Clinical trial NCT04371887: Comparing Strategies for Implementing Primary HPV Screening
Official title: Comparing Strategies for Implementing Primary HPV Testing for Routine Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Human Papillomavirus
Health Knowledge, Attitudes, Practice
Health Care Utilization
Keywords: Primary HPV Screening
Cervical Cancer Screening
Local Tailoring
Implementation Strategy
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-05-01
Enrollment: 45000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective study will use a cluster randomization design to compare two system-level implementation strategies for primary HPV screening, with outcomes measured at multiple levels. KPSC has 13 service areas linked to over 200 ambulatory clinics. Randomization will be performed at the service area level, since these are system-level implementation strategies. Service areas will first be matched in pairs on key attributes that may be associated with implementation success prior to randomization, such as the size and the number of clinics, access, and current screening rates. Thus, the two service areas in a matched pair will be most like each other in those attributes. Within each pair, the two service areas will then be randomized to determine which receives the local-tailored vs. hybrid usual care approach. The intervention period for both arms will take place immediately after the roll out of primary HPV screening.
Primary purpose: OTHER

Brief summary: Cervical cancer screening is an important component of women's health care. Most adult women are familiar with the conventional screening modality, Pap test, which has successfully reduced the burden of cervical cancer in industrialized countries. However, Pap test has limited accuracy and can miss a progressing disease. Advancement in knowledge and technology has led to changes in national recommendations to focus on the testing of high-risk human papillomavirus (HPV) infection, the cause of cervical cancer. Screening with primary HPV testing detects more diseases compared with Pap test alone or co-testing, and requires less number of tests. However, despite the advantages of primary HPV screening over conventional approaches, the switch to primary HPV screening is limited in the United States. The scientific literature reports barriers at both the provider and women level, which include lack of knowledge, resistance, and attachment to Pap test. We currently have insufficient guidance on how to select and deploy implementation strategies most likely to facilitate use of newly recommended cancer screening modality. This project seeks to generate evidence regarding effective strategies to achieve successful implementation of the primary HPV testing for routine cervical cancer screening in a large community-based health care system. A successful implementation will be defined by uptake of the primary HPV screening, adequate knowledge of the HPV test for both patients and providers, and patient/provider satisfaction during the transition. This project is important to most adult women, as a timely adoption of the best evidence-based cancer screening approach means better patient outcomes. Further, the proposed project will not only inform about cervical cancer screening, but other clinical conditions when a physician practice change is recommended by professional societies and/or national guideline body. By engaging patients, providers and other professional stakeholders in this project, we ensure that successful project outcomes are those most important for women and their doctors. Further, the stakeholder partners will help ensure generalizability of our findings to other health care systems, design strategies that maximize completeness in data collection, and lead the dissemination effort for wide application of the knowledge to be gained in this project.

Detailed description: Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures.

Limit: 32,000 characters.

Background and Significance: Strong evidence supports testing for the high risk human papillomavirus (HPV) infection, the etiology agent of cervical cancer, in routine cervical cancer screening. In 2014, the FDA approved the first test for primary HPV screening. Between 2015 and 2017, professional societies and national guideline bodies released practice recommendation for primary HPV screening. However, none of the large health care systems in the U.S. have systematically adopted this new screening strategy. Kaiser Permanente Southern California (KPSC) is preparing to transition to primary HPV screening in 2019, with considerable expected impact and barriers at multiple levels. There is a critical gap of knowledge on effective strategies to guide implementation of uptake of new evidence-based practice, especially around cancer screening where changes to clinical practice guidelines often created confusion among clinicians and patients. The overarching goals of this application is to generate insights and evidence regarding barriers and facilitators and effective strategies to achieve clinical practice substitution. Study Aims: SA1) Compare a local-tailored vs. a centralized approach for facilitating adoption of primary HPV testing for cervical cancer screening on (a) implementation outcomes including uptake of primary HPV screening, acceptability, appropriateness and feasibility; and (b) stakeholder-centered outcomes including knowledge, experience, behavior and satisfaction; SA2) Explain variations in implementation strategy effectiveness on study outcomes by multi-level factors; and SA3) Develop guidance for use of the effective implementation strategies in additional settings and for additional implementation problems. Study Descriptions: We will conduct a prospective, cluster randomized programmatic trial to compare and evaluate a local-tailored versus a centralized implementation approach. The local tailoring strategy will be guided by a structured process, using a menu of core functions and forms with evidence-based barrier assessment and intervention options. The centralized implementation will be based on the prevalent KPSC regional approach to new practice implementation, involving the design of a multi-component approach that is delivered in a relatively consistent manner. Twelve of the 14 KPSC medical centers will be randomized to receive one of the two implementation approaches, with two medical centers serving as pilot sites. The study subject will include screening age women, primary care and obstetrics \& gynecology physicians, as well as clinic staff, administrators and operational leaders. The primary outcome of interest is uptake of primary HPV screening at the provider level. The secondary outcomes include stakeholder-centered outcomes such as knowledge and satisfaction, and additional implementation and system outcomes as well as implementation process evaluation. Data collection will be via electronic medical record extraction, patient and provider surveys, and semi-structured key-informant interviews. Multi-level models and generalized estimating equations will be used to evaluate the effect of the local-tailored approach on each outcomes of interest. Effect heterogeneity by multi-level factors will be examined by interaction terms. Content analysis will be used to evaluate qualitative data collected for Aims 1 and 3. We will use the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) to inform our overall study approach and provide rigor and structure to our analyses.

Eligibility criteria: Inclusion Criteria:

This is a cluster randomized trial. All KPSC's 12 service areas except Orange Country will be randomized and included in this study. All providers (physicians, nurses and medical assistants) and department administrator from the primary care departments (family medicine and internal medicine) and the department of obstetrics and gynecology at these 12 service areas randomized to this arm will be included in the study, as well as female patients at these service areas between age 30-65 who received cervical cancer screening during the data collection period.

Exclusion Criteria:

* Patients who are younger than 30 years old
* Providers working for departments other than Ob/Gyn, family or internal medicine

Primary outcomes:
measure: Uptake of primary HPV testing
timeFrame: Within the 3 months after the end of the 2 months intervention window
Secondary outcomes:
measure: Provider-centered outcomes
timeFrame: Within the 3 months after the end of the 2 months intervention window
measure: Patient-centered outcomes
timeFrame: Within the 3 months after the end of the 2 months intervention window
measure: Time to colposcopy after a positive test result
timeFrame: Within the 6 months after the end of the 2 months intervention window
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: KPSC Department of Research and Evaluation
name: Chun R Chao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KPSC Orange County Medical Center Department of Obstetrics and Gynecology
name: Devansu Tewari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hahn EE, Munoz-Plaza C, Altman DE, Hsu C, Cannizzaro NT, Ngo-Metzger Q, Wride P, Gould MK, Mittman BS, Hodeib M, Tewari KS, Ajamian LH, Eskander RN, Tewari D, Chao CR. De-implementation and substitution of clinical care processes: stakeholder perspectives on the transition to primary human papillomavirus (HPV) testing for cervical cancer screening. Implement Sci Commun. 2021 Sep 23;2(1):108. doi: 10.1186/s43058-021-00211-z.