Protocol For Process Evaluation Research Articles

A dementia education programme for pre-registration nurses: a protocol for process and outcomes evaluation

A dementia education programme for pre-registration nurses: a protocol for process and outcomes evaluation

Commentary: A dementia education programme for pre-registration nurses: a protocol for process and outcomes evaluation.

Commentary: A dementia education programme for pre-registration nurses: a protocol for process and outcomes evaluation.

Protocol for the process evaluation of the GOAL trial: investigating how comprehensive geriatric assessment (CGA) improves patient-centred goal attainment in older adults with chronic kidney disease in the outpatient setting

IntroductionThe GOAL Cluster Randomised Controlled Trial (NCT04538157) is now underway, investigating the impact of comprehensive geriatric assessment (CGA) for frail older people with chronic kidney disease (CKD). The primary outcome...

Process evaluation protocol plan for a home-based physical activity intervention versus educational intervention for persistent taxane-induced peripheral neuropathy (B-HAPI study): a randomized controlled trial

BackgroundEvaluation publications typically summarize the results of studies to demonstrate the effectiveness of an intervention, but little is shared concerning any changes implemented during the study. We present a process evaluation protocol of a home-based gait, balance, and resistance exercise intervention to ameliorate persistent taxane-induced neuropathy study according to 7 key elements of process evaluation.MethodsThe process evaluation is conducted parallel to the longitudinal, randomized control clinical trial examining the effects of the home-based gait, balance, and resistance exercise program for women with persistent peripheral neuropathy following treatment with taxanes for breast cancer (IRB approval: Pro00040035). The flowcharts clarify how the intervention should be implemented in comparable settings, fidelity procedures help to ensure the participants are comfortable and identify their individual needs, and the process evaluation allows for the individual attention tailoring and focus of the research to avoid protocol deviation.ConclusionsThe publication of the evaluation protocol plan adds transparency to the findings of clinical trials and favors process replication in future studies. The process evaluation enables the team to systematically register information and procedures applied during recruitment and factors that impact the implementation of the intervention, thereby allowing proactive approaches to prevent deviations from the protocol. When tracking an intervention continuously, positive or negative intervention effects are revealed early on in the study, giving valuable insight into inconsistent results. Furthermore, a process evaluation adds a participant-centered element to the research protocols, which allows a patient-centered approach to be applied to data collection.Trial registrationClinicalTrials.gov NCT04621721, November 9, 2020, registered prospectively. Protocol version: April 27, 2020, v2.

Digital Interventions to Understand and Mitigate Stress Response: Protocol for Process and Content Evaluation of a Cohort Study.

Staffing and resource shortages, especially during the COVID-19 pandemic, have increased stress levels among health care workers. Many health care workers have reported feeling unable to maintain the quality of care expected within their profession, which, at times, may lead to moral distress and moral injury. Currently, interventions for moral distress and moral injury are limited. This study has the following aims: (1) to characterize and reduce stress and moral distress related to decision-making in morally complex situations using a virtual reality (VR) scenario and a didactic intervention; (2) to identify features contributing to mental health outcomes using wearable, physiological, and self-reported questionnaire data; and (3) to create a personal digital phenotype profile that characterizes stress and moral distress at the individual level. This will be a single cohort, pre- and posttest study of 100 nursing professionals in Ontario, Canada. Participants will undergo a VR simulation that requires them to make morally complex decisions related to patient care, which will be administered before and after an educational video on techniques to mitigate distress. During the VR session, participants will complete questionnaires measuring their distress and moral distress, and physiological data (electrocardiogram, electrodermal activity, plethysmography, and respiration) will be collected to assess their stress response. In a subsequent 12-week follow-up period, participants will complete regular assessments measuring clinical outcomes, including distress, moral distress, anxiety, depression, and loneliness. A wearable device will also be used to collect continuous data for 2 weeks before, throughout, and for 12 weeks after the VR session. A pre-post comparison will be conducted to analyze the effects of the VR intervention, and machine learning will be used to create a personal digital phenotype profile for each participant using the physiological, wearable, and self-reported data. Finally, thematic analysis of post-VR debriefing sessions and exit interviews will examine reoccurring codes and overarching themes expressed across participants' experiences. The study was funded in 2022 and received research ethics board approval in April 2023. The study is ongoing. It is expected that the VR scenario will elicit stress and moral distress. Additionally, the didactic intervention is anticipated to improve understanding of and decrease feelings of stress and moral distress. Models of digital phenotypes developed and integrated with wearables could allow for the prediction of risk and the assessment of treatment responses in individuals experiencing moral distress in real-time and naturalistic contexts. This paradigm could also be used in other populations prone to moral distress and injury, such as military and public safety personnel. ClinicalTrials.gov NCT05923398; https://clinicaltrials.gov/study/NCT05923398. DERR1-10.2196/54180.

Protocol for process evaluation of ARTEMIS cluster randomised controlled trial: an intervention for management of depression and suicide among adolescents living in slums in India

IntroductionThere are around 250 million adolescents (10–19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those...

Implementation of a nurse-led, multidisciplinary model of care for older adults with cancer: a process evaluation protocol

IntroductionCancer is predominantly a disease of older adults, with an increasing number of cancer diagnoses in individuals aged 65 or older. Multiple geriatric factors have been shown to impact patient...

Implementing the QUALI-DEC project in Argentina, Burkina Faso, Thailand and Viet Nam: a process delineation and theory-driven process evaluation protocol

ABSTRACT The project ‘Quality Decision-making by women and providers’ (QUALI-DEC) combines four non-clinical interventions to promote informed decision-making surrounding mode of birth, improve women’s birth experiences, and reduce caesarean sections among low-risk women. QUALI-DEC is currently being implemented in 32 healthcare facilities across Argentina, Burkina Faso, Thailand, and Viet Nam. In this paper, we detail implementation processes and the planned process evaluation, which aims to assess how and for whom QUALI-DEC worked, the mechanisms of change and their interactions with context and setting; adaptations to intervention and implementation strategies, feasibility of scaling-up, and cost-effectiveness of the intervention. We developed a project theory of change illustrating how QUALI-DEC might lead to impact. The theory of change, together with on the ground observations of implementation processes, guided the process evaluation strategy including what research questions and perspectives to prioritise. Main data sources will include: 1) regular monitoring visits in healthcare facilities, 2) quantitative process and output indicators, 3) a before and after cross-sectional survey among post-partum women, 4) qualitative interviews with all opinion leaders, and 5) qualitative interviews with postpartum women and health workers in two healthcare facilities per country, as part of a case study approach. We foresee that the QUALI-DEC process evaluation will generate valuable information that will improve interpretation of the effectiveness evaluation. At the policy level, we anticipate that important lessons and methodological insights will be drawn, with application to other settings and stakeholders looking to implement complex interventions aiming to improve maternal and newborn health and wellbeing. Trial registration: ISRCTN67214403.

Make My Day: primary prevention of stroke using engaging everyday activities as a mediator of sustainable health – a randomised controlled trial and process evaluation protocol

IntroductionThe individual, societal and economic benefits of stroke prevention are high. Even though most risk factors can be reduced by changes to lifestyle habits, maintaining new and healthy activity patterns...

Hospital-based violence prevention programmes in South Wales Emergency Departments: A process evaluation protocol.

Addressing violence related harm is a global public health priority. While violence is primarily managed in the criminal justice system, healthcare supports and manages those injured by violence. Emergency Departments (EDs), the primary destination for those seriously injured, have emerged as a candidate location for violence prevention initiatives. There is limited evaluation of ED-based violence prevention, and a lack of guidance for the implementation and delivery of them. Nurse-led Violence Prevention Teams (VPTs) have been developed and implemented in two EDs in Wales, UK. This protocol describes methods used in the process evaluation of these VPTs. To understand how VPTs function, how they were implemented, and mechanisms of impact, as well as the exploration of wider contextual factors influencing their function. Adopting a critical realist approach and informed by the Medical Research Council (MRC) guidance for process evaluations, the process evaluation will employ qualitative methods to collect and analyse data: a scoping review of evidence of effectiveness that considers the causal mechanisms underpinning violence; a documentary analysis to determine operational considerations concerning the development, implementation and delivery of the VPTs; a descriptive analysis of routine ED data to characterise the prevalence of violence-related attendances in each ED; interviews with professional stakeholders (N = 60) from the violence prevention ecologies in which the VPTs are embedded. This protocol outlines a process evaluation of a novel, nurse led violence prevention intervention. Findings will be used to inform policy makers' decision making on whether and how VPTs should be used in practice in other EDs across the UK, and the extent that a single operational model should be adjusted to address the local characteristic of violence. To the authors knowledge, this is the first process evaluation of a UK-based, nurse led Emergency Department Violence Prevention Team. Protocol registration ISRCTN: 15286575. Registered 13th March, 2023.

Implementation of dementia care management in routine care (RoutineDeCM): a study protocol for process evaluation

IntroductionDementia care management is a complex intervention intended to support persons with dementia and their (caring) relatives in home-based care arrangements. Dementia care management was developed in the federal state...

Implementation of a frailty intervention in the transition from hospital to home: a realist process evaluation protocol for the FORTRESS trial

IntroductionFrailty in Older people: Rehabilitation, Treatment, Research Examining Separate Settings (the FORTRESS study) is a multisite, hybrid type II, stepped wedge, cluster, randomised trial examining the uptake and outcomes of...

Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer: A process evaluation protocol for a pilot fractional factorial trial.

The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant's trial experience, and barriers and facilitators to recruitment and retention. The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. ISRCTN registry ( ISRCTN10487576, 16/12/2021).

Understanding the implementation of ‘Making Every Contact Count’ (MECC) delivered by healthcare professionals in a mental health hospital: protocol for a pragmatic formative process evaluation

ABSTRACT Background ‘Making Every Contact Count’ (MECC) is a public health strategy supporting public-facing workers to use opportunities during routine contacts to enable health behaviour change. A mental health hospital in the North East of England is currently implementing a programme to embed MECC across the hospital supporting weight management (‘A Weight Off Your Mind’). Bespoke MECC training has been developed to improve staff confidence in discussing physical activity, healthy eating, and related behaviour change with service users. This article describes the protocol for a pragmatic formative process evaluation to inform the implementation plan for MECC and facilitate successful implementation of the bespoke MECC training at scale. Methods/Design An 18-month, mixed method pragmatic formative process evaluation, including qualitative research, surveys, document review and stakeholder engagement. This project is conducted within a mental health inpatient setting in the North East of England. Programme documents will be reviewed, mapped against MECC national guidelines, Behaviour Change Techniques (BCTs) and intervention functions within the Behaviour Change Wheel. A cross-sectional survey (n = 365) and qualitative semi-structured interviews (n = 30) will be conducted with healthcare practitioners delivering MECC to assess capability, opportunity and motivation. Data collection and fidelity procedures will be examined, including design, training and delivery dimensions of fidelity. Interviews with service users (n = 20) will also be conducted. Discussion Anticipated outcomes include developing recommendations to overcome barriers to delivery of and access to MECC, including whether to either support the use of the existing MECC protocol or tailor the MECC training programme. The findings are anticipated to improve fidelity of MECC training within mental health inpatient settings as well as provide evidence for MECC training at a national level. We also expect findings to influence strategic plans, policy, and practice specific to MECC and inform best practice in implementing wider brief intervention programmes.

Acceptability, fidelity and trial experience of four intervention components to support medication adherence in women with breast cancer: A process evaluation protocol for a pilot fractional factorial trial

Background The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant’s trial experience, and barriers and facilitators to recruitment and retention. Methods The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration ISRCTN registry (ISRCTN10487576, 16/12/2021).

Civic Engagement in Neighbourhoods regarding serious illness, death and loss (CEIN): a study protocol for a convergent-parallel mixed-methods process and outcome evaluation that balances control and flexibility.

New public health approaches in palliative care attribute an active role to civic society in providing care for those who are seriously ill, caring, or bereaved. Accordingly, Civic Engagement In Neighbourhoods regarding serious illness, dying and loss (CEIN) are emerging worldwide. However, study protocols that advise on how to evaluate the impact and complex social change processes underlying these civic engagement initiatives are lacking. The main objective of this study is to describe the study protocol for the evaluation of civic engagement initiatives in serious illness, dying, and loss in two neighbourhoods in Flanders, Belgium. A convergent-parallel mixed-method process and outcome evaluation for the CEIN study. We look at the evaluation of CEIN through a critical realist lens, thereby including the social, political, and economic determinants of social change in CEIN, the mechanisms to achieve this social change, the outcomes, and the mutual connection between these three aspects. We will conduct a convergent-parallel mixed-method process and outcome evaluation in which qualitative (i.e. observations, interviews, group discussions, and ego network mapping) and quantitative data (i.e. a pre-post survey) are simultaneously but separately collected and analysed and in the last stage combined by narrative synthesis. This protocol illustrates the difficulty of operationalising the desired long-term impact of social changes regarding serious illness, dying, and loss into more manageable outcomes. We recommend a well-cogitated logic model that connects the outcomes of the study to its potential actions. Applying this protocol in practice is a constant exercise between providing sufficient flexibility to meet feasibility, desirability, and context-specific needs in the CEIN study and providing sufficient guidelines to structure and control the evaluation process.

Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol

IntroductionMedication non-initiation, or primary non-adherence, is a persistent public health problem that increases the risk of adverse clinical outcomes. The initial medication adherence (IMA) intervention is a complex multidisciplinary intervention...

Monitor to innovate with feedback loops: process evaluation protocol for an anemia prevention intervention.

Background: Digital process monitoring and evaluation tools designed to capture near-to-real-time intervention data paired with feedback loops have the potential to innovate intervention delivery. Objective: To describe how a multilevel social norms field trial (RANI) is using feedback loops to enhance intervention delivery. Methods: We use a mixed-methods process evaluation design to monitor the Reduction of Anemia through Normative Innovations (RANI) project; a three-year randomized control trial which aims to lower rates of anemia among women in Odisha, India. Surveys and structured observation monitor fidelity to implementation andacceptability ofimplementation activities among study participants. Quantitative data evaluates implementation dose, coverage, exposure, and reach of intervention activities, and qualitative data will delve more deeply into reasons for high or low functioning. Iron folic acid supplement supply and demand are also monitored for stock-outs. Data collected from 130 intervention villages is processed, visualized, and triangulated in near to real-time via Real-time Monitoring for Knowledge Generation (RPM4K), a locally developed software application. Data visualization products facilitate the examination of monitoring data to mitigate bottlenecks and identify and implement tweaks to our intervention delivery strategy on an ongoing basis. Discussion: Feedback loops facilitate timely course corrections. Feedback loops can also engender a shared understanding of ground realities for a geographically dispersed and culturally diverse team. Leveraging feedback loops, we identify opportunities to provide on-going supportive supervision for our community facilitators promoting joint problem-solving, and communication. Monthly media and hemoglobin level demonstration strategies are informed by participant engagement and acceptability. Stock-outs of iron folic acid tablets activate contingency plans to mobilize local stakeholders and advocate for timely resolutions. Unintended effects are monitored based on ongoing feedback from community facilitators. Conclusions: Documenting our processes can inform the future implementation or scale up of similar projects embracing feedback loops to iterate and innovate their intervention delivery.

Monitor to innovate with feedback loops: process evaluation protocol for an anemia prevention intervention

Background: Digital process monitoring and evaluation tools designed to capture near-to-real-time intervention data paired with feedback loops have the potential to innovate intervention delivery. Objective: To describe how a multilevel social norms field trial (RANI) is using feedback loops to enhance intervention delivery. Methods: We use a mixed-methods process evaluation design to monitor the Reduction of Anemia through Normative Innovations (RANI) project; a three-year randomized control trial which aims to lower rates of anemia among women in Odisha, India. Surveys and structured observation monitor fidelity to implementation and acceptability of implementation activities among study participants. Quantitative data evaluates implementation dose, coverage, exposure, and reach of intervention activities, and qualitative data will delve more deeply into reasons for high or low functioning. Iron folic acid supplement supply and demand are also monitored for stock-outs. Data collected from 130 intervention villages is processed, visualized, and triangulated in near to real-time via Real-time Monitoring for Knowledge Generation (RPM4K), a locally developed software application. Data visualization products facilitate the examination of monitoring data to mitigate bottlenecks and identify and implement tweaks to our intervention delivery strategy on an ongoing basis. Discussion: Feedback loops facilitate timely course corrections. Feedback loops can also engender a shared understanding of ground realities for a geographically dispersed and culturally diverse team. Leveraging feedback loops, we identify opportunities to provide on-going supportive supervision for our community facilitators promoting joint problem-solving, and communication. Monthly media and hemoglobin level demonstration strategies are informed by participant engagement and acceptability. Stock-outs of iron folic acid tablets activate contingency plans to mobilize local stakeholders and advocate for timely resolutions. Unintended effects are monitored based on ongoing feedback from community facilitators. Conclusions: Documenting our processes can inform the future implementation or scale up of similar projects embracing feedback loops to iterate and innovate their intervention delivery.

Enhancing and assessing fidelity in the TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD) trial: development of methods and recommendations for research design

BackgroundDevelopment of complex interventions for management of chronic conditions has become increasingly common, with guidance now provided. Fidelity (whether the intervention is designed, delivered and received as intended) is critical to understanding if, and how an intervention works (or not). However, methods for achieving this are still evolving. This study describes the methods used in the TANDEM trial – a large multicentre study evaluating the impact of a cognitive behavioural intervention preceding routine pulmonary rehabilitation for people with chronic obstructive pulmonary disease and anxiety and or depression. Results for enhancement and training aspects of fidelity, are presented.MethodsUsing the National Institute for Health Behaviour Change Consortium (NIH BCC) framework of fidelity, a set of enhancement strategies and a fidelity measurement strategy were developed with input from a multidisciplinary team. The Cognitive First Aid Rating Scale (CFARS) was used to assess Facilitator (the respiratory professional delivering TANDEM) therapeutic competence at the end of the initial training and throughout treatment delivery (on a randomly selected set of cases). A TANDEM specific treatment adherence measure was developed following previously recommended procedures. Together these (the CFARS and adherence measure) comprised the TANDEM treatment delivery fidelity tool.ResultsHiring of respiratory professionals to the initial training programme was successful, with 44% of those expressing initial interest in being a Facilitator successfully completing the process. Video recordings of potential Facilitators conducting standardized patient role plays at the end of the initial training demonstrated fidelity of training.ConclusionsAddressing fidelity in complex intervention trials is a time and resource intensive process but has significant potential to increase understanding of results and strengthen the evidence base for effective interventions. By defining a full fidelity assessment method prior to analysis we aimed to minimise bias when interpreting results.Trial registrationISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.