention was well received by both pts and clinicians. 97% of pts indicated they liked receiving the calls and 94% would recommend this protocol be offered to all pts receiving chemo. Clinicians and pts felt the calls reduced pt anxiety by providing just-in-time education and counselling. Twenty five (33%) pts reported at least one ED+H during chemo, lower than the historical rate of 44% for this population in Ontario. Challenges included introducing an intervention that involved both routine clinical personnel and research staff and incorporating the calls into existing work responsibilities. Conclusions: Telephone-based toxicity management during ESB chemo is feasible, perceived as valuable by clinicians and pts, and may be associated with lower rates of acute care use. Larger scale evaluations of this approach focusing on effectiveness are warranted.

Evaluating the patient-perceived impact of clinical pharmacy services and proactive follow-up care in an ambulatory chemotherapy unit.

Purpose To evaluate the patient-perceived impact of delivery of clinical pharmacy services, including a proactive follow-up program, on patient understanding, satisfaction, and toxicity management. Methods Patients who had received clinical pharmacy services at their initial chemotherapy treatment were identified and asked to complete a 20-point survey at the second or subsequent treatment. The services that the survey evaluated consist of face-to-face education during the first treatment and proactive telephone follow-up 3 to 7 days later. Results A total of 107 of the 112 respondents (95.5%) indicated that the time with the pharmacist at the first treatment was worthwhile and 92.6% of respondents reported that the interaction with the pharmacist increased their understanding of the medication regimen. Of the 113 respondents, the majority was either "Very Satisfied" or "Satisfied" with the time the pharmacist spent with them (94.7%), and the pharmacist's ability to answer their questions (92.9%). In addition, survey results indicate that the clinical pharmacy input provided in the pharmacist call-back program is valuable, with 92.6% of the 82 respondents indicating that this service is worthwhile, and 91.4% of 93 respondents stating that the pharmacist input helped them to manage side-effects at home. Conclusions Survey results indicate that patients value clinical pharmacy services in the ambulatory oncology chemotherapy setting. These services contribute to improve patient understanding of the medication regimen, a high level of patient satisfaction, and self-management of treatment-related toxicities. These results support the provision of clinical pharmacy services and proactive follow-up programs in ambulatory chemotherapy units.

Эффективность проактивной телефонной поддержки в отказе от потребления табака

Эффективность проактивной телефонной поддержки в отказе от потребления табака

Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial.

BackgroundThe Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention.MethodsHigh school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided.ResultsNo evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year.ConclusionsThere was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained for the long-term into young adulthood. In light of the positive short-term effectiveness consistently observed from this and other trials for teen smokers, together with the lack of evidence from this study that such short-term impact can endure into young adulthood, sustained interventions that continue into young adulthood should be developed and tested for long-term impact.Trial RegistrationClinicalTrials.gov NCT00115882

The Recruitment Experience of a Randomized Clinical Trial to Aid Young Adult Smokers to Stop Smoking without Weight Gain with Interactive Technology.

Multiple recruitment strategies are often needed to recruit an adequate number of participants, especially hard to reach groups. Technology-based recruitment methods hold promise as a more robust form of reaching and enrolling historically hard to reach young adults. The TARGIT study is a randomized two-arm clinical trial in young adults using interactive technology testing an efficacious proactive telephone Quitline versus the Quitline plus a behavioral weight management intervention focusing on smoking cessation and weight change. All randomized participants in the TARGIT study were required to be a young adult smoker (18–35 years), who reported smoking at least 10 cigarettes per day, had a BMI < 40 kg/m2, and were willing to stop smoking and not gain weight. Traditional recruitment methods were compared to technology-based strategies using standard descriptive statistics based on counts and proportions to describe the recruitment process from initial pre-screening (PS) to randomization into TARGIT. Participants at PS were majority Black (59.80%), female (52.66%), normal or over weight (combined 62.42%), 29.5 years old, and smoked 18.4 cigarettes per day. There were differences in men and women with respect to reasons for ineligibility during PS (p < 0.001; ignoring gender specific pregnancy-related ineligibility). TARGIT experienced a disproportionate loss of minorities during recruitment as well as a prolonged recruitment period due to either study ineligibility or not completing screening activities. Recruitment into longer term behavioral change intervention trials can be challenging and multiple methods are often required to recruit hard to reach groups.ClinicalTrials.gov Identifier NCT01199185The NHLBI funded TARGIT as part of a U01 Cooperative Agreement and as such the study design was approved. They did not have input into the data collection, analysis, or the interpretation of the data or in the writing of this report.

Patient satisfaction with telephone follow up after treatment

Anne Boardman and colleagues ask whether proactive telephone calls from staff to patients treated for cancer improve the quality, safety and outcomes of their care

Health-care interventions to promote and assist tobacco cessation: a review of efficacy, effectiveness and affordability for use in national guideline development.

AimsThis paper provides a concise review of the efficacy, effectiveness and affordability of health‐care interventions to promote and assist tobacco cessation, in order to inform national guideline development and assist countries in planning their provision of tobacco cessation support.MethodsCochrane reviews of randomized controlled trials (RCTs) of major health‐care tobacco cessation interventions were used to derive efficacy estimates in terms of percentage‐point increases relative to comparison conditions in 6–12‐month continuous abstinence rates. This was combined with analysis and evidence from ‘real world’ studies to form a judgement on the probable effectiveness of each intervention in different settings. The affordability of each intervention was assessed for exemplar countries in each World Bank income category (low, lower middle, upper middle, high). Based on World Health Organization (WHO) criteria, an intervention was judged as affordable for a given income category if the estimated extra cost of saving a life‐year was less than or equal to the per‐capita gross domestic product for that category of country.ResultsBrief advice from a health‐care worker given opportunistically to smokers attending health‐care services can promote smoking cessation, and is affordable for countries in all World Bank income categories (i.e. globally). Proactive telephone support, automated text messaging programmes and printed self‐help materials can assist smokers wanting help with a quit attempt and are affordable globally. Multi‐session, face‐to‐face behavioural support can increase quit success for cigarettes and smokeless tobacco and is affordable in middle‐ and high‐income countries. Nicotine replacement therapy, bupropion, nortriptyline, varenicline and cytisine can all aid quitting smoking when given with at least some behavioural support; of these, cytisine and nortriptyline are affordable globally.ConclusionsBrief advice from a health‐care worker, telephone helplines, automated text messaging, printed self‐help materials, cytisine and nortriptyline are globally affordable health‐care interventions to promote and assist smoking cessation. Evidence on smokeless tobacco cessation suggests that face‐to‐face behavioural support and varenicline can promote cessation.

Nursing intervention to enhance outpatient chemotherapy symptom management: Patient-reported outcomes of a randomized controlled trial.

The authors conducted a randomized controlled trial to evaluate a nurse practitioner (NP)-delivered symptom management intervention for patients initiating chemotherapy for nonmetastatic cancer. The aim was to reduce patient-reported symptom burden by facilitating patient-NP collaboration and the early management of symptoms. At the time of the first chemotherapy visit, adult participants with nonmetastatic breast, colorectal, or lung cancer (120 participants) completed self-report measures and were then randomly assigned to standard care plus the intervention or standard care alone. Intervention participants received proactive telephone calls from their oncology team NP during the week after each of the first 2 chemotherapy administration visits. Measures were repeated at the second and third chemotherapy visits. Group differences were analyzed with regard to patient-reported symptoms (Memorial Symptom Assessment Scale-Short Form items), satisfaction with care (Family Caregiver Satisfaction-patient scale), and the likelihood of depression or anxiety symptoms (Patient Health Questionnaire-4). At the time of the first visit, 50.8% of participants reported ≥1 physical symptom, most commonly lack of energy (35.8%) and drowsiness (30.8%). The number of symptoms (gamma coefficient [γ] = 0.16; P<.001), symptom distress (γ = 0.45; P<.001), and satisfaction with care (γ = 0.24; P = .004) increased whereas the likelihood of anxiety symptoms decreased (γ = -0.19; P = .02) and the likelihood of depression symptoms did not change (γ = 0.01; P = .91). Outcomes did not differ by randomized group. Randomized group interacted with emetogenic potential in predicting symptom distress (γ = 0.43; P = .03) and satisfaction with care (γ = -0.45; P = .045). The intervention did not appear to reduce symptom burden compared with standard care. Early symptoms highlight the importance of continuing to examine strategies to improve symptom management during chemotherapy for nonmetastatic disease.

A pilot study on the feasibility and acceptability of a text message-based aftercare treatment programme among alcohol outpatients.

To test the feasibility, acceptability and initial effectiveness of a text message-based aftercare treatment programme among alcohol outpatients. Clients treated for alcohol use disorders from three Swiss outpatient alcohol treatment centres were invited by their counsellors to participate in a study testing an interactive aftercare programme employing the use of text messages and personal phone calls. Fifty study participants were randomly assigned to either the 6-month aftercare programme (n = 25) or treatment as usual (n = 25). The intervention consisted of (a) monitoring of self-selected drinking goals at regular intervals, (b) motivational text messages to stick to self-selected drinking goals and (c) proactive telephone calls from counsellors when participants neglected to stick to their drinking goals or expressed a need for support. Follow-up interviews were conducted 6 months after randomization. Throughout the programme, participants received a total of 421 text message prompts. Out of these, participants provided valid replies to 371 (88.1%) within 48 h. Out of the 25 participants in the intervention group, 11 (44.0%) sent at least one call-for-help reply. Based on complete case data, at risk alcohol use at follow-up was 41.7% in the control group and 28.6% in the intervention group (OR = 0.56, 95% CI = 0.16-1.95, P = 0.36). The interactive low-intensive aftercare programme was well accepted by the participants. Testing its efficacy within an adequately powered randomized controlled trial might be reasonable.

The Economic Impact of Smoking and of Reducing Smoking Prevalence: Review of Evidence.

The Economic Impact of Smoking and of Reducing Smoking Prevalence: Review of Evidence.

Proactive outreach for smokers using VHA mental health clinics: protocol for a patient-randomized clinical trial.

BackgroundPersons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence, low rates of tobacco treatment referrals from mental health providers, and limited availability of tobacco treatment targeted to their needs. This manuscript describes the rationale and methods of a clinical trial with the following aims: 1) Compare the reach and efficacy of a proactive telephone-based tobacco cessation program for Veterans Health Administration (VHA) mental health clinic patients to VHA usual care and 2) Model longitudinal associations between baseline patient characteristics and long-term abstinence.Methods/designWe will use the electronic medical record to identify patients across four VHA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past six months and who have had a mental health clinic visit in the past 12 months. We will send each patient an introductory letter and baseline survey. Survey respondents (N = 3840) will be randomized in a 1:1 fashion to intervention or control. Control participants will receive VHA usual care. Intervention participants will receive proactive motivational telephone outreach to offer tobacco treatment. Intervention participants interested in treatment will receive eight weeks of nicotine replacement therapy plus eight sessions of specialized telephone counseling over two months, followed by monthly maintenance counseling for four months. We will conduct telephone surveys with participants at six and 12 months to assess study outcomes. We will collect a mailed saliva sample from patients reporting 7-day abstinence on the telephone surveys. The primary outcome will be cotinine-validated abstinence at 12-month follow-up.DiscussionMental health patients are a high-risk smoking population with significant barriers to cessation. This study will evaluate the efficacy of a program that proactively reaches out to smokers with a mental health treatment history to engage them into telephone cessation counseling targeted to the needs of mental health patients.Trial registrationClinicaltrials.gov: NCT01737281 (registered November 5, 2012).

132IN - Nurse Led Clinics: Involvement in Patient Management and Follow Up

ABSTRACT An increase in available oral anti-cancer medicines has enhanced treatment and prognosis for many patients. Studies suggest oral anti-cancer medicines are often the preferred option for patients due to reduced hospital attendances. International literature highlights concerns regarding a lack of processes to support and monitor patients to ensure they take oral anti-cancer medicines correctly, stop self medicating and contact clinicians when side effects occur. An emerging body of literature suggests some cancer patients may intentionally not adhere with self medication thus reducing drug efficacy. This presentation will describe the development and evaluation of patient centered nurse and pharmacist led clinics which aim to enhance patient self management and thus adherence with oral anti-cancer medicines. Focus will be on a pilot study of an intervention for patients prescribed an oral Tyrosine-Kinase Inhibitor (TKI) for metastatic renal cancer, which included education and consent, medicines reconciliation, on-treatment review, prescribing and pro-active telephone monitoring. Data were collected from seven patients who received the intervention and from eight patients who received standard care. Data sources included a 25 item patient survey, clinician reviews and patient records. Patient satisfaction appeared high across the intervention and control groups. However, patient experience of managing the TKI appeared enhanced within the intervention group due to identification of potential drug interactions, through medicines reconciliation and identification of an increased number of symptoms (average 3.1 versus 1.8). Furthermore, patients in the intervention group appeared more confident about when to report symptoms and more inclined to report these to nurses. Patients were proactively telephoned weekly and this aspect of the service appeared to be of most benefit in managing side effects and concerns during the first two treatment cycles. Independent working was facilitated through initial close medical support and acquirement of advanced assessment and non-medical prescribing qualifications. All patients prescribed oral anti-cancer medicines are now supported by a pharmacist or nurse and the pilot model has been extended to patients with other cancer diagnoses. Disclosure: All authors have declared no conflicts of interest.

Socioeconomic disparities in telephone-based treatment of tobacco dependence.

We examined socioeconomic disparities in tobacco dependence treatment outcomes from a free, proactive telephone counseling quitline. We delivered cognitive-behavioral treatment and nicotine patches to 6626 smokers and examined socioeconomic differences in demographic, clinical, environmental, and treatment use factors. We used logistic regressions and generalized estimating equations (GEE) to model abstinence and account for socioeconomic differences in the models. The odds of achieving long-term abstinence differed by socioeconomic status (SES). In the GEE model, the odds of abstinence for the highest SES participants were 1.75 times those of the lowest SES participants. Logistic regression models revealed no treatment outcome disparity at the end of treatment, but significant disparities 3 and 6 months after treatment. Although quitlines often increase access to treatment for some lower SES smokers, significant socioeconomic disparities in treatment outcomes raise questions about whether current approaches are contributing to tobacco-related socioeconomic health disparities. Strategies to improve treatment outcomes for lower SES smokers might include novel methods to address multiple factors associated with socioeconomic disparities.

Ringing Up about Breastfeeding: a randomised controlled trial exploring early telephone peer support for breastfeeding (RUBY) - trial protocol.

BackgroundThe risks of not breastfeeding for mother and infant are well established, yet in Australia, although most women initiate breastfeeding many discontinue breastfeeding altogether and few women exclusively breastfeed to six months as recommended by the World Health Organization and Australian health authorities. We aim to determine whether proactive telephone peer support during the postnatal period increases the proportion of infants who are breastfed at six months, replicating a trial previously found to be effective in Canada.Design/MethodsA two arm randomised controlled trial will be conducted, recruiting primiparous women who have recently given birth to a live baby, are proficient in English and are breastfeeding or intending to breastfeed. Women will be recruited in the postnatal wards of three hospitals in Melbourne, Australia and will be randomised to peer support or to ‘usual’ care. All women recruited to the trial will receive usual hospital postnatal care and infant feeding support. For the intervention group, peers will make two telephone calls within the first ten days postpartum, then weekly telephone calls until week twelve, with continued contact until six months postpartum. Primary aim: to determine whether postnatal telephone peer support increases the proportion of infants who are breastfed for at least six months. Hypothesis: that telephone peer support in the postnatal period will increase the proportion of infants receiving any breast milk at six months by 10% compared with usual care (from 46% to 56%).Outcome data will be analysed by intention to treat. A supplementary multivariate analysis will be undertaken if there are any baseline differences in the characteristics of women in the two groups which might be associated with the primary outcomes.DiscussionThe costs and health burdens of not breastfeeding fall disproportionately and increasingly on disadvantaged groups. We have therefore deliberately chosen trial sites which have a high proportion of women from disadvantaged backgrounds. This will be the first Australian randomised controlled trial to test the effectiveness and cost effectiveness of proactive peer telephone support for breastfeeding.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12612001024831.

Intervention Adherence is Related to Participant Retention: Implications for Research

Two challenging issues in Internet intervention research, as well as in other behavioral intervention trials, are ensuring that participants receive the intervention (adherence) and that their outcomes are captured at follow-up (retention) [1]. The interesting analysis presented by Murray et al [2] demonstrated that, at least in their study sample, the participant adherence and retention were positively related. One issue to consider is whether this finding can be replicated in other study samples. It is possible that research involving, for example, different recruitment methods or with higher (or lower) retention rates, might not display this same positive relationship. To that purpose, results were examined from an Internet intervention trial that employed a proactive telephone recruitment method and obtained complete follow-up data for 86% of participants [3-5]. As with the Murray et al study [2], adherence (measured by the number of intervention participants logging onto a brief alcohol intervention, where N=92; 57 participants logged onto the intervention and 35 participants did not log on) and retention were strongly positively related (retention at 3-months: logged onto intervention=100%, did not log on=80%, P<.001; retention at 6-months: logged onto intervention=100%; did not log on=80%, P<.001; retention at 12-months: logged onto intervention=96%; did not log on=74.3%, P=.002; Fisher’s Exact Tests). Given that the positive relationship between adherence and retention can be replicated, what are the implications of this finding? From one perspective, the fact that these two key issues are related could underline the increased importance of obtaining a good retention rate. This is because the positive relationship of adherence to retention implies that a confound in the interpretation of the results is more likely as loss to follow-up (or reduced adherence to the intervention) increases. Alternatively, it could be argued that this positive relationship might reduce the importance of obtaining a good retention rate. This is because traditional intent-to-treat analysis assumes that participants who are lost to follow-up do not make any change in their behavior from baseline to follow-up (and are included as imputed values in the analysis based on this assumption). If it is then assumed that only those participants who accessed the intervention will actually make a change in their behavior, then the fact that participants who adhere to the intervention are more likely to follow-up can only increase the likelihood that participants who are lost to follow-up are less likely to have made a change in their behavior (thus validating the intent-to-treat analysis assumption). Determining which of these implications is correct is important, particularly in a field where low retention rates are an unfortunate reality in many research trials [1].

Antenatal telephone support intervention with and without uterine artery Doppler screening for low risk nulliparous women: a randomised controlled trial.

BackgroundThe number of routine antenatal visits provided to low risk nulliparous women has been reduced in the UK, acknowledging this change in care may result in women being less satisfied with their care and having poorer psychosocial outcomes. The primary aim of the study was to investigate whether the provision of proactive telephone support intervention (TSI) with and without uterine artery Doppler screening (UADS) would reduce the total number of antenatal visits required. A secondary aim was to investigate whether the interventions affected psychological outcomes.MethodsA three-arm randomised controlled trial involving 840 low risk nulliparous women was conducted at a large maternity unit in North East England. All women received antenatal care in line with current UK guidance. Women in the TSI group (T) received calls from a midwife at 28, 33 and 36 weeks and women in the telephone and Doppler group (T + D) received the TSI and additional UADS at 20 weeks’ gestation. The main outcome measure was the total number of scheduled and unscheduled antenatal visits received after 20 weeks’ gestation.ResultsThe median number of unscheduled (n = 2.0), scheduled visits (n = 7.0) and mean number of total visits (n = 8.8) were similar in the three groups. The majority (67%) of additional antenatal visits were made to a Maternity Assessment Unit because of commonly occurring pregnancy complications. Additional TSI+/–UADS was not associated with differences in clinical outcomes, levels of anxiety, social support or satisfaction with care. There were challenges to the successful delivery of the telephone support intervention; 59% of women were contacted at 29 and 33 weeks gestation reducing to 52% of women at 37 weeks.ConclusionsProvision of additional telephone support (with or without UADS) in low risk nulliparous women did not reduce the number of unscheduled antenatal visits or reduce anxiety. This study provides a useful insight into the reasons why this client group attend for unscheduled visits.Trial registrationISRCTN62354584

Effectiveness of proactive quitline counselling for smoking parents recruited through primary schools: results of a randomized controlled trial

To test the effectiveness of tailored quitline (telephone) counselling among smoking parents recruited into cessation support through their children's primary schools. Two-arm randomized controlled trial with 3- and 12-month follow-up. Proactive telephone counselling was administered by the Dutch national quitline. Smoking parents were recruited through their children's primary schools and received either intensive quitline support in combination with tailored supplementary materials (n = 256) or a standard self-help brochure (n = 256). The primary outcome was 7-day point-prevalence abstinence at 12-month follow-up. Also measured were baseline characteristics, use of and adherence to nicotine replacement therapy and pharmacotherapy, smoking characteristics and implementation of a home smoking ban. Parents who received quitline counselling were more likely to report 7-day point-prevalence abstinence at 12-month assessment [34.0 versus 18.0%, odds ratio (OR) = 2.35, confidence interval (CI) = 1.56-3.54] than those who received a standard self-help brochure. Parents who received quitline counselling were more likely to use nicotine replacement therapy (P < 0.001) than those who received a standard self-help brochure. Among parents who did not achieve abstinence, those who received quitline counselling smoked fewer cigarettes at 3-month (P < 0.001) and 12-month assessment (P < 0.001), were more likely to make a quit attempt (P < 0.001), to achieve 24 hours' abstinence (P < 0.001) and to implement a complete home smoking ban (P < 0.01). Intensive quitline support tailored to smoking parents is an effective method for helping parents quit smoking and promoting parenting practices that protect their children from adverse effects of smoking.