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Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial.

ABSTRACT: OBJECTIVE:To evaluate the effect of a theory-based, culturally targeted intervention on adherence to follow-up among low-income and minority women who experience an abnormal Pap test. METHOD:5,049 women were enrolled and underwent Pap testing. Of these, 378 had an abnormal result and 341 (90%) were randomized to one of three groups to receive their results: Intervention (I): culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; Active Control (AC): nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; or Standard Care Only (SCO). The primary outcome was attendance at the initial follow-up appointment. Secondary outcomes included delay in care, completion of care at 18 months, state anxiety (STAI Y-6), depressive symptoms (CES-D), and distress (CDDQ). Anxiety was assessed at enrollment, notification of results, and 7-14 days later with the CDDQ and CES-D. RESULTS:299 women were included in intent-to-treat analyses. Adherence rates were 60% (I), 54% (AC), and 58% (SCO), p = .73. Completion rates were 39% (I) and 35% in the AC and SCO groups, p = .77. Delay in care (in days) was (M ± SD): 58 ± 75 (I), 69 ± 72 (AC), and 54 ± 75 (SCO), p = .75. Adherence was associated with higher anxiety at notification, p < .01 and delay < 90 days (vs. 90+) was associated with greater perceived personal responsibility, p < .05. Women not completing their care (vs. those who did) had higher CES-D scores at enrollment, p < .05. CONCLUSIONS:A theory-based, culturally targeted message was not more effective than a nontargeted message or standard care in improving behavior.

SUBMITTER: Breitkopf CR

PROVIDER: S-EPMC4025914 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial.

Breitkopf Carmen Radecki CR Dawson Lauren L Grady James J JJ Breitkopf Daniel M DM Nelson-Becker Carolyn C Snyder Russell R RR

Health psychology : official journal of the Division of Health Psychology, American Psychological Association 20130603 4

<h4>Objective</h4>To evaluate the effect of a theory-based, culturally targeted intervention on adherence to follow-up among low-income and minority women who experience an abnormal Pap test.<h4>Method</h4>5,049 women were enrolled and underwent Pap testing. Of these, 378 had an abnormal result and 341 (90%) were randomized to one of three groups to receive their results: Intervention (I): culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constrai ...[more]

PMID: 23730719

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Project description:ImportanceRealizing the benefits of cancer screening requires testing of eligible individuals and processes to ensure follow-up of abnormal results.ObjectiveTo test interventions to improve timely follow-up of overdue abnormal breast, cervical, colorectal, and lung cancer screening results.Design, setting, and participantsPragmatic, cluster randomized clinical trial conducted at 44 primary care practices within 3 health networks in the US enrolling patients with at least 1 abnormal cancer screening test result not yet followed up between August 24, 2020, and December 13, 2021.InterventionAutomated algorithms developed using data from electronic health records (EHRs) recommended follow-up actions and times for abnormal screening results. Primary care practices were randomized in a 1:1:1:1 ratio to (1) usual care, (2) EHR reminders, (3) EHR reminders and outreach (a patient letter was sent at week 2 and a phone call at week 4), or (4) EHR reminders, outreach, and navigation (a patient letter was sent at week 2 and a navigator outreach phone call at week 4). Patients, physicians, and practices were unblinded to treatment assignment.Main outcomes and measuresThe primary outcome was completion of recommended follow-up within 120 days of study enrollment. The secondary outcomes included completion of recommended follow-up within 240 days of enrollment and completion of recommended follow-up within 120 days and 240 days for specific cancer types and levels of risk.ResultsAmong 11 980 patients (median age, 60 years [IQR, 52-69 years]; 64.8% were women; 83.3% were White; and 15.4% were insured through Medicaid) with an abnormal cancer screening test result for colorectal cancer (8245 patients [69%]), cervical cancer (2596 patients [22%]), breast cancer (1005 patients [8%]), or lung cancer (134 patients [1%]) and abnormal test results categorized as low risk (6082 patients [51%]), medium risk (3712 patients [31%]), or high risk (2186 patients [18%]), the adjusted proportion who completed recommended follow-up within 120 days was 31.4% in the EHR reminders, outreach, and navigation group (n = 3455), 31.0% in the EHR reminders and outreach group (n = 2569), 22.7% in the EHR reminders group (n = 3254), and 22.9% in the usual care group (n = 2702) (adjusted absolute difference for comparison of EHR reminders, outreach, and navigation group vs usual care, 8.5% [95% CI, 4.8%-12.0%], P < .001). The secondary outcomes showed similar results for completion of recommended follow-up within 240 days and by subgroups for cancer type and level of risk for the abnormal screening result.Conclusions and relevanceA multilevel primary care intervention that included EHR reminders and patient outreach with or without patient navigation improved timely follow-up of overdue abnormal cancer screening test results for breast, cervical, colorectal, and lung cancer.Trial registrationClinicalTrials.gov Identifier: NCT03979495.

Project description:BackgroundDespite the availability and accessibility of free Papanicolaou (Pap) smear as a screening tool for cervical cancer, the uptake of Pap smear in Malaysia has not changed in the last 15 years. Previous studies have shown that the high uptake of Pap smear reduces the mortality rate of patients with cervical cancer. The low uptake of Pap smear is multifactorial, and the problem could be minimized through the use of mobile technologies. Nevertheless, most intervention studies focused on individual factors, while other important aspects such as mobile technologies, especially WhatsApp, have not been investigated yet.ObjectiveThis study aims to determine the effects of a theory-based educational intervention and WhatsApp follow-up (Pap smear uptake [PSU] intervention) in improving PSU among postnatal women in Seremban, Negeri Sembilan, Malaysia.MethodsA 2-arm, parallel single-blind cluster randomized controlled trial was conducted among postpartum women from the Seremban district. Twelve health clinics were randomly assigned to the intervention and control groups. At baseline, both groups received a self-administered questionnaire. The intervention group received standard care and PSU intervention delivered by a researcher. This 2-stage intervention module was developed based on Social Cognitive Theory, where the first stage was conducted face-to-face and the second stage included a WhatsApp follow-up. The control group received standard care. Participants were observed immediately and at 4, 8, and 12 weeks after the intervention. The primary endpoint was PSU, whereas the secondary endpoints were knowledge, attitude, and self-efficacy scores for Pap smear screening self-assessed using a Google Forms questionnaire. A generalized mixed model was used to determine the effectiveness of the intervention. All data were analyzed using IBM SPSS (version 25), and P value of .05 was considered statistically significant.ResultsWe analyzed 401 women, of whom 76 (response rate: 325/401, 81%) had withdrawn because of the COVID-19 pandemic, with a total of 162 respondents in the intervention group and 163 respondents in the control group. The proportion of Pap smears at the 12-week follow-up was 67.9% (110/162) in the intervention group versus 39.8% (65/163) in the control group (P<.001). Significant differences between the intervention and control groups were found for Pap smear use (F4,1178; P<.001), knowledge scores (F4,1172=14.946; P<.001), attitude scores (F4,1172=24.417; P<.001), and self-efficacy scores (F1,1172=10.432; P<.001).ConclusionsThis study demonstrated that the PSU intervention is effective in increasing the uptake of Pap smear among postnatal women in Seremban district, Malaysia. This intervention module can be tested in other populations of women.Trial registrationThai Clinical Trials Registry TCTR20200205001; https://www.thaiclinicaltrials.org/show/TCTR20200205001.

Project description:ImportancePosthospitalization follow-up visits are prescribed frequently for children with bronchiolitis. The rationale for this practice is unclear, but prior work has indicated that families value these visits for the reassurance provided. The overall risks and benefits of scheduled visits have not been evaluated.ObjectiveTo assess whether an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing anxiety among parents of children hospitalized for bronchiolitis.Design, setting, and participantsThis open-label, noninferiority randomized clinical trial, performed between January 1, 2018, and April 31, 2019, assessed children younger than 24 months of age hospitalized for bronchiolitis at 2 children's hospitals (Primary Children's Hospital, Salt Lake City, Utah, and Lucile Packard Children's Hospital, Palo Alto, California) and 2 community hospitals (Intermountain Riverton Hospital, Riverton, Utah, and Packard El Camino Hospital, Mountain View, California). Data analysis was performed in an intention-to-treat manner.InterventionsRandomization (1:1) to a scheduled (n = 151) vs an as-needed (n = 153) posthospitalization follow-up visit.Main outcome and measuresThe primary outcome was parental anxiety 7 days after hospital discharge, measured using the anxiety portion of the Hospital Anxiety and Depression Scale, which ranged from 0 to 28 points, with higher scores indicating greater anxiety. Fourteen prespecified secondary outcomes were assessed.ResultsAmong 304 children randomized (median age, 8 months; interquartile range, 3-14 months; 179 [59%] male), the primary outcome was available for 269 patients (88%). A total of 106 children (81%) in the scheduled follow-up group attended a scheduled posthospitalization visit compared with 26 children (19%) in the as-needed group (absolute difference, 62%; 95% CI, 53%-71%). The mean (SD) 7-day parental anxiety score was 3.9 (3.5) among the as-needed posthospitalization follow-up group and 4.2 (3.5) among the scheduled group (absolute difference, -0.3 points; 95% CI, -1.0 to 0.4 points), with the upper bound of the 95% CI within the prespecified noninferiority margin of 1.1 points. Aside from a decreased mean number of clinic visits (absolute difference, -0.6 visits per patient; 95% CI, -0.4 to -0.8 visits per patient) among the as-needed group, there were no significant between-group differences in secondary outcomes, including readmissions (any hospital readmission before symptom resolution: absolute difference, -1.6%; 95% CI, -5.7% to 2.5%) and symptom duration (time from discharge to cough resolution: absolute difference, -0.6 days; 95% CI, -2.4 to 1.2 days; time from discharge to child reported "back to normal": absolute difference, -0.8 days; 95% CI, -2.7 to 1.0 days; and time from discharge to symptom resolution: absolute difference, -0.6 days; 95% CI, -2.5 to 1.3 days).Conclusions and relevanceAmong parents of children hospitalized for bronchiolitis, an as-needed posthospitalization follow-up visit is noninferior to a scheduled posthospitalization follow-up visit with respect to reducing parental anxiety. These findings support as-needed follow-up as an effective posthospitalization follow-up strategy.Trial registrationClinicalTrials.gov Identifier: NCT03354325.

Project description:INTRODUCTION:Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. The country needs novel, large-scale, and sustainable interventions to improve hypertension control. We report the 12 month follow-up results of a cluster randomized feasibility trial in Hung Yen province, Vietnam, which evaluated the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" and a didactic intervention. METHODS:The storytelling intervention included stories in the patients' own words about coping with hypertension and didactic content about the importance of healthy lifestyle behaviors in controlling elevated blood pressure levels. The didactic intervention included only didactic content, which were general recommendations for managing several important risk factors for hypertension and other non-communicable diseases. The storytelling intervention was delivered by two DVDs three months apart; the didactic intervention included only one DVD. The trial was conducted in patients with poorly controlled hypertension from 4 communes (communities), which were equally randomized to the two interventions. RESULTS:The mean age of the 160 patients was 66 years and 54% were men. Between baseline enrollment and the 12 month follow-up, mean systolic blood pressure declined by 10.8 mmHg (95% CI: 6.5-14.9) in the storytelling group and by 5.8 mmHg (95% CI: 1.6-10.0) in the didactic content group. The storytelling group also experienced more improvement in several health behaviors, including increased levels of physical activity and reduced consumption of salt and alcohol. CONCLUSIONS:We observed considerable long-term beneficial effects of both interventions, especially of our storytelling intervention, among patients with inadequately controlled hypertension. A large scale randomized trial should more systematically compare the short and long-term effectiveness of the two interventions in controlling hypertension. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02483780.

Project description:Background:Fecal immunochemical testing is the most commonly used method for colorectal cancer screening worldwide. However, its effectiveness is frequently undermined by failure to obtain follow-up colonoscopy after positive test results. Purpose:To evaluate interventions to improve rates of follow-up colonoscopy for adults after a positive result on a fecal test (guaiac or immunochemical). Data Sources:English-language studies from the Cochrane Central Register of Controlled Trials, PubMed, and Embase from database inception through June 2017. Study Selection:Randomized and nonrandomized studies reporting an intervention for colonoscopy follow-up of asymptomatic adults with positive fecal test results. Data Extraction:Two reviewers independently extracted data and ranked study quality; 2 rated overall strength of evidence for each category of study type. Data Synthesis:Twenty-three studies were eligible for analysis, including 7 randomized and 16 nonrandomized studies. Three were at low risk of bias. Eleven studies described patient-level interventions (changes to invitation, provision of results or follow-up appointments, and patient navigators), 5 provider-level interventions (reminders or performance data), and 7 system-level interventions (automated referral, precolonoscopy telephone calls, patient registries, and quality improvement efforts). Moderate evidence supported patient navigators and provider reminders or performance data. Evidence for system-level interventions was low. Seventeen studies reported the proportion of test-positive patients who completed colonoscopy compared with a control population, with absolute differences of -7.4 percentage points (95% CI, -19 to 4.3 percentage points) to 25 percentage points (CI, 14 to 35 percentage points). Limitation:More than half of studies were at high or very high risk of bias; heterogeneous study designs and characteristics precluded meta-analysis. Conclusion:Patient navigators and giving providers reminders or performance data may help improve colonoscopy rates of asymptomatic adults with positive fecal blood test results. Current evidence about useful system-level interventions is scant and insufficient. Primary Funding Source:National Cancer Institute. (PROSPERO: CRD42016048286).

Dataset Information

Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial.

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Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial.

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