Prescription Digital Therapeutics for Substance Use Disorder in Primary Care: Mixed Methods Evaluation of a Pilot Implementation Study.

BACKGROUND: Delivering prescription digital therapeutics (ie, evidence-based interventions designed to treat, manage, or prevent disorders via websites or smartphone apps) in primary care could increase patient access to substance use disorder (SUD) treatments. However, the optimal approach to implementing prescription digital therapeutics in primary care remains unknown. OBJECTIVE: This pilot study is a precursor to a larger trial designed to test whether implementation strategies (practice facilitation [PF] and health coaching [HC]) improve the delivery of prescription digital therapeutics for SUDs in primary care. This mixed methods study describes outcomes among patients in the 2 pilot clinics and presents qualitative findings on implementation. METHODS: From February 10 to August 6, 2021, a total of 3 mental health specialists embedded in 2 primary care practices of the same integrated health system were tasked with offering app-based prescription digital therapeutics to patients with SUD. In the first half of the pilot, implementation activities included training and supportive tools. PF (at 1 clinic) and HC (at 2 clinics) were added in the second half. All study analyses relied on secondary data, including electronic health records and digital therapeutic vendor data. Primary outcomes were the proportion of patients reached by the prescription digital therapeutics and fidelity related to ideal use. We used qualitative methods to assess the adherence to planned activities and the barriers and facilitators to implementing prescription digital therapeutics. RESULTS: Of all 18 patients prescribed the apps, 10 (56%) downloaded the app and activated their prescription, and 8 (44%) completed at least 1 module of content. Patients who activated the app completed 1 module per week on average. Ideal use (fidelity) was defined as completing 4 modules per week and having a monthly SUD-related visit; 1 (6%) patient met these criteria for 10 weeks (of the 12-week prescription period). A total of 5 (28%) patients had prescriptions while HC was available, 2 (11%) were successfully contacted, and both declined coaching. Clinicians reported competing clinical priorities, technical challenges, and logistically complex workflows in part because the apps required a prescription. Some pilot activities were impacted by staff turnover that coincided with the COVID-19 pandemic. The facilitators to implementation were high engagement and the perception that the apps could meet patient needs. CONCLUSIONS: The pilot study encountered the barriers to implementing prescription digital therapeutics in a real-world primary care setting, especially staffing shortages, turnover, and competing priorities for clinic teams. The larger randomized trial will clarify the extent to which PF and HC improve the implementation of digital therapeutics. TRIAL REGISTRATION: ClinicalTrials.gov NCT04907045; https://clinicaltrials.gov/study/NCT04907045.

Impact of different financial incentive structures on a web-based health survey: do timing and amount matter?

Aim: Financial incentives improve response to electronic health surveys, yet little is known about how unconditional incentives (guaranteed regardless of survey completion), conditional incentives, and various combinations of incentives influence response rates. We compared electronic health survey completion with two different financial incentive structures. Methods: We invited women aged 30-64 years enrolled in a U.S. healthcare system and overdue for Pap screening to complete a web-based survey after receiving a mailed human papillomavirus (HPV) self-sampling kit in a pragmatic trial. HPV kit returners (n = 272) and non-returners (n = 1,083) were allocated to one of two different incentive structures: (1) Unconditional: $5 pre-incentive only (n = 653); (2) Combined: $2 pre-incentive plus $10 post-incentive conditional on completion (n = 702). Chi-square tests evaluated whether survey completion differed by incentive structure within kit return groups or was modified by kit return status. For each incentive-by-kit status group, the cost-per-survey response was calculated as: ([number invited*pre-incentive amount] + [number responses*post-incentive amount]) / number responses. Results: Overall, survey response was higher in kit returners vs. kit non-returners (42.6% vs. 11.0%, P < 0.01), and survey response was higher in the combined (20.1%) vs. unconditional (14.4%) incentive group (P = 0.01). Kit return status did not modify the association between incentive type and survey response (P = 0.52). Among respondents, time to survey completion did not differ by incentive type among either kit returners or non-returners. Among returners, the cost-per-survey response was similar between groups ($13.57 unconditional; $14.15 combined); among non-returners, the cost was greater in the unconditional ($57.78) versus the combined ($25.22) group. Conclusion: A combined incentive can be cost-effective for increasing survey response in health services research, particularly in hard-to-reach populations.

Implementation and workflow strategies for integrating digital therapeutics for alcohol use disorders into primary care: a qualitative study.

BACKGROUND: Alcohol use disorders (AUD) are prevalent and often go untreated. Patients are commonly screened for AUD in primary care, but existing treatment programs are failing to meet demand. Digital therapeutics include novel mobile app-based treatment approaches which may be cost-effective treatment options to help fill treatment gaps. The goal of this study was to identify implementation needs and workflow design considerations for integrating digital therapeutics for AUD into primary care. METHODS: We conducted qualitative interviews with clinicians, care delivery leaders, and implementation staff (n = 16) in an integrated healthcare delivery system in the United States. All participants had experience implementing digital therapeutics for depression or substance use disorders in primary care. Interviews were designed to gain insights into adaptations needed to optimize existing clinical processes, workflows, and implementation strategies for use with alcohol-focused digital therapeutics. Interviews were recorded and transcribed and then analyzed using a rapid analysis process and affinity diagramming. RESULTS: Qualitative themes were well represented across health system staff roles. Participants were enthusiastic about digital therapeutics for AUD, anticipated high patient demand for such a resource, and made suggestions for successful implementation. Key insights regarding the implementation of digital therapeutics for AUD and unhealthy alcohol use from our data include: (1) implementation strategy selection must be driven by digital therapeutic design and target population characteristics, (2) implementation strategies should seek to minimize burden on clinicians given the large numbers of patients with AUD who are likely to be interested in and eligible for digital therapeutics, and (3) digital therapeutics should be offered alongside many other treatment options to accommodate individual patients' AUD severity and treatment goals. Participants also expressed confidence that previous implementation strategies used with other digital therapeutics such as clinician training, electronic health record supports, health coaching, and practice facilitation would be effective for the implementation of digital therapeutics for AUD. CONCLUSIONS: The implementation of digital therapeutics for AUD would benefit from careful consideration of the target population. Optimal integration requires tailoring workflows to meet anticipated patient volume and designing workflow and implementation strategies to meet the unique needs of patients with varying AUD severity.

Study protocol for a factorial-randomized controlled trial evaluating the implementation, costs, effectiveness, and sustainment of digital therapeutics for substance use disorder in primary care (DIGITS Trial).

BACKGROUND: Experts recommend that treatment for substance use disorder (SUD) be integrated into primary care. The Digital Therapeutics for Opioids and Other SUD (DIGITS) Trial tests strategies for implementing reSET® and reSET-O®, which are prescription digital therapeutics for SUD and opioid use disorder, respectively, that include the community reinforcement approach, contingency management, and fluency training to reinforce concept mastery. This purpose of this trial is to test whether two implementation strategies improve implementation success (Aim 1) and achieve better population-level cost effectiveness (Aim 2) over a standard implementation approach. METHODS/DESIGN: The DIGITS Trial is a hybrid type III cluster-randomized trial. It examines outcomes of implementation strategies, rather than studying clinical outcomes of a digital therapeutic. It includes 22 primary care clinics from a healthcare system in Washington State and patients with unhealthy substance use who visit clinics during an active implementation period (up to one year). Primary care clinics implemented reSET and reSET-O using a multifaceted implementation strategy previously used by clinical leaders to roll-out smartphone apps ("standard implementation" including discrete strategies such as clinician training, electronic health record tools). Clinics were randomized as 21 sites in a 2x2 factorial design to receive up to two added implementation strategies: (1) practice facilitation, and/or (2) health coaching. Outcome data are derived from electronic health records and logs of digital therapeutic usage. Aim 1's primary outcomes include reach of the digital therapeutics to patients and fidelity of patients' use of the digital therapeutics to clinical recommendations. Substance use and engagement in SUD care are additional outcomes. In Aim 2, population-level cost effectiveness analysis will inform the economic benefit of the implementation strategies compared to standard implementation. Implementation is monitored using formative evaluation, and sustainment will be studied for up to one year using qualitative and quantitative research methods. DISCUSSION: The DIGITS Trial uses an experimental design to test whether implementation strategies increase and improve the delivery of digital therapeutics for SUDs when embedded in a large healthcare system. It will provide data on the potential benefits and cost-effectiveness of alternative implementation strategies. CLINICALTRIALS: gov Identifier: NCT05160233 (Submitted 12/3/2021). https://clinicaltrials.gov/ct2/show/NCT05160233.

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 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.

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.

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.

Balancing Hope and Risk Among Adolescent and Young Adult Cancer Patients with Late-Stage Cancer: A Qualitative Interview Study.

PURPOSE: Previous studies have called for further research to explore adolescent and young adult (AYA) decision-making in the context of advanced cancer to understand the perspectives of this understudied population. We conducted a qualitative study with patients and providers to better understand the decision-making experience of AYA patients with advanced stages of cancer. METHODS: Semistructured qualitative telephone interviews were conducted from April 2016 to October 2016. English-speaking AYAs and healthcare providers were recruited through the social media sites Twitter and Facebook. AYAs were eligible if they were aged 18-39 years at diagnosis and self-reported having metastatic cancer; any provider who worked with AYAs with metastatic cancer was eligible. Researchers with expertise in qualitative methods conducted inductive thematic content analysis of transcribed interviews. The analyzed data were used to formulate recommendations for clinicians. RESULTS: Twelve AYA patients with self-reported stage IV cancer and five clinicians who care for AYAs with advanced stages of cancer were enrolled and shared their experience about AYA medical decision-making. Four primary themes emerged: (1) AYAs describe receiving unclear prognosis, (2) AYAs balance concepts of hope and risk, (3) AYAs choose aggressive treatment options, and (4) AYAs want support facing mortality. Recommendations for clinicians include clear communication about prognosis and side effects and concerted efforts to elicit patient values. CONCLUSION: AYA patients and clinicians provided insights into the experiences and decision-making processes of AYA patients choosing to continue or discontinue treatment and into the areas for improvement in patient-centered oncology care. Taken together, these data provide important suggestions for clinicians caring for this vulnerable population.

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.

Barriers to and facilitators of physical activity program use among older adults.

OBJECTIVE: Regular physical activity (PA) is important for maintaining long-term physical, cognitive, and emotional health. However, few older adults engage in routine PA, and even fewer take advantage of programs designed to enhance PA participation. Though most managed Medicare members have free access to the Silver Sneakers and EnhanceFitness PA programs, the vast majority of eligible seniors do not utilize these programs. The goal of this qualitative study was to better understand the barriers to and facilitators of PA and participation in PA programs among older adults. DESIGN: This was a qualitative study using focus group interviews. SETTING: Focus groups took place at three Group Health clinics in King County, Washington. PARTICIPANTS: Fifty-two randomly selected Group Health Medicare members between the ages of 66 to 78 participated. METHODS: We conducted four focus groups with 13 participants each. Focus group discussions were audio-recorded, transcribed, and analyzed using an inductive thematic approach and a social-ecological framework. RESULTS: Men and women were nearly equally represented among the participants, and the sample was largely white (77%), well-educated (69% college graduates), and relatively physically active. Prominent barriers to PA and PA program participation were physical limitations due to health conditions or aging, lack of professional guidance, and inadequate distribution of information on available and appropriate PA options and programs. Facilitators included the motivation to maintain physical and mental health and access to affordable, convenient, and stimulating PA options. CONCLUSION: Older adult populations may benefit from greater support and information from their providers and health care systems on how to safely and successfully improve or maintain PA levels through later adulthood. Efforts among health care systems to boost PA among older adults may need to consider patient-centered adjustments to current PA programs, as well as alternative methods for promoting overall active lifestyle choices.