Mixed-methods Implementation Study Research Articles

Scaling a group intervention to promote caregiver mental health in Uttarakhand, India: A mixed-methods implementation study.

Caregivers are integral to health and social care systems in South Asian countries yet are themselves at higher risk of mental illness. Interventions to support caregiver mental health developed in high-income contexts may be contextually inappropriate in the Global South. In this mixed-methods study, we evaluated the implementation and scaling of a locally developed mental health group intervention for caregivers and others in Uttarakhand, India. We describe factors influencing implementation using the updated Consolidated Framework for Implementation Research, and selected implementation outcomes. Key influencing factors we found in common with other programs included: an intervention that was relevant and adaptable; family support and stigma operating in the outer setting; training and support for lay health worker providers, shared goals, and relationships with the community and the process of engaging with organisational leaders and service users within the inner setting. We identified further factors including the group delivery format, competing responsibilities for caregivers and opportunities associated with the partnership delivery model as influencing outcomes. Implementation successfully reached target communities however attrition of 20% of participants highlights the potential for improving outcomes by harnessing enablers and addressing barriers. Findings will inform others implementing group mental health and caregiver interventions in South Asia.

Feasibility, performance and acceptability of an innovative vital signs monitor for sick newborns in Western Kenya: A mixed-methods study.

Low- and middle-income countries (LMICs) account for 99% of the global neonatal mortality. Limited access to advanced technology, such as bedside patient monitors contributes to disproportionately poor outcomes for critically ill newborns in LMICs. We designed a study to assess the feasibility, performance, and acceptability of a low-cost wireless wearable technology for continuous monitoring of sick newborns in resource-limited settings. This was a mixed-methods implementation study conducted between March and April 2021 at two health facilities in Western Kenya. Inclusion criteria for newborns monitored included: age 0 to 28 days, birthweight ≥2.0 kg, low-to-moderate severity of illness at admission and the guardian's willingness to provide informed consent. Medical staff who participated in monitoring the newborns were surveyed about their experience with the technology. We used descriptive statistics to summarize our quantitative findings and qualitative data was coded and analyzed as an iterative process to summarize quotes on user acceptability. The results of the study demonstrated that adoption of neoGuard was feasible and acceptable in this setting. Medical staff described the technology as safe, user-friendly and efficient, after successfully monitoring 134 newborns. Despite the positive user experience, we did observe some notable technology performance issues such as a high percentage of missing vital signs data. The results of this study were critical in informing the iterative process of refining and validating an innovative vital signs monitor for patients in resource-limited settings. Further research and development are underway to optimize neoGuard's performance and to examine its clinical impact and cost effectiveness.

Protocol for a mixed methods feasibility and implementation study of a community-based integrated care model for home-dwelling older adults: The INSPIRE project.

Evaluations of integrated care models for home-dwelling frail older adults have shown inconclusive results on health and service outcomes. However, limited research has focused on the implementation of integrated care models. Applying implementation science methods may facilitate uptake of integrated care models, thus generating positive outcomes e.g., reduced hospital admissions. This paper describes the protocol to assess the feasibility of an integrated care model (featuring a four-step comprehensive geriatric assessment: screening, a multi-dimensional assessment, a coordinated individualized care plan and follow-up) designed for a new community-based center for home-dwelling older adults in Switzerland. The study includes the following objectives: 1) to assess implementation by a) monitoring respondents to the outreach strategies and describing the Center's visitors; b) assessing implementation outcomes related to the care model (i.e., adoption, acceptability, feasibility, fidelity) and implementation processes related to collaboration; and 2) assessing implementation costs. For objective 1a, we will use a descriptive design to assess respondents to the outreach strategies and describe the Center's visitors. We will use a parallel convergent mixed methods design for objective 1b. Implementation outcomes data will be collected from meetings with the Center's staff, interviews with older adults and their informal caregivers, and reviewing older adults' health records at the Center. Implementation processes related to collaboration will be assessed through a questionnaire to external collaborators (e.g., GPs) towards the end of the study. For objective 2, implementation costs will be calculated using time-driven activity-based costing methods. Data collection is anticipated to occur over approximately six months. This study of a contextually adapted integrated care model will inform adaptations to the outreach strategies, care model and implementation strategies in one community center, prior to evaluating the care model effectiveness and potentially scaling out the intervention. Feasibility study registration ID with clinicaltrials.gov: NCT05302310; registration ID with BMC: ISRCTN12324618.

Mixed-methods implementation study of a virtual culturally tailored diabetes self-management programme for African and Caribbean communities (HEAL-D) in south London and its scaling up across NHS regions in England: study protocol

IntroductionThe National Health Service Insight Prioritisation Programme was established to accelerate the implementation and evaluation of innovation that supports post-pandemic working. Supporting this, the Academic Health Science Network and National...

G6PD testing and radical cure for Plasmodium vivax in Cambodia: A mixed methods implementation study.

IntroductionCambodia aims to eliminate malaria by 2025, however tackling Plasmodium vivax (P.v) presents multiple challenges. The prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency has prevented the deployment of 8-aminoquinolones for “radical cure”, due to the risk of severe haemolysis. Patients with P. vivax have therefore continued to experience recurrent relapses leading to cumulative health and socioeconomic burden. The recent advent of point of care testing for G6PD deficiency has made radical cure a possibility, however at the time of the study lack of operational experience and guidance meant that they had not been introduced. This study therefore aimed to design, implement and evaluate a new care pathway for the radical cure of P.vivax.MethodsThis implementation study took place in Pursat province, Western Cambodia. The interventions were co-developed with key stakeholders at the national, district, and local level, through a continuous process of consultations as well as formal meetings. Mixed methods were used to evaluate the feasibility of the intervention including its uptake (G6PD testing rate and the initiation of primaquine treatment according to G6PD status); adherence (self-reported); and acceptability, using quantitative analysis of primary and secondary data as well as focus group discussions and key informant interviews.ResultsThe co-development process resulted in the design of a new care pathway with supporting interventions, and a phased approach to their implementation. Patients diagnosed with P.v infection by Village Malaria Workers (VMWs) were referred to local health centres for point-of-care G6PD testing and initiation of radical cure treatment with 14-day or 8-week primaquine regimens depending on G6PD status. VMWs carried out follow-up in the community on days 3, 7 and 14. Supporting interventions included training, community sensitisation, and the development of a smartphone and tablet application to aid referral, follow-up and surveillance. The testing rate was low initially but increased rapidly over time, reflecting the deliberately cautious phased approach to implementation. In total 626 adults received G6PD testing, for a total of 675 episodes. Of these 555 occurred in patients with normal G6PD activity and nearly all (549/555, 98.8%) were initiated on PQ14. Of the 120 with deficient/intermediate G6PD activity 61 (50.8%) were initiated on PQ8W. Self-reported adherence was high (100% and 95.1% respectively). No severe adverse events were reported. The pathway was found to be highly acceptable by both staff and patients. The supporting interventions and gradual introduction were critical to success. Challenges included travel to remote areas and mobility of P.v patients.ConclusionThe new care pathway with supporting interventions was highly feasible with high levels of uptake, adherence and acceptability in this setting where high prevalence of G6PD deficiency is high and there is a well-established network of VMWs. Scaling up of the P.v radical cure programme is currently underway in Cambodia and a decline in reduction in the burden of malaria is being seen, bringing Cambodia a step closer to elimination.

The Impact of a Digital Artificial Intelligence System on the Monitoring and Self-management of Nonmotor Symptoms in People With Parkinson Disease: Proposal for a Phase 1 Implementation Study.

BackgroundNonmotor symptoms of Parkinson disease are a major factor of disease burden but are often underreported in clinical appointments. A digital tool has been developed to support the monitoring and management of nonmotor symptoms.ObjectiveThe aim of this study is to establish evidence of the impact of the system on patient confidence, knowledge, and skills for self-management of nonmotor symptoms, symptom burden, and quality of life of people with Parkinson and their care partners. It will also evaluate the usability, acceptability, and potential for adoption of the system for people with Parkinson, care partners, and health care professionals.MethodsA mixed methods implementation and feasibility study based on the nonadoption, abandonment, scale-up, spread, and sustainability framework will be conducted with 60 person with Parkinson–care partner dyads and their associated health care professionals. Participants will be recruited from outpatient clinics at the University Hospitals Plymouth NHS Trust Parkinson service. The primary outcome, patient activation, will be measured over the 12-month intervention period; secondary outcomes include the system’s impact on health and well-being outcomes, safety, usability, acceptability, engagement, and costs. Semistructured interviews with a subset of participants will gather a more in-depth understanding of user perspectives and experiences with the system. Repeated measures analysis of variance will analyze change over time and thematic analysis will be conducted on qualitative data. The study was peer reviewed by the Parkinson’s UK Non-Drug Approaches grant board and is pending ethical approval.ResultsThe study won funding in August 2021; data collection is expected to begin in December 2022.ConclusionsThe study’s success criteria will be affirming evidence regarding the system’s feasibility, usability and acceptability, no serious safety risks identified, and an observed positive impact on patient activation. Results will be disseminated in academic peer-reviewed journals and in platforms and formats that are accessible to the general public, guided by patient and public collaborators.Trial RegistrationClinicalTrials.gov NCT05414071; https://clinicaltrials.gov/ct2/show/NCT05414071International Registered Report Identifier (IRRID)PRR1-10.2196/40317

Behaviourally informed, patient-led interventions to reduce missed appointments in general practice: a 12-month implementation study.

Scalable, positive, behaviourally informed interventions may help people remember to attend their primary care appointment or cancel in good time, but have not yet been implemented long term. To examine effects of social norms and making active commitments on missed and cancelled appointments in primary care over 12 months and explore implementation factors. A mixed-methods design evaluation and implementation study led by a Patient Participation Group (PPG) member in a large GP practice in the West Midlands. Following a 6-month baseline, waiting room notices were redesigned to emphasise positive social norms for desired behaviours. When booking appointments, receptionists were trained to invite patients to (i) verbally actively commit to cancelling if needed; (ii) write down their own appointment details. Monthly missed appointments (MAs) and cancellations were statistically compared with baseline averages and seasonally equivalent months. To explore implementation, reception staff completed a knowledge, attitude, and behaviour questionnaire at 9 months, analysed descriptively. Study team field notes were thematically analysed. Across 12 intervention months there was a mean of 37.67 fewer MAs per month (20% reduction) and 102.66 more cancellations (21.07% increase) compared with 6-month baseline means [MAs t(11) = -6.15, P < 0.001; cancellations t(11) = 3.637, P = 0.004] with statistically significant differences in seasonally equivalent months [MAs t(5) = -4.65, P = 0.006; cancellations t(5) = 3.263, P = 0.022]. Receptionists (n = 12) reported implementing the strategies except when facing pressures; knowledge and attitudes varied. Behaviourally informed interventions reduced primary care MAs longer term; PPGs and practice teams can work together on quality improvement projects with support from leaders to prioritise and embed new practices.

Novel Implementation Strategy to Electronically Screen and Signpost Patients to Health Behavior Apps: Mixed Methods Implementation Study (OptiMine Study).

BackgroundBehavior change apps have the potential to provide individual support on a population scale at low cost, but they face numerous barriers to implementation. Electronic health records (EHRs) in acute care hospitals provide a valuable resource for identifying patients at risk, who may benefit from behavior change apps. A novel, emerging implementation strategy is to use digital technologies not only for providing support to help-seeking individuals but also for signposting patients at risk to support services (also called proactive referral in the United States).ObjectiveThe OptiMine study aimed to increase the reach of behavior change apps by implementing electronic signposting for smoking cessation and alcohol reduction in a large, at-risk population that was identified through an acute care hospital EHR.MethodsThis 3-phase, mixed methods implementation study assessed the acceptability, feasibility, and reach of electronic signposting to behavior change apps by using a hospital’s EHR system to identify patients who are at risk. Phase 1 explored the acceptability of the implementation strategy among the patients and staff through focus groups. Phase 2 investigated the feasibility of using the hospital EHR to identify patients with target risk behaviors and contact them via SMS text message, email, or patient portal. Phase 3 assessed the impact of SMS text messages sent to patients who were identified as smokers or risky drinkers, which signposted them to behavior change apps. The primary outcome was the proportion of participants who clicked on the embedded link in the SMS text message to access information about the apps. The acceptability of the SMS text messages among the patients who had received them was also explored in a web-based survey.ResultsOur electronic signposting strategy—using SMS text messages to promote health behavior change apps to patients at risk—was found to be acceptable and feasible and had good reach. The hospital sent 1526 SMS text messages, signposting patients to either the National Health Service Smokefree or Drink Free Days apps. A total of 13.56% (207/1526) of the patients clicked on the embedded link to the apps, which exceeded our 5% a priori success criterion. Patients and staff contributed to the SMS text message content and delivery approach, which were perceived as acceptable before and after the delivery of the SMS text messages. The feasibility of the SMS text message format was determined and the target population was identified by mining the EHR.ConclusionsThe OptiMine study demonstrated the proof of concept for this novel implementation strategy, which used SMS text messages to signpost at-risk individuals to behavior change apps at scale. The level of reach exceeded our a priori success criterion in a non–help-seeking population of patients receiving unsolicited SMS text messages, disconnected from hospital visits.International Registered Report Identifier (IRRID)RR2-10.2196/23669

Primary Prevention of Stroke in Children With Sickle Cell Anemia in Nigeria: Protocol for a Mixed Methods Implementation Study in a Community Hospital.

BackgroundIn Nigeria, approximately 150,000 children with sickle cell anemia (SCA) are born annually, accounting for more than half of all SCA births worldwide. Without intervention, about 11% of children with SCA will develop a stroke before their 20th birthday. Evidence-based practices for primary stroke prevention include screening for abnormal transcranial Doppler (TCD) measurements coupled with regular blood transfusion therapy for at least one year, followed by hydroxyurea (HU) therapy indefinitely. In high-resource countries, this strategy contributes to a 92% decrease in stroke incidence rates. In 2016, as part of a capacity building objective of the Stroke Prevention Trial in Nigeria (1R01NS094041: SPRING), TCD screening was adopted as standard care at Barau Dikko Teaching Hospital in Kaduna. However, with just 70 radiologists and only 3 certified in TCD screening in the state, just 5.49% (1101/20,040) of eligible children with SCA were screened. Thus, there is a need to explore alternate implementation strategies to ensure children with SCA receive standard care TCD screening to decrease stroke incidence.ObjectiveThis protocol describes a study to create a stroke prevention program in a community hospital in Kaduna through task shifting TCD screening to nurses and training medical officers to initiate and monitor HU utilization for stroke prevention.MethodsThis study will be conducted at 2 sites (teaching hospital and community hospital) over a period of 3 years (November 2020 to November 2023), in 3 phases using both quasi-experimental and effectiveness-implementation study designs. In the needs assessment phase, focus groups and structured interviews will be conducted with health care providers and hospital administrators to identify barriers and facilitators to evidence-based stroke prevention practices. Results from the needs assessment will inform intervention strategies and a process plan to fit the needs of the community hospital. In the capacity building phase, nurses and medical officers at the community hospital will be trained on TCD screening and HU initiation and monitoring. In the implementation phase, children with SCA aged 2-16 years will be recruited into a nonrandomized single-arm prospective trial to determine the feasibility of initiating a task-shifted stroke prevention program by recording recruitment, retention, and adherence rates. The Reach and Effectiveness components of the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework will be used to evaluate implementation outcomes between the community and teaching hospitals.ResultsThe needs assessment phase of the study was completed in February 2021. Manuscript on findings is currently in preparation. Capacity building is ongoing with TCD training and sickle cell disease and stroke education sessions for nurses and doctors in the community hospital. Recruitment for the implementation trial is expected to commence in July 2022.ConclusionsThis study proposes a structured, theory-driven approach to create a stroke prevention program in a community hospital in Kaduna, Nigeria, to decrease stroke incidence among children with SCA. Results will provide preliminary data for a definitive randomized clinical trial in implementation science.International Registered Report Identifier (IRRID)PRR1-10.2196/37927

Evaluating Implementation Outcomes of a Home Garden Intervention in Rural Guatemala Using the RE-AIM Framework

ObjectivesTo identify implementation barriers and facilitators for a home gardening intervention in rural Guatemala. MethodsHouseholds were eligible if they had a child 6–24 months of age with stunting. Households received seeds and seedlings for 16 crops, garden construction materials, agronomist-delivered education and technical assistance, and a standard-of-care nutrition program for 6 months. A mixed-methods implementation study was conducted from January 2019 to July 2020 using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Data were collected from program records, staff observations, household surveys (n = 70), and interviews or focus groups with staff (n = 4), participants (n = 6) and community stakeholders (n = 3). Descriptive statistics were calculated for quantitative outcomes and qualitative data were organized into themes. ResultsReach: Seventy of 78 (90%) eligible households participated. Many households in the community expressed interested in participating but did not have a young child with stunting. Effectiveness: Participants and stakeholders felt the intervention increased access to diverse foods. Over the six-month period, households cultivated, on average, an additional 5 species of crops (95% CI: 4–6) overall and 2 species (95% CI: 1–3) that they self-reported consuming. Adoption: Concerns about water use for garden irrigation were a barrier, with only 1 of 4 candidate communities authorizing the project. Implementation: There was good adoption of agricultural best practices (e.g., fencing, staggered planting, adding organic material, saving seeds, intercropping). Gray water filters (facilitating use of recycled water for garden irrigation) and flexible implementation promoted participation. Maintenance: At 6 months, crops failure rates were low, with only 3 of the 16 crops having failure rates above 25%. Costs for garden materials and program delivery were ∼773 USD per household. There were concerns about seed access outside of the project. ConclusionsInterest and engagement with a home garden intervention in rural Guatemala were high. Future projects should plan to address gaps between garden production and consumption, water use, and seed sourcing. Funding SourcesAcademy of Nutrition and Dietetics Foundation.

Scaling up tobacco cessation within TB programmes: findings from a multi-country, mixed-methods implementation study

BackgroundBrief behavioural support can effectively help tuberculosis (TB) patients quit smoking and improve their outcomes. In collaboration with TB programmes in Bangladesh, Nepal and Pakistan, we evaluated the implementation and scale-up of cessation support using four strategies: (1) brief tobacco cessation intervention, (2) integration of tobacco cessation within routine training, (3) inclusion of tobacco indicators in routine records and (4) embedding research within TB programmes.MethodsWe used mixed methods of observation, interviews, questionnaires and routine data. We aimed to understand the extent and facilitators of vertical scale-up (institutionalization) within 59 health facility learning sites in Pakistan, 18 in Nepal and 15 in Bangladesh, and horizontal scale-up (increased coverage beyond learning sites). We observed training and surveyed all 169 TB health workers who were trained, in order to measure changes in their confidence in delivering cessation support. Routine TB data from the learning sites were analysed to assess intervention delivery and use of TB forms revised to report smoking status and cessation support provided. A purposive sample of TB health workers, managers and policy-makers were interviewed (Bangladesh n = 12; Nepal n = 13; Pakistan n = 19). Costs of scale-up were estimated using activity-based cost analysis.ResultsRoutine data indicated that health workers in learning sites asked all TB patients about tobacco use and offered them cessation support. Qualitative data showed use of intervention materials, often with adaptation and partial implementation in busy clinics. Short (1–2 hours) training integrated within existing programmes increased mean confidence in delivering cessation support by 17% (95% CI: 14–20%). A focus on health system changes (reporting, training, supervision) facilitated vertical scale-up. Dissemination of materials beyond learning sites and changes to national reporting forms and training indicated a degree of horizontal scale-up. Embedding research within TB health systems was crucial for horizontal scale-up and required the dynamic use of tactics including alliance-building, engagement in the wider policy process, use of insider researchers and a deep understanding of health system actors and processes.ConclusionsSystem-level changes within TB programmes may facilitate routine delivery of cessation support to TB patients. These strategies are inexpensive, and with concerted efforts from TB programmes and donors, tobacco cessation can be institutionalized at scale.

Cost-Effectiveness of Constraint-Induced Movement Therapy Implementation in Neurorehabilitation: The ACTIveARM Project.

BackgroundConstraint-induced movement therapy (CIMT) is a recommended intervention for improving arm recovery following stroke and traumatic brain injury; however, delivery in practice remains rare.PurposeThe aim of this study was to investigate the costs and cost effectiveness of CIMT delivery, and the use of a CIMT implementation package designed to improve CIMT uptake and delivery by therapists in Sydney, Australia.MethodsThis economic evaluation was conducted with a subset of CIMT programmes (n = 20) delivered by neurological rehabilitation teams at five varied hospitals within a mixed methods implementation study (ACTIveARM). The costs of delivering the CIMT implementation package and publicly funded CIMT were calculated using a bottom-up approach. A cost-effectiveness analysis was conducted, using decision analytic modelling. We compared the uptake and outcomes of people who received CIMT from health services that had received a CIMT implementation package, with those receiving standard upper limb therapy. An Australian health care system perspective was used in the model, over a 3-week time horizon (the average timeframe of a CIMT programme). All costs were calculated in Australian dollars (AUD). Inputs were derived from the ACTIveARM study and relevant literature. The Action Research Arm Test was used to measure arm outcomes. Sensitivity analyses assessed the impact of improving CIMT uptake, scale-up of the implementation package and resource adjustment, including a ‘best-case’ scenario analysis.ResultsThe total cost of delivering the implementation package to nine teams across five hospitals was $110,336.43 AUD over 18 months. The mean cost of delivering an individual CIMT programme was $1233.38 AUD per participant, and $936.03 AUD per participant for group-based programmes. The incremental cost-effectiveness ratio (ICER) of individual CIMT programmes was $8052 AUD per additional person achieving meaningful improvement in arm function, and $6045 AUD for group-based CIMT. The ICER was most sensitive to reductions in staffing costs. In the ‘best-case’ scenario, the ICER for both individual and group-based CIMT was $245 AUD per additional person gaining a meaningful change in function.ConclusionTherapists improved CIMT uptake and delivery with the support of an implementation package, however cost effectiveness was unclear.Clinical Trial Registrationhttps://anzctr.org.au/Trial ID: ACTRN12617001147370.Supplementary InformationThe online version contains supplementary material available at 10.1007/s41669-022-00323-9.

Mixed-Methods Implementation Study of a Home Garden Intervention in Rural Guatemala Using the RE-AIM Framework

BackgroundHome gardening is a strategy to improve nutrition and food security. More information is needed about optimizing gardens in different contexts. ObjectiveThe aim was to identify implementation barriers and facilitators for a home gardening intervention in rural Guatemala and inform future larger-scale interventions in the region. DesignA mixed-methods implementation study using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework was conducted from January 2019 to July 2020. Participants/settingFamilies (n = 70) in rural Guatemala participated in the intervention. Staff (n = 4), families (n = 6), and community stakeholders (n = 3) participated in interviews or focus groups. InterventionParticipating households received seeds and seedlings for 16 crops, garden construction materials, agronomist-delivered education and assistance, and a standard-of-care nutrition program. Main outcome measuresImplementation data were collected from program records and observations, participant surveys, and interviews and focus groups. Crop count and nutritional functional diversity of home gardens were assessed. Statistical analyses performedDescriptive statistics were calculated for quantitative outcomes. Qualitative data were double-coded and organized into overarching themes. ResultsReach: Ninety percent of eligible households participated. Child nutritional eligibility criteria was a barrier to reach. Effectiveness: Participants and stakeholders felt the intervention improved access to diverse foods. Cultivated crops increased an average of five species (95% confidence interval [CI], 4–6) at 6 months, although not all were consumed. Adoption: The main community adoption barrier was water sourcing for garden irrigation. Implementation: Raised beds were the most common gardening method, with good adoption of agricultural best practices. Gray water filters and flexible implementation were important for participation. Maintenance: Crops failure rates were low. Seed availability was a sustainability challenge. Direct costs were 763 USD per household. ConclusionsInterest and engagement with a home garden intervention in Guatemala were high. Gaps between garden production and consumption, access to water, and seed sourcing should be addressed in future work.

Implementing a standardised perioperative nutrition care pathway in upper gastrointestinal cancer surgery: a mixed-methods analysis of implementation using the Consolidated Framework for Implementation Research

BackgroundImplementation studies of complex interventions such as nutrition care pathways are important to health services research, as they support translation of research into practice. There is limited research regarding implementation of a nutrition care pathway in an upper gastrointestinal (UGI) cancer population. The aim of this study was to comprehensively evaluate the implementation process of a perioperative nutrition care pathway in UGI cancer surgery using The Consolidated Framework for Implementation Research (CFIR).MethodsThis was a mixed methods implementation study conducted during a pilot study of a standardised nutrition care pathway across four major hospitals between September 2018 to August 2019. Outcome measures included five focus groups among study dietitians (n = 4–8 per group), and quantitative satisfaction surveys from multi-disciplinary team (MDT) members (n = 14) and patients (n = 18). Focus group responses were analysed thematically using the CFIR constructs, which were used as a priori codes. Survey responses were summarised using means and standard deviations. A convergent parallel mixed methods approach according to CFIR domains and constructs was used to integrate qualitative and quantitative data.ResultsQualitative data demonstrated that dietitian perceptions primarily aligned with five CFIR constructs (networks and communications, structural characteristics, adaptability, compatibility and patient needs/resources), indicating a complex clinical and implementation environment. Challenges to implementation mostly related to adapting the pathway, and the compatibility of nutrition coordination to existing aspects of care within each setting. Identified benefits from dietitian qualitative data and MDT survey responses included increased engagement between the dietitian and MDT, and a more proactive approach to nutrition care. Patients were highly satisfied with the service, with the majority of survey items being rated highly (≥4 of a possible 5 points).ConclusionsThe nutrition care pathway was perceived to be beneficial by key stakeholders. Based on the findings, sustainability and compliance to this model of care may be achieved with improved systems level coordination and communication.

Implementation of an Intensive Telehealth Intervention for Rural Patients with Clinic-Refractory Diabetes.

BackgroundRural patients with type 2 diabetes (T2D) may experience poor glycemic control due to limited access to T2D specialty care and self-management support. Telehealth can facilitate delivery of comprehensive T2D care to rural patients, but implementation in clinical practice is challenging.ObjectiveTo examine the implementation of Advanced Comprehensive Diabetes Care (ACDC), an evidence-based, comprehensive telehealth intervention for clinic-refractory, uncontrolled T2D. ACDC leverages existing Veterans Health Administration (VHA) Home Telehealth (HT) infrastructure, making delivery practical in rural areas.DesignMixed-methods implementation study.Participants230 patients with clinic-refractory, uncontrolled T2D.InterventionACDC bundles telemonitoring, self-management support, and specialist-guided medication management, and is delivered over 6 months using existing VHA HT clinical staffing/equipment. Patients may continue in a maintenance protocol after the initial 6-month intervention period.Main MeasuresImplementation was evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. The primary effectiveness outcome was hemoglobin A1c (HbA1c).Key ResultsFrom 2017 to 2020, ACDC was delivered to 230 patients across seven geographically diverse VHA sites; on average, patients were 59 years of age, 95% male, 80% white, and 14% Hispanic/Latinx. Patients completed an average of 10.1 of 12 scheduled encounters during the 6-month intervention period. Model-estimated mean baseline HbA1c was 9.56% and improved to 8.14% at 6 months (− 1.43%, 95% CI: − 1.64, − 1.21; P < .001). Benefits persisted at 12 (− 1.26%, 95% CI: − 1.48, − 1.05; P < .001) and 18 months (− 1.08%, 95% CI − 1.35, − 0.81; P < .001). Patients reported increased engagement in self-management and awareness of glycemic control, while clinicians and HT nurses reported a moderate workload increase. As of this submission, some sites have maintained delivery of ACDC for up to 4 years.ConclusionsWhen strategically designed to leverage existing infrastructure, comprehensive telehealth interventions can be implemented successfully, even in rural areas. ACDC produced sustained improvements in glycemic control in a previously refractory population.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-07281-8.

A mixed methods implementation study of a participatory intervention to prevent health problems among workers with a lower socioeconomic position

A mixed methods implementation study of a participatory intervention to prevent health problems among workers with a lower socioeconomic position

Utilization of Chest Pain Decision Aids in a Community Hospital Emergency Department: A Mixed-methods Implementation Study.

Chest pain is a common reason for emergency department (ED) visits. Evidence-based decision aids assessing risk for an adverse cardiac event are underused in community hospital emergency care. This study explored the acceptability, barriers, facilitators, and potential strategies for implementation of the HEART Score risk stratification tool, accelerated diagnostic pathway, and shared decision-making visual aid with physicians and chest pain patients ages >45 in a community hospital ED. Single center, mixed-methods study. (1) Physician semistructured interviews using The Consolidated Framework for Implementation Research for systematic analysis. (2) Patient and physician surveys. (3) 16-week intervention of physician training and pilot testing of decision aids with ED patients. Physician interviews (n = 19); key facilitators: electronic medical record decision support, ease of use, risk stratification and disposition support, and shared decision-making training. Key barriers: time constraints, patient ability, and/or willingness to participate in shared decision-making, lack of integration with medical record and change in practice workflow. Patient study participants (n = 184) with a survey response rate of 92% (n = 170). Most patients (85%) were satisfied with the shared decision-making visual aid. Physicians surveyed (n = 84) with a response rate of 50% (n = 42). Most physicians, 95% (n = 40), support use of the HEART Score, with limited acceptance of the shared decision-making visual aid of 57% (n = 24). Using evidence-based chest pain decision aids in a community hospital ED is feasible and acceptable. Key barriers and facilitators for implementation were identified. Further research in community hospitals is needed to verify findings, examine generalizability, and test implementation strategies.

Perceived Benefits, Barriers, and Facilitators of a Digital Patient-Reported Outcomes Tool for Routine Diabetes Care: Protocol for a National, Multicenter, Mixed Methods Implementation Study.

BackgroundThere is growing evidence that digital patient-reported outcome (PRO) questionnaires and PRO-based decision support tools may help improve the active engagement of people with diabetes in self-care, thereby improving the quality of care. However, many barriers still exist for the real-world effectiveness and implementation of such PRO tools in routine care. Furthermore, limited research has evaluated the acceptability, feasibility, and benefits of such tools across different health care settings.ObjectiveThis study aims to evaluate the acceptability, feasibility, and perceived benefits of the Danish digital PRO diabetes tool in different health care settings in Denmark and to determine the factors affecting its implementation. Furthermore, the study evaluates the psychometric characteristics of the Danish PRO Diabetes Questionnaire and the validity of the scoring algorithms for dialogue support. The objective of this study is to guide the ongoing optimization of the PRO diabetes tool, its implementation, and the design of future randomized controlled effectiveness studies.MethodsWe designed a multicenter, mixed methods, single-arm acceptability-feasibility implementation study protocol to contribute to the real-world pilot test of a new digital PRO diabetes tool in routine diabetes care. The use of the tool involves two main steps. First, the people with diabetes will complete a digital PRO Diabetes Questionnaire in the days before a routine diabetes visit. Second, the health care professional (HCP) will use a digital PRO tool to review the PRO results together with the people with diabetes during the visit. The PRO diabetes tool is designed to encourage and support people to take an active role for the people with diabetes in their own care and to expedite the delivery of person-centered, collaborative, and coordinated care.ResultsA multicenter pilot study protocol and psychometrically designed digital data collection tools for evaluation were developed and deployed as part of a national evaluation of a new digital PRO diabetes intervention. A total of 598 people with diabetes and 34 HCPs completed the study protocol by April 1, 2021.ConclusionsA large-scale, mixed methods, multicenter study for evaluating the use of the nationally developed PRO Diabetes Questionnaire in routine care across all health care sectors in Denmark by using the RE-AIM (Reach, Efficacy, Adoption, Implementation and Maintenance) model as a framework has been designed and is ongoing. This study is expected to provide new important and detailed information about the real-world acceptability, perceived relevance, and benefits of the PRO diabetes tool among a large heterogeneous population of people with diabetes in Denmark and HCPs in different care settings. The results will be used to further improve the PRO tool, design implementation facilitation support strategies, and design future controlled effectiveness studies.International Registered Report Identifier (IRRID)DERR1-10.2196/28391

Enhanced lateral flow testing strategies in care homes are associated with poor adherence and were insufficient to prevent COVID-19 outbreaks: results from a mixed methods implementation study.

IntroductionCare homes have been severely affected by the SARS-CoV-2 pandemic. Rapid antigen testing could identify most SARS-CoV-2 infected staff and visitors before they enter homes. We explored implementation of staff and visitor testing protocols using lateral flow devices (LFDs).MethodsAn evaluation of a SARS-CoV-2 LFD-based testing protocol in 11 care homes in Liverpool, UK, including staff and visitor testing, plus a qualitative exploratory study in nine of these homes. The proportion of pilot homes with outbreaks, and outbreak size, were compared to non-pilot homes in Liverpool. Adherence to testing protocols was evaluated. Fifteen staff were interviewed, and transcript data were thematically coded using an iterative analysis to identify and categorize factors influencing testing implementation.ResultsIn total, 1,638 LFD rapid tests were performed on 407 staff. Protocol adherence was poor with 8.6% of staff achieving >75% protocol adherence, and 25.3% achieving n}{}ge50%. Six care homes had outbreaks during the study. Compared to non-pilot care homes, there was no evidence of significant difference in the proportion of homes with outbreaks, or the size of outbreaks. Qualitative data showed difficulty implementing testing strategies due to excessive work burden. Factors influencing adherence related to test integration and procedural factors, socio-economic factors, cognitive overload and the emotional value of testing.ConclusionImplementation of staff and visitor care home LFD testing protocols was poorly adhered to and consequently did not reduce the number or scale of COVID-19 outbreaks. More focus is needed on the contextual and behavioural factors that influence protocol adherence.

Implementation fidelity of the Falls Management Exercise Programme: a mixed methods analysis using a conceptual framework for implementation fidelity

ObjectivesFalls in older adults cause significant morbidity and mortality and incur cost to health and care services. The Falls Management Exercise (FaME) programme is a 24-week intervention for older adults that, in clinical trials, improves balance and functional strength and leads to fewer falls. Similar but more modest outcomes have been found when FaME is delivered in routine practice. Understanding the degree to which the programme is delivered with fidelity is important if ‘real-world’ delivery of FaME is to achieve the same magnitude of outcome as in clinical trials. The objective of this study was to examine the implementation fidelity of FaME when delivered in the community to inform quality improvement strategies that maximise programme effectiveness. Study designA mixed methods implementation study of FaME programme delivery. MethodsData from programme registers, expert observations of FaME classes, and semistructured interviews with FaME instructors were triangulated using a conceptual framework for implementation fidelity. Quantitative data were analysed using descriptive statistics. Interviews were transcribed verbatim and analysed using thematic analysis. ResultsIn total, 356 participants enrolled on 29 FaME programmes, and 143 (40%) participants completed at least 75% of the classes within a programme. Observations showed that 72%–78% of programme content was delivered, and 80%–84% quality criteria were met. Important content that was most often left out included home exercises, Tai Chi moves, and floor work, whereas quality items most frequently missed out included asking about falls in the previous week, following up attendance absence and explaining the purpose of exercises. Only 24% of class participants made the expected strength training progression. Interviews with FaME instructors helped explain why elements of programme content and quality were not delivered. Strategies for improving FaME delivery were established and helped to maintain quality and fidelity. ConclusionsFaME programmes delivered in the ‘real world’ can be implemented with a high degree of fidelity, although important deviations were found. Facilitation strategies could be used to further improve programme fidelity and maximise participant outcomes.