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Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

ABSTRACT: Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients.We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening.This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities.ClinicalTrials.gov NCT02054598.

SUBMITTER: Brenner AT

PROVIDER: S-EPMC4100055 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

Brenner Alison T AT Getrich Christina M CM Pignone Michael M Rhyne Robert L RL Hoffman Richard M RM McWilliams Andrew A de Hernandez Brisa Urquieta BU Weaver Mark A MA Tapp Hazel H Harbi Khalil K Reuland Daniel D

Trials 20140708

<h4>Background</h4>Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC scre ...[more]

PMID: 25004983

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Project description:Importance:Colorectal 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. Objective:To determine the combined effect of a CRC screening decision aid and patient navigation compared with usual care on CRC screening completion. Design, Setting, and Participants:In 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. Interventions:Intervention 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 Measures:The primary outcome was CRC screening completion within 6 months of the index study visit assessed by blinded medical record review. Results:Characteristics 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 Relevance:A patient decision aid plus patient navigation increased the rate of CRC screening completion in compared with usual care invulnerable primary care patients. Trial Registration:clinicaltrials.gov Identifier: NCT02054598.

Project description:BackgroundAlthough colorectal cancer (CRC) screening is effective in reducing CRC mortality, screening rates in vulnerable populations served by community health centers (CHCs) remain below national targets. CHCs in North Carolina are challenged to reach CRC screening targets as they tend to be under-resourced, have limited capacity to implement and sustain population health interventions, and typically operate independently from one another and from regional colonoscopy providers. The Scaling Colorectal Cancer Screening Through Outreach, Referral, and Engagement (SCORE) project is designed to address barriers to CRC screening in partnership with CHCs by implementing a multilevel intervention that includes centralized support infrastructure for mailed fecal immunochemical test (FIT) outreach and patient navigation to follow-up colonoscopy. This paper describes protocols for the SCORE implementation trial.MethodsWe will conduct a type 2 hybrid effectiveness-implementation trial that will assess effectiveness at increasing CRC screening and follow-up rates while also assessing implementation outcomes. The planned trial sample will include 4000 CHC patients who are at average CRC risk and due for screening. Participants will be randomized 1:1 to receive either usual care or a multilevel intervention that includes mailed FIT outreach and patient navigation support to follow-up colonoscopy for those with abnormal FIT. The primary effectiveness outcome is completion of any CRC screening test at six months after randomization. We will also conduct a multilevel assessment of implementation outcomes and determinants.DiscussionThis hybrid effectiveness-implementation trial will evaluate the effectiveness and implementation of an intervention that provides centralized infrastructure for mailed FIT screening and patient navigation for CHCs that operate independently of other healthcare facilities. Findings from this research will enhance understanding of the effectiveness of a centralized approach and factors that determine successful implementation in vulnerable patient populations.Trial registrationThe trial was registered on May 28, 2020, at ClinicalTrials.gov (identifier NCT04406714).

Project description:BackgroundShared decision making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results.PurposeTo assess the impact of decision aid-assisted SDM on CRC screening uptake.DesignRCT.Setting/participantsThe study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50-75 years due for CRC screening.InterventionStudy participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers.Main outcome measuresThe primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011.ResultsPatients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%, p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%, p=0.15). Assignment to the decision-aid arm (AOR=1.48, 95% CI=1.04, 2.10), black race (AOR=1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decision-making approach (AOR=1.55, 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect.ConclusionsDecision aid-assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone.Trial registrationThis study is registered at www.clinicaltrials.govNCT00251862.

Dataset Information

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

Publications

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial.

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