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.

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.

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.

Uptake in cancer screening programmes.

For cancer screening programmes to bring about reductions in mortality, a substantial proportion of the population must participate. Programmes with low uptake can be ineffective and can promote inequalities in health-service provision. Strategies to promote uptake are multifaceted, reflecting differences in the cancers targeted, invitees, health-service contexts, and the tests themselves. Accordingly, there is no universal approach. Strategies should accommodate the many factors that can influence uptake and should incorporate the need to promote informed choice. Screening has the potential to cause harm, and there is an ethical imperative to seek out strategies that provide balanced information on cancer screening. Further research is needed to assess newer approaches to promoting uptake, such as IT-based programmes, and to identify strategies that are balanced, self-sustaining, and affordable.

Practice-based research network studies and institutional review boards: two new issues.

BACKGROUND: Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. OBJECTIVE: To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. RESULTS: Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects' training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. CONCLUSIONS: IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non-federally mandated IRB requirements should be based on an identified need with evidence to support the solution.

Impact of workplace sociocultural attributes on participation in health assessments.

OBJECTIVE: To investigate the impact of sociocultural workplace attributes on participation in employer sponsored health assessments. METHODS: Medical center employees were encouraged to participate in free, voluntary, and confidential biometric screening and on-line health risk appraisal. A job satisfaction database, aggregated by job type and work area, was used to identify workplace sociocultural attributes correlated with participation. RESULTS: : Thirty-seven percent of the population engaged in the health assessments; however, participation varied widely by work area (10% to 83%) and by job type (17% to 56%). Participation was significantly correlated with selected aspects of job satisfaction. CONCLUSIONS: Overall participation rates in employee population health assessments can disguise large variation in employee engagement. This variation is associated with work sociocultural characteristics. Attention to these attributes may be essential to improving involvement in employer sponsored health promotion.

The usefulness and cost of a shorter duration of fasting in workplace screening for glucose intolerance and metabolic syndrome.

For worksite biometric screening, we shortened traditional fasting instructions to 4h. The positive predictive value (PPV) of elevated capillary glucose test results (> or =100mg/dL) for predicting elevated values obtained on repeat testing after an 8h fast was 57%, which rivals the PPV of an 8h fasting glucose.

Problem-solving treatment and coping styles in primary care for minor depression.

Research was undertaken to compare problem-solving treatment for primary care (PST-PC) with usual care for minor depression and to examine whether treatment effectiveness was moderated by coping style. PST-PC is a 6-session, manual-based, psychosocial skills intervention. A randomized controlled trial was conducted in 2 academic, primary care clinics. Those subjects who were eligible were randomized (N = 151), and 107 subjects completed treatment (57 PST-PC, 50 usual care) and a 35-week follow-up. Analysis with linear mixed modeling revealed significant effects of treatment and coping, such that those in PST-PC improved at a faster rate and those initially high in avoidant coping were significantly more likely to have sustained benefit from PST-PC.

Impact of pain on the outcomes of depression treatment: results from the RESPECT trial.

OBJECTIVE: Pain is prevalent in patients with depression. The purpose of this study was to determine the impact of pain on depression treatment outcomes. METHODS: Data was analyzed from a randomized controlled trial comparing a collaborative care intervention to usual care for the treatment of depression in 60 primary care practices. A total of 405 patients with either current major depressive disorder or dysthymia were enrolled, and assessed at baseline, 3, and 6 months. Main measures included the 20-item Hopkins Symptom Check List (HSCL-20) depression score, and the SF-36 pain interference score. RESULTS: Pain severe enough to produce at least moderate interference with daily activities was present in 42% of depressed patients at baseline. Pain outcomes did not differ between intervention and control groups but improved similarly in both over time. However, pain was still at least moderately severe in 32% of patients at 6 months. Both baseline pain and the amount of pain improvement over time were associated with depression remission and response rates. In a multivariate model controlling for age, gender, and medical co-morbidity, depression severity increased with higher pain interference and decreased with the passage of time (p<.0001 for both). There was also a significant pain by time by treatment group interaction (p=.027). The beneficial effects of collaborative care on depression outcome persisted (p=.049) even after controlling for pain interference, time, covariates, and interaction effects. CONCLUSIONS: Pain has a strong negative impact on the response of depression to treatment. Recognizing and optimizing the management of comorbid pain that commonly coexists with depression may be important in enhancing depression response and remission rates.

The impact of an appearance-based educational intervention on adolescent intention to use sunscreen.

During adolescence, there is a steady decline in the use of sun protection and increased use of indoor tanning lights. Previous health education efforts have changed knowledge but not these behaviors. Middle school students (n=113) received a single educational class that included personal viewing of skin changes visible under ultraviolet (UV) filtered light. Pre-/post-surveys assessed past, current and future intent to use sunscreen, as well as sun benefit and sun risk attitudes. Prior to the session, 42% were sunscreen non-users and 21% were consistent users. At post-test, one-third of students who had not previously intended to use sunscreen in the next month now intended to use it. Among students who had seen skin damage, 59% reported intention to use sunscreen in the next month versus 35% who did not see skin changes (P = 0.04). Viewing sun damage was an independent predictor of intent to use sunscreen in the next month (OR 2.9, P = 0.04), as was older age (OR 2.6, P = 0.04) and previous consistent sunscreen use (OR 6.1, P = 0.004). A brief educational intervention that emphasizes risk-to-appearance and personalizes the risks of UV exposure has the potential to influence early adolescent sun protection. Long-term studies of this approach are needed.