A Randomized Controlled Trial to Increase Cancer Screening and Reduce Depression Among Low-Income Women.

Low-income women of color receive fewer cancer screenings and have higher rates of depression, which can interfere with cancer screening participation. This study assessed the comparative effectiveness of two interventions for improving colorectal, breast, and cervical cancer screening participation and reducing depression among underserved women in Bronx, NY, with depression. This comparative effectiveness randomized controlled trial (RCT) with assessments at study entry, 6, and 12 months utilized an intent-to-treat statistical approach. Eligible women were aged 50 to 64, screened positive for depression, and were overdue for ≥ 1 cancer screening (colorectal, breast, and/or cervical). Participants were randomized to a collaborative depression care plus cancer screening intervention (CCI + PCM) or cancer screening intervention alone (PCM). Interventions were telephone-based, available in English or Spanish, delivered over 12 months, and facilitated by a skilled care manager. Cancer screening data were extracted from electronic health records. Depression was measured with a validated self-report instrument (PHQ-9). Seven hundred fifty seven women consented and were randomized (CCI + PCM, n = 378; PCM, n = 379). Analyses revealed statistically significant increases in up-to-date status for all three cancer screenings; depression improved in both intervention groups. There were no statistically significant differences between the interventions in improving cancer screening rates or reducing depression. CCI and PCM both improved breast, cervical, and colorectal cancer screening and depression in clinical settings in underserved communities; however, neither intervention showed an advantage in outcomes. Decisions about which approach to implement may depend on the nature of the practice and alignment of the interventions with other ongoing priorities and resources.

Integrating Cancer Screening and Mental Health Services in Primary Care: Protocol and Baseline Results of a Patient-Centered Outcomes Intervention Study.

BACKGROUND: Low-income and minority women are significantly more likely to be diagnosed with preventable, late-stage cancers and suffer from depression than the general population. Intervention studies aiming to reduce depression to increase cancer screening among underserved minority women are sparse. METHODS: This patient-centered outcomes trial compared Collaborative Care Intervention plus Cancer Prevention Care Management (CCI+PCM) versus PCM alone. Participants from six Federally Qualified Health Centers (FQHCs) were interviewed at baseline, 6-and 12-month follow-up to monitor adherence to screening guidelines, depressive symptoms, quality of life, barriers to screening, and other psychosocial and health-related variables. RESULTS: Participants included 757 English-or Spanish-speaking women (ages 50-64) who screened positive for depression on the Patient Health Questionnaire (PHQ)-9 and were not up-to-date for breast, cervical, and/or colorectal cancer screening. CONCLUSIONS: Study methodology and baseline participant characteristics are reported to contribute to the literature on evidence-based interventions for cancer screening among underserved, depressed women.

Preventing the voltage drop: keeping practice-based research network (PBRN) practices engaged in studies.

INTRODUCTION: Practice-based research continues to evolve and has become a major methodology for many pragmatic studies. While early practice-based network projects were usually short term, current studies often introduce or compare practice innovations that require long-term evaluation. That change requires that practice sites remain engaged in research work for up to 5 years, a time that can allow for a significant "voltage drop," or decline in active participation. METHODS: Over the past 15 years we have developed and adapted several strategies to facilitate and encourage the continued active engagement of practices in practice-based research network studies of up to 5 years' duration. The concepts, details, evaluation, and results (when available) of the strategies are described. RESULTS: Eight strategies that enhance practice sites' attention to enrollment, data collection and continued use of the implemented practice change are described. CONCLUSION: The loss of momentum, or "voltage drop," that happens in longer-term practice-based research network studies can be addressed using multiple strategies.

Telephone outreach to increase colon cancer screening in medicaid managed care organizations: a randomized controlled trial.

PURPOSE: Health Plans are uniquely positioned to deliver outreach to members. We explored whether telephone outreach, delivered by Medicaid managed care organization (MMCO) staff, could increase colorectal cancer (CRC) screening among publicly insured urban women, potentially reducing disparities. METHODS: We conducted an 18-month randomized clinical trial in 3 MMCOs in New York City in 2008-2010, randomizing 2,240 MMCO-insured women, aged 50 to 63 years, who received care at a participating practice and were overdue for CRC screening. MMCO outreach staff provided cancer screening telephone support, educating patients and helping overcome barriers. The primary outcome was the number of women screened for CRC during the 18-month intervention, assessed using claims. RESULTS: MMCO staff reached 60% of women in the intervention arm by telephone. Although significantly more women in the intervention (36.7%) than in the usual care (30.6%) arm received CRC screening (odds ratio [OR] = 1.32; 95% CI, 1.08-1.62), increases varied from 1.1% to 13.7% across the participating MMCOs, and the overall increase was driven by increases at 1 MMCO. In an as-treated comparison, 41.8% of women in the intervention arm who were reached by telephone received CRC screening compared with 26.8% of women in the usual care arm who were not contacted during the study (OR = 1.84; 95% CI, 1.38, 2.44); 7 women needed to be reached by telephone for 1 to become screened. CONCLUSIONS: The telephone outreach intervention delivered by MMCO staff increased CRC screening by 6% more than usual care among randomized women, and by 15.1% more than usual care among previously overdue women reached by the intervention. Our research-based intervention was successfully translated to the health plan arena, with variable effects in the participating MMCOs.

RESPECT-PTSD: re-engineering systems for the primary care treatment of PTSD, a randomized controlled trial.

BACKGROUND: Although collaborative care is effective for treating depression and other mental disorders in primary care, there have been no randomized trials of collaborative care specifically for patients with Posttraumatic stress disorder (PTSD). OBJECTIVE: To compare a collaborative approach, the Three Component Model (3CM), with usual care for treating PTSD in primary care. DESIGN: The study was a two-arm, parallel randomized clinical trial. PTSD patients were recruited from five primary care clinics at four Veterans Affairs healthcare facilities and randomized to receive usual care or usual care plus 3CM. Blinded assessors collected data at baseline and 3-month and 6-month follow-up. PARTICIPANTS: Participants were 195 Veterans. Their average age was 45 years, 91% were male, 58% were white, 40% served in Iraq or Afghanistan, and 42% served in Vietnam. INTERVENTION: All participants received usual care. Participants assigned to 3CM also received telephone care management. Care managers received supervision from a psychiatrist. MAIN MEASURES: PTSD symptom severity was the primary outcome. Depression, functioning, perceived quality of care, utilization, and costs were secondary outcomes. KEY RESULTS: There were no differences between 3CM and usual care in symptoms or functioning. Participants assigned to 3CM were more likely to have a mental health visit, fill an antidepressant prescription, and have adequate antidepressant refills. 3CM participants also had more mental health visits and higher outpatient pharmacy costs. CONCLUSIONS: Results suggest the need for careful examination of the way that collaborative care models are implemented for treating PTSD, and for additional supports to encourage primary care providers to manage PTSD.

Postpartum Depression: Screening, Diagnosis, and Management Programs 2000 through 2010.

The value and appropriateness of universal postpartum depression (PPD) screening remains controversial in the United States. To date, several PPD screening programs have been introduced and a few have been evaluated. Among those programs that have been evaluated, most report screening rates, diagnosis rates, or treatment initiation rates. Only four studies included patient outcomes such as the level of depressive symptoms at 6 to 12 months postpartum, and only two reported success in improving outcomes. Program characteristics that appear to result in low rates of diagnosis and followup after PPD screening include requirements for a formal psychiatric evaluation, the need to refer women to another site for therapy, and failure to integrate the PPD screening into the care provided at the woman's or her child's medical home. The two programs that reported improved outcomes were both self-contained within primary care and included specific followup, management, and therapy procedures. Both resulted in the need for outside referrals in less than 10% of women diagnosed with postpartum depression. Future studies should be based on the successful programs and their identified facilitators while avoiding identified barriers. To affect policies, the future program must report maternal outcomes going beyond the often reported process outcomes of screening, referral, and therapy initiation rates.

TRIPPD: a practice-based network effectiveness study of postpartum depression screening and management.

PURPOSE: Postpartum depression is common but inadequately recognized and undertreated. Continuing depressive symptoms are associated with adverse outcomes for the woman, her infant, and family. We wanted to determine the effect of a practice-based training program for screening, diagnosis, and management of depression in postpartum mothers. METHODS: In this practice-based effectiveness study, 28 practices were randomized to usual care (n = 14) or intervention (n = 14), and 2,343 women were enrolled between 5 and 12 weeks' postpartum. The intervention sites received education and tools for postpartum depression screening, diagnosis, initiation of therapy, and follow-up within their practices. Usual-care practices received a 30-minute presentation about postpartum depression. Screening information for the usual care was obtained from baseline surveys sent directly to the central site but was not available for patient care. Outcomes were based on patient-reported outcomes (level of depressive symptoms) from surveys at 6 and 12 months, plus medical record review (diagnosis and therapy initiation). RESULTS: Among the 2,343 women enrolled, 1,897 (80.1%) provided outcome information, and were included in the analysis. Overall, 654 (34.5% of 1,897) women had elevated screening scores indicative of depression, with comparable rates in the intervention and usual-care groups. Among the 654 women with elevated postpartum depression screening scores, those in the intervention practices were more likely to receive a diagnosis (P = .0006) and therapy for postpartum depression (P = .002). They also had lower depressive symptom levels at 6 (P = .07) and 12 months' (P=.001) postpartum. CONCLUSIONS: Primary care-based screening, diagnosis, and management improved mother's depression outcomes at 12 months. This practical approach could be implemented widely with modest resources.

State-of-the-art and future directions in multilevel interventions across the cancer control continuum.

We conducted literature searches and analyses to describe the current state of multilevel intervention (MLI) research and to identify opportunities to advance cancer control and prevention. We found single-level studies that considered other contextually important levels, and multilevel health-care systems research and community-wide studies. This literature is characterized by limited reporting of theoretical, contextual, temporal, and implementation factors. Most MLIs focus on prevention and screening, rather than diagnosis, treatment, or survivorship. Opportunities relate to 1) dynamic, adaptive emergent interventions and research designs that evolve over time by attending to contextual factors and interactions across levels; 2) analyses that include simulation modeling, or multimethod approaches that integrate quantitative and qualitative methods; and 3) translation and intervention approaches that locally reinvent MLIs in different contexts. MLIs have great potential to reduce cancer burden by using theory and integrating quantitative, qualitative, participatory, and transdisciplinary methods that continually seek alignment across intervention levels, pay attention to context, and adapt over time.

Barriers to colorectal cancer screening among publicly insured urban women: no knowledge of tests and no clinician recommendation.

OBJECTIVES: To assess barriers to colorectal cancer screening among urban publicly insured women and to evaluate how barriers among underscreened urban women have changed between 2001 and 2007-2008. METHODS: Eligible women were selected using Medicaid Managed Care Organization (MMCO) administrative data. MMCO outreach staff interviewed women by phone between October 2007 and February 2008, and assessed their barriers to colorectal cancer screening. We compared the results of these interviews with interviews conducted in 2001 with women in community health center waiting rooms. RESULTS: Thirty percent of overdue women had never heard of either colonoscopy or sigmoidoscopy, and 55% had never heard of home fecal occult blood testing (FOBT). Among overdue women who had heard of colonoscopy or sigmoidoscopy, 33% reported misconceptions and 28% reported worry as a barrier. No clinician recommendation was the most commonly reported barrier to home FOBT (44%) and was also reported as a barrier to endoscopy by 22% of women. Between 2001 and 2007-2008, the proportion of women reporting that they had not received a clinician's recommendation for endoscopy or home FOBT increased significantly. CONCLUSIONS: A lack of information, no clinician recommendation, misconceptions, and worry persist as barriers to colon cancer screening among this underscreened urban population. An increased focus on clinician recommendation and patient education about stool-based as well as endoscopic screening methods could lead to greater screening compliance.

Depression care management: can employers purchase improved outcomes?

Fourteen vendors are currently selling depression care management products to US employers after randomized trials demonstrate improved work outcomes. The research team interviewed 10 (71.4%) of these vendors to compare their products to four key components of interventions demonstrated to improve work outcomes. Five of 10 depression products incorporate all four key components, three of which are sold by health maintenance organizations (HMOs); however, HMOs did not deliver these components at the recommended intensity and/or duration. Only one product delivered by a disease management company delivered all four components of care at the recommended intensity and duration. This "voltage drop," which we anticipate will increase with product implementation, suggests that every delivery system should carefully evaluate the design of its depression product before implementation for its capacity to deliver evidence-based care, repeating these evaluations as new evidence emerges.

Matching colonoscopy and pathology data in population-based registries: development of a novel algorithm and the initial experience of the New Hampshire Colonoscopy Registry.

BACKGROUND: The quality of polyp-level data in a population-based registry depends on the ability to match each polypectomy recorded by the endoscopist to a specific diagnosis on the pathology report. OBJECTIVE: To review impediments encountered in matching colonoscopy and pathology data in a population-based registry. DESIGN: New Hampshire Colonoscopy Registry data from August 2006 to November 2008 were analyzed for prevalence of missing reports, discrepancies between colonoscopy and pathology reports, and the proportion of polyps that could not be matched because of multiple polyps submitted in the same container. SETTING: New Hampshire Colonoscopy Registry. PATIENTS: This study involved all consenting patients during the study period. INTERVENTION: Develop an algorithm for capturing number, size, location, and histology of polyps and for defining and flagging discrepancies to ensure data quality. MAIN OUTCOME MEASUREMENTS: The proportion of polyps with no assumption or discrepancy, the proportion of patient records eligible for determining the adenoma detection rate (ADR), and the number of patients with ≥3 adenomas. RESULTS: Only 50% of polyps removed during this period were perfectly matched, with no assumption or discrepancy. Records from only 69.9% and 29.7% of eligible patients could be used to determine the ADR and the number of patients with ≥3 adenomas, respectively. LIMITATIONS: Rates of missing reports may have been higher in the early phase of establishment of the registry. CONCLUSION: This study highlights the impediments in collecting polyp-level data in a population-based registry and provides useful parameters for evaluating the quality and accuracy of data obtained from such registries.

The influence of smoking, gender, and family history on colorectal adenomas.

Evidence independently links smoking, family history, and gender with increased risk of adenomatous polyps. Using data from the New Hampshire Colonoscopy Registry (2004-2006), we examined the relation of combined risk factors with adenoma occurrence in 5,395 individuals undergoing screening colonoscopy. Self-reported data on smoking, family history and other factors were linked to pathology reports identifying adenomatous polyps and modeled with multiple logistic regression. In adjusted models a >15 pack-year smoking history increased the likelihood of an adenoma (OR = 1.54, 95% CI 1.28-1.86), although /=15 pack-years associated with 61% higher odds of adenoma at successively larger size categories (95% CI 1.34-1.93). For individuals with a family history of colorectal cancer, smoking does not further increase the risk of adenomas. Smoking duration is linked to occurrence and size of adenoma, especially for men.

Practice benefit from participating in a practice-based research network study of postpartum depression: a national research network (NRN) report.

BACKGROUND: At the midpoint of a large clinical trial taking place in a practice-based research network (PBRN), we asked leaders of the enrolled practices about the impact of participating in a PBRN study. METHODS: Using semistructured interviews, the lead study nurse and physician from each site were queried about the impact of study participation on issues related to the study topic of postpartum depression (PPD) as well as any other impacts on the practice not directly related to PPD. From the results, initial themes were identified by 3 of the investigators (BPY, SB, MK) and confirmed by all the authors. Interviewee responses were grouped by theme. RESULTS: Forty-eight study leaders from 28 solo, moderately sized group and residency practices were interviewed during a period of 60 days. Practices were located in 20 different states, and 54% were in rural communities. Six major themes emerged. Study participation led to: ((1)) the recognition of the need for systematic approaches; ((2)) more effective teamwork and communication within the practice; ((3)) adaptation and extension of the PPD study tools and a systematic approach to the care of other chronic conditions; ((4)) increased professional self-worth and community recognition; ((5)) opportunity and support for staff members to "stretch" into new roles; and ((6)) increased research literacy within the practice. CONCLUSIONS: Participating in a PBRN research study can provide advantages to practices that extend beyond the study's specific purpose and content. These results provide further support for the value of PBRN research funding.

Intraclass correlation estimates for cancer screening outcomes: estimates and applications in the design of group-randomized cancer screening studies.

BACKGROUND: Screening has become one of our best tools for early detection and prevention of cancer. The group-randomized trial is the most rigorous experimental design for evaluating multilevel interventions. However, identifying the proper sample size for a group-randomized trial requires reliable estimates of intraclass correlation (ICC) for screening outcomes, which are not available to researchers. We present crude and adjusted ICC estimates for cancer screening outcomes for various levels of aggregation (physician, clinic, and county) and provide an example of how these ICC estimates may be used in the design of a future trial. METHODS: Investigators working in the area of cancer screening were contacted and asked to provide crude and adjusted ICC estimates using the analysis of variance method estimator. RESULTS: Of the 29 investigators identified, estimates were obtained from 10 investigators who had relevant data. ICC estimates were calculated from 13 different studies, with more than half of the studies collecting information on colorectal screening. In the majority of cases, ICC estimates could be adjusted for age, education, and other demographic characteristics, leading to a reduction in the ICC. ICC estimates varied considerably by cancer site and level of aggregation of the groups. CONCLUSIONS: Previously, only two articles had published ICCs for cancer screening outcomes. We have complied more than 130 crude and adjusted ICC estimates covering breast, cervical, colon, and prostate screening and have detailed them by level of aggregation, screening measure, and study characteristics. We have also demonstrated their use in planning a future trial and the need for the evaluation of the proposed interval estimator for binary outcomes under conditions typically seen in GRTs.

Staffing time required to increase cancer-screening rates through telephone support.

We describe the staff time required by the prevention care manager-tailored telephone support intervention, which significantly increased breast, cervical, and colorectal cancer-screening rates among female patients of Community Health Centers in New York City. For a sample of 38 women whose intervention was timed, prevention care managers spent an average of 99 minutes per woman on the phone and on related follow-up tasks over 18 months, or 248 minutes for each additional cancer-screening test obtained. Potential modifications to decrease the time required include automation of common tasks and the use of administrative data to further tailor outreach calls.

Improving the quality of colorectal cancer screening: assessment of familial risk.

BACKGROUND: Accuracy of familial risk assessment by endoscopists in determining colonoscopic screening and surveillance intervals is unknown. AIMS: To investigate follow-up recommended by endoscopists for individuals at average or increased familial risk, following colonoscopies that were normal or yielded hyperplastic polyps only. METHODS: Colonoscopy registry data was analyzed on 5,982 patients who had colonoscopy between 2004 and 2006. Patient information was linked with colonoscopy procedure information and pathology results. Patients with a personal or family history of colorectal cancer (CRC) or polyps, inflammatory bowel disease, or who had diagnostic, incomplete or suboptimally prepped examinations were excluded. The final analysis, which included 2,414 patients, investigated concordance of risk assessment between patient and endoscopist, and resulting endoscopist follow-up recommendations. RESULTS: Following normal colonoscopy, 76% of average risk individuals were told to follow-up in 10 years, but if a hyperplastic polyp was found, less than 10 years was suggested for 76%. Many patients reporting a known familial cancer syndrome or a very strong family history did not have that history indicated on the endoscopist's procedure form, and recommended follow-up intervals were beyond guideline recommendations for 60.4% of the very high-risk group. CONCLUSIONS: Endoscopists may sometimes be unaware of the presence of familial risk factors, even for individuals at very high familial risk. Greater consistency and accuracy in familial risk assessments could significantly increase the efficacy of screening in preventing colorectal cancer.

Concordance of Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ-9) to assess increased risk of depression among postpartum women.

OBJECTIVES: To compare the Edinburgh Postnatal Depression Scale (EPDS) and Patient Health Questionnaire (PHQ-9) as screening tools for postpartum depression. METHODS: This study population included the first 500 women to enroll and return their packets during an ongoing study of postpartum depression. RESULTS: The primary outcome of this study was to find rates of concordance and discordance in the EPDS and PHQ-9 categories of "normal" and "increased risk for major depressive disorder." Overall, 97% of eligible women enrolled and 70% returned the packets that included the EPDS and PHQ-9. Four hundred eighty-one of the first 500 packets had complete data, with elevated EPDS or PHQ-9 scores in 138 and 132 women, respectively. Concordance of the EPDS and PHQ-9 were present in 399 women (83%): 326 (67.8%) had "normal" score on both, and 73 (15.2%) had elevated scores for both. Discordant scores in 82 women included 17 with elevated PHQ-9 scores but normal EPDS scores and 65 with elevated EPDS scores and PHQ-9 scores <10. In multivariate logistic regression modeling, only age >30 and low education level were predictive of discordant scores, using EPDS and PHQ-9 scores of > or =10 as elevated (odds ratio, 1.9 and P = .02; and odds ratio, 2.3 and P = .01, respectively). PHQ-9 scores of 5 to 9 have been referred to as consistent with "mild depressive symptoms" and appropriate for "watchful waiting" and repeat PHQ-9 at follow-up. Using this follow-up approach would require re-evaluation of 120 (25%) of the women screened. CONCLUSIONS: Postpartum depression screening is feasible in primary care practices, and for most women the EPDS and PHQ-9 scores were concordant. Further work is required to identify reasons for the 17% discordant scores as well as to provide definitive recommendations for PHQ-9 scores of 5 to 9.