Selection of study cases
Within the study setting in Cook County, IL, a complex healthcare community that serves 5.2 million residents with diverse health issues exists. Over 37 hospitals, several dozen Federally Qualified Health Centers (hereafter FQHCs), six certified local health departments, and nearly 100 regional and community-based organizations work to improve population health through a statewide, Alliance for Health Equity collaborative (hereafter AHE).
Two FI screening and referral programs were selected for this study using criterion sampling from a larger sample of FI screening initiatives that were identified from a previous AHE environmental scan. The scan identified 13 programs implemented within primary care settings in urban and suburban Cook County, IL. The two programs selected for this study differed in the type of setting (i.e. one public, government funded organization, the other an academic medical center). Distinct program differences allowed for the exploration of program implementation in different contexts and the extraction of common, overarching implementation themes.
Inclusion criteria were based on previous research and national recommendations for
clinical FI screening initiatives(7,15–17). Study cases met the following criteria: 1) Programs that utilized the standardized two question Hunger Vital Signs tool; 2) Programs that incorporated a referral system for food delivery; 3) Programs that incorporated a referral system for SNAP enrollment; 4) Programs that had been implemented for a minimum of one year. The last criterion allowed for the examination of programs that had been presumably functioning long enough that initial challenges common to start-up programs had already been addressed. The focus of this study was to explore ongoing issues that hindered or assisted implementation and sustainability.
Three programs fit the established study criteria. One program voluntarily opted out of the study. Therefore, two cases participated in this study--hereafter, Program A and Program B.
Table 2 Characteristics of study cases
Cases
|
Characteristic of Healthcare Organization
|
Program Funding
|
Food Organization
|
Location
|
Initiative
|
Stage of
Implementation
|
1. Program A
|
Public, government funded healthcare system
|
None
|
Local food bank
|
Urban setting
|
Food security screening, mobile food truck, enrollment/referral to benefits program
|
Full Implementation (1 year and beyond)
|
2. Program B
|
Private, academic medical center
|
Federal funding and local grants
|
Urban garden collective
|
Suburban setting
|
Food security screening, onsite food distribution, enrollment
to benefits program
|
Full Implementation (1 year and beyond)
|
Study design
An embedded multiple case study design was used to examine the phenomenon of primary care situated FI screening and referral processes (18,19). The embedded nature of this study refers to the multiple units of analysis within each case (19). Preliminary research for this study indicated that the healthcare context drove how FI screening programs were implemented and what types of food assistance programs were incorporated. Implementation challenges at multiple levels within the healthcare setting, such as clinicians at the micro, clinic level were examined. Program resources, technology and infrastructure, were identified as implementation barriers at the macro, systems level. Therefore, each case in this study was identified as one individual screening initiative and the units of analysis were organization wide program actors within the healthcare setting as illustrated in Figure 1.
Participants
Over the course of six months, an iterative sampling approach was used to recruit participants for this study from a convenience sample of implementation actors at each case until data saturation was achieved (N=19). The individual that led implementation at each case was recruited first to learn more about each program’s concept, design and execution. Implementation leaders provided rich data about the implementation context representative of the following CFIR concepts: intervention characteristics, the inner setting, the outer setting, key individuals involved in the program, as well as critical implementation processes and program outcomes. Through a purposive sampling process, implementation leaders were asked to identify and recruit additional key actors within the healthcare organization critical to program implementation that could best inform the study with their experiences (20).
Study instrument and data collection
The interview guide used for this study was developed using the adapted CFIR framework (see Additional File 1). The guide was tailored to the program role of each implementation actor that was interviewed. As in similar research, the questions broadly asked about program activities, implementation processes, program outcomes and about major challenges/facilitators that affected feasibility and fidelity of program implementation (21).
A trained qualitative researcher (ST) conducted semi-structured, key informant interviews for this study. The interviews were face-to-face at each program site or over the telephone at the study participant’s discretion. Each interview lasted 30 – 45 minutes and were audio recorded for data analysis purposes. Participants recruited for the study were made aware of the audio recording at the beginning of each session and were required to provide verbal consent prior to participation in the study. This study was approved for a claim of exemption (Protocol # 2019-0610) from an academic Institutional Review Board on August 30, 2019.
The researcher took detailed notes during each interview that provided initial insights to the study. Revisions to the instrument guide were made after each interview for clarity and to collect additional program details.
Data collection, coding and analysis
Data were collected, managed and analyzed concurrently over a period of seven months until data saturation was achieved. Transcriptions of the interviews were uploaded to Atlas.ti v.8 Qualitative Data Analysis Software for data management, coding and assistance with analysis. All personal identifying information was removed from the data prior to analysis. All data were stored on a password protected computer only accessible by the researcher. A coding system developed a priori based on the adapted CFIR framework for data interpretation was used during data collection and analysis (see Additional File 2). Codes were added to or removed from the codebook as new ideas and concepts emerged, illustrated in Figure 2.
CFIR was adapted to fit the study context based on previous research (9). “Patient Needs,” originally categorized under the construct, “Outer Setting,” were found to span both the “Outer Setting” and the “Inner Setting,” as it related to how the program met patient needs. Therefore, the “Patient Needs” category was placed in a separate domain as its own construct to account for the high frequency and diversity of patient issues that were reported during patient visits, as well as before and after their visits. Operational codes, such as screening, referral and program enrollment, also needed to be accounted for during the coding process and were added into the “Design” category of the “Intervention Characteristics” domain.
In addition, the “Inner Setting” domain was broken out into organizational levels during data collection. The system level, regional level, department level and/or clinical level were added to the framework to understand how macro, meso and micro levels within each organization affected implementation processes. Other healthcare studies that applied the CFIR framework for practice-based research similarly divided the inner setting into hierarchical levels to evaluate how factors at each level affected implementation of patient-centered programs (22). Based on organizational theory, this process allows researchers to understand the different levels of change that need to occur within a healthcare organization for a new innovation to be implemented effectively (23). We wanted to also understand if programs achieved fidelity through current implementation processes what barriers or facilitators emerged. Therefore, “Fidelity” was added to the “Execution” construct under the “Process” domain.
Two experienced PhD level university students (ST and LC) established interrater reliability of the coding process until 80 percent agreement was achieved as recommended for qualitative research (24).
As data were collected, memos were used to document progress, study decisions and emerging themes (25). Matrices and frameworks were developed to guide thematic analysis and anchor emerging concepts to specific CFIR constructs (26). The themes and patterns that emerged from each interview were compared to previous interview findings. This allowed the identification of commonalities, disparities and outliers in the data and for a rich understanding of program implementation to emerge (18).
For each case, program activities, time of occurrence and implementation actors were confirmed. Implementation processes were also described as originally intended, as well as unanticipated implementation facilitators and challenges and the unique implementation context that resulted in program adaptations.
Program outcomes were also collected to assess implementation feasibility, effectiveness, as well as overall program fidelity (21,27). The following program outcomes were identified across cases: the number of patients screened; the number that identified as FI; the number of patients referred to food assistance programs; the number of patients that participated in the food assistance program. The frequency that clinicians completed essential program activities was also collected to tie outcomes specific program elements. During the cross-case analysis, the binding implementation themes were identified and gave meaning to program outcomes.
Atlas.ti v8 exploratory functions were used to further analyze and confirm findings, as was source triangulation between participants. The data were mined specifically for statements that juxtaposed with each program activity, outcome and implementation processes. This method allowed for a clearer picture about specific facilitators/challenges and brought clarity to implementation processes. Overlap between constructs helped to establish the semantic relationships between CFIR constructs. Prior to the finalization of study results, one program leader and one clinician from each case were asked to participate in member-checks. They each reviewed the results from their respective case, and provided feedback where necessary to ensure validity of study findings.