A randomized trial comparing the effect of two phone-based interventions on colorectal cancer screening adherence.
Ontology highlight
ABSTRACT: Background
Early-stage diagnosis of colorectal cancer is associated with high survival rates; screening prevalence, however, remains suboptimal.Purpose
This study seeks to test the hypothesis that participants receiving telephone-based tailored education or motivational interviewing had higher colorectal cancer screening completion rates compared to usual care.Methods
Primary care patients not adherent with colorectal cancer screening and with no personal or family history of cancer (n = 515) were assigned by block randomization to control (n = 169), tailored education (n = 168), or motivational interview (n = 178). The response rate was 70%; attrition was 24%.Results
Highest screening occurred in the tailored education group (23.8%, p < .02); participants had 2.2 times the odds of completing a post-intervention colorectal cancer screening than did the control group (AOR = 2.2, CI = 1.2-4.0). Motivational interviewing was not associated with significant increase in post-intervention screening.Conclusions
Tailored education showed promise as a feasible strategy to increase colorectal cancer screening.
SUBMITTER: Menon U
PROVIDER: S-EPMC3232176 | biostudies-literature | 2011 Dec
REPOSITORIES: biostudies-literature
Publications
A randomized trial comparing the effect of two phone-based interventions on colorectal cancer screening adherence.
Menon Usha U Belue Rhonda R Wahab Stéphanie S Rugen Kathryn K Kinney Anita Y AY Maramaldi Peter P Wujcik Debra D Szalacha Laura A LA
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine 20111201 3
<h4>Background</h4>Early-stage diagnosis of colorectal cancer is associated with high survival rates; screening prevalence, however, remains suboptimal.<h4>Purpose</h4>This study seeks to test the hypothesis that participants receiving telephone-based tailored education or motivational interviewing had higher colorectal cancer screening completion rates compared to usual care.<h4>Methods</h4>Primary care patients not adherent with colorectal cancer screening and with no personal or family histor ...[more]
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Project description:Background and aimsIn 2013, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) steering group published recommendations to standardize reporting quality in randomized controlled trials (RCTs). We aim to assess adherence to SPIRIT reporting guidelines in RCTs on endoscopic colorectal cancer (CRC) screening and participants' adherence to trial protocols.MethodsWe searched databases for RCTs evaluating flexible sigmoidoscopy or colonoscopy for CRC screening published in English language through September 2023. Each eligible study was evaluated using the 8 core SPIRIT statement areas, totaling 51 points. Each item received 1 point if it met the criteria and 0 points if it did not. Adherence to SPIRIT items was calculated, and participant adherence to RCT protocols was assessed as the proportion of participants screened compared to those invited.ResultsFive RCTs, including 4 on flexible sigmoidoscopy and 1 on colonoscopy, were analyzed. Adherence to SPIRIT guidance ranged from 82.4% to 92.2%. The most missed recommendation was item 2b (trial registrations), scored 0 across all studies. Additionally, item 32 (informed consent materials) scored 20%, and items 17a & b (blinding) scored 40% each. In total, 587,572 participants were randomized across the 5 RCTs. Of these, 37% (200,610) underwent CRC screening, with 69.8% (139,983/200,610) adhering to the protocol. The Nordic-European Initiative on Colorectal Cancer (NordICC) trial, employing a unique invitation method, had a lower adherence rate of 42%. Excluding this trial would raise the adherence rate to 74.3% (128,050/172,390).ConclusionThe published CRC screening trials have acceptable adherence to the SPIRIT reporting guidelines. However, reporting appended consent form materials and disclosing all WHO trial registration data can be improved.
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Project description:BackgroundTuberculosis contributes significantly to morbidity and mortality among HIV-infected children in sub-Saharan Africa. Isoniazid prophylaxis can reduce tuberculosis incidence in this population. However, for the treatment to be effective, adherence to the medication must be optimized. We investigated adherence to isoniazid prophylaxis administered daily, compared to three times a week, and predictors of adherence amongst HIV-infected children.MethodsWe investigated adherence to study medication in a two centre, randomized trial comparing daily to three times a week dosing of isoniazid. The study was conducted at two tertiary paediatric care centres in Cape Town, South Africa. Over a 5 year period, we followed 324 HIV-infected children aged >or= 8 weeks. Adherence information based on pill counts was available for 276 children. Percentage adherence was calculated by counting the number of pills returned. Adherence >or= 90% was considered to be optimal. Analysis was done using summary and repeated measures, comparing adherence to the two dosing schedules. Mean percentage adherence (per child during follow-up time) was used to compare the mean of each group as well as the proportion of children achieving an adherence of >or= 90% in each group. For repeated measures, percentage adherence (per child per visit) was dichotomized at 90%. A logistic regression model with generalized estimating equations, to account for within-individual correlation, was used to evaluate the impact of the dosing schedule. Adjustments were made for potential confounders and we assessed potential baseline and time-varying adherence determinants.ResultsThe overall adherence to isoniazid was excellent, with a mean adherence of 94.7% (95% confidence interval [CI] 93.5-95.9); similar mean adherence was achieved by the group taking daily medication (93.8%; 95% CI 92.1-95.6) and by the three times a week group (95.5%; 95% CI 93.8-97.2). Two-hundred and seventeen (78.6%) children achieved a mean adherence of >or= 90%. Adherence was similar for daily and three times a week dosing schedules in univariate (odds ratio [OR] 0.88; 95% CI 0.66-1.17; P = 0.38) and multivariate (adjusted OR 0.85; 95% CI 0.64-1.11; P = 0.23) models. Children from overcrowded homes were less adherent (adjusted OR 0.71; 95% CI 0.54-0.95; P = 0.02). Age at study visit was predictive of adherence, with better adherence achieved in children older than 4 years (adjusted OR 1.96; 95% CI 1.16-3.32; P = 0.01).ConclusionAdherence to isoniazid was excellent regardless of the dosing schedule used. Intermittent dosing of isoniazid prophylaxis can be considered as an alternative to daily dosing, without compromising adherence or efficacy.Trial registrationClinical Trials NCT00330304.
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Project description:BackgroundDespite the demonstrated need to increase screening mammography utilization and strong evidence that mail and telephone outreach to women can increase screening, most managed care organizations have not adopted comprehensive outreach programs. The uncertainty about optimum strategies and cost effectiveness have retarded widespread acceptance. While 70% of women report getting a mammogram within the prior 2 years, repeat mammography rates are less than 50%. This 5-year study is conducted though a Central Massachusetts healthcare plan and affiliated clinic. All women have adequate health insurance to cover the test.Methods/designThis randomized study compares 3 arms: reminder letter alone; reminder letter plus reminder call; reminder letter plus a second reminder and booklet plus a counselor call. All calls provide women with the opportunity to schedule a mammogram in a reasonable time. The invention period will span 4 years and include repeat attempts. The counselor arm is designed to educate, motivate and counsel women in an effort to alleviate PCP burden.All women who have been in the healthcare plan for 24 months and who have a current primary care provider (PCP) and who are aged 51-84 are randomized to 1 of 3 arms. Interventions are limited to women who become ≥ 18 months from a prior mammogram. Women and their physicians may opt out of the intervention study.Measurement of completed mammograms will use plan billing records and clinic electronic records. The primary outcome is the proportion of women continuously enrolled for ≥ 24 months who have had ≥ 1 mammogram in the last 24 months. Secondary outcomes include the number of women who need repeat interventions. The cost effectiveness analysis will measure all costs from the provider perspective.DiscussionSo far, 18,509 women aged 51-84 have been enrolled into our tracking database and were randomized into one of three arms. At baseline, 5,223 women were eligible for an intervention. We anticipate that the outcome will provide firm data about the maximal effectiveness as well as the cost effectiveness of the interventions both for increasing the mammography rate and the repeat mammography rate.Trial registrationhttp://clinicaltrials.gov/NCT01332032.
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Project description:ImportanceColorectal cancer (CRC) screening is underused in the US. Tailored message interventions have shown benefit for increasing screening uptake of mammography and Papanicolaou testing, but their role in CRC screening is less clear.ObjectiveTo evaluate the effectiveness of a tailored message telephone intervention prior to scheduling of a screening or surveillance colonoscopy and its effect on CRC screening completion rates.Design, setting, and participantsThis randomized clinical trial was conducted from July 2017 through August 2018 at the University of Pennsylvania Health System (UPHS), an urban academic medical center. Participants were asymptomatic patients aged 50 to 75 years who were eligible for CRC screening or surveillance, had been referred for colonoscopy, and did not have a scheduled colonoscopy appointment. Data analysis was conducted from January to September 2019.InterventionsPatients underwent block randomization in a 1:1:1 ratio to 1 of 3 study arms. Participants in the usual care group were contacted via a mailed letter and instructed to call to schedule a colonoscopy. In the generic message group, participants were contacted by telephone, completed an assessment, and received a uniform, nontailored message encouraging colonoscopy scheduling. Participants in the tailored message group were contacted by telephone, completed an assessment, and received a tailored message encouraging colonoscopy scheduling based on their identified assessment cohort.Main outcomes and measuresThe primary outcome was colonoscopy completion rate within 120 days of enrollment. The secondary outcome was colonoscopy scheduling rate appointment within 120 days of enrollment.ResultsA total of 600 participants (median [IQR] age, 56 [51-63] years; 373 women [62.2%]) were enrolled, including 200 participants randomized to usual care, 200 participants randomized to the generic message, and 200 participants randomized to the tailored message. The total sample included 12 Asian participants (2.0%), 324 Black participants (54.0%), and 227 White participants (37.8%), and 9 participants (1.5%) were of Latino or Hispanic ethnicity. Colonoscopy completion was significantly higher for both the tailored message group (69 participants [34.5%]) and the generic message group (64 participants [32.0%]) compared with the usual care group (37 participants [18.5%]) (P < .001 and P = .002, respectively). Scheduling rates were also significantly higher in both groups, with 106 participants (53.0%) in the tailored message group and 105 participants (52.5%) in the generic message group scheduling appointments, compared with 54 participants (27.0%) in the usual care arm (P < .001 for both).Conclusions and relevanceIn this randomized clinical trial among individuals whose CRC screening was not up to date, both a tailored message intervention and a generic message intervention were significantly more effective at increasing colonoscopy scheduling and completion rates compared with usual care. These findings suggest that individualized health communications can increase individual motivation to obtain CRC screening.Trial registrationClinicalTrials.gov Identifier: NCT03310892.
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Project description:Background & aimsFinancial incentives might increase participation in prevention such as screening colonoscopy. We studied whether incentives informed by behavioral economics increase participation in risk assessment for colorectal cancer (CRC) and completion of colonoscopy for eligible adults.MethodsEmployees of a large academic health system (50-64 y old; n = 1977) were randomly assigned to groups that underwent risk assessment for CRC screening and direct access colonoscopy scheduling (control), or risk assessment, direct access colonoscopy scheduling, a $10 loss-framed incentive to complete risk assessment, and a $25 unconditional incentive for colonoscopy completion (incentive). The primary outcome was the percentage of participants who completed screening colonoscopy within 3 months of initial outreach. Secondary outcomes included the percentage of participants who scheduled colonoscopy and the percentage who completed the risk assessment.ResultsAt 3 months, risk assessment was completed by 19.5% of participants in the control group (95% CI, 17.0-21.9%) and 31.9% of participants in the incentive group (95% CI, 29.0-34.8%) (P < .001). At 3 months, 0.7% of controls had completed a colonoscopy (95% CI, .2%-1.2%) compared with 1.2% of subjects in the incentive group (95% CI, .5%-1.9%) (P = .25).ConclusionsIn a randomized trial of participants who underwent risk assessment for CRC with vs without financial incentive, the financial incentive increased CRC risk assessment completion but did not result in a greater completion of screening colonoscopy. Clinicaltrials.gov no: NCT03068052.
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Project description:BackgroundChildren with cerebral palsy receive a variety of long-term physical and occupational therapy interventions to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. Considerable human and financial resources are directed at the "intervention" of the problems of cerebral palsy, although the available evidence supporting current interventions is inconclusive. A considerable degree of uncertainty remains about the appropriate therapeutic approaches to manage the habilitation of children with cerebral palsy. The primary objective of this project is to conduct a multi-site randomized clinical trial to evaluate the efficacy of a task/context-focused approach compared to a child-focused remediation approach in improving performance of functional tasks and mobility, increasing participation in everyday activities, and improving quality of life in children 12 months to 5 years of age who have cerebral palsy.Method/designA multi-centred randomized controlled trial research design will be used. Children will be recruited from a representative sample of children attending publicly-funded regional children's rehabilitation centers serving children with disabilities in Ontario and Alberta in Canada. Target sample size is 220 children with cerebral palsy aged 12 months to 5 years at recruitment date. Therapists are randomly assigned to deliver either a context-focused approach or a child-focused approach. Children follow their therapist into their treatment arm. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes represent the components of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment).DiscussionThis paper presents the background information, design and protocol for a randomized controlled trial comparing a task/context-focused approach to a child-focused remediation approach in improving functional outcomes for young children with cerebral palsy.Trial registration[clinical trial registration #: NCT00469872].
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