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✪ Implementation Research at NHLBI: Methodological and Design Challenges and Lessons Learned from the DECIPHeR Initiative

Authors:

David M Murray, Patrick Heagerty, James Troendle, Feng-Chang Lin, Jonathan Moyer, June Stevens, Leslie Lytle, Xinzhi Zhang, Maliha Ilias, Mary Y Masterson, Nicole Redmond, Veronica Tonwe, Dave Clark & George A Mensah

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Ethnicity & Disease

Abstract:

NHLBI funded seven projects as part of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Initiative. They were expected to collaborate with community partners to (1) employ validated theoretical or conceptual implementation research frameworks, (2) include implementation research study designs, (3) include implementation measures as primary outcomes, and (4) inform our understanding of mediators and mechanisms of action of the implementation strategy. Several projects focused on late-stage implementation strategies that optimally and sustainably delivered two or more evidence-based multilevel interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and to improve population health in high-burden communities. Projects that were successful in the three-year planning phase transitioned to a 4-year execution phase. NHLBI formed a Technical Assistance Workgroup during the planning phase to help awardees refine study aims, strengthen research designs, detail analytic plans, and to use valid sample size methods. This paper highlights methodological and study design challenges encountered during this process. Important lessons learned included (1) the need for greater emphasis on implementation outcomes, (2) the need to clearly distinguish between intervention and implementation strategies in the protocol, (3) the need to address clustering due to randomization of groups or clusters, (4) the need to address the cross-classification that results when intervention agents work across multiple units of randomization in the same arm, (5) the need to accommodate time-varying intervention effects in stepped-wedge designs, and (6) the need for data-based estimates of the parameters required for sample size estimation.

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

✪ Improving safety and preventing falls using an evidence-based, front-line staff huddling practice: protocol for a pragmatic trial to increase quality of care in State Veterans Homes, Katherine Ritchey

Authors:

Princess Nash, Valerie Clark, Eleanor McConnell, Whitney Mills, Robert Morgan, Camilla Pimentel, Katherine Ritchey, Cari Levy, A Lynn Snow, & Christine Hartmann

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Falls in nursing homes are a major cause for decreases in residents’ quality of life and overall health. This study aims to reduce resident falls by implementing the LOCK Falls Programme, an evidence-based quality improvement intervention. The LOCK Falls Programme involves the entire front-line care team in (1) focusing on evidence of positive change, (2) collecting data through systematic observation and (3) facilitating communication and coordination of care through the practice of front-line staff huddles.

Methods and analysis

The study protocol describes a mixed-methods, 4-year hybrid (type 2) effectiveness-implementation study in State Veterans Homes in the USA. The study uses a pragmatic stepped-wedge randomised trial design and employs relational coordination theory and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework to guide implementation and evaluation. A total of eight State Veterans Homes will participate and data will be collected over an 18-month period. Administrative data inclusive of all clinical assessments and Minimum Data Set assessments for Veterans with a State Veterans Home admission or stay during the study period will be collected (8480 residents total). The primary outcome is a resident having any fall. The primary analysis will be a partial intention-to-treat analysis using the rate of participants experiencing any fall. A staff survey (n=1200) and qualitative interviews with residents (n=80) and staff (n=400) will also be conducted. This research seeks to systematically address known barriers to nursing home quality improvement efforts associated with reducing falls.

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

✪ Responding to the challenge of Adolescent Perinatal Depression (RAPiD): Protocol for a cluster randomized hybrid trial of psychosocial intervention in primary maternal care

Authors:

Oye Gureje, Lola Kola, Bibilola D. Oladeji, Jibril Abdulmalik, Olatunde Ayinde, Phyllis Zelkowitz & Ian Bennett

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2020

Read the full text in the open access journal Trials

Abstract:

Background

Adolescent pregnancy is a pressing public health issue globally, and particularly in low and middle-income countries. Depression occurring in the perinatal period is common among women and more so among adolescent mothers. Effective treatments for the condition have been demonstrated in adults but the needs of adolescents are often unique, making such treatments unlikely to meet those needs.

Method/study design

A hybrid effectiveness–implementation research study is described in which a cluster randomized trial design is used to explore the effectiveness as well as the utility in routine practice of an intervention package specifically designed for adolescents with perinatal depression. Consenting pregnant adolescents (aged less than 20 years) who are newly registered for antenatal care are enrolled into the trial if their fetal gestational age is less than 36 weeks and they score 12 or more on the Edinburgh Postnatal Depression Scale (EPDS). The intervention package consists of structured sessions of behavior activation, problem-solving treatment, and parenting skills training, and is delivered by primary maternal health care providers, complemented by support provided by a “neighborhood mother” identified by the adolescent.

Mothers in the control arm receive care as usual. The trial is conducted in clinics where the maternal providers are trained to deliver routine depression care with the use of the WHO Mental Health Gap Action Programme, intervention guide. Assessments are undertaken by trained blinded assessors at baseline, at childbirth, and at 3 and 6 months postpartum. The primary outcome, assessed at 6 months, is the level of maternal depression (measured with the EPDS). The secondary outcome is parenting skills (assessed with the Home Observation Measurement of the Environment, Infant–Toddler version), while tertiary outcomes include measures of disability, quality of life, mother–child bonding, as well as infants’ nutritional and growth indices.

Discussion

This, to the best of our knowledge, will be the first fully-powered trial of an intervention package specifically designed to address the unique needs of adolescents with perinatal depression.

Trial registration

ISRCTN16775958. Registered on 30 April 2019.

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

Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania

Authors:

Shannon Dorsey, Leah Lucid, Prerna Martin, Kevin M. King, Karen O’Donnell, Laura K. Murray, Augustine I. Wasonga, Dafrosa K. Itemba, Judith A. Cohen, Rachel Manongi, Kathryn Whetten

University of Washington affiliated authors are displayed in bold.

Published: January 2020

Read the full text in the subscription access journal JAMA Psychiatry

✪ 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**

The Pediatric Guideline Adherence and Outcomes (PEGASUS) programme in severe traumatic brain injury: A single-centre hybrid implementation and effectiveness study

Authors:

Monica S. Vavilala, Mary A. King, Jen-Ting Yang, Scott L. Erickson, Brianna Mills, Rosemary M. Grant, Carolyn Blayney, Qian Qiu, Randall M. Chesnut, Kenneth M. Jaffe, Bryan J. Weiner, & Brian D. Johnston

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: November 2018

Read the full text in the subscription access journal Lancet Child and Adolescent Health