Dataset Information

Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population.

ABSTRACT:

Background

Colorectal cancer (CRC) screening reduces mortality yet remains underutilized. Low health literacy may contribute to this underutilization by interfering with patients' ability to understand and receive preventive health services.

Purpose

To determine if a web-based multimedia CRC screening patient decision aid, developed for a mixed-literacy audience, could increase CRC screening.

Design

RCT. Patients aged 50-74 years and overdue for CRC screening were randomized to the web-based decision aid or a control program seen immediately before a scheduled primary care appointment.

Setting/participants

A large community-based, university-affiliated internal medicine practice serving a socioeconomically disadvantaged population.

Main outcome measures

Patients completed surveys to determine their ability to state a screening test preference and their readiness to receive screening. Charts were abstracted by masked observers to determine if screening tests were ordered and completed.

Results

Between November 2007 and September 2008, a total of 264 patients enrolled in the study. Data collection was completed in 2009, and data analysis was completed in 2010. A majority of participants (mean age=57.8 years) were female (67%), African-American (74%), had annual household incomes of <$20,000 (76%), and had limited health literacy (56%). When compared to control participants, more decision-aid participants had a CRC screening preference (84% vs 55%, p<0.0001) and an increase in readiness to receive screening (52% vs 20%, p=0.0001). More decision-aid participants had CRC screening tests ordered (30% vs 21%) and completed (19% vs 14%), but no statistically significant differences were seen (AOR=1.6, 95% CI=0.97, 2.8, and AOR=1.7, 95% CI=0.88, 3.2, respectively). Similar results were found across literacy levels.

Conclusions

The web-based decision aid increased patients' ability to form a test preference and their intent to receive screening, regardless of literacy level. Further study should examine ways the decision aid can be combined with additional system changes to increase CRC screening.

SUBMITTER: Miller DP

PROVIDER: S-EPMC3480321 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population.

Miller David P DP Spangler John G JG Case L Doug LD Goff David C DC Singh Sonal S Pignone Michael P MP

American journal of preventive medicine 20110601 6

<h4>Background</h4>Colorectal cancer (CRC) screening reduces mortality yet remains underutilized. Low health literacy may contribute to this underutilization by interfering with patients' ability to understand and receive preventive health services.<h4>Purpose</h4>To determine if a web-based multimedia CRC screening patient decision aid, developed for a mixed-literacy audience, could increase CRC screening.<h4>Design</h4>RCT. Patients aged 50-74 years and overdue for CRC screening were randomize ...[more]

PMID: 21565651

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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:BACKGROUND:Hydroxyurea, chronic blood transfusions, and bone marrow transplantation are efficacious, disease-modifying therapies for sickle cell disease but involve complex risk-benefit trade-offs and decisional dilemma compounded by the lack of comparative studies. A patient decision aid can inform patients about their treatment options, the associated risks and benefits, help them clarify their values, and allow them to participate in medical decision making. OBJECTIVE:The objective of this study was to develop a literacy-sensitive Web-based patient decision aid based on the Ottawa decision support framework, and through a randomized clinical trial estimate the effectiveness of the patient decision aid in improving patient knowledge and their involvement in decision making. METHODS:We conducted population decisional needs assessments in a nationwide sample of patients, caregivers, community advocates, policy makers, and health care providers using qualitative interviews to identify decisional conflict, knowledge and expectations, values, support and resources, decision types, timing, stages and learning, and personal clinical characteristics. Interview transcripts were coded using QSR NVivo 10. Alpha testing of the patient decision aid prototype was done to establish usability and the accuracy of the information it conveyed, and then was followed by iterative cycles of beta testing. We conducted a randomized clinical trial of adults and of caregivers of pediatric patients to evaluate the efficacy of the patient decision aid. RESULTS:In a decisional needs assessment, 223 stakeholders described their preferences, helping to guide the development of the patient decision aid, which then underwent alpha testing by 30 patients and 38 health care providers and iterative cycles of beta testing by 87 stakeholders. In a randomized clinical trial, 120 participants were assigned to either the patient decision aid or standard care (SC) arm. Qualitative interviews revealed high levels of usability, acceptability, and utility of the patient decision aid in education, values clarification, and preparation for decision making. On the acceptability survey, 72% (86/120) of participants rated the patient decision aid as good or excellent. Participants on the patient decision aid arm compared to the SC arm demonstrated a statistically significant improvement in decisional self-efficacy (P=.05) and a reduction in the informed sub-score of decisional conflict (P=.003) at 3 months, with an improvement in preparation for decision making (P<.001) at 6 months. However, there was no improvement in terms of the change in knowledge, the total or other domain scores of decisional conflicts, or decisional self-efficacies at 6 months. The large amount of missing data from survey completion limited our ability to draw conclusions about the effectiveness of the patient decision aid. The patient decision aid met 61 of 62 benchmarks of the international patient decision aid collaboration standards for content, development process, and efficacy. CONCLUSIONS:We have developed a patient decision aid for sickle cell disease with extensive input from stakeholders and in a randomized clinical trial demonstrated its acceptability and utility in education and decision making. We were unable to demonstrate its effectiveness in improving patient knowledge and involvement in decision making. TRIAL REGISTRATION:ClinicalTrials.gov NCT03224429; https://clinicaltrials.gov/ct2/show/NCT03224429 and ClinicalTrials.gov NCT02326597; https://clinicaltrials.gov/ct2/show/NCT02326597.

Project description:Background. When stakeholders offer divergent input, it can be unclear how to prioritize information for decision aids (DAs) on mammography screening. Objectives. This analysis triangulates perspectives (breast cancer screening experts, primary care providers [PCPs], and patients with limited health literacy [LHL]) to understand areas of divergent and convergent input across stakeholder groups in developing a breast cancer screening DA for younger women with LHL. Design. A modified online Delphi panel of 8 experts rated 57 statements for inclusion in a breast cancer screening DA over three rounds. Individual interviews with 25 patients with LHL and 20 PCPs from a large safety net hospital explored informational needs about mammography decision making. Codes from the qualitative interviews and open-ended responses from the Delphi process were mapped across stakeholders to ascertain areas where stakeholder preferences converged or diverged. Results. Four themes regarding informational needs were identified regarding 1) the benefits and harms of screening, 2) different screening modalities, 3) the experience of mammography, and 4) communication about breast cancer risk. Patients viewed pain as the primary harm, while PCPs and experts emphasized the harm of false positives. Patients, but not PCPs or experts, felt that information about the process of getting a mammogram was important. PCPs believed that mammography was the only evidence-based screening modality, while patients believed breast self-exam was also important for screening. All stakeholders described incorporating personal risk information as important. Limitations. As participants came from one hospital, perceptions may reflect local practices. The Delphi sample size was small. Conclusions. Patients, experts, and PCPs had divergent views on the most important information needed for screening decisions. More evidence is needed to guide integration of multiple stakeholder perspectives into the content of DAs.

Project description:BackgroundWeb-based tools developed to facilitate a shared decision-making (SDM) process may facilitate the implementation of lung cancer screening (LCS), an evidence-based intervention to improve cancer outcomes. Veterans have specific risk factors and shared experiences that affect the benefits and potential harms of LCS and thus may value a veteran-centric LCS decision tool (LCSDecTool).ObjectiveThis study aims to conduct usability testing of an LCSDecTool designed for veterans receiving care at a Veteran Affairs medical center.MethodsUsability testing of the LCSDecTool was conducted in a prototype version (phase 1) and a high-fidelity version (phase 2). A total of 18 veterans and 8 clinicians participated in phase 1, and 43 veterans participated in phase 2. Quantitative outcomes from the users included the System Usability Scale (SUS) and the End User Computing Satisfaction (EUCS) in phase 1 and the SUS, EUCS, and Patient Engagement scale in phase 2. Qualitative data were obtained from observations of user sessions and brief interviews. The results of phase 1 informed the modifications of the prototype for the high-fidelity version. Phase 2 usability testing took place in the context of a pilot hybrid type 1 effectiveness-implementation trial.ResultsIn the phase 1 prototype usability testing, the mean SUS score (potential range: 0-100) was 81.90 (SD 9.80), corresponding to an excellent level of usability. The mean EUCS score (potential range: 1-5) was 4.30 (SD 0.71). In the phase 2 high-fidelity usability testing, the mean SUS score was 65.76 (SD 15.23), corresponding to a good level of usability. The mean EUCS score was 3.91 (SD 0.95); and the mean Patient Engagement scale score (potential range 1 [low] to 5 [high]) was 4.62 (SD 0.67). The median time to completion in minutes was 13 (IQR 10-16). A thematic analysis of user statements documented during phase 2 high-fidelity usability testing identified the following themes: a low baseline level of awareness and knowledge about LCS increased after use of the LCSDecTool; users sought more detailed descriptions about the LCS process; the LCSDecTool was generally easy to use, but specific navigation challenges remained; some users noted difficulty understanding medical terms used in the LCSDecTool; and use of the tool evoked veterans' struggles with prior attempts at smoking cessation.ConclusionsOur findings support the development and use of this eHealth technology in the primary care clinical setting as a way to engage veterans, inform them about a new cancer control screening test, and prepare them to participate in an SDM discussion with their provider.

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.

Project description:BackgroundIn cancers with a chronic phase, patients and family caregivers face difficult decisions such as whether to start a novel therapy, whether to enroll in a clinical trial, and when to stop treatment. These decisions are complex, require an understanding of uncertainty, and necessitate the consideration of patients' informed preferences. For some cancers, such as medullary thyroid carcinoma, these decisions may also involve significant out-of-pocket costs and effects on family members. Providers have expressed a need for web-based interventions that can be delivered between consultations to provide education and prepare patients and families to discuss these decisions. To ensure that these tools are effective, usable, and understandable, studies are needed to identify patients', families', and providers' decision-making needs and optimal design strategies for a web-based patient decision aid.ObjectiveFollowing the international guidelines for the development of a web-based patient decision aid, the objectives of this study are to engage potential users to guide development; review the existing literature and available tools; assess users' decision-making experiences, needs, and design recommendations; and identify shared decision-making approaches to address each need.MethodsThis study used the decisional needs assessment approach, which included creating a stakeholder advisory panel, mapping decision pathways, conducting an environmental scan of existing materials, and administering a decisional needs assessment questionnaire. Thematic analyses identified current decision-making pathways, unmet decision-making needs, and decision support strategies for meeting each need.ResultsThe stakeholders reported wide heterogeneity in decision timing and pathways. Relevant existing materials included 2 systematic reviews, 9 additional papers, and multiple educational websites, but none of these met the criteria for a patient decision aid. Patients and family members (n=54) emphasized the need for plain language (46/54, 85%), shared decision making (45/54, 83%), and help with family discussions (39/54, 72%). Additional needs included information about uncertainty, lived experience, and costs. Providers (n=10) reported needing interventions that address misinformation (9/10, 90%), foster realistic expectations (9/10, 90%), and address mistrust in clinical trials (5/10, 50%). Additional needs included provider tools that support shared decision making. Both groups recommended designing a web-based patient decision aid that can be tailored to (64/64, 100%) and delivered on a hospital website (53/64, 83%), focuses on quality of life (45/64, 70%), and provides step-by-step guidance (43/64, 67%). The study team identified best practices to meet each need, which are presented in the proposed decision support design guide.ConclusionsPatients, families, and providers report multifaceted decision support needs during the chronic phase of cancer. Web-based patient decision aids that provide tailored support over time and explicitly address uncertainty, quality of life, realistic expectations, and effects on families are needed.

Project description:BackgroundWhether early detection and treatment of prostate cancer (PCa) will reduce disease-related mortality remains uncertain. As a result, tools are needed to facilitate informed decision making. While there have been several decision aids (DAs) developed and tested, very few have included an exercise to help men clarify their values and preferences about PCa screening. Further, only one DA has utilized an interactive web-based format, which allows for an expansion and customization of the material. We describe the development of two DAs, a booklet and an interactive website, each with a values clarification component and designed for use in diverse settings.MethodsWe conducted two feasibility studies to assess men's (45-70 years) Internet access and their willingness to use a web- vs. a print-based tool. The booklet was adapted from two previous versions evaluated in randomized controlled trials (RCTs) and the website was created to closely match the content of the revised booklet. Usability testing was conducted to obtain feedback regarding draft versions of the materials. The tools were also reviewed by a plain language expert and the interdisciplinary research team. Feedback on the content and presentation led to iterative modifications of the tools.ResultsThe feasibility studies confirmed that the Internet was a viable medium, as the majority of men used a computer, had access to the Internet, and Internet use increased over time. Feedback from the usability testing on the length, presentation, and content of the materials was incorporated into the final versions of the booklet and website. Both the feasibility studies and the usability testing highlighted the need to address men's informed decision making regarding screening.ConclusionsInformed decision making for PCa screening is crucial at present and may be important for some time, particularly if a definitive recommendation either for or against screening does not emerge from ongoing prostate cancer screening trials. We have detailed our efforts at developing print- and web-based DAs to assist men in determining how to best meet their PCa screening preferences. Following completion of our ongoing RCT designed to test these materials, our goal will be to develop a dissemination project for the more effective tool.Trial registrationNCT00623090.

Dataset Information

Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population.

Background

Purpose

Design

Setting/participants

Main outcome measures

Results

Conclusions

Publications

Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population.

Similar Datasets

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