Cost-effectiveness Archives - Implementation Science at UW

✪ Study protocol for testing the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in elementary schools: a hybrid type 3 effectiveness-implementation randomized controlled trial

Abstract:

Background

Schools need to implement universal student supports that prevent social, emotional, and behavioral difficulties; minimize associated risks; and promote social, emotional, and behavioral competencies. The purpose of this study is to examine the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy for promoting school-level implementation leadership, implementation climate, and high-fidelity delivery of an evidence-based practice. We will test HELM with an exemplar EBP, Positive Behavioral Interventions and Supports (PBIS). The specific aims of the study are to: 1) experimentally evaluate the effects of HELM versus PBIS training and technical assistance only (control condition); and 2) explore for whom, under what conditions, how equitably, and through which processes HELM works to improve outcomes, as well as its cost-effectiveness.

Methods

This study will use a hybrid type 3 effectiveness-implementation trial to provide a rigorous test of the effects of HELM in elementary schools. Schools will be randomly assigned to HELM + PBIS training and technical assistance (n = 21 schools; n = 210 educators) or PBIS training and technical assistance only (n = 21 schools; n = 210 educators) in a 1:1 ratio within cohorts using covariate constrained randomization that accounts for degree of prior PBIS exposure (measured using the Tiered Fidelity Inventory at baseline) and school size. A series of mixed effects models (time within educator, educator within school) will test within-subject/between-subject interactions across three timepoints (12 months total) to examine whether HELM will show steeper gains than the control on implementation leadership (primary outcome), implementation climate, PBIS fidelity, and student outcomes. Mediational analyses will test hypothesized mechanisms of change (i.e., implementation leadership and climate) of HELM on PBIS fidelity. Sequential mixed-methods data collection and analyses will further explore how organizational mechanisms are linked to implementation outcomes. Cost-effectiveness analyses will compare costs and outcomes of PBIS training and technical assistance only versus PBIS implementation with HELM.

Discussion

The nature of leadership support in schools can make the difference between successful and unsuccessful EBP implementation. Testing HELM within the context of PBIS implementation will provide rigorous evidence about whether and how HELM can equitably address important EBP and student outcomes.

Trial Registration

Clinical Trials ID: NCT06586723. Date of Registration: August 27, 2024. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06586723?intr=helm&rank=1

Contributions to the Literature

Few effective strategies to enhance evidence-based practice implementation in schools address implementation leadership and climate, and those that do have only been evaluated qualitatively.
Schools have unique organizational characteristics, and it is important to test whether organizational implementation strategies developed in other contexts can be effective in improving implementation outcomes in schools.
This study will evaluate the effects of a tailored adaptation of the Leadership and Organizational Change for Implementation (LOCI) strategy for schools, entitled Helping Educational Leaders Mobilize Evidence (HELM), on implementation mechanisms (implementation leadership and implementation climate), PBIS fidelity, and student outcomes.
This study also will explore for whom, under what conditions, and how equitably HELM demonstrates its effects, providing critical information about influence on – and the limitations of – the impact of this organizational implementation strategy.
Finally, the study will evaluate the processes through which HELM works to improve outcomes, contributing to the emerging literature on implementation mechanisms, as well as its cost-effectiveness.

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

Name of the registry
clinicaltrials.gov.

Peer Review reports

✪ Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya’s public sector

Abstract:

Background

In 2017, the Kenyan Ministry of Health integrated provision of pre-exposure prophylaxis (PrEP) into public HIV-1 care clinics as a key component of the national HIV-1 prevention strategy. Estimates of the cost of PrEP provision are needed to inform the affordability and cost-effectiveness of PrEP in Kenya.

Methods

We conducted activity-based micro-costing from the payer perspective to estimate both the financial and economic costs of all resources and activities required to provide PrEP in Kenya’s public sector. We estimated total and unit costs in 2019 United States dollars from a combination of project expense reports, Ministry of Health training reports, clinic staff interviews, time-and-motion observations, and routinely collected data from PrEP recipient files from 25 high-volume HIV-1 care clinics.

Results

In the first year of programmatic PrEP delivery in 25 HIV-1 care clinics, 2,567 persons initiated PrEP and accrued 8,847 total months of PrEP coverage, accounting for 2 % of total outpatient clinic visits. The total financial cost to the Ministry of Health was $91,175, translating to an average of $10.31 per person per month. The majority (69 %) of financial costs were attributable to PrEP medication, followed by administrative supplies (17 %) and training (9 %). Economic costs were higher ($188,584 total; $21.32 per person per month) due to the inclusion of the opportunity cost of staff time re-allocated to provide PrEP and a proportional fraction of facility overhead. The vast majority (88 %) of the annual $80,811 economic cost of personnel time was incurred during activities to recruit new clients (e.g., discussion of PrEP within HIV-1 testing and counseling services), while the remaining 12 % was for activities related to both initiation and maintenance of PrEP provision (e.g., client consultations, technical advising, support groups).

Conclusions

Integration of PrEP provision into existing public health HIV-1 care service delivery platforms resulted in minimal additional staff burden and low incremental costs. Efforts to improve the efficiency of PrEP provision should focus on reductions in the cost of PrEP medication and extra-clinic demand creation and community sensitization to reduce personnel time dedicated to recruitment-related activities.

Trial registration

ClinicalTrials.gov registration NCT03052010. Retrospectively registered on February 14, 2017.

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

✪ Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: Protocol for a cluster randomized feasibility trial

Abstract:

Background

Cervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.

Methods

We designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.

Discussion

Our trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.

Trial registration

ClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.

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

✪ Protocol for a hybrid type 2 cluster randomized trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy

Abstract:

Background

More than two-thirds of youth experience trauma during childhood, and up to 1 in 5 of these youth develops posttraumatic stress symptoms that significantly impair their functioning. Although trauma-focused cognitive behavior therapy (TF-CBT) has a strong evidence base, it is rarely adopted, delivered with adequate fidelity, or evaluated in the most common setting where youth access mental health services—schools. Given that individual behavior change is ultimately required for successful implementation, even when organizational factors are firmly in place, focusing on individual-level processes represents a potentially parsimonious approach. Beliefs and Attitudes for Successful Implementation in Schools (BASIS) is a pragmatic, motivationally focused multifaceted strategy that augments training and consultation and is designed to target precise mechanisms of behavior change to produce enhanced implementation and youth clinical outcomes. This study protocol describes a hybrid type 2 effectiveness-implementation trial designed to concurrently evaluate the main effects, mediators, and moderators of both the BASIS implementation strategy on implementation outcomes and TF-CBT on youth mental health outcomes.

Methods

Using a cluster randomized controlled design, this trial will assign school-based mental health (SMH) clinicians and schools to one of three study arms: (a) enhanced treatment-as-usual (TAU), (b) attention control plus TF-CBT, or (c) BASIS+TF-CBT. With a proposed sample of 120 SMH clinicians who will each recruit 4–6 youth with a history of trauma (480 children), this project will gather data across 12 different time points to address two project aims. Aim 1 will evaluate, relative to an enhanced TAU condition, the effects of TF-CBT on identified mechanisms of change, youth mental health outcomes, and intervention costs and cost-effectiveness. Aim 2 will compare the effects of BASIS against an attention control plus TF-CBT condition on theoretical mechanisms of clinician behavior change and implementation outcomes, as well as examine costs and cost-effectiveness.

Discussion

This study will generate critical knowledge about the effectiveness and cost-effectiveness of BASIS—a pragmatic, theory-driven, and generalizable implementation strategy designed to enhance motivation—to increase the yield of evidence-based practice training and consultation, as well as the effectiveness of TF-CBT in a novel service setting.

Trial registration

ClinicalTrials.gov registration number NCT04451161. Registered on June 30, 2020.

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

✪ Breast cancer early detection: A phased approach to implementation

Authors:

Ophira Ginsburg, Cheng‐Har Yip, Ari Brooks, Anna Cabanes, Maira Caleffi, Jorge Antonio, Dunstan Yataco, Bishal Gyawali, Valerie McCormack, Myrna McLaughlin de Anderson, Ravi Mehrotra, Alejandro Mohar, Raul Murillo, Lydia E. Pace, Electra D. Paskett, Anya Romanoff, Anne F. Rositch, John R. Scheel, Miriam Schneidman, Karla Unger‐Saldaña, Verna Vanderpuye, Tsu‐Yin Wu, Safina Yuma, Allison Dvaladze, Catherine Duggan, and Benjamin O. Anderson

^{University of Washington affiliated authors are displayed in bold.}

✪ Open Access

Published: April 2020

Read the full text in the open access journal Cancer

Abstract:

When breast cancer is detected and treated early, the chances of survival are very high. However, women in many settings face complex barriers to early detection, including social, economic, geographic, and other interrelated factors, which can limit their access to timely, affordable, and effective breast health care services. Previously, the Breast Health Global Initiative (BHGI) developed resource‐stratified guidelines for the early detection and diagnosis of breast cancer.

In this consensus article from the sixth BHGI Global Summit held in October 2018, the authors describe phases of early detection program development, beginning with management strategies required for the diagnosis of clinically detectable disease based on awareness education and technical training, history and physical examination, and accurate tissue diagnosis. The core issues address include finance and governance, which pertain to successful planning, implementation, and the iterative process of program improvement and are needed for a breast cancer early detection program to succeed in any resource setting.

Examples are presented of implementation, process, and clinical outcome metrics that assist in program implementation monitoring. Country case examples are presented to highlight the challenges and opportunities of implementing successful breast cancer early detection programs, and the complex interplay of barriers and facilitators to achieving early detection for breast cancer in real‐world settings are considered.

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

The impact of localized implementation: Determining the cost-effectiveness of HIV prevention and care interventions across six United States cities

Authors:

Emanuel Krebs, Xiao Zang, Benjamin Enns, Jeong E. Min, Czarina N. Behrends, Carlos del Rio, Julia C. Dombrowski, Daniel J. Feaster, Kelly A. Gebo, Matthew Golden, Brandon D.L. Marshall, Lisa R. Metsch, Bruce R. Schackman, Steven Shoptaw, Steffanie A. Strathdee, Bohdan Nosyk on behalf of the Localized Economic Modeling Study Group

^{University of Washington affiliated authors are displayed in bold.}

Subscription Required for Full Text Access

Published: March 2020

Read the full text in the subscription access journal AIDS

✪ Evaluating the sustainability, scalability, and replicability of an STH transmission interruption intervention: The DeWorm3 implementation science protocol

Authors:

Arianna Rubin Means, Sitara S. R. Ajjampur, Robin Bailey, Katya Galactionova, Marie-Claire Gwayi-Chore, Katherine Halliday, Moudachirou Ibikounle, Sanjay Juvekar, Khumbo Kalua, Gagandeep Kang, Pallavi Lele, Adrian J. F. Luty, Rachel Pullan, Rajiv Sarkar, Fabian Schär, Fabrizio Tediosi, Bryan J. Weiner, Elodie Yard, & Judd Walson, on behalf of the DeWorm3 Implementation Science Team

^{University of Washington affiliated authors are displayed in bold.}

✪ Open Access

Published: January 2018

Read the full text in the open access journal PLOS: Neglected Tropical Diseases

✪ A Cost-Effectiveness Tool to Guide the Prioritization of Interventions for Rheumatic Fever and Rheumatic Heart Disease Control in African Nations

Abstract:

Background

Rheumatic heart disease (RHD) prevalence and mortality rates remain especially high in many parts of Africa. While effective prevention and treatment exist, coverage rates of the various interventions are low. Little is known about the comparative cost-effectiveness of different RHD interventions in limited resource settings. We developed an economic evaluation tool to assist ministries of health in allocating resources and planning RHD control programs.

Methodology/Principal Findings

We constructed a Markov model of the natural history of acute rheumatic fever (ARF) and RHD, taking transition probabilities and intervention effectiveness data from previously published studies and expert opinion. Our model estimates the incremental cost-effectiveness of scaling up coverage of primary prevention (PP), secondary prevention (SP) and heart valve surgery (VS) interventions for RHD. We take a healthcare system perspective on costs and measure outcomes as disability-adjusted life-years (DALYs), discounting both at 3%. Univariate and probabilistic sensitivity analyses are also built into the modeling tool. We illustrate the use of this model in a hypothetical low-income African country, drawing on available disease burden and cost data. We found that, in our hypothetical country, PP would be cost saving and SP would be very cost-effective. International referral for VS (e.g., to a country like India that has existing surgical capacity) would be cost-effective, but building in-country VS services would not be cost-effective at typical low-income country thresholds.

Conclusions/Significance

Our cost-effectiveness analysis tool is designed to inform priorities for ARF/RHD control programs in Africa at the national or subnational level. In contrast to previous literature, our preliminary findings suggest PP could be the most efficient and cheapest approach in poor countries. We provide our model for public use in the form of a Supplementary File. Our research has immediate policy relevance and calls for renewed efforts to scale up RHD prevention.

Author Summary

Rheumatic heart disease is a major cause of cardiovascular morbidity and mortality in Africa. Although there are effective medications and surgical procedures for rheumatic heart disease, they are under-used. What is more, these interventions can be expensive—even if they are feasible and effective. Unfortunately, there are currently very few economic studies on rheumatic heart disease, leaving ministries of health with little guidance on how to choose among various interventions and allocate resources to control programs. Our study describes the methods and data we used to develop a cost-effectiveness analysis tool that was intended specifically for decision-making in African countries. In our study, we also illustrate, in a hypothetical low-income African country, how the tool could be used. In our illustrative example, a prevention-oriented approach would save money in the long term, although other interventions could be cost-effective and feasible if enough financial resources were present. These findings contrast with previous studies and make a strong case that rheumatic heart disease prevention could be a high-priority intervention in Africa. We are making our tool publicly available and anticipate that ministries of health will use it as they develop or expand their rheumatic heart disease control programs.

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

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✪ Open Access

Read the full text in the open access journal Cancer

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Read the full text in the open access journal PLOS: Neglected Tropical Diseases

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✪ Open Access

Read the full text open access in the subscription journal JAIDS