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Evaluating the implementation of Nuevo Amanecer-II in rural community settings using mixed methods and equity frameworks
Archives of Public Health volume 81, Article number: 194 (2023)
Abstract
Background
The 10-week Nuevo Amanecer-II intervention, tested through a randomized controlled trial, reduced anxiety and improved stress management skills among Spanish-speaking Latina breast cancer survivors. This paper describes the implementation and equity evaluation outcomes of the Nuevo Amanecer-II intervention delivered in three California rural communities.
Methods
Using implementation and equity frameworks, concurrent convergent mixed methods were applied to evaluate implementation (feasibility, fidelity, acceptability, adoption, appropriateness, and sustainability) and equity (shared power and capacity building) outcomes. Quantitative data were collected using tracking forms, fidelity rating forms, and program evaluation surveys; qualitative data were collected using semi-structured in-depth interviews. Respondents included community-based organization (CBO) administrators, recruiters, compañeras (interventionists), and program participants.
Results
Of 76 women randomized to the intervention, 65 (86%) completed at least 7 of 10 sessions. Participants’ knowledge (85% correct of 7 questions) and skills mastery were high (85% able to correctly perform 14 skills). Mean fidelity ratings across compañeras ranged from 3.8 (modeled skills) to 5.0 (used supportive/caring communication); 1–5 scale. The program was rated as very good/excellent by 90% of participants. Participants and compañeras suggested including family members; compañeras suggested expanding content on managing thoughts and mood and healthy living and having access to participant’s survivorship care plan to tailor breast cancer information. CBOs adopted the program because it aligned with their priority populations and mission. Building on CBOs’ knowledge, resources, and infrastructure, implementation success was due to shared power, learning, responsibility, and co-ownership, resulting in a co-created tailored program for community and organizational contexts. Building intervention capacity prior to implementation, providing funding, and ongoing technical support to CBOs were vital for fidelity and enhancement of recruiter and compañera professional skills. Two of three CBOs created plans for program sustainability beyond the clinical trial; all administrators discussed the need for new funding sources to sustain the program as delivered.
Conclusions
Building on community assets and using equitable participatory research processes were central to the successful implementation of a peer-delivered psychosocial intervention in three rural communities among Spanish-speaking Latinas with breast cancer.
Text box 1. Contributions to the literature |
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• We evaluate implementation of a 10-week peer delivered stress management program for Spanish-speaking Latinas with breast cancer, in three rural California communities, using mixed-methods to comprehensively evaluate the implementation process from multiple perspectives. |
• We apply implementation and equity frameworks to evaluate implementation (feasibility, fidelity, acceptability, adoption, appropriateness, sustainability) and equity (shared power, capacity building) outcomes. |
• Implementation success was due largely to use of shared responsibility and learning, and co-ownership strategies, resulting in a co-created, co-tailored program for Spanish-speaking Latinas with breast cancer and the community and organizational context. |
• We summarize best practices for how investigators can equitably engage community organizations to implement behavioral interventions. |
Background
Psychosocial interventions for women with breast cancer can effectively decrease psychological distress and improve quality of life [1, 2]. These interventions have been designed and tested in a wide variety of populations and settings [3]. They have been implemented within health care, public health, and community-based organization (CBO) settings. They have been delivered by a range of interventionists from health professionals to trained peers or community health workers. To reach non-white or limited English proficient women, interventions have been translated and delivered in the client’s native language(s) [4, 5]. The interventions typically have small but beneficial effects on various psychosocial outcomes (i.e., quality of life, depression, cancer-related distress, and anxiety) [5].
Despite efforts to provide supportive services to women with breast cancer, very few have been offered to rural Latinas with breast cancer [6,7,8], representing a significant science-to-practice gap. Throughout rural California, Latinos disproportionately live in poverty and medically underserved areas, and fewer have a high school degree/some college, compared to Latinos in urban areas [9,10,11]. Providing programs in rural areas requires addressing specific barriers such as limited English proficiency (LEP), low literacy, travel distances, lack of transportation, limited insurance coverage, unfamiliarity with the healthcare systems, and problems paying for medical care [12, 13]. Despite the need in rural communities, psychosocial interventions are rarely tested in these low-resourced and challenging settings [14, 15].
To fill this gap, we designed a stress reduction intervention specifically for rural-dwelling Spanish-speaking breast cancer survivors. We partnered with three CBOs in rural settings to translate/adapt our first-generation Nuevo Amanecer (NA) program into Nuevo Amanecer-II (NA-II), after demonstrating the efficacy of NA among urban Latinas living with newly diagnosed breast cancer [16]. The adaptations made to NA for these rural settings are described elsewhere [17]. The effectiveness of NA-II was evaluated with a 6-month randomized controlled trial (RCT), and was found to reduce anxiety and improve stress management skills [18]. Briefly, this RCT was conducted in real-world settings with the aim to increase generalizability to women throughout survivorship. Thus, eligibility was open to women regardless of time since diagnosis. Trained, community‐based recruiters conducted in‐person 60‐minute baseline assessments (in Spanish) in the participant’s home or CBO’s office. Randomization to receive the intervention or control group was stratified by recruitment site. Before initiating recruitment, stratum‐specific sequential identification numbers were generated and randomly preassigned in blocks of random sizes. The individual was the unit of randomization with 1:1 allocation to experimental groups. Academic researchers were blind to group assignment. In total 153 primarily monolingual (85%) Spanish-speaking Latina women with non-metastatic breast cancer were randomized. The majority were Mexican immigrants (97%) and most had less than high school education (69%). This paper describes the evaluation of the implementation of NA-II within three rural communities using the Proctor implementation Outcomes Framework [19] and the Conceptual Model for Evaluating Equity within the Context of Community-based Participatory Research (CBPR) Partnerships (henceforth, Conceptual Model for Evaluating Equity) [20]. Results can inform future efforts by investigators implementing behavioral interventions in rural communities.
Methods
Nuevo Amanecer-II (NA-II) overview
Partners and partnership approaches
NA-II was a partnership between the University of California San Francisco (UCSF) (academic partner), Círculo de Vida Cancer Support and Resource Center (lead community partner/compañera (interventionist) supervisor), and three CBOs that implemented the program in rural California communities. The lead community partner is a bilingual-bicultural clinical psychologist, Co-Principal Investigator on the study, and Executive Director of a San-Francisco-based CBO providing cancer support services to Latinos. Partnering CBOs serving as implementation sites included: WomenCARE (Watsonville, CA), Kaweah Delta Health Care District (Visalia, CA), and Cancer Resource Center of the Desert (El Centro, CA). Sites are described in detail elsewhere [17].
Implementation of NA-II was guided by the Transcreation Framework [21] and CBPR principles (e.g., trust, shared decision-making, equal value placed on scientific and community knowledge) [22]. NA-II partners were engaged in all research phases (i.e., program adaption/co-creation, implementation, evaluation, interpretation of results, and dissemination). Monthly partnership meetings included all study staff (UCSF-academic partner, lead community partner staff, and individuals from three CBO implementation sites (administrators, recruiters, and compañeras). The partnership shared responsibility for and ownership of intervention and data collection activities, while emphasizing CBO’s strengths and resources and building capacity [23].
Personnel and organizational structure
CBOs received funds for study implementation ($45,000 each) and controlled their budget. Three types of CBO personnel participated in the study: administrators, recruiters, and compañeras (interventionists). One administrator from each CBO was actively involved throughout the study, serving as key decision maker regarding program design and implementation. Input was secured throughout from all study staff. Two CBO staff members or volunteers were identified by each administrator to be recruiters. Recruiters promoted NA-II in the community, explained the study, and enrolled eligible women (consent, baseline survey, and randomization into the RCT). Two individuals (Latina breast cancer survivors at least three years post-diagnosis with no recurrence) were identified by each CBO to deliver the intervention (compañeras). Recruiters and compañeras were trained by the academic and lead community partners (Co-Principal Investigators). The lead community partner supervised the compañeras in the field.
Nuevo Amanecer-II program
NA-II was a 10-week structured program delivered in Spanish by a trained compañera in the woman’s home or alternate site chosen by participants. Structured weekly modules provided training in cognitive-behavioral coping skills to manage stress and emotions and emotional support from the compañera (a culturally similar breast cancer survivor). The program is described in detail elsewhere [17]. Sessions included a deep breathing practice, review of the prior session to reinforce key concepts, review of the new week’s material, hands-on exercises, modeling and coaching by the compañera, role-playing, and a recap of the new material and weekly goals to practice new skills introduced. Women received a program manual and DVD containing stress management and breast cancer informational videos with instructions and a YouTube link. During sessions, compañeras and participants used the manual and pre-loaded tablet with videos to practice skills and review information.
Study design and frameworks for evaluating implementation and equity
We used a concurrent convergent mixed-methods design with qualitative and quantitative data collected from multiple perspectives (CBO administrators, recruiters, compañeras, compañera supervisor, and participants). Multiple data types were collected concurrently, analyzed separately, and then integrated and converged to conduct a comprehensive equity-informed implementation process evaluation [24]. The evaluation is guided by the Proctor implementation outcomes framework [19] and the Conceptual Model for Evaluating Equity [20]. Based on these frameworks, evaluation outcomes specified a priori were: implementation (feasibility, fidelity, acceptability, adoption, appropriateness, and sustainability) and equity outcomes (shared power and capacity building). The Proctor framework was selected due to its distinct yet inter-related implementation outcomes [19]. The Conceptual Model for Evaluating Equity was employed to evaluate CBPR partnership equity outcomes outlined by Ward and colleagues [20]. Equity outcomes were included as the literature highlights the challenges of communication, inclusiveness, and community involvement to successful implementation process [25] and successful CBPR [20].
Respondents
CBO administrators, recruiters, and compañeras were contacted for a semi-structured interview about program implementation. Compañeras completed a structured program tracking form for all intervention group participants (end-users) after each weekly session. The compañera supervisor completed a structured fidelity rating form for observed program sessions. All participants completing the program (including intervention and wait-list control group women who elected to receive the program after the final outcomes survey) were invited to complete a structured program evaluation survey. We randomly selected 10 participants who completed the program evaluation survey for a semi-structured interview about their experiences.
Data collection
Five types (sources) of program evaluation data were collected. Data were managed using a secure REDCap [26] data system.
RCT tracking form
Recruiters used a paper tracking form to document recruitment and retention for each potential participant (name obtained through outreach). The form included name, contact information, study ID, study eligibility questions, and a check list of study enrollment requirements (study consent, baseline survey, and randomization), with places to record dates/times of phone calls/contacts, recruitment disposition (e.g., enrolled, not interested), and reasons why participants did not enroll (e.g., too busy). The academic team entered all RCT tracking forms into the REDCap data system. Similar tracking forms were used for women enrolled in the study that included a check list of 3-month study requirements: 3-month survey, program evaluation survey (if assigned to intervention group) and 6-month survey. The disposition (e.g., completed survey, loss to follow-up) and reasons why participants did not complete the surveys (e.g., too busy, disconnected phone) or reasons that intervention group women discontinued the study at any point (e.g., experiencing serious treatment side effects, traveling) were documented. The academic team used tracking forms to assess retention rates.
Fidelity rating form
The compañera supervisor made site visits to CBOs to directly observe intervention sessions (1–2 intervention sessions per compañera). Using structured rating scales (1 = not at all to 5 = all the time), the supervisor rated compliance with six program components (the extent to which they followed the manual for that session, explained concepts in language the participant understood, checked that participant understood the material, modeled the skills, spoke in a supportive/caring way, and provided praise/feedback to participant when practiced the skills) and the extent to which compañeras encouraged participants to practice the seven skills being taught.
Program tracking form
Compañeras completed structured program tracking forms after each session and recorded program attendance and logistics, reasons why participants missed a session, and several aspects of program uptake (whether participant completed the assigned goal(s) for that week (yes or no), whether the participant reported difficulty in doing the goal (yes or no) and type of difficulty (open-ended), whether participants were able to answer correctly a few questions about a session’s material (correct or incorrect), and whether they were able to demonstrate skills covered in the prior session (yes or no).
Program evaluation survey
A few weeks after completing the program, a structured program evaluation survey was administered by telephone by a bilingual-bicultural research associate to participants who completed at least 7 of 10 sessions. The interview lasted about 10-minutes and women received $10.
Semi-structured interviews
After the RCT, all CBO administrators, recruiters, compañeras, and a subsample of participants were invited to semi-structured interviews via telephone to debrief them about their experiences in implementing the program and participating in the study. Interviews with administrators were conducted in English (by informants’ choice) by a trained bilingual-bicultural interviewer and lasted 60-minutes. Interviews with recruiters and compañeras were conducted in Spanish (by informants’ choice) by a trained bilingual-bicultural interviewer and lasted 90-minutes. Administrators, recruiters, and compañeras each received $50. Participant semi-structured interviews were conducted in Spanish via telephone by a trained bilingual-bicultural interviewer; the interview lasted 30-minutes, and each participant received $25.
Semi-structured interviews were audio-recorded and transcribed verbatim in English or Spanish by a professional transcription service. Transcriptions were de-identified and were analyzed in their original language to prevent nuances from getting ‘lost in translation’ [27].
Implementation outcomes
Implementation outcomes include: feasibility, fidelity, acceptability, adoption, appropriateness, and sustainability [19]. Shared power and capacity building were the equity outcomes of interest because of the importance of communication, inclusiveness, and community involvement to successful implementation and CBPR processes [20, 25]. Table 1 provides an overview of the outcomes with definitions, operationalization (content), respondent, and data source.
Feasibility is defined as the extent to which a program can be successfully used or carried out within a given setting [19]. We focused on the feasibility of recruitment and retention, and dose of the program received. The overall RCT enrollment goal was 150 women across all three sites; thus each organization was responsible for enrolling 50 women. Retention at 6 months was defined as completing the 6-month study survey. The retention goal was 90% at 6 months. Data on recruitment and retention were collected on the RCT tracking form. Program dose was measured by the number of program sessions attended as recorded by compañeras on the program tracking form. Program adherence was defined as having completed at least 7 of 10 sessions.
Fidelity is the degree to which a program was implemented as described in the original protocol [19]. For NA-II, fidelity was operationalized separately for participants (adherence to program) and compañeras (adherence to program delivery). For participants, fidelity was operationalized in terms of 1) participants’ adherence to and uptake of the program protocol as noted on tracking forms by compañeras. For compañeras, fidelity was operationalized in terms of (1) compañeras’ adherence to the program delivery protocol, and (2) the quality of program delivery, based on supervisor ratings during directly observed sessions.
Acceptability reflects participants’ and compañeras’ perceptions of whether the program was agreeable, palatable, or satisfactory [19]. To assess acceptability, we used participants’ program evaluation surveys and semi-structured interviews with participants and compañeras. Using structured response choices, the program evaluation survey assessed participant’s program acceptability, specifically: participants’ format preferences (timing, number of sessions, and delivery format); quality of the program, videos, and compañera skills; perceived usefulness (how much the program helped them cope with breast cancer); ease of use; and suggestions for program improvement. Women rated the usefulness of each session content/topic (i.e., cancer information, survivorship care plan, communicating with doctors, communicating with family members, managing thoughts and mood, managing stress, healthy living, and setting goals). Ease of use was assessed by asking how easy it was to understand the manual, how convenient the program was, and how often they continued to practice the skills learned after completing the program. Participant semi-structured interview questions were parallel to the program evaluation survey but more in-depth. In the compañera semi-structured interview, we asked about their perceptions of program acceptability, usefulness of program content and materials, appropriateness of format and delivery, how the program helped participant’s cope, whether participants understood or had problems understanding content or materials, barriers to successful completion of sessions and how these might be overcome, and suggestions for improvements.
Adoption is defined as the intention, initial decision, or action to employ an evidence-based program by CBO administrators as part of the real-world implementation efforts in their settings [19]. We asked about administrators’ initial decisions to implement NA-II and its relevance to their site and community needs.
Appropriateness reflects perceptions of the fit or practicability of the program and research methods [19]. Appropriateness was assessed through semi-structured interviews with recruiters, compañeras, and CBO administrators. Recruiters were asked about the appropriateness of recruitment and enrollment methods, e.g., outreach, recruitment, consent, baseline interview, randomization, and strategies for reaching more women. Compañeras and administrators were asked about their involvement in tailoring the program for their clients and settings. Administrators were also asked about hiring and supervision of compañeras and recruiters.
Sustainability is defined as the extent to which a newly implemented program is maintained or institutionalized within a CBO’s ongoing operations [19]. Sustainability was assessed through semi-structured interviews with administrators asking them about incentives/disincentives to implementing the program (e.g., resources, infrastructure), barriers and facilitators to program implementation at the individual, organization, and community levels, and plans for program sustainability.
Equity outcomes
Shared power reflects the perceptions of individuals engaged in the partnership including leadership, dynamics, communication, decision-making, resources, governance mechanisms, efficiency, and partnership challenges [20, 28]. Related semi-structured interview questions included, “How could the communication between your organization and the research team be improved?”; “How did the research team take into account your organization’s unique needs?”; “What was the leadership style of the research team?” Community recruiters and compañeras were asked parallel questions.
Capacity building reflects perceptions of personal growth (e.g., expertise, knowledge gained, personal skills) or how their organization was enhanced (e.g., services, reputation) as a result of the partnership [20, 28]. Related semi-structured interview questions for administrators and compañeras included, “How did the training you received through the Nuevo Amanecer program benefit your organization?” and “What were the changes in your community or organization as a result of this study?”
Data analyses
We first analyzed quantitative and qualitative data separately then converged qualitative and quantitative findings.
Feasibility data from the RCT and compañera program tracking forms were summarized in terms of frequencies and percentages for the recruitment rate (participants enrolled/invited/ineligible), retention (completed 6-month survey), and program dose (completed at least 7 program sessions/assigned to intervention group).
The compañera supervisor’s fidelity rating forms were summarized across compañeras using means and standard deviations. For the seven skills, we report the frequency of how much compañeras encouraged participants to practice skills.
Acceptability outcomes from the structured program evaluation survey were summarized in terms of frequencies and percentages. Semi-structured interviews with participants and compañeras were analyzed using a deductive thematic approach [29] using Dedoose software [30]. The program evaluation survey was used to create a structured program codebook since, as described above, the participant and compañera semi-structured interview questions were parallel to the program evaluation survey but more in-depth. The structured program codebook was replicated in Dedoose to organize and analyze the data. Analysis started with one author (JS-O) coding interview transcripts to ascertain themes and constructs aligned with the structured program codebook. Two coders then independently coded each interview using the structured program codebook then reviewed the themes to determine coding consensus. Themes were then summarized by respondent type (participant vs. compañeras).
For adoption, appropriateness, sustainability, shared power, and capacity building outcomes, the semi-structured interviews with CBO administrators, recruiters, and compañeras were analyzed using the similar methods [29] using Dedoose software [30] as described for the acceptability-related semi-structured interview data. Semi-structured interview responses were triangulated iteratively across respondent types [31]. Analysis started with one author (JS-O) coding interview transcripts to identify themes and constructs that aligned with Proctor’s [19] implementation outcome definitions and equity outcomes described in the Conceptual Model for Evaluating Equity [20], using Dedoose to create an initial structured outcome codebook organized by outcome. The structured outcome codebook was then used to code two transcripts over two rounds of iterative coding by two coders independently. Any outcome codebook modifications were discussed with JS-O. Any remaining transcripts were coded using the modified outcome codebook. Codes by outcome were then reviewed by all coders and any discrepancies were discussed until consensus was reached. Once consensus was reached, the most relevant quotes were highlighted and extracted from the transcripts, and the quotes were translated into English, if in Spanish, for reporting purposes.
Results
We conducted semi-structured in-depth interviews with all three CBO administrators, four of five recruiters (one was unavailable), and five of six compañeras (one was unavailable), and nine of 10 participants sampled (one was unavailable). Sixty of 65 participants completed the program evaluation survey (5 were unable to be reached).
Implementation outcome: feasibility
CBOs reached their enrollment goal of 50 women each (two enrolled 50 women and one enrolled 53 women). Across sites, 231 women were invited to participate, and 24 were ineligible. Of 207 eligible, 54 refused for a recruitment rate of 74% (207/231). We randomly assigned the final sample of 153 women to the intervention (n = 76) or control group (n = 77). Six-month retention was 92% overall (140/153), 88% for the intervention group, and 95% for the control group.
Of 76 women randomized to the intervention group, 65 (86%) completed at least 7 of 10 sessions (9% completed 1 to 6 sessions, and 5% completed no sessions). Primary reasons women did not complete ≥ 7 sessions were no longer needing a support program because they had completed active treatment, treatment side effects, and travel.
Implementation outcome: fidelity
Participants’ adherence and uptake
Across sessions, participants’ knowledge (> 85% correct on seven questions) and uptake of skills mastery were high (> 85% able to correctly perform all 14 skills); Table 2. Every week except the first, participants were asked to complete a weekly goal reinforcing a skill covered that week. For weeks 2–5, participants were asked to complete a distress thermometer to measure anxiety and practice deep breathing at home. At week 2 and 3, 78% and 79% of participants completed the distress thermometer, decreasing each week thereafter, with 61% completing it by week 5. Completion of deep breathing was consistently high for weeks 2–5 (83%). Completion rates for other weekly goals ranged from 72 to 88% except that only 19% were able complete the weekly goal of talking with the person with whom she had difficulty expressing herself. The most frequently mentioned problems with completing the weekly goal, from most to least often were: too busy; side effects; forgot; unable to play the DVD; and did not know how.
Compañeras adherence to and quality of program delivery
Mean fidelity ratings across the 6 compañeras ranged from 3.8 (modeled skills presented) to 5.0 (used supportive/caring communication) on the 1–5 rating scale (Table 3). All ratings of the extent to which the compañeras encouraged the participant to practice each of the skills were “all” or “most” of the time, except for seeking cancer information/asking doctors questions (one compañera encouraged it “some of the time”).
The compañera supervisor (direct observer) rated highly the compañeras’ ability to deliver the program as designed, and this was supported further by compañeras’ ratings of participants’ ability to learn new information, master skills, and complete most weekly goals.
Implementation outcome: acceptability
Of 65 intervention group participants who completed ≥ 7 sessions, 60 (92%) completed the program evaluation survey.
Program format preferences
Regarding program timing, 55% would have preferred to have started the program when they were diagnosed, a quarter when they were undergoing treatment, and 18% after (Table 4). No one reported preferring fewer sessions, over two-thirds (72%) preferred the same number of sessions, and 28% would have preferred more sessions. Almost all (95%) preferred the program as delivered (in person) rather than by telephone or manual only; some preferred group meetings (18%).
Qualitative results from participants and compañeras confirmed quantitative results (Table 4) with the following program improvement suggestions: (1) offering the program earlier (at diagnosis or treatment initiation), (2) offering more or longer sessions (weekly sessions lasted on average of 93 min (SD = 18.2) from program tracking form), and (3) augmenting individual sessions with 1 or 2 group sessions.
Overall quality of program, DVD, and compañeras
The program was rated as very good/excellent by most participants (90%). The DVD was rated as very good/excellent by 77% and poor/fair/good by 17%. Few respondents (7%) lacked a DVD player. Most respondents (97%) rated compañeras’ skills as very good/excellent. Suggestions from qualitative participant and compañera interviews included having alternative ways of playing the videos. Participants related strengths of the program as having personal contact with a breast cancer survivor.
Perceived program usefulness
Almost all participants (98%) rated how much the program helped them cope with breast cancer as quite a bit/very much. The highest ratings pertained to communicating with doctors (92% quite/very useful) and family members (94%), managing thoughts and mood (95%), managing stress (97%), healthy eating (98%), and setting goals (93%). Participants and compañeras related strengths of the program as stress management skills, communication skills with doctors and family, learning to cope with thoughts and mood, and goal setting. The lowest ratings were for cancer information (77%) and survivorship care planning (70%). Participants found the breast cancer treatment video less applicable to their post-treatment circumstances.
Suggestions for program improvement
Participants and compañeras suggested including family members. Compañeras suggested expanding content on managing thoughts and mood and healthy living and having access to participant’s survivorship care plan to tailor breast cancer information.
Program ease of use
Ease of understanding the manual (88% reported being quite/very easy) and program convenience (88% reported being very convenient) received high participant ratings. About 3/4 (77%) of participants reported currently practicing the skills often. From the qualitative results, participants and compañeras said the program was easy to use but found some content repetitive. Participants found the program convenient because sessions were delivered in participants’ homes or CBO sites. Compañeras identified challenges with scheduling sessions and travel distances (mileage was reimbursed). Compañeras’ mean weekly round trip travel time was 37 min (SD = 24.4) and mean round trip travel distance was 29 miles (SD = 24.5).
Implementation outcome: adoption
Administrators had been employed at their organizations for > 10 years. Four themes were identified regarding administrators’ decision to adopt NA-II (Table 5). Administrators described that the program aligned with their CBO’s priority population, mission and/or service model. CBOs were well established in their community, providing services to rural, medically underserved, primarily Spanish-speaking Latino populations. Administrators decided to adopt the program because it filled a community need.
Administrators highlighted how they capitalized on their existing CBO resources (with two sub-themes). Sub-themes included availability of CBO internal resources (e.g., staff, electronic records, physical space, knowledge of population) for program implementation, and pre-existing relationships with external organizations (e.g., established connections with medical staff, community resources) to obtain program referrals or additional resources (e.g., medical, food, cash assistance).
Implementation outcome: appropriateness
We identified two overarching themes (program model and research process, staffing) on contextual factors that supported/hindered appropriateness (Table 5). Respondents discussed how the program fit their community setting because it utilized community health workers, home visits, and one-on-one delivery given common barriers in rural areas (e.g., travel distance, large geographic service area). Administrators and compañeras stressed that elicitation and incorporation of their input on program and training materials prior to implementation was a major strength.
Recruiters commented on how the academic partner made adaptations to the research methods (e.g., simplified wording, shortened survey) based on their input on research methods so they were more appropriate and easier to use. Administrators and recruiters discussed that having the flexibility with locale to conduct program sessions or enrollment at the CBO office or women’s homes made it practical.
Administrators discussed how staffing, with three sub-themes (hiring community members, overseeing staff, staff turnover), affected appropriateness for their setting. Administrators talked positively about their ability to hire community members to deliver the program or enroll women. They also expressed challenges overseeing staff, e.g., role confusion or lack of communication.
Lastly, staff turnover was a limiting factor. One organization lost one of their compañeras and had to pause recruitment until the position was filled. Another organization had difficulty identifying a suitable, bilingual recruiter.
Implementation outcome: sustainability
Administrators identified two sustainability related themes (Table 5). All administrators discussed the need for new funding sources to sustain the program as delivered. Two administrators talked about potential funding sources (foundation grant, billing Medicaid). All administrators discussed how they would incorporate aspects of program into current CBO services such as delivering skills training within their support groups. They discussed keeping the program but altering the delivery mode to a group setting or individual sessions at the CBO (no home visits).
Equity outcome: shared power
We identified five themes regarding shared power (Table 6). Administrators spoke of the partnership structural dynamics (e.g., funding allocation, memorandums of understanding) that supported program implementation and indirect staff (e.g., administrative assistant, data analyst). All three administrators spoke highly of the partnership collaboration and the high-quality communication that provided opportunity for information exchange between CBO and academic partners. They valued the monthly conference calls to address issues, troubleshoot, and brainstorm solutions. There was resounding agreement among the administrators about the professionalism of the academic and lead community partner and the sense of mutual respect. Administrators spoke about the academic team’s reputation working with community as a strength of the partnership. One administrator said that they joined the partnership because a colleague from another organization (not involved in the project) recommended the principal investigators and program.
Equity outcome: capacity building
We identified three overarching themes related to capacity building, training/ongoing technical support, individual-level capacity, and CBO-level capacity (Table 6). With respect to training and technical support, three sub-themes emerged (training, providing ongoing technical support, and role modeling). Compañeras and recruiters spoke highly of the training provided and that they felt prepared for their duties. Compañeras would have liked training on additional breast cancer related content (e.g., intimacy, sexuality, nutrition). An administrator suggested that compañeras and recruiters be cross trained on each other’s roles to address turnover. Administrators at times were unsure how to best support recruiters and compañeras given the roles of the academic and lead community partner.
Informants reported that a key determinant of success was provision of ongoing technical support to compañeras and recruiters by the academic team and lead supervisor. Compañeras, appreciated receiving positive reinforcement and feedback on program delivery via fidelity checks. However, they mentioned that fidelity check visits were difficult to coordinate given that they required alignment across supervisor, compañera, and participant schedules. Conducting fidelity checks required the supervisor to travel from 100 to 600 miles to study sites. In addition to the monthly meetings of all staff, there was a sentiment that compañeras needed more support to process their interactions with participants.
Recruiters discussed that the academic team was readily accessible to answer questions. Two administrators discussed how well the academic team supported their recruiters. Another administrator talked about how the academic team assisted them in developing institutional review board approved procedures to recruit potential participants using hospital records, providing template letters and post cards. Lastly, compañeras and recruiters spoke highly of the value that role modeling had on enhancing their program delivery or recruitment capacity.
Compañeras reported their individual-level enhanced capacity to deliver the NA-II program and their self-application of program skills to their personal lives. Several compañeras wished they had had access to this type of program when they were undergoing their diagnosis. Recruiters reported increased research skills capacity and increased knowledge of the psychosocial impact of breast cancer.
At the CBO-level, administrators talked about enhancing their CBO’s program capacity. They saw the cognitive behavioral coping skills as being transferable to individuals with other cancer types/other genders. Administrators indicated that because the organization had limited staff development funds, staff were able to obtain skills through the study that they otherwise would not have. In addition, it enhanced their CBO’s research skills capacity to participate in other research projects with other researchers. Lastly, administrators discussed that their participation enhanced their CBO’s reputation in the community through media coverage or town halls of their CBO’s participation in NA-II.
Distilled from the data, we summarize best practices for how investigators can equitably engage community organizations to implement behavioral interventions (Table 7). Highlights include provide compensation for community partners to engage in all phases of the research, create synergy on mission and priorities, build on community assets, build further community capacity, and provide ongoing technical assistance throughout implementation.
Discussion
This study used an innovative, comprehensive, mixed methods approach to evaluate the implementation processes of NA-II, a peer delivered stress management program designed for Spanish-speaking Latinas with breast cancer in partnership with CBOs serving three rural California communities. A broad implementation evaluation framework was applied to explore various implementation process outcomes, supplemented with an equity evaluation framework that went beyond traditional implementation science outcomes.
Our choice of this broad approach was based on the innovative NA-II design, which was guided by the Transcreation Framework for Community-Engaged Behavioral Interventions to Reduce Health Disparities [21]. The Transcreation framework describes a 7-step process that fully engages the community in planning, delivering, and evaluating a program. It emphasizes principles of shared decision making, equal value placed on scientific and community knowledge, and building capacity to conduct future programs. The CBOs were thus engaged in program adaptation, implementation, and evaluation through monthly meetings that included all community-based staff (administrators, recruiters, and interventionists) in addition to the academic partner and lead community partner staff. The implementation evaluation thus required a matching approach that reflected these principles, the perspective of all of these individuals, and that enabled evaluation of the strengths and challenges of training community-based individuals to fill these roles.
We illustrate here how we tailored our implementation evaluation to this unique approach. Our traditional implementation evaluation framework included feasibility, fidelity, acceptability, adoption, appropriateness, and sustainability. However, we defined these in somewhat unique ways. For example, fidelity was examined in terms of participants’ uptake of program components (traditional definition) as well as in terms of community-based interventionists’ ability to deliver the program per protocol (unique definition). We selected equity outcomes to evaluate the extent to which we succeeded in sharing power and building capacity. In another example, we evaluated shared power by exploring their sense of the partnership dynamics such as governance and communication.
Implementing psychosocial interventions in rural areas face considerable challenges over and above those in urban areas. Because of the paucity of services in rural areas, strategies require extensive collaboration between institutions to augment conventional delivery systems [32]. The three CBOs (mental health service organization, Latino/a-serving cancer organization, and safety-net hospital) provided varied settings for implementing the intervention. The settings were chosen for their expertise providing services to Spanish-speaking Latinas, and because NA-II aligned with the CBOs’ priority populations and missions. Understanding local community contexts for implementing psychosocial interventions helps address large differences that can exist across rural communities and relative to the original program test sites [33]. Contextual factors such as funding, competing demands, organizational structure, and CBO staffing needs influenced the implementation process. Program acceptability for CBO staff was evidenced, with minimal suggestions for improvement.
Equity success was due largely to use of strategies of shared responsibility and learning and co-ownership (shared power), resulting in a co-created, co-tailored program for Spanish-speaking Latinas with breast cancer and the community and organizational context. In this study, it was important that all partnership members share responsibility and ownership of intervention and data collection processes [23] for a successful implementation [25]. Training and ongoing technical assistance were key factors. Building capacity beyond the program was imperative for CBOs. A common barrier to equitably engaging community members in implementation science is CBOs’ resource limitations, thus, compensating them for their full involvement in the research process was a pre-requisite [34]. Acquisition of research skills enabled community members to apply their new skills and knowledge to subsequent projects and enabled extension of training on the program to others within their communities [35, 36].
Challenges to community involvement typically relate to communication, inclusiveness, and trust issues, which can affect implementation [25] and CBPR success [20, 37]. By evaluating the partnership from the perspectives of CBO administrators, recruiters, and compañeras (interventionists), we were able to explore the extent to which partners were engaged in co-equal decision making. Suggested best practices include providing compensation for community partners, engaging them in co-creation and adaption of intervention materials and study procedures, designing implementation processes to build on community assets, building community capacity, and providing ongoing technical assistance. Evaluation of implementation processes using data from multiple perspectives builds the evidence-base to inform future implementation [38]. Reporting complied with TIDieR reporting standards [39] (see Additional file 1).
Successful implementation of NA-II was due in part to the long history of the academic and lead community partners’ use of CBPR principles to test community-based psychosocial interventions among Latina breast cancer survivors. Even though the three rural CBOs were new partners, they recognized the reputations and the prior partnership of the academic and lead community partner with other CBOs to improve psychosocial health among Latinos with cancer [16, 40,41,42,43]. This credibility contributed to intervention adoption and is hyper critical in communities that have been traditionally disenfranchised by institutionalized power structures that limit access to health-sustaining resources.
Limitations
CBOs and staff participating in our study may not be representative of other rural organizations. Results therefore may not generalize to other culturally and linguistically diverse communities and populations. While the NA-II intervention reduced anxiety and improved stress management skills [18], parts of it may not have been relevant to long-term breast cancer survivors. Yet findings may have implications for addressing the psychosocial needs of long-term breast cancer survivors across the care continuum and their lifespan [44]. Sample sizes were small for each type of informant and data were self-reported, potentially introducing social desirability bias (answers that they believed would please the interviewers). Finally, greater attention to sustainability would have been helpful. Two of three CBOs had plans in place to obtain additional funding to continue NA-II; thus more funding to provide technical assistance to achieve these plans would have been extremely helpful.
Conclusions
Applying an equity-focused approach to co-creation, implementation, and evaluation of Nuevo Amanecer-II offered the opportunity for individual and organizational capacity building, an equitable partnership, and an acceptable and effective psychosocial intervention designed for a vulnerable population. The inclusion of both implementation and equity outcomes from multiple community perspectives offers a comprehensive evaluation to better inform community implementation of peer-based programs designed to address populations and settings that have experienced limited access to health preserving resources.
Data Availability
The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
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Funding
This research was supported by funds from the California Breast Cancer Research Grants Program Office of the University of California grants number 21OB-0135, and the Division of Intramural Research, National Institute on Minority Health and Health Disparities, National Institutes of Health. Dr. Santoyo-Olsson was supported by the National Institute on Aging (grant number T32-AG000212). Dr. Stewart was supported by the National Institutes of Health/National Institute on Aging (grant number 2P30AG015272). The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the National Institutes of Health or the U.S. Government.
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Contributions
Conceptualization: JS-O, ALS, and AMN. Methodology: JS-O, ALS, and AMN. Investigation and data curation: JS-O, ALS, CO, HP, AT-N, LC, and AMN. Formal analysis: JS-O, AMN, AA, SQ, JB, and VS-U. Data interpretation: All authors. Project administration: JS-O, CO, HP, AT-N, LC, and AMN. Funding acquisition: AMN. Writing—original draft: JS-O. Writing—review and editing: All authors. All authors read and approved the final manuscript.
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Ethics approval was obtained from the UCSF Institutional Review Board (#16-18737) and informed consent was obtained from all study participants. Trial registration on ClinicalTrials.gov, NCT02931552. Registered 11 October 2016 - Retrospectively registered, https://clinicaltrials.gov/search?term=NCT02931552.
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Santoyo-Olsson, J., Stewart, A.L., Ortiz, C. et al. Evaluating the implementation of Nuevo Amanecer-II in rural community settings using mixed methods and equity frameworks. Arch Public Health 81, 194 (2023). https://doi.org/10.1186/s13690-023-01207-y
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DOI: https://doi.org/10.1186/s13690-023-01207-y