Skip to content

✪ Expanding Hybrid Studies for Implementation Research: Intervention, Implementation Strategy, and Context

Authors:

Christopher G. Kemp, Bradley H. Wagenaar, and Emily E. Haroz

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2019

Read the full text in the open access journal Frontiers in Public Health

Abstract:

Successful implementation reflects the interplay between intervention, implementation strategy, and context. Hybrid effectiveness-implementation studies allow investigators to assess the effects of both intervention and implementation strategy, though the role of context as a third independent variable (IV) is incompletely specified. Our objective is to expand the hybrid typology to include mixtures of all three types of IVs: intervention, implementation strategy, and context.

We propose to use I to represent the IV of intervention, IS to represent implementation strategy, and C to represent context. Primary IVs are written first and in upper case. Secondary IVs are written after a forward slash and in lower case; co-primary IVs are written after a dash and in upper case. The expanded framework specifies nine two-variable hybrid types: I/is, I-IS, IS/i, IS/c, IS-C, C/is, C/i, I-C, and I/c. We describe four in detail: I/is, IS/c, IS-C, and C/is. We also specify seven three-variable hybrid types. We argue that many studies already meet our definitions of two- or three-variable hybrids.

Our proposal builds from the typology proposed by Curran et al. (1), but offers a more complete specification of hybrid study types. We need studies that measure the implementation-related effects of variations in contextual determinants, both to advance the science and to optimize intervention delivery in the real world. Prototypical implementation studies that evaluate the effectiveness of an implementation strategy, in isolation from its context, risk perpetuating the gap between evidence and practice, as they will not generate context-specific knowledge around implementation, scale-up, and de-implementation.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Implementation strategy and cost of Mozambique’s HPV vaccine demonstration project

Authors:

Caroline Soi, Joseph B. Babigumira, Baltazar Chilundo, Vasco Muchanga, Luisa Matsinhe, Sarah Gimbel, Orvalho Augusto & Kenneth Sherr
University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2019

Read the full text in the open access journal BMC Public Health

Abstract:

Background

Cost is an important determinant of health program implementation. In this study, we conducted a comprehensive evaluation of the implementation strategy of Mozambique’s school-based HPV vaccine demonstration project. We sought to estimate the total costs for the program, cost per fully immunized girl (FIG), and compute projections for the total cost of implementing a similar national level vaccination program.

Methods

We collected primary data through document review, participatory observation, and key informant interviews at all levels of the national health system and Ministry of Education. We used a combination of micro-costing methods—identification and measurement of resource quantities and valuation by application of unit costs, and gross costing—for consideration of resource bundles as they apply to the number of vaccinated girls. We extrapolated the cost per FIG to the HPV-vaccine-eligible population of Mozambique, to demonstrate the projected total annual cost for two scenarios of a similarly executed HPV vaccine program.

Results

The total cost of the Mozambique HPV vaccine demonstration project was $523,602. The mean cost per FIG was $72 (Credibility Intervals (CI): $62 - $83) in year one, $38 (CI: $37 - $40) in year two, and $54 CI: $49 - $61) for years one and two. The mean cost per FIG with the third HPV vaccine dose excluded from consideration was $60 (CI: $50 - $72) in year one, $38 (CI: $31 - $46) in year two, and $48 (CI: $42 - $55) for years one and two. The mean cost per FIG when only one HPV vaccine dose is considered was $30 (CI: $27 - $33)) in year one, $19 (CI: $15–$23) in year two, and $24 (CI: $22–$27) for both years. The projected annual cost of a two-and one-dose vaccine program targeting all 10-year-old girls in the country was $18.2 m (CI: $15.9 m - $20.7 m) and $9 m (CI: $8 m - $10 m) respectively.

Conclusion

National adaptation and scale-up of Mozambique’s school-based HPV vaccine strategy may result in substantial costs depending on dosing. For sustainability, stakeholders will need to negotiate vaccine price and achieve higher efficiency in startup activities and demand creation.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ The power of peers: an effectiveness evaluation of a cluster-controlled trial of group antenatal care in rural Nepal

Authors:

Poshan Thapa, Alex Harsha Bangura, Isha Nirola, David Citrin, Bishal Belbase, Bhawana Bogati, B. K. Nirmala, Sonu Khadka, Lal Kunwar, Scott Halliday, Nandini Choudhury, Al Ozonoff, Jasmine Tenpa, Ryan Schwarz, Mukesh Adhikari, S. P. Kalaunee, Sharon Rising, Duncan Maru & Sheela Maru

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2019

Read the full text in the open access journal Reproductive Health

Abstract:

Background

Reducing the maternal mortality ratio to less than 70 per 100,000 live births globally is one of the Sustainable Development Goals. Approximately 830 women die from pregnancy- or childbirth-related complications every day. Almost 99% of these deaths occur in developing countries. Increasing antenatal care quality and completion, and institutional delivery are key strategies to reduce maternal mortality, however there are many implementation challenges in rural and resource-limited settings. In Nepal, 43% of deliveries do not take place in an institution and 31% of women have insufficient antenatal care. Context-specific and evidence-based strategies are needed to improve antenatal care completion and institutional birth. We present an assessment of effectiveness outcomes for an adaptation of a group antenatal care model delivered by community health workers and midwives in close collaboration with government staff in rural Nepal.

Methods

The study was conducted in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized, cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allowed for iterative improvement in design by making changes to improve the quality of the intervention. We evaluated effectiveness through a difference in difference analysis of institutional birth rates between groups prior to implementation of the intervention and 1 year after implementation. Additionally, we assessed the change in knowledge of key danger signs and the acceptability of the group model compared with individual visits in a nested cohort of women receiving home visit care and home visit care plus group antenatal care. Using a directed content and thematic approach, we analyzed qualitative interviews to identify major themes related to implementation.

Results

At baseline, there were 457 recently-delivered women in the six village clusters receiving home visit care and 214 in the seven village clusters receiving home visit care plus group antenatal care. At endline, there were 336 and 201, respectively. The difference in difference analysis did not show a significant change in institutional birth rates nor antenatal care visit completion rates between the groups. There was, however, a significant increase in both institutional birth and antenatal care completion in each group from baseline to endline. We enrolled a nested cohort of 52 participants receiving home visit care and 62 participants receiving home visit care plus group antenatal care. There was high acceptability of the group antenatal care intervention and home visit care, with no significant differences between groups. A significantly higher percentage of women who participated in group antenatal care found their visits to be ‘very enjoyable’ (83.9% vs 59.6%, p = 0.0056). In the nested cohort, knowledge of key danger signs during pregnancy significantly improved from baseline to endline in the intervention clusters only (2 to 31%, p < 0.001), while knowledge of key danger signs related to labor and childbirth, the postpartum period, and the newborn did not in either intervention or control groups. Qualitative analysis revealed that women found that the groups provided an opportunity for learning and discussion, and the groups were a source of social support and empowerment. They also reported an improvement in services available at their village clinic. Providers noted the importance of the community health workers in identifying pregnant women in the community and linking them to the village clinics. Challenges in birth planning were brought up by both participants and providers.

Conclusion

While there was no significant change in institutional birth and antenatal care completion at the population level between groups, there was an increase of these outcomes in both groups. This may be secondary to the primary importance of community health worker involvement in both of these groups. Knowledge of key pregnancy danger signs was significantly improved in the home visit plus group antenatal care cohort compared with the home visit care only group. This initial study of Nyaya Health Nepal’s adapted group care model demonstrates the potential for impacting women’s antenatal care experience and should be studied over a longer period as an intervention embedded within a community health worker program.

Trial registration

ClinicalTrials.gov Identifier: NCT02330887, registered 01/05/2015, retroactively registered.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Capturing the patient voice: implementing patient-reported outcomes across the health system

Authors:

Elizabeth Austin, Cynthia LeRouge, Andrea L. Hartzler, Courtney Segal, & Danielle C. Lavallee

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: October 2019

Read the full text provided with open access, by the hybrid subscription journal Quality of Life Research

Abstract:

Purpose

Supporting the capture and use of patient-reported outcomes (PROs) at the point-of-care enriches information about important clinical and quality of life outcomes. Yet the ability to scale PROs across healthcare systems has been limited by knowledge gaps around how to manage the diversity of PRO uses and leverage health information technology. In this study, we report learnings and practice insights from UW Medicine’s practice transformation efforts to incorporate patient voice into multiple areas of care.

Methods

Using a participatory, action research approach, we engaged with UW Medicine clinical and administrative stakeholders experienced with PRO implementation to inventory PRO implementations across the health system, characterize common clinical uses for PROs, and develop recommendations for system-wide governance and implementation of PROs.

Results

We identified a wide breadth of PRO implementations (n = 14) in practice and found that nearly half (47%) of employed PRO measures captured shared clinical domains (e.g., depression). We developed three vignettes (use cases) that illustrate how users interact with PROs, characterize common ways PRO implementations support clinical care across the health system (1) Preventive care, (2) Chronic/Specialty care, and (3) Surgical/Interventional care), and elucidate opportunities to enhance efficient PRO implementations through system-level standards and governance.

Conclusions

Practice transformation efforts increasingly require integration of the patient voice into clinical care, often through the use of PROs. Learnings from our work highlight the importance of proactively considering how PROs will be used across the layers of healthcare organizations to optimize the design and governance of PROs.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Implementation Strategies to Enhance the Implementation of eHealth Programs for Patients With Chronic Illnesses: Realist Systematic Review

Authors:

Cecilie Varsi, Lise Solberg Nes, Olöf Birna Kristjansdottir, Saskia M Kelders, Una Stenberg, Heidi Andersen Zangi, Elin Børøsund, Karen Elizabeth Weiss, Audun Stubhaug, Rikke Aune Asbjørnsen, Marianne Westeng, Marte Ødegaard, Hilde Eide

University of Washington affiliated authors are displayed in bold.

Published: September 2019

Read the full text in the open access Journal of Medical Internet Research

 

BACK TO THE ARCHIVE

Abstract:

Background

There is growing evidence of the positive effects of electronic health (eHealth) interventions for patients with chronic illness, but implementation of such interventions into practice is challenging. Implementation strategies that potentially impact implementation outcomes and implementation success have been identified. Which strategies are actually used in the implementation of eHealth interventions for patients with chronic illness and which ones are the most effective is unclear.

Objective

This systematic realist review aimed to summarize evidence from empirical studies regarding (1) which implementation strategies are used when implementing eHealth interventions for patients with chronic illnesses living at home, (2) implementation outcomes, and (3) the relationship between implementation strategies, implementation outcomes, and degree of implementation success.

Methods

A systematic literature search was performed in the electronic databases MEDLINE, Embase, PsycINFO, Scopus, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library. Studies were included if they described implementation strategies used to support the integration of eHealth interventions into practice. Implementation strategies were categorized according to 9 categories defined by the Expert Recommendations for Implementing Change project: (1) engage consumers, (2) use evaluative and iterative strategies, (3) change infrastructure, (4) adapt and tailor to the context, (5) develop stakeholder interrelationships, (6) use financial strategies, (7) support clinicians, (8) provide interactive assistance, and (9) train and educate stakeholders. Implementation outcomes were extracted according to the implementation outcome framework by Proctor and colleagues: (1) acceptability, (2) adoption, (3) appropriateness, (4) cost, (5) feasibility, (6) fidelity, (7) penetration, and (8) sustainability. Implementation success was extracted according to the study authors’ own evaluation of implementation success in relation to the used implementation strategies.

Results

The implementation strategies management support and engagement, internal and external facilitation, training, and audit and feedback were directly related to implementation success in several studies. No clear relationship was found between the number of implementation strategies used and implementation success.

Conclusions

This is the first review examining implementation strategies, implementation outcomes, and implementation success of studies reporting the implementation of eHealth programs for patients with chronic illnesses living at home. The review indicates that internal and external facilitation, audit and feedback, management support, and training of clinicians are of importance for eHealth implementation. The review also points to the lack of eHealth studies that report implementation strategies in a comprehensive way and highlights the need to design robust studies focusing on implementation strategies in the future.

Trial Registration

PROSPERO CRD42018085539

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Use of Human-Centered Design to Improve Implementation of Evidence-Based Psychotherapies in Low-Resource Communities: Protocol for Studies Applying a Framework to Assess Usability


Authors:

Aaron R Lyon, Sean A Munson, Brenna N Renn, David C Atkins, Michael D Pullmann, Emily Friedman, & Patricia A Areán

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2019

Read the full text in the open access journal JMIR Research Protocols

Abstract:

Background

This paper presents the protocol for the National Institute of Mental Health (NIMH)–funded University of Washington’s ALACRITY (Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness) Center (UWAC), which uses human-centered design (HCD) methods to improve the implementation of evidence-based psychosocial interventions (EBPIs). We propose that usability—the degree to which interventions and implementation strategies can be used with ease, efficiency, effectiveness, and satisfaction—is a fundamental, yet poorly understood determinant of implementation.

Objective

We present a novel Discover, Design/Build, and Test (DDBT) framework to study usability as an implementation determinant. DDBT will be applied across Center projects to develop scalable and efficient implementation strategies (eg, training tools), modify existing EBPIs to enhance usability, and create usable and nonburdensome decision support tools for quality delivery of EBPIs.

Methods

Stakeholder participants will be implementation practitioners/intermediaries, mental health clinicians, and patients with mental illness in nonspecialty mental health settings in underresourced communities. Three preplanned projects and 12 pilot studies will employ the DDBT model to (1) identify usability challenges in implementing EBPIs in underresourced settings; (2) iteratively design solutions to overcome these challenges; and (3) compare the solution to the original version of the EPBI or implementation strategy on usability, quality of care, and patient-reported outcomes. The final products from the center will be a streamlined modification and redesign model that will improve the usability of EBPIs and implementation strategies (eg, tools to support EBPI education and decision making); a matrix of modification targets (ie, usability issues) that are both common and unique to EBPIs, strategies, settings, and patient populations; and a compilation of redesign strategies and the relative effectiveness of the redesigned solution compared to the original EBPI or strategy.

Results

The UWAC received institutional review board approval for the three separate studies in March 2018 and was funded in May 2018.

Conclusions

The outcomes from this center will inform the implementation of EBPIs by identifying cross-cutting features of EBPIs and implementation strategies that influence the use and acceptability of these interventions, actively involving stakeholder clinicians and implementation practitioners in the design of the EBPI modification or implementation strategy solution and identifying the impact of HCD-informed modifications and solutions on intervention effectiveness and quality.

Trial Registration

ClinicalTrials.gov NCT03515226 (https://clinicaltrials.gov/ct2/show/NCT03515226), NCT03514394 (https://clinicaltrials.gov/ct2/show/NCT03514394), and NCT03516513 (https://clinicaltrials.gov/ct2/show/NCT03516513).

International Registered Report Identifier (IRRID)

DERR1-10.2196/14990

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**