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A randomized, controlled trial to increase discussion of breast cancer in primary care.

ABSTRACT: Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral.We conducted a randomized controlled trial of a multiethnic, multilingual sample of women ages 40 to 74 years from two primary care practices (one academic, one safety net) to test a breast cancer risk assessment and education intervention. Patients were randomly assigned to control or intervention group. All patients completed a baseline telephone survey and risk assessment (via telephone for controls, via tablet computer in clinic waiting room before visit for intervention). Intervention (BreastCARE) patients and their physicians received an individualized risk report to discuss during the visit. One-week follow-up telephone surveys with all patients assessed patient-physician discussion of family cancer history, personal breast cancer risk, high-risk clinics, and genetic counseling/testing.A total of 655 control and 580 intervention women completed the risk assessment and follow-up interview; 25% were high-risk by family history, Gail, or Breast Cancer Surveillance Consortium risk models. BreastCARE increased discussions of family cancer history [OR, 1.54; 95% confidence interval (CI), 1.25-1.91], personal breast cancer risk (OR, 4.15; 95% CI, 3.02-5.70), high-risk clinics (OR, 3.84; 95% CI, 2.13-6.95), and genetic counseling/testing (OR, 2.22; 95% CI, 1.34-3.68). Among high-risk women, all intervention effects were stronger.An intervention combining an easy-to-use, quick risk assessment tool with patient-centered risk reports at the point of care can successfully promote discussion of breast cancer risk reduction between patients and primary care physicians, particularly for high-risk women.Next steps include scaling and dissemination of BreastCARE with integration into electronic medical record systems.

SUBMITTER: Kaplan CP

PROVIDER: S-EPMC4167008 | biostudies-literature | 2014 Jul

REPOSITORIES: biostudies-literature

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A randomized, controlled trial to increase discussion of breast cancer in primary care.

Kaplan Celia P CP Livaudais-Toman Jennifer J Tice Jeffrey A JA Kerlikowske Karla K Gregorich Steven E SE Pérez-Stable Eliseo J EJ Pasick Rena J RJ Chen Alice A Quinn Jessica J Karliner Leah S LS

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 20140424 7

<h4>Background</h4>Assessment and discussion of individual risk for breast cancer within the primary care setting are crucial to discussion of risk reduction and timely referral.<h4>Methods</h4>We conducted a randomized controlled trial of a multiethnic, multilingual sample of women ages 40 to 74 years from two primary care practices (one academic, one safety net) to test a breast cancer risk assessment and education intervention. Patients were randomly assigned to control or intervention group. ...[more]

PMID: 24762560

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Project description:BackgroundProvider recommendation is a predictor of colorectal cancer (CRC) screening.PurposeTo compare the effects of two clinic-based interventions on patient-provider discussions about CRC screening.DesignTwo-group RCT with data collected at baseline and 1 week post-intervention.Setting/participantsAfrican-American patients that were non-adherent to CRC screening recommendations (n=693) with a primary care visit between 2008 and 2010 in one of 11 urban primary care clinics.InterventionParticipants received either a computer-delivered tailored CRC screening intervention or a nontailored informational brochure about CRC screening immediately prior to their primary care visit.Main outcome measuresBetween-group differences in odds of having had a CRC screening discussion about a colon test, with and without adjusting for demographic, clinic, health literacy, health belief, and social support variables, were examined as predictors of a CRC screening discussion using logistic regression. Intervention effects on CRC screening test order by PCPs were examined using logistic regression. Analyses were conducted in 2011 and 2012.ResultsCompared to the brochure group, greater proportions of those in the computer-delivered tailored intervention group reported having had a discussion with their provider about CRC screening (63% vs 48%, OR=1.81, p<0.001). Predictors of a discussion about CRC screening included computer group participation, younger age, reason for visit, being unmarried, colonoscopy self-efficacy, and family member/friend recommendation (all p-values <0.05).ConclusionsThe computer-delivered tailored intervention was more effective than a nontailored brochure at stimulating patient-provider discussions about CRC screening. Those who received the computer-delivered intervention also were more likely to have a CRC screening test (fecal occult blood test or colonoscopy) ordered by their PCP.Trial registrationThis study is registered at www.clinicaltrials.gov NCT00672828.

Project description:BackgroundProfessional organizations recommend that physicians discuss prostate cancer with patients to make individual screening decisions. However, few studies have tested strategies to encourage such discussions, particularly among high-risk populations. We examined the effects of two low-literacy interventions on the frequency of prostate cancer discussion and screening.DesignRandomized, blinded, controlled trial with concealed allocation.Setting/participantsInner-city primary care clinic, serving a predominately African-American population. Participants were men aged 45-70 with no history of prostate cancer, presenting for a regular appointment.InterventionsWhile waiting to see their physician, patients received a patient education handout on prostate cancer screening (PtEd), a handout simply encouraging patients to talk to their doctor about prostate cancer (Cue), or a control handout. The interventions did not advocate for or against screening.MeasuresPatient-reported discussion of prostate cancer with the physician and chart reviews determine prostate-specific antigen (PSA) test orders and performance of digital rectal examination (DRE). Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were computed. Data were collected in 2003, and analyses were completed in 2006.ResultsMost of the 250 subjects (90.4%) were African American and 78.8% read below the ninth grade level. Overall, 48.4% reported discussing prostate cancer during the appointment. Compared to the control group (37.3%), discussions were significantly more common in the Cue group (58.0%, aOR=2.39 [1.26-4.52]), as well as in the PtEd group (50.0%, aOR=1.92 [1.01-3.65]). When prostate cancer was discussed, patients in the intervention groups more commonly initiated the conversation (47.6% PtEd and 40.0% Cue, vs 9.7% control, p<0.01 for each comparison to control). Compared to the control group (2.4%), PSA test orders increased in the PtEd group (14.1%, aOR=7.62 [1.62-35.83]) and in the Cue group (12.3%, aOR=5.86 [1.24-27.81]). Documentation of DRE did not change significantly (4.7% PtEd, 6.2% Cue, and 6.0% control).ConclusionsTwo simple low-literacy interventions significantly increased discussion of prostate cancer and PSA test orders but not performance of DRE. Both interventions were effective in empowering low-literacy patients to initiate conversations about prostate cancer with their physician.

Project description:ImportanceTo promote the identification of women carrying BRCA1/2 variants, the US Preventive Services Task Force recommends that primary care clinicians screen asymptomatic women for an increased risk of carrying a BRCA1/2 variant risk.ObjectiveTo examine the effects of patient and clinician decision support about BRCA1/2 genetic testing compared with standard education alone.Design, setting, and participantsThis clustered randomized clinical trial was conducted at an academic medical center including 67 clinicians (unit of randomization) and 187 patients. Patient eligibility criteria included women aged 21 to 75 years with no history of breast or ovarian cancer, no prior genetic counseling or testing for hereditary breast and ovarian cancer syndrome (HBOC), and meeting family history criteria for BRCA1/2 genetic testing.InterventionsRealRisks decision aid for patients and the Breast Cancer Risk Navigation Tool decision support for clinicians. Patients scheduled a visit with their clinician within 6 months of enrollment.Main outcomes and measuresThe primary end point was genetic counseling uptake at 6 months. Secondary outcomes were genetic testing uptake at 6 and 24 months, decision-making measures (perceived breast cancer risk, breast cancer worry, genetic testing knowledge, decision conflict) based upon patient surveys administered at baseline, 1 month, postclinic visit, and 6 months.ResultsFrom December 2018 to February 2020, 187 evaluable patients (101 in the intervention group, 86 in the control group) were enrolled (mean [SD] age: 40.7 [13.2] years; 88 Hispanic patients [46.6%]; 15 non-Hispanic Black patients [8.1%]; 72 non-Hispanic White patients [38.9%]; 35 patients [18.9%] with high school education or less) and 164 (87.8%) completed the trial. There was no significant difference in genetic counseling uptake at 6 months between the intervention group (20 patients [19.8%]) and control group (10 patients [11.6%]; difference, 8.2 percentage points; OR, 1.88 [95% CI, 0.82-4.30]; P = .14). Genetic testing uptake within 6 months was also statistically nonsignificant (13 patients [12.9%] in the intervention group vs 7 patients [8.1%] in the control group; P = .31). At 24 months, genetic testing uptake was 31 patients (30.7%) in intervention vs 18 patients (20.9%) in control (P = .14). Comparing decision-making measures between groups at baseline to 6 months, there were significant decreases in perceived breast cancer risk and in breast cancer worry (standard mean differences = -0.48 and -0.40, respectively).Conclusions and relevanceThis randomized clinical trial did not find a significant increase in genetic counseling uptake among patients who received patient and clinician decision support vs those who received standard education, although more than one-third of the ethnically diverse women enrolled in the intervention underwent genetic counseling. These findings suggest that the main advantage for these high-risk women is the ability to opt for screening and preventive services to decrease their cancer risk.Trial registrationClinicalTrials.gov Identifier: NCT03470402.

Project description:Evidence on the effectiveness of printed educational messages in contributing to increasing evidence-based clinical practice is contradictory. Nonetheless, these messages flood physician offices, in an attempt to promote treatments that can reduce costs while improving patient outcomes. This study evaluated the ability of printed educational messages to promote the choice of thiazides as the first-line treatment for individuals newly diagnosed with hypertension, a practice supported by good evidence and included in guidelines, and one which could reduce costs to the health care system.The study uses a pragmatic, cluster randomized controlled trial (randomized by physician practice group).The setting involves all Ontario general/family practice physicians. Messages advising the use of thiazides as the first-line treatment of hypertension were mailed to each physician in conjunction with a widely read professional newsletter. Physicians were randomized to receive differing versions of printed educational messages: an "insert" (two-page evidence-based article) and/or one of two different versions of an "outsert" (short, directive message stapled to the outside of the newsletter). One outsert was developed without an explicit theory and one with messages developed targeting factors from the theory of planned behaviour or neither (newsletter only, with no mention of thiazides). The percentage of patients aged over 65 and newly diagnosed with hypertension who were prescribed a thiazide as the sole initial prescription medication. The effect of the intervention was estimated using a logistic regression model estimated using generalized estimating equation methods to account for the clustering of patients within physician practices.Four thousand five hundred four physicians (with 23,508 patients) were randomized, providing 97 % power to detect a 5 % absolute increase in prescription of thiazides. No intervention effect was detected. Thiazides were prescribed to 27.6 % of the patients who saw control physicians, 27.4 % for the insert, 26.8 % for the outsert and 28.3 % of the patients who saw insert + outsert physicians, p = 0.54.The study conclusively failed to demonstrate any impact of the printed educational messages on increasing prescribing of thiazide diuretics for first-line management of hypertension.ISRCTN72772651.

Project description:BackgroundInformation technology offers the promise, as yet unfulfilled, of delivering efficient, evidence-based health care.ObjectiveTo evaluate whether a primary care network-based informatics intervention can improve breast cancer screening rates.DesignCluster-randomized controlled trial of 12 primary care practices conducted from March 20, 2007 to March 19, 2008.PatientsWomen 42-69 years old with no record of a mammogram in the prior 2 years.InterventionsIn intervention practices, a population-based informatics system was implemented that: connected overdue patients to appropriate care providers, presented providers with a Web-based list of their overdue patients in a non-visit-based setting, and enabled "one-click" mammography ordering or documented deferral reasons. Patients selected for mammography received automatically generated letters and follow-up phone calls. All practices had electronic health record reminders about breast cancer screening available during clinical encounters.Main measuresThe primary outcome was the proportion of overdue women undergoing mammography at 1-year follow-up.Key resultsBaseline mammography rates in intervention and control practices did not differ (79.5% vs 79.3%, p = 0.73). Among 3,054 women in intervention practices and 3,676 women in control practices overdue for mammograms, intervention patients were somewhat younger, more likely to be non-Hispanic white, and have health insurance. Most intervention providers used the system (65 of 70 providers, 92.9%). Action was taken for 2,652 (86.8%) intervention patients [2,274 (74.5%) contacted and 378 (12.4%) deferred]. After 1 year, mammography rates were significantly higher in the intervention arm (31.4% vs 23.3% in control arm, p < 0.001 after adjustment for baseline differences; 8.1% absolute difference, 95% CI 5.1-11.2%). All demographic subgroups benefited from the intervention. Intervention patients completed screening sooner than control patients (p < 0.001).ConclusionsA novel population-based informatics system functioning as part of a non-visit-based care model increased mammography screening rates in intervention practices.Trial registrationClinicalTrials.gov; NCT00462891.

Project description:Purpose The purpose of this study was to examine the effects of a randomized controlled trial (RCT) of treatment summaries and survivorship care plans coupled with a nurse counseling session, primarily on physician implementation of and secondarily on patient adherence to recommended survivorship care, among a low-income population of breast cancer survivors (survivors). Methods We recruited 212 low-income, predominantly Latina (72.6%) survivors with stage 0 to III breast cancer, with an average age of 53 years, from two Los Angeles County public hospitals into an RCT of a survivorship care nurse counseling session coupled with the provision of individualized treatment summaries and survivorship care plans to patients and their health care providers from December 2012 to July 2014. One hundred seven survivors received the experimental intervention, and 105 survivors received usual care. Multiple linear regression analyses were performed to assess intervention effects on physician implementation of and patient adherence to recommended survivorship care. Scales that served as covariables were Knowledge of Survivorship Issues, Perceived Efficacy in Patient-Physician Interactions, and Satisfaction With Care and Information. Results Survivors in the intervention group reported greater physician implementation of recommended breast cancer survivorship care, for example, treatment of depression or hot flashes, than did those in the control group (adjusted difference, 16 ± 5.3; P = .003). Baseline Satisfaction With Care and Information was positively associated with physician implementation (coefficient, 5.2 ± 2.2; P = .02). Being married/partnered (-11.8 ± 4.0; P = .004) and age (-0.5 ± 0.2; P = .028) were negatively associated with patient adherence. Conclusion To our knowledge, this is the first RCT of survivorship care plans to show benefits in clinical outcomes, in this case, showing increased physician implementation of recommended breast cancer survivorship care in the intervention group, compared with the control group.

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A randomized, controlled trial to increase discussion of breast cancer in primary care.

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A randomized, controlled trial to increase discussion of breast cancer in primary care.

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