Cost effectiveness of interventions to promote screening for colorectal cancer: a randomized trial

Objectives

Screening for colorectal cancer is considered cost effective, but is underutilized in the U.S. Information on the efficiency of "tailored interventions" to promote colorectal cancer screening in primary care settings is limited. The paper reports the results of a cost effectiveness analysis that compared a survey-only control group to a Centers for Disease Control (CDC) web-based intervention (screen for life) and to a tailored interactive computer-based intervention.

Methods

A randomized controlled trial of people 50 and over, was conducted to test the interventions. The sample was 1224 partcipants 50-70 years of age, recruited from Kelsey-Seybold Clinic, a large multi-specialty clinic in Houston, Texas. Screening status was obtained by medical chart review after a 12-month follow-up period. An "intention to treat" analysis and micro costing from the patient and provider perspectives were used to estimate the costs and effects. Analysis of statistical uncertainty was conducted using nonparametric bootstrapping.

Results

The estimated cost of implementing the web-based intervention was $40 per person and the cost of the tailored intervention was $45 per person. The additional cost per person screened for the web-based intervention compared to no intervention was $2602 and the tailored intervention was no more effective than the web-based strategy.

Conclusions

The tailored intervention was less cost-effective than the web-based intervention for colorectal cancer screening promotion. The web-based intervention was less cost-effective than previous studies of in-reach colorectal cancer screening promotion. Researchers need to continue developing and evaluating the effectiveness and cost-effectiveness of interventions to increase colorectal cancer screening.     

Preference-based electronic decision aid to promote colorectal cancer screening: results of a randomized controlled trial

OBJECTIVE: Despite the burden of colorectal cancer and improved health care outcomes with early detection and treatment, screening rates among eligible adults are low. We previously developed through a series of studies an interactive electronic tool, Colorectal Web, to promote colorectal cancer screening. METHOD: From May 2002 to December 2003, we conducted a randomized controlled trial of Colorectal Web compared to a standard Web site on colorectal cancer screening in urban, suburban, and rural communities in Michigan with high colorectal cancer burden. Study participants were age 50 years and older, with no previous colorectal cancer screening. Major outcome was screened for colorectal cancer by 24 weeks post-intervention. RESULTS: 174 eligible adults were randomized and participated. Immediately post-intervention, Colorectal Web participants were significantly more likely to have a preferred colorectal cancer screening method, but this difference did not persist at subsequent follow-up. Eighty-nine participants had been screened for colorectal cancer by 24 weeks post-intervention. The probability of being screened for the Colorectal Web intervention study arm compared to the control is OR=3.23 (2.73-3.50 95% Confidence Interval). CONCLUSION: Colorectal Web is more effective than a standard colorectal cancer Web site at prompting previously unscreened individuals to choose a preferred colorectal cancer screening test and to be screened for colorectal cancer.     

Patient reminder letters to promote annual mammograms: a randomized controlled trial

BACKGROUND: This study assessed the effects of a reminder letter from a physician (relative to a mammography facility letter or no letter) on appointment compliance among women 50-74 years of age due for an annual screening mammogram. METHODS: A total of 1,562 women were randomly as signed to the groups. Each Group 1 subject received a reminder letter from her physician, each Group 2 subject received a reminder letter from her mammography facility, and Group 3 served as a control group. RESULTS: The return rates for Groups 1, 2, and 3 were 47.7, 46.6, and 28.3%, respectively; the overall difference was significant using a chi(2) analysis (P < 0.001). Bonferroni pairwise comparisons indicated no difference between Groups 1 and 2 but significant differences (P < 0.001) between Group 3 and the other two groups. Logistic regression indicated that relative to Group 3, the adjusted odds of returning for Groups 1 and 2 were 2.37 and 2.24, respectively. CONCLUSIONS: Mammography providers and their patients likely will benefit from in-reach reminder systems. Physicians who do not use reminder systems should refer their patients to facilities that use these systems.     

Who uses decision aids? Subgroup analyses from a randomized controlled effectiveness trial of two prostate cancer screening decision support interventions

OBJECTIVE: To examine who reported using unsolicited prostate cancer screening decision aids distributed as part of a randomized controlled trial, whether reported use varied by type of aid (video or pamphlet), and what affect reported use had on study outcomes. METHODS: A total of 1,152 men aged 50 and older from four medical facilities in the United States were randomly assigned to pamphlet, video or usual care (control). Materials were mailed 2 weeks prior to clinic appointments in general internal medicine. Outcomes were assessed by phone survey 1 week after appointments. Analyses examined the reported use of materials by study group, the association between patient characteristics and reported use, and the impact of reported use (adjusting for patient characteristics) on a 10-item knowledge index. RESULTS: Fifty-six percent of those randomized to receive the video and 50% of those randomized to receive the pamphlet reported using the materials. Reported use of the video was higher for patients who had greater than a high school education (OR 1.73), were married (OR 2.20), and reported no prior abnormal prostate cancer screening test results (OR 3.39). Reported use of the pamphlet did not vary by patient characteristics. In intent-to-treat analyses (ignoring reported use), individuals randomized to the video and pamphlet groups had significantly higher knowledge scores relative to the control group (7.44, 7.26 and 6.90 respectively). Adjusting for reported use modestly increased the estimated differences across treatment groups but did not substantially change conclusions about the relative effects of these aids on knowledge. CONCLUSIONS: Only half of men receiving unsolicited prostate cancer screening decision aids before a visit reported using the aids, and who reported using them varied by type of aid. Efforts to broadly implement decision aids may need to offer a variety of approaches, and incorporate creative strategies to enhance reaching all population subgroups.     

Brief education to promote maternal influenza vaccine uptake: A randomized controlled trial

BackgroundAlthough pregnant women are the highest priority group for seasonal influenza vaccination, maternal influenza vaccination rates remain suboptimal. The purpose of this study was to evaluate the effect of a brief education intervention on maternal influenza vaccine uptake.MethodsDuring the 2013–14 and 2014–15 influenza seasons, we recruited 321 pregnant women from the antenatal clinics of 4 out of 8 public hospitals in Hong Kong with obstetric services. Hospitals were geographically dispersed and provided services to pregnant women with variable socioeconomic backgrounds. Participants were randomized to receive either standard antenatal care or brief one-to-one education. Participants received telephone follow-up at 2 weeks postpartum. The primary study outcome was self-reported receipt of influenza vaccination during pregnancy. The secondary outcomes were the proportion of participants who initiated discussion about influenza vaccination with a health care professional and the proportion of participants who attempted to get vaccinated.ResultsCompared with participants who received standard care, the vaccination rate was higher among participants who received brief education (21.1% vs. 10%; p = 0.006). More participants in the education group initiated discussion about influenza vaccination with their HCP (19.9% vs. 13.1%; p = 0.10), but the difference was not statistically significant. Of participants who did not receive the influenza vaccine (n = 271), 45 attempted to get vaccinated. A significantly higher proportion of participants who attempted to get vaccinated were in the intervention group (82.2% vs. 17.8%; p < 0.001). If participants who had attempted vaccination had received the vaccine, vaccination rates would have been substantially higher (44.1% vs. 15%; p < 0.001). Twenty-six participants were advised against influenza vaccination by a healthcare professional, including general practitioners, obstetricians, and nurses.ConclusionAlthough brief education was effective in improving vaccination uptake among pregnant women, overall vaccination rates remain suboptimal. Multicomponent approaches, including positive vaccination recommendations by healthcare professionals, are needed to promote maternal influenza vaccination.Clinical Trial Registration: www.clinicaltrials.gov (NCT01772901).     

A randomized controlled trial of shared decision making for prostate cancer screening.

OBJECTIVE: To evaluate a patient-educational approach to shared decision making for prostate cancer screening. DESIGN: Randomized controlled trial with preoffice visit assessment and 2-week follow-up. SETTING: University-based family practice center. PATIENTS: Men aged 45 through 70 years with no history of prostate cancer or treatment for prostate disease (N = 160). Two patients were unavailable for follow-up. INTERVENTION: Twenty-minute educational videotape on advantages and disadvantages of prostate-specific antigen (PSA) screening for prostate cancer. MAIN OUTCOME MEASURES: A measure of patients' core knowledge of prostate cancer developed for this study, reported preferences for PSA testing, and ratings of the videotape. RESULTS: Patients' core knowledge at baseline was poor. At 2-week follow-up, subjects undergoing videotape intervention showed a 78% improvement in the number of knowledge questions answered correctly (P = .001), and knowledge increased about mortality due to early-stage prostate cancer, PSA screening performance, treatment-related complications, and disadvantages of screening. No overall change was observed for control subjects. At follow-up, 48 (62%) of 78 intervention patients planned to have the PSA test compared with 64 (80%) of 80 control patients (18.5% absolute reduction; 95% confidence interval, 4.6%-32.4%; P = .009). Intervention subjects rated favorably the amount of information provided and the clarity, balance, and length of the videotape and would recommend the videotape to others. CONCLUSIONS: Patient education regarding the potential benefits and harms of early detection of prostate cancer can lead to more informed decision making. Incorporating the PSA videotape into the periodic health examination for asymptomatic men aged 50 years and older is recommended.     

Reaching out to promote physical activity in Australia: a statewide randomized controlled trial of a stage-targeted intervention

PURPOSE: This study examined the broader use of a print-media intervention, which was previously shown to be effective at promoting physical activity to participants recruited from a regional Australian community, as a strategy suitable for a more diverse statewide population sample. METHODS: Participants were randomly selected adults who responded to a telephone interview conducted by the New South Wales Health Department and consented to participate in a randomized controlled trial. Consenters were allocated to either intervention (n = 361) or control (n = 358) conditions. The intervention, a personalized letter plus stage-targeted booklets, was sent 1 week postbaseline. Data were collected via telephone interview at baseline and 2 and 8 months and were analyzed using repeated measures analysis of variance (ANOVA) and chi2 statistics. RESULTS: The groups were similar at baseline (mean age 43 +/- 3 years; 64% women). Process evaluation showed high intervention recall (76% at 2 months) and high follow-up response rates (> 85% at 8 months) were achieved. Nonsignificant increases in physical activity were observed (F1,719 = 2.18, p = .14). DISCUSSION: A single mailing of stage-targeted print materials was not effective in promoting increases in physical activity among participants selected from the statewide population. Future research could examine how the effectiveness of print media might be enhanced, possibly by using supplementary media, community-based prompts, or other incentives.     

Educational strategies to promote evidence-based community pharmacy practice: a cluster randomized controlled trial (RCT)

BACKGROUND: Community pharmacists have increasing involvement in the self-management of minor illness as a result of the availability of a wider range of over-the-counter (OTC) medicines. We undertook a randomized controlled trial (RCT) to assess the effectiveness and efficiency of educational strategies to implement evidence-based guidelines for the sale of OTC anti-fungals in the community pharmacy setting. OBJECTIVE: The aim of the study was to compare the effectiveness and efficiency of two guideline dissemination strategies in community pharmacy settings. METHODS: A 2 x 2 factorial, cluster RCT was conducted with 60 community pharmacies in the Grampian region of Scotland. The interventions included dissemination of an evidence-based guideline for OTC management of vulvovaginal candidiasis (thrush) by postal dissemination (control), educational outreach visit or attendance at a continuing professional education session. Pre- and post-intervention simulated patient visits were made to participating pharmacies. The simulated patients completed assessment forms following each visit. The primary outcome was the appropriateness (based upon the guidelines) of sale or no sale of OTC anti-fungals. RESULTS: There were no significant differences in the proportion of appropriate outcomes following educational outreach [odds ratio (OR) = 1.1; 95% confidence interval (CI) 0.52 to 2.45] or continuing professional education (OR = 0.88; 95% CI 0.41 to 1.91). CONCLUSIONS: Neither strategy was effective in improving the appropriateness of OTC management of vulvovaginal candidiasis by community pharmacy staff. Further research is needed to identify barriers to guideline implementation and evidence-based practice in this setting.     

Occupation-focused interventions for well older people: An exploratory randomized controlled trial

Abstract

Objective: The aim of this exploratory randomised controlled trial (RCT) was to evaluate three different occupation-focused interventions for well older people by estimating effect sizes for leisure engagement and ability in activities of daily living (ADL) and thereby identifying the most effective interventions. Methods: One hundred and seventy seven persons, 77–82 years old, living alone and without home help, were randomized to a control group (CG), an individual intervention (IG), an activity group (AG), and a one-meeting discussion group (DG). All interventions focused on occupational engagement and how persons can cope with age-related activity restrictions in order to enhance occupational engagement. Data were collected by blinded research assistants at baseline, three, and 12 months. Ordinal outcome data were converted, using Rasch measurement methods, to linear measures of leisure engagement and ADL ability. Standardized between-group effect sizes, Cohen’s d, were calculated. Results: While all groups showed a decline in leisure engagement and ADL over time, the IG and the DG were somewhat effective in minimizing the decline at both three and 12 months. However, the effect sizes were small. Conclusions: The findings indicate that occupation-focused interventions intended to minimize a decline in leisure engagement and ADL were sufficiently promising to warrant their further research.     

Results of a randomized controlled trial to promote physical activity behaviours in mothers with young children

ObjectiveIncreasing levels of physical activity in mothers have long-term health benefits for the mother and family. The study aimed to evaluate the effect of a six-month, physical activity RCT for mothers of young children.MethodsWomen were recruited via playgroups and randomly assigned to intervention (n = 394) or control group (n = 322). The intervention group received a six-month multi-strategy programme delivered via playgroups in Perth, Australia. measures were mean minutes per week of moderate (M) and vigorous (V) intensity physical activity (PA), and number of days/week of muscle strength exercises.ResultsThe intervention had a significant effect on mean time for vigorous (p = 0.008), moderate (p = 0.023) and total physical activity (p = 0.001) when compared to the control group. The intervention group increased their vigorous activity by a mean of 24 min/week, moderate activity by 23 min/week and total physical activity by 72 min/week.ConclusionsA relatively minimum home based intervention was able to demonstrate modest but statistically significant improvements in physical activity in a hard to reach group. These changes if maintained over a longer period are likely to improve the health of mothers and have a positive impact on their partners and children. Australian and New Zealand Clinical Trials Registry ACTRN12609000735257.     

Environmental interventions for eating and physical activity: a randomized controlled trial in middle schools

BACKGROUND: Our objective was to evaluate the effects of environmental, policy, and social marketing interventions on physical activity and fat intake of middle school students on campus. DESIGN: Twenty-four middle schools were randomly assigned to intervention or control conditions. Baseline measures were collected in spring 1997, and interventions were conducted during the 1997-1998 and 1998-1999 school years SETTING/PARTICIPATION: The schools had mean enrollments of 1109, with 44.5% nonwhite students.Over 2 years, physical activity interventions were designed to increase physical activity in physical education classes and throughout the school day. Nutrition interventions were designed to provide and market low-fat foods at all school food sources, including cafeteria breakfasts and lunches, a la carte sources, school stores, and bag lunches. School staff and students were engaged in policy change efforts, but there was no classroom health education. MAIN OUTCOMES MEASURES: Primary outcomes were measured by direct observation and existing records. RESULTS: Randomized regression models (N =24 schools) revealed a significant intervention effect for physical activity for the total group (p <0.009) and boys (p <0.001), but not girls (p <0.40). The intervention was not effective for total fat (p <0.91) or saturated fat (p <0.79). Survey data indicated that the interventions reduced reported body mass index for boys (p <0.05). CONCLUSIONS: Environmental and policy interventions were effective in increasing physical activity at school among boys but not girls. The interventions were not effective in reducing fat intake at school. School environmental and policy interventions have the potential to improve health behavior of the student population, but barriers to full implementation need to be better understood and overcome.     

Limitations of the randomized controlled trial in evaluating population-based health interventions

Population- and systems-based interventions need evaluation, but the randomized controlled trial (RCT) research design has significant limitations when applied to their complexity. After some years of being largely dismissed in the ranking of evidence in medicine, alternatives to the RCT have been debated recently in public health and related population and social service fields to identify the trade-offs in their use when randomization is impractical or unethical. This review summarizes recent debates and considers the pragmatic and economic issues associated with evaluating whole-population interventions while maintaining scientific validity and credibility.     

Patient education for informed decision making about prostate cancer screening: a randomized controlled trial with 1-year follow-up

PURPOSE: The efficacy of prostate cancer screening is uncertain, and professional organizations recommend educating patients about potential harms and benefits. We evaluated the effect of a videotape decision aid on promoting informed decision making about prostate cancer screening among primary care patients. METHODS: A group of 160 men, 45 to 70 years of age, with no history of prostate cancer, were randomized to view or not to view a 20-minute educational videotape before a routine office visit at a university-based family medicine clinic. The subjects were contacted again 1 year after their visit to assess their receipt of prostate cancer screening (digital rectal examination [DRE] or prostate-specific antigen [PSA] testing), their satisfaction with their screening decision, and knowledge retention since the baseline assessment. RESULTS: Follow-up assessments were completed for 87.5% of the intervention subjects and 83.8% of the control subjects. The rate of DRE did not differ between the 2 groups. Prostate-specific antigen testing was reported by 24 of 70 (34.3%) intervention subjects and 37 of 67 (55.2%) control subjects (P = .01). African American men were more likely to have had PSA testing (9 of 16, 56.3%) than were white men (13 of 46, 28.3%) (P = .044). Satisfaction with the screening decision did not differ between the study groups. Intervention subjects were more knowledgeable of prostate cancer screening than were control subjects, although these differences declined within 1 year (P < .001). CONCLUSIONS: Decision aids for prostate cancer screening can have a long-term effect on screening behavior and appear to promote informed decision making.     

Three independent factors predicted adherence in a randomized controlled trial of resistance exercise training among prostate cancer survivors

OBJECTIVE: To examine predictors of adherence in a randomized controlled trial of resistance exercise training (RET) in prostate cancer survivors receiving androgen deprivation therapy. STUDY DESIGN AND SETTING: A randomized controlled trial conducted at fitness centers in Ottawa and Edmonton, Canada. Prostate cancer survivors (n=155) completed measures of social cognitive variables, quality of life (QOL), behavior, and fitness before being randomized to either an exercise (n=82) or control (n=73) group. The exercise group was asked to perform supervised RET three times per week for 12 weeks. RESULTS: The exercise group attended 28.2 of the 36 (78.3%) RET sessions. Univariate analyses revealed eight different significant (Ps <.05) predictors of exercise adherence including exercise stage of change, intention, age, QOL, fatigue, subjective norm, leg-press test, and perceived behavioral control. A multivariate analysis indicated that there were three independent predictors of adherence that explained 20.4% of the variance: exercise stage of change (beta=0.26; P=.013), age (beta=-0.22; P=.037), and intention (beta=0.19; P=.073). CONCLUSION: Exercise adherence in the trial was very good but not optimal. Adherence was predicted by variables from many different categories including social cognitive, QOL, behavioral, fitness, and demographic. These findings may have important implications for maximizing adherence during clinical trials of exercise in prostate cancer survivors.     

Reach and uptake of Internet- and phone-based smoking cessation interventions: Results from a randomized controlled trial

ObjectiveTo study whether demographic and smoking-related characteristics are associated with participation (reach) in a smoking cessation trial and subsequent use (uptake) of two specific smoking interventions (Internet-based program and proactive telephone counseling).MethodsWe used data from a four-arm randomized smoking cessation trial (2011). Participants (n = 1,809) were recruited among 9,924 smokers who previously participated in two health surveys in Denmark (2007–2008 and 2010). Interventions were as follows: (1) an Internet-based smoking cessation program, (2) proactive telephone counseling, (3) reactive telephone counseling and (4) a self-help booklet.ResultsReach (defined as the proportion accepting to participate in the trial of those invited) was highest among persons aged 40–59 years, women, heavy smokers and persons with long education. Among trial participants, uptake (defined as any use of the specific intervention at 1-month follow-up) was 69% for the Internet-based program, 74% and 9% for proactive and reactive telephone counseling, respectively, and 84% for the self-help booklet. Young age was associated with the uptake of the Internet-based program, and short education was associated with using proactive telephone counseling.ConclusionsInternet-based interventions and proactive telephone counseling appeal to different age and educational groups. Further, offering similar intervention content by a proactive and a reactive approach can be associated with different intervention uptake.     

The efficacy of Web-based and print-delivered computer-tailored interventions to reduce fat intake: results of a randomized, controlled trial

ObjectiveTo test and compare the efficacy of interactive- and print-delivered computer-tailored nutrition education targeting saturated fat intake reduction.DesignA 3-group randomized, controlled trial (2003-2005) with posttests at 1 and 6 months post-intervention.SettingWorksites and 2 neighborhoods in the urban area of Rotterdam.ParticipantsA convenience sample of healthy Dutch adults (n = 442).InterventionsAn interactive, computer-tailored intervention delivered on a CD-ROM (interactive-tailored condition); a print-delivered, computer-tailored intervention (print-tailored condition); and print-delivered, generic information.Main Outcome MeasuresTotal and saturated fat intake (grams/day and percentage-energy) and energy intake per day assessed with validated food frequency questionnaires at 1 and 6 months post-intervention.AnalysisMultilevel linear regression analyses.ResultsMean total fat, saturated fat, and energy intakes were significantly lower in both tailored conditions compared to the generic condition at 1-month follow-up. These differences were still significant for the print-tailored condition at 6-months follow-up. Effects were most pronounced among participants with unfavorable fat intakes at baseline. There were no significant differences between the 2 tailoring conditions.Conclusions and ImplicationsThe results indicate that interactive and print-delivered computer-tailored interventions can have similar short-term effects on fat intake and that the effects of the print-delivered tailored feedback are maintained in the longer term.     

Preventing alcohol-exposed pregnancies: a randomized controlled trial

BACKGROUND: Prenatal alcohol exposure is a leading preventable cause of birth defects and developmental disabilities in the United States. DESIGN: A randomized controlled trial (2002-2005; data analyzed 2005-2006) of a brief motivational intervention to reduce the risk of an alcohol-exposed pregnancy (AEP) in preconceptional women by focusing on both risk drinking and ineffective contraception use. SETTING/PARTICIPANTS: A total of 830 nonpregnant women, aged 18-44 years, and currently at risk for an AEP were recruited in six diverse settings in Florida, Texas, and Virginia. Combined settings had higher proportions of women at risk for AEP (12.5% overall) than in the general population (2%). INTERVENTIONS: Participants were randomized to receive information plus a brief motivational intervention (n=416) or to receive information only (n=414). The brief motivational intervention consisted of four counseling sessions and one contraception consultation and services visit. MAIN OUTCOME MEASURES: Women consuming more than five drinks on any day or more than eight drinks per week on average, were considered risk drinkers; women who had intercourse without effective contraception were considered at risk of pregnancy. Reversing either or both risk conditions resulted in reduced risk of an AEP. RESULTS: Across the follow-up period, the odds ratios (ORs) of being at reduced risk for AEP were twofold greater in the intervention group: 3 months, 2.31 (95% confidence interval [CI]=1.69-3.20); 6 months, 2.15 (CI=1.52-3.06); 9 months, 2.11 (CI=1.47-3.03). Between-groups differences by time phase were 18.0%, 17.0%, and 14. 8%, respectively. CONCLUSIONS: A brief motivational intervention can reduce the risk of an AEP.