Dataset Information

Human-centered implementation research: a new approach to develop and evaluate implementation strategies for strengthening referral networks for hypertension in western Kenya.

ABSTRACT:

Background

Human-centered design (HCD) is an increasingly recognized approach for engaging stakeholders and developing contextually appropriate health interventions. As a component of the ongoing STRENGTHS study (Strengthening Referral Networks for Management of Hypertension Across the Health System), we report on the process and outcomes of utilizing HCD to develop the implementation strategy prior to a cluster-randomized controlled trial.

Methods

We organized a design team of 15 local stakeholders to participate in an HCD process to develop implementation strategies. We tested prototypes for acceptability, appropriateness, and feasibility through focus group discussions (FGDs) with various community stakeholder groups and a pilot study among patients with hypertension. FGD transcripts underwent content analysis, and pilot study data were analyzed for referral completion and reported barriers to referral. Based on this community feedback, the design team iteratively updated the implementation strategy. During each round of updates, the design team reflected on their experience through FGDs and a Likert-scale survey.

Results

The design team developed an implementation strategy consisting of a combined peer navigator and a health information technology (HIT) package. Overall, community participants felt that the strategy was acceptable, appropriate, and feasible. During the pilot study, 93% of referrals were completed. FGD participants felt that the implementation strategy facilitated referral completion through active peer engagement; enhanced communication between clinicians, patients, and health administrators; and integrated referral data into clinical records. Challenges included referral barriers that were not directly addressed by the strategy (e.g. transportation costs) and implementation of the HIT package across multiple health record systems. The design team reflected that all members contributed significantly to the design process, but emphasized the need for more transparency in how input from study investigators was incorporated into design team discussions.

Conclusions

The adaptive process of co-creation, prototyping, community feedback, and iterative redesign aligned our implementation strategy with community stakeholder priorities. We propose a new framework of human-centered implementation research that promotes collaboration between community stakeholders, study investigators, and the design team to develop, implement, and evaluate HCD products for implementation research. Our experience provides a feasible and replicable approach for implementation research in other settings.

Trial registration

Clinicaltrials.gov, NCT02501746 , registration date: July 17, 2015.

SUBMITTER: Pillsbury MKM

PROVIDER: S-EPMC8414706 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral networks between different levels of the health system is one factor that threatens the ability to achieve adequate blood pressure control and prevent CVD-related morbidity. Health information technology and peer support are two strategies that have improved care coordination and clinical outcomes for other disease entities in other settings; however, their effectiveness and cost-effectiveness in strengthening referral networks to improve blood pressure control and reduce CVD risk in low-resource settings are unknown. METHODS/DESIGN:We will use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research, focused on strengthening referral networks for hypertension in western Kenya. We will conduct a baseline needs and contextual assessment using a mixed-methods approach, in order to inform a participatory, community-based design process to fully develop a contextually and culturally appropriate intervention model that combines health information technology and peer support. Subsequently, we will conduct a two-arm cluster randomized trial comparing 1) usual care for referrals vs 2) referral networks strengthened with our intervention. The primary outcome will be one-year change in systolic blood pressure. The key secondary clinical outcome will be CVD risk reduction, and the key secondary implementation outcomes will include referral process metrics such as referral appropriateness and completion rates. We will conduct a mediation analysis to evaluate the influence of changes in referral network characteristics on intervention outcomes, a moderation analysis to evaluate the influence of baseline referral network characteristics on the effectiveness of the intervention, as well as a process evaluation using the Saunders framework. Finally, we will analyze the incremental cost-effectiveness of the intervention relative to usual care, in terms of costs per unit decrease in systolic blood pressure, per percentage change in CVD risk score, and per disability-adjusted life year saved. DISCUSSION:This study will provide evidence for the implementation of innovative strategies for strengthening referral networks to improve hypertension control in LMICs. If effective, it has the potential to be a scalable model for health systems strengthening in other low-resource settings worldwide. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03543787 . Registered on 29 June 2018.

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Project description:Monitoring and evaluating policies and programs in low- and middle-income countries are often difficult because of the lack of routine data. High mobile phone ownership in these countries presents an opportunity for efficient data collection through telephone interviews. This study examined the feasibility of collecting data on medicines through telephone interviews in Kenya. Data on the availability and prices of medicines at 137 health facilities and 639 patients were collected in September 2016 via in-person interviews. Between December 2016 and December 2017, monthly telephone interviews were conducted with health facilities and patients. An unannounced in-person interview was conducted with respondents to validate the telephone interview within 24 h. A bottom-up itemization costing approach was used to estimate the costs of telephone and in-person data collection. In-depth interviews were conducted with data collectors and respondents to explore their perceptions on both modes of data collection. The level of agreement between data on medicines availability collected through phone and in-person interviews was strong at the health facility level [kappa = 0.90; confidence interval (CI) 0.88-0.92] and moderate at the household level (kappa = 0.50, CI 0.39-0.60). Price data from telephone and in-person interviews showed strong intra-class correlation at health facilities [intra-class correlation coefficient (ICC) = 0.96] and moderate intra-class correlation at households (ICC = 0.47). The cost per phone interview at health facilities and households were $19.73 and $16.86, respectively, compared to $186.20 for a baseline in-person interview. Participants considered telephone interviews to be more convenient. In countries with high cell phone penetration, telephone data collection should be considered in monitoring and evaluating public health programs especially at health facilities. Additional strategies may be needed to optimize this mode of data collection at the household level. Variations in cell phone ownership, telecommunication network and data collection costs across different settings may limit the generalizability of the findings from this study.

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