Dataset Information

Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial.

ABSTRACT:

Importance

Colorectal 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.

Objective

To 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 participants

This 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.

Interventions

Patients 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 measures

The primary outcome was colonoscopy completion rate within 120 days of enrollment. The secondary outcome was colonoscopy scheduling rate appointment within 120 days of enrollment.

Results

A 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 relevance

In 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 registration

ClinicalTrials.gov Identifier: NCT03310892.

SUBMITTER: Oyalowo A

PROVIDER: S-EPMC8972032 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial.

Oyalowo Akinbowale A Forde Kimberly A KA Lamanna Alicia A Kochman Michael L ML

JAMA network open 20220301 3

<h4>Importance</h4>Colorectal 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.<h4>Objective</h4>To 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.<h4>Design, setting, and participants</h4>This ra ...[more]

PMID: 35357457

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Project description:ImportanceColorectal cancer (CRC) screening reduces CRC mortality; however, screening rates remain well below the national benchmark of 80%.ObjectiveTo determine whether an electronic primer message delivered through the patient portal increases the completion rate of CRC screening in a mailed fecal immunochemical test (FIT) outreach program.Design, setting, and participantsIn this randomized clinical quality improvement trial at the University of California, Los Angeles Health of 2339 patients enrolled in a FIT mailing program from August 28, 2019, to September 20, 2020, patients were randomly assigned to either the control or intervention group, and the screening completion rate was measured at 6 months. Participants were average-risk managed care patients aged 50 to 75 years, with a valid mailing address, no mailed CRC outreach in the previous 6 months, and an active electronic health record (EHR) patient portal who were due for CRC screening. Data were analyzed on an intention-to-treat basis.InterventionsEligible patients were randomly assigned to receive either (1) the standard FIT mailed outreach (control group) or (2) the standard FIT mailed outreach plus an automated primer to notify patients of the upcoming mailed FIT sent through the electronic patient portal (intervention group).Main outcomes and measuresThe primary outcome was the screening completion rate (ie, returning the FIT). Secondary outcomes were (1) were the time to CRC screening from the FIT mailing date, (2) screening modality completed, and (3) the effect of opening the electronic primer on screening completion rate.ResultsThe study included 2339 patients (1346 women [57.5%]; mean [SD] age, 58.9 [7.5] years). The screening completion rate was higher in the intervention group than in the control group (37.6% [445 of 1182] vs 32.1% [371 of 1157]; P = .005). The time to screening was shorter in the intervention group than in the control group (adjusted hazard ratio, 1.24; 95% CI, 1.08-1.42; P = .003). The proportion of each screening test modality completed was similar in both groups. In a subanalysis of the 900 of 1182 patients (76.1%) in the intervention group who opened the patient portal primer message, there was a 7.3-percentage point (95% CI, 2.3-12.4 percentage points) increase in CRC screening (local mean treatment effect; P = .004).Conclusions and relevanceImplementation of an electronic patient portal primer message in a mailed FIT outreach program led to a significant increase in CRC screening and improvement in the time to screening completion. The findings provide an evidence base for additional refinements to mailed FIT outreach quality improvement programs in large health systems.Trial registrationClinicalTrials.gov Identifier: NCT05115916.

Project description:ImportanceMailing fecal immunochemical test (FIT) kits to patients' homes has been shown to boost colorectal cancer screening rates, but response rates remain limited, and organized programs typically require repeated outreach attempts. Behavioral economics has shown that offering salient financial incentives to patients may increase participation in preventive health.ObjectiveTo compare the impact of different financial incentives for mailed FIT outreach.Design, setting, and participantsThis 4-parallel-arm randomized clinical trial included patients aged 50 to 75 years who had an established primary care clinician, at least 2 visits in the prior 2 years, and were eligible for colorectal cancer screening and not up-to-date. This study was conducted at urban primary care practices at an academic health system from December 2015 to February 2018. Data analysis was conducted from March 2018 to September 2018.InterventionsEligible patients received a letter from their primary care clinician that included a mailed FIT kit and instructions for use. They were randomized in a 1:1:1:1 ratio to receive (1) no financial incentive; (2) an unconditional $10 incentive included with the mailing; (3) a $10 incentive conditional on FIT completion; or (4) a conditional lottery with a 1-in-10 chance of winning $100 after FIT completion.Main outcomes and measuresFecal immunochemical test completion within 2 and 6 months of initial outreach.ResultsA total of 897 participants were randomized, with a median age of 57 years (interquartile range, 52-62 years); 56% were women, and 69% were black. The overall completion rate across all arms was 23.5% at 2 months. The completion rate at 2 months was 26.0% (95% CI, 20.4%-32.3%) in the no incentive arm, 27.2% (95% CI, 21.5%-33.6%) in the unconditional incentive arm, 23.2% (95% CI, 17.9%-29.3%) in the conditional incentive arm, and 17.7% (95% CI, 13.0%-23.3%) in the lottery incentive arm. None of the arms with an incentive were statistically superior to the arm without incentive. The overall FIT completion rate across all arms was 28.9% at 6 months, and there was also no difference by arm. The completion rate at 6 months was 32.7% (95% CI, 26.6%-39.3%) in the no incentive arm, 31.7% (95% CI, 25.7%-38.2%) in the unconditional incentive arm, 26.8% (95% CI, 21.1%-33.1%) in the conditional incentive arm, and 24.3% (95% CI, 18.9%-30.5%) in the lottery incentive arm.Conclusions and relevanceMailed FIT resulted in high colorectal cancer screening response rates in this population, but different forms of financial incentives of the same expected value ($10) did not incrementally increase FIT completion rates. The incentive value may have been too small or financial incentives may not be effective in this context.Trial registrationClinicalTrials.gov Identifier: NCT02594150.

Project description:ImportanceIncreasing participation in fecal screening tests is a major challenge in countries that have implemented colorectal cancer (CRC) screening programs.ObjectiveTo determine whether providing general practitioners (GPs) a list of patients who are nonadherent to CRC screening enhances patient participation in fecal immunochemical testing (FIT).Design, setting, and participantsA 3-group, cluster-randomized study was conducted from July 14, 2015, to July 14, 2016, on the west coast of France, with GPs in 801 practices participating and involving adult patients (50-74 years) who were at average risk of CRC and not up-to-date with CRC screening. The final follow-up date was July 14, 2016.InterventionsGeneral practitioners were randomly assigned to 1 of 3 groups: 496 received a list of patients who had not undergone CRC screening (patient-specific reminders group, 10 476 patients), 495 received a letter describing region-specific CRC screening adherence rates (generic reminders group, 10 606 patients), and 455 did not receive any reminders (usual care group, 10 147 patients).Main outcomes and measuresThe primary end point was patient participation in CRC screening 1 year after the intervention.ResultsAmong 1482 randomized GPs (mean age, 53.4 years; 576 women [38.9%]), 1446 participated; of the 33 044 patients of these GPs (mean age, 59.7 years; 17 949 women [54.3%]), follow-up at 1 year was available for 31 229 (94.5%). At 1 year, 24.8% (95% CI, 23.4%-26.2%) of patients in the specific reminders group, 21.7% (95% CI, 20.5%-22.8%) in the generic reminders group, and 20.6% (95% CI, 19.3%-21.8%) in the usual care group participated in the FIT screening. The between-group differences were 3.1% (95% CI, 1.3%-5.0%) for the patient-specific reminders group vs the generic reminders group, 4.2% (95% CI, 2.3%-6.2%) for the patient-specific reminders group vs the usual care group, and 1.1% (95% CI, -0.6% to 2.8%) for generic reminders group vs the usual care group.Conclusions and relevanceProviding French GPs caring for adults at average risk of CRC with a list of their patients who were not up-to-date with their CRC screening resulted in a small but significant increase in patient participation in FIT screening at 1 year compared with patients who received usual care. Providing GPs with generic reminders about regional rates of CRC screening did not increase screening rates compared with usual care.Trial registrationclinicaltrials.gov Identifier: NCT02515344.

Project description:ImportanceColorectal cancer (CRC) screening is underused, especially among vulnerable populations. Decision aids and patient navigation are potentially complementary interventions for improving CRC screening rates, but their combined effect on screening completion is unknown.ObjectiveTo determine the combined effect of a CRC screening decision aid and patient navigation compared with usual care on CRC screening completion.Design, setting, and participantsIn this randomized clinical trial, data were collected from January 2014 to March 2016 at 2 community health center practices, 1 in North Carolina and 1 in New Mexico, serving vulnerable populations. Patients ages 50 to 75 years who had average CRC risk, spoke English or Spanish, were not current with recommended CRC screening, and were attending primary care visits were recruited and randomized 1:1 to intervention or control arms.InterventionsIntervention participants viewed a CRC screening decision aid in English or Spanish immediately before their clinician encounter. The decision aid promoted screening and presented colonoscopy and fecal occult blood testing as screening options. After the clinician encounter, intervention patients received support for screening completion from a bilingual patient navigator. Control participants viewed a food safety video before the encounter and otherwise received usual care.Main outcomes and measuresThe primary outcome was CRC screening completion within 6 months of the index study visit assessed by blinded medical record review.ResultsCharacteristics of the 265 participants were as follows: their mean age was 58 years; 173 (65%) were female, 164 (62%) were Latino; 40 (15%) were white non-Latino; 61 (23%) were black or of mixed race; 191 (78%) had a household income of less than $20 000; 101 (38%) had low literacy; 75 (28%) were on Medicaid; and 91 (34%) were uninsured. Intervention participants were more likely to complete CRC screening within 6 months (68% vs 27%); adjusted-difference, 40 percentage points (95% CI, 29-51 percentage points). The intervention was more effective in women than in men (50 vs 21 percentage point increase, interaction P = .02). No effect modification was observed across other subgroups.Conclusions and relevanceA patient decision aid plus patient navigation increased the rate of CRC screening completion in compared with usual care invulnerable primary care patients.Trial registrationclinicaltrials.gov Identifier: NCT02054598.

Project description:ImportanceColonoscopy and fecal immunochemical testing (FIT) are considered top-tier tests for colorectal cancer (CRC) screening. Behavioral economic insights about "choice architecture" suggest that participation could be influenced by how people are presented test options.ObjectiveTo investigate response rates for offering colonoscopy only compared with sequential choice (colonoscopy and then FIT) or active choice (colonoscopy or FIT) through mailed outreach.Design, setting, and participantsThree-arm pragmatic randomized clinical trial conducted between November 14, 2017, and May 14, 2018. The setting was primary care practices at an academic health system. Patients aged 50 to 74 years with at least 2 primary care visits in the 2-year preenrollment period were included if they were eligible but not up to date on CRC screening.InterventionsEligible patients received mailed outreach about CRC screening. Equal numbers of eligible patients were randomly assigned to 3 outreach groups to receive mailings about CRC screening with the following options: (1) direct phone number to call for scheduling colonoscopy (colonoscopy only), (2) direct phone number to call for colonoscopy and a mailed FIT kit if no response within 4 weeks (sequential choice), or (3) direct phone number to call for colonoscopy and a mailed FIT kit offered at the same time (active choice).Main outcomes and measuresThe primary outcome was CRC screening completion (FIT or colonoscopy) within 4 months of initial outreach. The secondary outcomes were CRC screening completion within 6 months of outreach and the choice of colonoscopy as a screening test.ResultsIn total, 438 patients were included in the intent-to-treat analysis, with a median age of 56 years (interquartile range, 52-63 years); 55.0% were women. At 4 months, the CRC screening completion rates were 14.4% (95% CI, 8.7%-20.1%) in the colonoscopy-only arm, 17.1% (95% CI, 11.0%-23.2%) in the sequential choice arm, and 19.9% (95% CI, 13.4%-26.4%) in the active choice arm. Neither choice arm achieved a screening rate statistically greater than that in the colonoscopy-alone arm. Among those who completed CRC screening at 4 months, 90.5% (95% CI, 78.0%-103.0%) chose colonoscopy in the colonoscopy-only arm, which was significantly higher than the 52.0% (95% CI, 32.4%-71.6%; P = .005) and 37.9% (95% CI, 20.2%-55.6%; P < .001) in the sequential choice and active choice arms, respectively.Conclusions and relevanceThere was no significant increase in CRC screening when offering sequential or active choice, but there was a lower rate of colonoscopy in the choice arms than in the colonoscopy-only arm. Subtle changes in sequencing or defaults can alter patient decision making related to preventive health.Trial registrationClinicalTrials.gov identifier: NCT03246438.

Project description:ImportanceColorectal cancer is a major health burden. Screening is recommended in many countries.ObjectiveTo estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial.Design, setting, and participantsRandomized clinical trial of 100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway. Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011. Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry.InterventionsParticipants randomized to the screening group were invited to undergo screening. Within the screening group, participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT). Participants with positive screening test results (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention.Main outcomes and measuresColorectal cancer incidence and mortality.ResultsA total of 98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT). Adherence with screening was 63%. After a median of 10.9 years, 71 participants died of colorectal cancer in the screening group vs 330 in the control group (31.4 vs 43.1 deaths per 100,000 person-years; absolute rate difference, 11.7 [95% CI, 3.0-20.4]; hazard ratio [HR], 0.73 [95% CI, 0.56-0.94]). Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group (112.6 vs 141.0 cases per 100,000 person-years; absolute rate difference, 28.4 [95% CI, 12.1-44.7]; HR, 0.80 [95% CI, 0.70-0.92]). Colorectal cancer incidence was reduced in both the 50- to 54-year age group (HR, 0.68; 95% CI, 0.49-0.94) and the 55- to 64-year age group (HR, 0.83; 95% CI, 0.71-0.96). There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups.Conclusions and relevanceIn Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50- to 54-year and the 55- to 64-year age groups.Trial registrationclinicaltrials.gov Identifier: NCT00119912.

Project description:ImportanceAlthough some countries have implemented widespread colonoscopy screening, most European countries have not introduced it because of uncertainty regarding participation rates, procedure-related pain and discomfort, endoscopist performance, and effectiveness. To our knowledge, no randomized trials on colonoscopy screening currently exist.ObjectiveTo investigate participation rate, adenoma yield, performance, and adverse events of population-based colonoscopy screening in several European countries.Design, setting, and populationA population-based randomized clinical trial was conducted among 94 959 men and women aged 55 to 64 years of average risk for colon cancer in Poland, Norway, the Netherlands, and Sweden from June 8, 2009, to June 23, 2014.InterventionsColonoscopy screening or no screening.Main outcomes and measuresParticipation in colonoscopy screening, cancer and adenoma yield, and participant experience. Study outcomes were compared by country and endoscopist.ResultsOf 31 420 eligible participants randomized to the colonoscopy group, 12 574 (40.0%) underwent screening. Participation rates were 60.7% in Norway (5354 of 8816), 39.8% in Sweden (486 of 1222), 33.0% in Poland (6004 of 18 188), and 22.9% in the Netherlands (730 of 3194) (P < .001). The cecum intubation rate was 97.2% (12 217 of 12 574), with 9726 participants (77.4%) not receiving sedation. Of the 12 574 participants undergoing colonoscopy screening, we observed 1 perforation (0.01%), 2 postpolypectomy serosal burns (0.02%), and 18 cases of bleeding owing to polypectomy (0.14%). Sixty-two individuals (0.5%) were diagnosed with colorectal cancer and 3861 (30.7%) had adenomas, of which 1304 (10.4%) were high-risk adenomas. Detection rates were similar in the proximal and distal colon. Performance differed significantly between endoscopists; recommended benchmarks for cecal intubation (95%) and adenoma detection (25%) were not met by 6 (17.1%) and 10 of 35 endoscopists (28.6%), respectively. Moderate or severe abdominal pain after colonoscopy was reported by 601 of 3611 participants (16.7%) examined with standard air insufflation vs 214 of 5144 participants (4.2%) examined with carbon dioxide (CO2) insufflation (P < .001).Conclusions and relevanceColonoscopy screening entails high detection rates in the proximal and distal colon. Participation rates and endoscopist performance vary significantly. Postprocedure abdominal pain is common with standard air insufflation and can be significantly reduced by using CO2.Trial registrationclinicaltrials.gov Identifier: NCT00883792.

Project description:ImportanceGuidelines recommend individualized decision-making for colorectal cancer (CRC) screening among adults aged 76 to 84 years, a process that includes a consideration of health state and patient preference.ObjectiveTo determine whether a targeted patient decision aid would align older adults' screening preference with their potential to benefit from CRC screening.Design, setting, and participantsThis is a prespecified secondary analysis from a randomized clinical trial. Participants aged 70 to 84 years who were not up to date with screening and had an appointment within 6 weeks were purposively sampled by health state (poor, intermediate, or good) at 14 community-based primary care practices and block randomized to receive the intervention or control. Patients were recruited from March 1, 2012, to February 28, 2015, and these secondary analyses were performed from January 15 to March 1, 2022.InterventionsPatient decision aid targeted to age and sex.Main outcomes and measuresThe primary outcome of this analysis was patient preference for CRC screening. The a priori hypothesis was that the decision aid (intervention) group would reduce the proportion preferring screening among those in poor and intermediate health compared with the control group.ResultsAmong the 424 participants, the mean (SD) age was 76.8 (4.2) years; 248 (58.5%) of participants were women; and 333 (78.5%) were White. The proportion preferring screening in the intervention group was less than in the control group for those in the intermediate health state (34 of 76 [44.7%] vs 40 of 73 [54.8%]; absolute difference, -10.1% [95% CI, -26.0% to 5.9%]) and in the poor health state (24 of 62 [38.7%] vs 33 of 61 [54.1%]; absolute difference, -15.4% [95% CI, -32.8% to 2.0%]). These differences were not statistically significant. The proportion of those in good health who preferred screening was similar between the intervention and control groups (44 of 74 [59.5%] for intervention vs 46 of 75 [61.3%] for control; absolute difference, -1.9% [95% CI, -17.6% to 13.8%]).Conclusions and relevanceThe findings of this secondary analysis of a clinical trial did not demonstrate statistically significant differences in patient preferences between the health groups. Additional studies that are appropriately powered are needed to determine the effect of the decision aid on the preferences of older patients for CRC screening by health state.Trial registrationClinicalTrials.gov Identifier: NCT01575990.

Dataset Information

Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial.

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