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Implementation fidelity of a clinical medication review intervention: process evaluation.

ABSTRACT: Background Implementation of clinical medication reviews in daily practice is scarcely evaluated. The Opti-Med intervention applied a structured approach with external expert teams (pharmacist and physician) to conduct medication reviews. The intervention was effective with respect to resolving drug related problems, but did not improve quality of life. Objective The objective of this process evaluation was to gain more insight into the implementation fidelity of the intervention. Setting Process evaluation alongside a cluster randomized trial in 22 general practices and 518 patients of 65 years and over. Method A mixed methods design using quantitative and qualitative data and the conceptual framework for implementation fidelity was used. Implementation fidelity is defined as the degree to which the various components of an intervention are delivered as intended. Main outcome measure Implementation fidelity for key components of the Opti-Med intervention. Results Patient selection and preparation of the medication analyses were carried out as planned, although mostly by the Opti-Med researchers instead of practice nurses. Medication analyses by expert teams were performed as planned, as well as patient consultations and patient involvement. 48% of the proposed changes in the medication regime were implemented. Cooperation between expert teams members and the use of an online decision-support medication evaluation facilitated implementation. Barriers for implementation were time constraints in daily practice, software difficulties with patient selection and incompleteness of medical files. The degree of embedding of the intervention was found to influence implementation fidelity. The total time investment for healthcare professionals was 94 min per patient. Conclusion Overall, the implementation fidelity was moderate to high for all key components of the Opti-Med intervention. The absence of its effectiveness with respect to quality of life could not be explained by insufficient implementation fidelity.

SUBMITTER: Willeboordse F

PROVIDER: S-EPMC5984963 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background"We Act" is a health-promoting school intervention comprising an educational, a parental and a school component. The intervention was implemented in 4 Danish public schools with 4 control schools. The objectives were to improve pupils' dietary habits, physical activity, well-being and social capital using the Investigation, Vision, Action & Change (IVAC) health educational methodology. The target group was pupils in grades 5-6. The purpose of this study was to evaluate implementation fidelity and interacting context factors in the intervention schools.MethodsThe Medical Research Council's new guidance for process evaluation was used as a framework. Data were collected concurrently and evenly at the 4 intervention schools through field visits (n = 43 days), questionnaires (n = 17 teachers, 52 parents), and interviews (n = 9 teachers, 4 principals, 52 pupils). The data were analysed separately and via triangulation.ResultsA total of 289 pupils participated, and 22 teachers delivered the educational component in 12 classes. In all schools, the implementation fidelity to the educational methodology was high for the Investigation and Vision phases as the teachers delivered the proposed lessons and activities. However, the implementation fidelity to the Action & Change phase was low, and little change occurred in the schools. The pupils' presentation of their visions did not work as intended as an impact mechanism to prompt actions. The implementation of the parental and the school components was weak. The main context factors influencing implementation fidelity were a poor fit into the school-year plan and weak management support.ConclusionsAlthough 'We Act' was designed to comply with evidence- and theory-based requirements, IVAC and the health-promoting school approach did not result in change. The time dedicated to schools' preparation and competence development may have been too low. This must be considered in future process evaluation research on health-promoting schools and by school health promotion administrators when planning future school interventions.Trial registrationISRCTN85203017.

Project description:BACKGROUND:Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation. OBJECTIVE:This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective. METHODS:The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients' beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients' overall experience of care after coronary heart disease. RESULTS:The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known. CONCLUSIONS:This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions.

Project description:BACKGROUND:Despite improvements in diagnostics and therapy, the majority of lung tumours are diagnosed at advanced stage IV with a poor prognosis. Due to the nature of an incurable disease, patients need to engage in shared decision making on advance care planning. To implement this in clinical practice, effective communication between patients, caregivers and healthcare professionals is essential. The Heidelberg Milestones Communication Approach (MCA) is delivered by a specifically trained interprofessional tandem and consists of four milestone conversations (MCs) at pivotal times in the disease trajectory. MC 1 (Diagnosis): i.e. prognosis; MC 2 (Stable disease): i.e. prognostic awareness; MC 3 (Progression): i.e. reassessment; MC 4 (Best supportive care): i.e. end of treatment. In between MCs, follow-up calls are carried out to sustain communication. This study aimed to assess to what extent the MCA was implemented as planned and consolidated in specialized oncology practice. METHODS:A prospective observational process evaluation study was conducted, which focused on the implementation fidelity of the MCA. All MCs during two assessment periods were included. We analysed all written records of the conversations, which are part of the routine documentation during MCs and follow-up calls. Adherence to key aspects of the manual was documented on structured checklists at the beginning of the implementation of the MCA and after 6?months. The analysis was descriptive. Differences between the two assessment periods are analysed with chi-square tests. RESULTS:A total of 133 MCs and 54 follow-up-calls (t1) and of 172 MCs and 92 follow-up calls (t2) were analysed. MC 2 were the most frequently completed conversations (n =?51 and n =?47). Advance care planning was discussed in 26 and 13% of MC 2 in the respective assessment periods; in 31 and 47% of MC 2, prognostic awareness was recorded. The most frequently documented topic in the follow-up calls was the physical condition in patients (82 and 83%). CONCLUSION:The implementation of a trajectory-specific communication concept was largely successful. Additional studies are needed to understand how fidelity could be further improved. TRIAL REGISTRATION:DRKS00013469 / Date of registration: 22.12.2017.

Project description:BackgroundThe Integrated Chronic Disease Management (ICDM) model has been implemented in South Africa to enhance quality of clinical services in Primary Healthcare (PHC) clinics in a context of a high prevalence of chronic conditions and multi-morbidity. This study aimed to assess the implementation fidelity (adherence to guidelines) of the ICDM model.MethodsA cross-sectional study in 16 PHC clinics in two health districts in South Africa: Dr. Kenneth Kaunda (DKK) and West Rand (WR). A fidelity assessment tool with 89 activities and maximum score of 158 was developed from the four interrelated ICDM model components: facility re-organization, clinical supportive management, assisted self-management and strengthening of support systems. Value stream mapping of patient flow was conducted to analyse waiting time and identify operational inefficiencies. ICDM items were scored based on structured observations, facility document reviews and structured questionnaires completed by healthcare workers. Fidelity scores were summarized using medians and proportions and compared by facilities and districts using Chi-Square and Kruskal Wallis test.ResultsThe monthly patient headcount over a six-month period in these 16 PHC clinics was a median of 2430 (IQR: 1685-2942) individuals over 20 years. The DKK district had more newly diagnosed TB patients per month [median 5.5 (IQR: 4.00-9.33) vs 2.0 (IQR: 1.67-2.92)], and fewer medical officers per clinic [median 1 (IQR: 1-1) vs 3.5 (IQR:2-4.5)] compared to WR district. The median fidelity scores in both districts for facility re-organization, clinical supportive management, assisted self-management and strengthening of support systems were 78% [29/37, IQR: 27-31)]; 77% [30/39 (IQR: 27-34)]; 77% [30/39 (IQR: 28-34)]; and 80% [35/44 (IQR: 30-37)], respectively. The overall median implementation fidelity of the ICDM model was 79% (125/158, IQR, 117-132); WR was 80% (126/158, IQR, 123-132) while DKK was 74% (117/158, IQR, 106-130), p = 0.1409. The lowest clinic fidelity score was 66% (104/158), while the highest was 86% (136/158). A patient flow analysis showed long (2-5 h) waiting times and one stream of care for acute and chronic services.ConclusionThere was some variability of scores on components of the ICDM model by PHC clinics. More research is needed on contextual adaptations of the model.

Project description:BackgroundHospital to community pharmacy transfer of care medicines-related interventions for inpatients discharged home aim to improve continuity of care and patient outcomes. One such intervention has been provided for seven years within a region in England. This study reports upon the implementation process and fidelity of this intervention.MethodsThe process evaluation guidance issued by the Medical Research Council has informed this study. A logic model to describe the intervention and causal assumptions was developed from preliminary semi-structured interviews with project team members. Further semi-structured interviews were undertaken with intervention providers from hospital and community pharmacy, and with patient and public representatives. These aimed to investigate intervention implementation process and fidelity. The Consolidated Framework for Implementation Research and the Consolidated Framework for Intervention Fidelity informed interview topic guides and underpinned the thematic framework analysis using a combined inductive and deductive approach.ResultsThemes provided information about intervention fidelity and implementation that were mapped across the sub processes of implementation: planning, execution, reflection and evaluation, and engagement. Interviewees described factors such as lack of training, awareness, clarity on the service specification, governance and monitoring and information and feedback which caused significant issues with the process of intervention implementation and suboptimal intervention fidelity.ConclusionsThis provides in-depth insight into the implementation process and fidelity of a ToC intervention, and the extant barriers and facilitators. The findings offer learning to inform the design and implementation of similar interventions, contribute to the evidence base about barriers and facilitators to such interventions and provides in-depth description of the implementation and mechanisms of impact which have the potential to influence clinical and economic outcome evaluation.

Project description:BACKGROUND:Accessibility to efficient and person-centered healthcare delivery drives healthcare transformation in many countries. In Singapore, specialist outpatient clinics (SOCs) are commonly congested due to increasing demands for chronic care. To improve this situation, the National University Health System (NUHS) Regional Health System (RHS) started an integrated care initiative,the Right-Site Care (RSC) program in 2014. Through collaborations between SOCs at the National University Hospital and primary and community care (PCC) clinics in the western region of the county, the program was designed to facilitate timely discharge and appropriate transition of patients, who no longer required specialist care, to the community. The aim of this study was to evaluate the implementation fidelity of the NUHS RHS RSC program using the modified Conceptual Framework for Implementation Fidelity (CFIF), at three distinct levels; providers, organizational, and system levels to explain outcomes of the program and to inform further development of (similar) programs. METHODS:A convergent parallel mixed methods study using the realist evaluation approach was used. Data were collected between 2016 and 2018 through non-participatory observations, reviews of medical records and program database, together with semi-structured interviews with healthcare providers. Triangulation of data streams was applied guided by the modified CFIF. RESULTS:Our findings showed four out of six program components were implemented with low level of fidelity, and 9112 suitable patients were referred to the program while 3032 (33.3%) declined to be enrolled. Moderating factors found to influence fidelity included: (i) complexity of program, (ii) evolving providers' responsiveness, (iii) facilitation through synergistic partnership, training of PCC providers by specialists and supportive structures: care coordinators, guiding protocols, shared electronic medical record and shared pharmacy, (iv) lack of organization reinforcement, and (v) mismatch between program goals, healthcare financing and providers' reimbursement. CONCLUSION:Functional integration alone is insufficient for a successful right-site care program implementation. Improvement in relationships between providers, organizations, and patients are also warranted for further development of the program.

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Implementation fidelity of a clinical medication review intervention: process evaluation.

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