Effect of Patient Characteristics on Uptake of Screening Using a Mailed Human Papillomavirus Self-sampling Kit: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Mailing human papillomavirus (HPV) self-sampling kits increases cervical cancer screening participation, but effects may differ across subpopulations. Subpopulation data can inform US health care system implementation. Objective: To identify patient characteristics that modify effectiveness of a mailed kit intervention at increasing screening. Design, Setting, and Participants: This was a secondary analysis of data from the Home-Based Options to Make Cervical Cancer Screening Easy (HOME) randomized clinical trial conducted from 2014 to 2018 at Kaiser Permanente Washington. Data analysis was performed from March 2018 to May 2022. Individuals aged 30 to 64 years with female sex, health plan enrollment longer than 3 years and 5 months, a current primary care clinician, and no Papanicolaou test within the prior 3 years and 5 months were identified through electronic medical records and randomized (1:1) to the control or intervention group. Interventions: The control group received usual care Papanicolaou screening reminders and outreach. The intervention group received usual care plus an unsolicited mailed HPV self-sampling kit. Main Outcomes and Measures: Screening uptake was captured within 6 months after randomization. Baseline patient characteristics (age, race, ethnicity, travel time to clinic, income, body mass index, tobacco use, health plan enrollment duration, time since last Papanicolaou test, mammography, comorbidities, and colorectal cancer screening adherence) were extracted from the electronic medical record. Results: Of 19 734 individuals (mean [SD] age, 50.1 [9.5] years; 14 129 [71.6%] White), 9843 were randomized to the intervention group, and 9891 were randomized to the control group. Screening uptake was 26.3% (2592 of 9843 individuals) in the intervention group vs 17.4% (1719 of 9891 individuals) in the control group (relative risk [RR], 1.51; 95% CI, 1.43-1.60). Although absolute differences in uptake by group varied little by screening history, relative effects were greater with longer vs shorter time since last Papanicolaou test (no prior Papanicolaou test: RRs, 1.85-3.25; ≥10 years: RR, 2.78; 5-10 years: RRs, 1.69-1.86; <5 years: RRs 1.29-1.37). Relative effects were greater in participants overdue (RR, 2.03; 95% CI, 1.73-2.38) vs up-to-date with mammography (RR, 1.53; 95% CI, 1.41-1.67), although absolute difference was greater in the up-to-date group. Differences by age were not significant, with RRs of 1.33 to 1.48 across 5-year age groups in participants 30 to 54, vs 1.60 (95% CI, 1.40-1.82) in participants 55 to 59 and 1.77 (95% CI, 1.56-2.01) in participants 60 to 64 years. Among those mailed kits, there were differences in kit use vs in-clinic screening by age, race, plan enrollment duration, underscreening duration, and colorectal cancer screening adherence. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, clinically important improvements in screening uptake were observed for all subgroups. Differences in magnitude of intervention effect and kit use highlighted opportunities to optimize HPV self-sampling for priority groups. Trial Registration: ClinicalTrials.gov Identifier: NCT02005510.

Approaches for implementing digital interventions for alcohol use disorders in primary care: A qualitative, user-centered design study.

Background: Digital interventions, such as smartphone apps, can be effective in treating alcohol use disorders (AUD). However, efforts to integrate digital interventions into primary care have been challenging. To inform successful implementation, we sought to understand how patients and clinicians preferred to use apps in routine primary care. Methods: This study combined user-centered design and qualitative research methods, interviewing 18 primary care patients with AUD and nine primary care clinicians on topics such as prior experiences with digital tools, and design preferences regarding approaches for offering apps for AUD in primary care. Interviews were recorded and transcribed for template analysis whereby a priori codes were based on interview topics and refined through iterative coding. New codes and cross-cutting themes emerged from the data. Results: Patient participants with AUD indicated they would be more likely to engage in treatment if primary care team members were involved in their use of apps. They also preferred to see clinicians "invested" and recommended that clinicians ask about app use and progress during follow-up appointments or check-ins. Clinician participants valued the opportunity to offer apps to their patients but noted that workflows would need to be tailored to individual patient needs. Time pressures, implementation complexity, and lack of appropriate staffing were cited as barriers. Clinicians proposed concrete solutions (e.g., education, tools, and staffing models) that could improve their ability to use apps within the constraints of primary care and suggested that some patients could potentially use apps without clinician support. Conclusions: A user-centered approach to engaging patients in digital alcohol interventions in primary care may require personalized support for both initiation and follow-up. Meeting patients' needs likely require increased staffing and efficient workflows in primary care. Health systems should consider offering multiple pathways for enrolling patients in apps to accommodate individual preferences and contextual barriers. Plain Language Summary: Healthcare systems have begun using app-based treatments to help patients manage their health conditions, including alcohol use disorders. Some apps have been tested in research studies and appear to be effective. However, it is difficult for healthcare teams to offer apps to patients. Clinicians must engage in new activities that they have not done before, such as "teaching" patients to use apps and checking in on their use of the apps. Identifying how to use apps in routine healthcare is critical to their successful implementation. This study interviewed 27 people, including healthcare providers and patients in primary care, to uncover the most optimal ways to offer apps to patients with alcohol use disorders. The interviews combined the use of qualitative research methods and user-centered design. Results suggest that to use to address alcohol use disorders, primary care teams should be prepared to offer personalized support to patients. Both patient and clinician interviewees said that the steps required to use apps must be intuitive and simple. Patients could gain more benefits if clinicians introduced the apps and guided patients to use them, as opposed to making apps available for patients to download and use on their own. However, the exact approach to offering apps would depend on a given patient's preferences and the extent that staffing was available in the clinic to support patients. Health systems should be prepared to offer and support patients in their use of apps, which should accommodate patient preferences and the constraints of the clinic.

Approaches for Implementing App-Based Digital Treatments for Drug Use Disorders Into Primary Care: A Qualitative, User-Centered Design Study of Patient Perspectives.

BACKGROUND: Digital interventions, such as websites and smartphone apps, can be effective in treating drug use disorders (DUDs). However, their implementation in primary care is hindered, in part, by a lack of knowledge on how patients might like these treatments delivered to them. OBJECTIVE: This study aims to increase the understanding of how patients with DUDs prefer to receive app-based treatments to inform the implementation of these treatments in primary care. METHODS: The methods of user-centered design were combined with qualitative research methods to inform the design of workflows for offering app-based treatments in primary care. Adult patients (n=14) with past-year cannabis, stimulant, or opioid use disorder from 5 primary care clinics of Kaiser Permanente Washington in the Seattle area participated in this study. Semistructured interviews were recorded, transcribed, and analyzed using qualitative template analysis. The coding scheme included deductive codes based on interview topics, which primarily focused on workflow design. Inductive codes emerged from the data. RESULTS: Participants wanted to learn about apps during visits where drug use was discussed and felt that app-related conversations should be incorporated into the existing care whenever possible, as opposed to creating new health care visits to facilitate the use of the app. Nearly all participants preferred receiving clinician support for using apps over using them without support. They desired a trusting, supportive relationship with a clinician who could guide them as they used the app. Participants wanted follow-up support via phone calls or secure messaging because these modes of communication were perceived as a convenient and low burden (eg, no copays or appointment travel). CONCLUSIONS: A user-centered implementation of treatment apps for DUDs in primary care will require health systems to design workflows that account for patients' needs for structure, support in and outside of visits, and desire for convenience.

Patients' Reactions to Being Offered Financial Incentives to Increase Colorectal Screening: A Qualitative Analysis.

PURPOSE: To explore financial incentives as an intervention to improve colorectal cancer screening (CRCS) adherence among traditionally disadvantaged patients who have never been screened or are overdue for screening. APPROACH: We used qualitative methods to describe patients' attitudes toward the offer of incentives, plans for future screening, and additional barriers and facilitators to CRCS. SETTING: Kaiser Permanente Washington (KPWA). PARTICIPANTS: KPWA patients who were due or overdue for CRCS. METHOD: We conducted semi-structured qualitative interviews with 37 patients who were randomized to 1 of 2 incentives (guaranteed $10 or a lottery for $50) to complete CRCS. Interview transcripts were analyzed using a qualitative content approach. RESULTS: Patients generally had positive attitudes toward both types of incentives, however, half did not recall the incentive offer at the time of the interview. Among those who recalled the offer, 95% were screened compared to only 25% among those who did not remember the offer. Most screeners stated that staying healthy was their primary motivator for screening, but many suggested that the incentive helped them prioritize and complete screening. CONCLUSIONS: Incentives to complete CRCS may help motivate patients who would like to screen but have previously procrastinated. Future studies should ensure that the incentive offer is noticeable and shorten the deadline for completion of FIT screening.

Reactions of women underscreened for cervical cancer who received unsolicited human papillomavirus self-sampling kits.

OBJECTIVES: To evaluate experiences and reactions after receiving a mailed, unsolicited human papillomavirus self-sampling kit and identify psychosocial correlates of using kits. METHODS: Survey participants were underscreened women aged 30-64 who were mailed human papillomavirus kits as part of a pragmatic trial at Kaiser Permanente Washington, a United States integrated health care system. Six months after the mailing, we invited kit returners and non-returners to complete a web survey that measured psychosocial factors (e.g. cervical cancer/human papillomavirus knowledge, attitudes toward screening), experiences, and reactions to kits. We compared responses between kit returners and non-returners. RESULTS: Comparing 116 kit returners (272 invited) and 119 non-returners (1083 invited), we found no clinically significant differences in psychosocial factors. Overall, survey respondents showed knowledge gaps in human papillomavirus natural history (82% did not know human papillomavirus infection can clear on its own) and interpreting human papillomavirus test results (37% did not know a human papillomavirus-negative result indicates low cancer risk). Kit returners found kits convenient and easy to use (>90%). The most common reason for non-return was low confidence in ability to correctly use a kit, although many non-returners (49%) indicated that they would consider future use. Women reported low trust in human papillomavirus testing to identify women at high risk for cervical cancer (52% in returners, 42% in non-returners). CONCLUSIONS: Screening programs could improve uptake and acceptability of human papillomavirus self-sampling through outreach materials that emphasize the high efficacy of human papillomavirus testing for cervical cancer screening and educate patients about how to interpret results.

Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial.

Importance: In the United States, more than 50% of cervical cancers are diagnosed in underscreened women. Cervical cancer screening guidelines now include primary human papillomavirus (HPV) testing as a recommended strategy. Home-based HPV self-sampling is a viable option for increasing screening compliance and effectiveness; however, US data are needed to inform health care system implementation. Objective: To evaluate effectiveness of mailed HPV self-sampling kits vs usual care reminders for in-clinic screening to increase detection and treatment of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and uptake of cervical cancer screening. Design, Setting, and Participants: Randomized clinical trial conducted in Kaiser Permanente Washington, a US integrated health care delivery system. Women aged 30 to 64 years with health plan enrollment for 3 years and 5 months or more, a primary care clinician, no Papanicolaou test within 3 years and 5 months, and no hysterectomy were identified through electronic medical records and enrolled from February 25, 2014, to August 29, 2016, with follow-up through February 26, 2018. Interventions: The control group received usual care (annual patient reminders and ad hoc outreach from primary care clinics). The intervention group received usual care plus a mailed HPV self-sampling kit. Main Outcomes and Measures: Two primary outcomes were (1) CIN2+ detection within 6 months of screening and (2) treatment within 6 months of CIN2+ detection. Screening uptake within 6 months of randomization was a secondary outcome. Results: A total of 19 851 women (mean [SD] age, 50.1 [9.5] years) were included, with 9960 randomized to the intervention group and 9891 randomized to the control group. All women randomized were included in analysis. In the intervention group, 12 participants with CIN2+ were detected compared with 8 in the control group (relative risk, 1.49; 95% CI, 0.61-3.64) and 12 cases were treated vs 7 in the control group (relative risk, 1.70; 95% CI, 0.67-4.32). Screening uptake was higher in the intervention group (2618 participants [26.3%] vs 1719 participants [17.4%]; relative risk, 1.51; 95% CI, 1.43-1.60). Conclusions and Relevance: Mailing HPV kits to underscreened women increased screening uptake compared with usual care alone, with no significant differences in precancer detection or treatment. Results support the feasibility of mailing HPV kits to women who are overdue for screening as an outreach strategy to increase screening uptake in US health care systems. Efforts to increase kit uptake and follow-up of positive results are warranted to maximize detection and treatment of CIN2+. Trial Registration: ClinicalTrials.gov identifier: NCT02005510.

Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial.

Importance: Colorectal cancer screening rates are suboptimal, particularly among sociodemographically disadvantaged groups. Objective: To examine whether guaranteed money or probabilistic lottery financial incentives conditional on completion of colorectal cancer screening increase screening uptake, particularly among groups with lower screening rates. Design, Setting, and Participants: This parallel, 3-arm randomized clinical trial was conducted from March 13, 2017, through April 12, 2018, at 21 medical centers in an integrated health care system in western Washington. A total of 838 age-eligible patients overdue for colorectal cancer screening who completed a questionnaire that confirmed eligibility and included sociodemographic and psychosocial questions were enrolled. Interventions: Interventions were (1) mail only (n = 284; up to 3 mailings that included information on the importance of colorectal cancer screening and screening test choices, a fecal immunochemical test [FIT], and a reminder letter if necessary), (2) mail and monetary (n = 270; mailings plus guaranteed $10 on screening completion), or (3) mail and lottery (n = 284; mailings plus a 1 in 10 chance of receiving $50 on screening completion). Main Outcomes and Measures: The primary outcome was completion of any colorectal cancer screening within 6 months of randomization. Secondary outcomes were FIT or colonoscopy completion within 6 months of randomization. Intervention effects were compared across sociodemographic subgroups and self-reported psychosocial measures. Results: A total of 838 participants (mean [SD] age, 59.7 [7.2] years; 546 [65.2%] female; 433 [52.2%] white race and 101 [12.1%] Hispanic ethnicity) were included in the study. Completion of any colorectal screening was not significantly higher for the mail and monetary group (207 of 270 [76.7%]) or the mail and lottery group (212 of 284 [74.6%]) than for the mail only group (203 of 284 [71.5%]) (P = .11). For FIT completion, interventions had a statistically significant effect (P = .04), with a net increase of 7.7% (95% CI, 0.3%-15.1%) in the mail and monetary group and 7.1% (95% CI, -0.2% to 14.3%) in the mail and lottery group compared with the mail only group. For patients with Medicaid insurance, the net increase compared with mail only in FIT completion for the mail and monetary or the mail and lottery group was 37.7% (95% CI, 11.0%-64.3%) (34.2% for the mail and monetary group and 40.4% for the mail and lottery group) compared with a net increase of only 5.6% (95% CI, -0.9% to 12.2%) among those not Medicaid insured (test for interaction P = .03). Conclusions and Relevance: Financial incentives increased FIT uptake but not overall colorectal cancer screening. Financial incentives may decrease screening disparities among some sociodemographically disadvantaged groups. Trial Registration: ClinicalTrials.gov identifier: NCT00697047.

Understanding Patients' Perspectives and Information Needs Following a Positive Home Human Papillomavirus Self-Sampling Kit Result.

OBJECTIVE: We explored patient perspectives after a positive human papillomavirus (HPV) self-sampling result to describe experiences and information needs for this home-based screening modality. MATERIALS AND METHODS: We recruited women who tested high-risk (hr) HPV positive during a pragmatic trial evaluating mailed hrHPV self-sampling kits as an outreach strategy for women overdue for Pap screening in a U.S. integrated health care system. Telephone interviews were conducted from 2014 to 2017. Five independent coders analyzed transcripts using iterative content analysis. RESULTS: Forty-six women (61% of invited; median age 55.5 years) completed a semistructured interview. Six themes emerged: (1) convenience of home-based screening, (2) intense feelings and emotions after receiving positive kit results, (3) importance of seeing provider and discussing kit results, (4) information seeking from various sources, (5) confusion about purpose and meaning of HPV versus Pap tests, and (6) concern that HPV self-sampling is inaccurate when the subsequent Pap test is normal. CONCLUSIONS: Although women liked the kit's convenience, discussion about discordant home HPV and in-clinic Pap results led them to question the accuracy of HPV self-sampling. Patient-provider communication around home HPV kits is more complex than for reflex or cotesting because clinician-collected Pap results are unknown at the time of the positive kit result. Patients need education about differences between HPV and Pap tests and how they are used for screening and follow-up. To reassure patients and keep them interested in self-sampling, education should be provided at multiple time points during the screening process.

Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system.

Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (>3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial.

Cancer Screening Reminders: Addressing the Spectrum of Patient Preferences.

CONTEXT: Health care systems continue to seek evidence about how to optimize the efficiency and effectiveness of cancer screening reminders. Annual reminders to receive preventive services can be an efficient strategy. OBJECTIVE: To understand patient motivators and barriers to cancer screening and preferences about reminder strategies. DESIGN: We conducted 11 focus groups among adults recommended for cancer screening within Kaiser Permanente Washington. We held separate focus groups with women aged 21 to 49 years, women 50 to 75 years, and men 50 to 75 years. We used an inductive, validated coding scheme for analysis. MAIN OUTCOME MEASURES: Motivators and barriers to obtaining recommended cancer screening and general cancer screening reminder content and modality preferences. RESULTS: Half of our participants were women aged 50 to 75 years, and 25% were men aged 50 to 75 years. Differences by age, sex, insurance status, financial status, and health beliefs all drove the participants' preferences for whether they seek these recommended services and how and when they wish to be reminded about recommended cancer screening. Most participants preferred personalized reminders, and many favored receiving reminders less than 3 months before the recommended procedure date rather than a consolidated annual reminder. Younger participants more commonly requested electronic reminders, such as texts and e-mails. CONCLUSION: Optimizing cancer screening reminders within a health care system involves a multifaceted approach that enables members to request which form of reminder they prefer (eg, electronic, paper, telephone) and the timing with which they want to be reminded, while staying affordable and manageable to the health care system.