Process evaluation protocol of a cluster randomised trial for a scalable solution for delivery of Diabetes Self-Management Education in Thailand (DSME-T)

IntroductionType 2 diabetes mellitus is a major global challenge, including for Thai policy-makers, as an estimated 4 million people in Thailand (population 68 million) have this condition. Premature death and disability due to diabetes are primarily due to complications which can be prevented by good risk factor control. Diabetes Self-Management Education (DSME) programmes provide patients with diabetes with the necessary knowledge and skills to effectively manage their disease. Currently, a trial is being conducted in Thailand to evaluate the effectiveness, defined as HbA1c<7 at 12 months after enrolment, of a culturally tailored DSME in Thailand. A process evaluation can provide further interpretation of the results from complex interventions as well as insight into the success of applying the programme into a broader context.Methods and analysisThe aim of the process evaluation is to understand how and why the intervention was effective or ineffective and to identify contextually relevant strategies for future successful implementation. For the process evaluation, the design will be a mixed-method study collecting data from nurse providers, and village health volunteers (community health workers) as well as patients. This will be conducted using observations, interviews and focus groups from the three purposively selected groups at the beginning and end of trial. Quantitative data will be collected through surveys conducted at the beginning, during 6-month follow-up, and at the end of trial. The mixed-methods analysis will be triangulated to assess differences and similarities across the various data sources. The overall effectiveness of the intervention will be examined using multilevel analysis of repeated measures.Ethics and disseminationStudy approved by the Chiang Mai University Research Ethics Committee (326/2018) and the London School of Hygiene & Tropical Medicine (16113/RR/12850). Results will be published in open access, peer-reviewed scientific journals.Trial registration numberNCT03938233.

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Action leveraging evidence to reduce perinatal mortality and morbidity (ALERT): study protocol for a stepped-wedge cluster-randomised trial in Benin, Malawi, Tanzania and Uganda

BMC Health Services Research ◽

10.1186/s12913-021-07155-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Joseph Akuze ◽

Kristi Sidney Annerstedt ◽

Lenka Benova ◽

Effie Chipeta ◽

Jean-Paul Dossou ◽

...

Keyword(s):

Perinatal Mortality ◽

Process Evaluation ◽

Study Protocol ◽

Health Workers ◽

Randomised Trial ◽

User Participation ◽

Cluster Randomised Trial ◽

Evidence Based ◽

Stepped Wedge ◽

Cluster Randomised

Abstract Background Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a deterrence to achieving the Sustainable Development Goal 3. The majority of deaths occur during the intrapartum and immediate postnatal period. Overcoming the knowledge-do-gap to ensure implementation of known evidence-based interventions during this period has the potential to avert at least 2.5 million deaths in mothers and their offspring annually. This paper describes a study protocol for implementing and evaluating a multi-faceted health care system intervention to strengthen the implementation of evidence-based interventions and responsive care during this crucial period. Methods This is a cluster randomised stepped-wedge trial with a nested realist process evaluation across 16 hospitals in Benin, Malawi, Tanzania and Uganda. The ALERT intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement supported by data from a clinical perinatal e-registry and iv) empowerment and leadership mentoring of maternity unit leaders complemented by district based bi-annual coordination and accountability meetings. The trial’s primary outcome is in-facility perinatal (stillbirths and early neonatal) mortality, in which we expect a 25% reduction. A perinatal e-registry will be implemented to monitor the trial. Our nested realist process evaluation will help to understand what works, for whom, and under which conditions. We will apply a gender lens to explore constraints to the provision of evidence-based care by health workers providing maternity services. An economic evaluation will assess the scalability and cost-effectiveness of ALERT intervention. Discussion There is evidence that each of the ALERT intervention components improves health providers’ practices and has modest to moderate effects. We aim to test if the innovative packaging, including addressing specific health systems constraints in these settings, will have a synergistic effect and produce more considerable perinatal mortality reductions. Trial registration Pan African Clinical Trial Registry (www.pactr.org): PACTR202006793783148. Registered on 17th June 2020.

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Barriers to a software reminder system for risk assessment of stroke in atrial fibrillation: a process evaluation of a cluster randomised trial in general practice

British Journal of General Practice ◽

10.3399/bjgp18x699809 ◽

2018 ◽

Vol 68 (677) ◽

pp. e844-e851

Author(s):

Tim A Holt ◽

Andrew RH Dalton ◽

Susan Kirkpatrick ◽

Jenny Hislop ◽

Tom Marshall ◽

...

Keyword(s):

Atrial Fibrillation ◽

Risk Assessment ◽

General Practice ◽

Process Evaluation ◽

Oral Anticoagulants ◽

Qualitative Interviews ◽

Randomised Trial ◽

Software Tool ◽

Cluster Randomised Trial ◽

Cluster Randomised

BackgroundOral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants.AimTo investigate the implementation of the software in UK general practice.Design and settingProcess evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial.MethodAn initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability.ResultsIn a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised.ConclusionAutomated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.

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Effectiveness of expanding annual mass azithromycin distribution treatment coverage for trachoma in Niger: a cluster randomised trial

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2017-310916 ◽

2017 ◽

Vol 102 (5) ◽

pp. 680-686 ◽

Cited By ~ 10

Author(s):

Abdou Amza ◽

Boubacar Kadri ◽

Beido Nassirou ◽

Sun Y Cotter ◽

Nicole E Stoller ◽

...

Keyword(s):

Repeated Measures ◽

Randomised Trial ◽

Chlamydia Infection ◽

Cluster Randomised Trial ◽

Active Trachoma ◽

Treatment Coverage ◽

Significant Difference ◽

Registration Number ◽

Rate Of Decline ◽

Antibiotic Coverage

Background/aimsThe WHO recommends 3–5 years of annual mass azithromycin distribution with at least 80% treatment coverage to districts with active trachoma prevalence over 10% among children. Here, we assess the efficacy of expanding the coverage target to at least 90% for trachoma control in a mesoendemic region of Niger.MethodsTwenty-four communities were randomised to a single day of azithromycin distribution with a coverage target of 80% of the community or up to 4 days of treatment, aiming for greater than 90% coverage. Distributions were annual and individuals above 6 months of age were treated. Children under 5 years of age were monitored for ocular chlamydia infection and active trachoma.ResultsAt baseline, ocular chlamydia prevalence was 20.5% (95% CI 9.8% to 31.2%) in the standard coverage arm and 21.9% (95% CI 11.3% to 32.5%) in the enhanced coverage arm, which reduced to 4.6% (95% CI 0% to 9.5%, p=0.008) and 7.1% (95% CI 2.7% to 11.4%, p<0.001) at 36 months, respectively. There was no significant difference in 36-month ocular chlamydia prevalence between the two arms (p=0.21). There was no difference in the rate of decline in ocular chlamydia between the two arms in a repeated measures model (p=0.80).ConclusionsFor annual mass azithromycin distribution programme to an entire community, there may be no additional benefit of increasing antibiotic coverage above the WHO’s 80% target.Trial registration numberNCT00792922, post-results.

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Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation

BMJ Open ◽

10.1136/bmjopen-2019-031438 ◽

2019 ◽

Vol 9 (11) ◽

pp. e031438 ◽

Cited By ~ 3

Author(s):

Cindy Mann ◽

Ali R G Shaw ◽

Bruce Guthrie ◽

Lesley Wye ◽

Mei-See Man ◽

...

Keyword(s):

Mixed Methods ◽

Process Evaluation ◽

Randomised Trial ◽

Implementation Fidelity ◽

Skills Training ◽

Cluster Randomised Trial ◽

Implementation Barriers ◽

Recommended Care ◽

Intervention Failure ◽

Implementation Failure

ObjectivesDuring a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.DesignMixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients.SettingThirty-three UK general practices in three areas.ParticipantsThe trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview.ResultsStaff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from ‘tick-box’ to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns.ConclusionsImplementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention.Trial registration numberISRCTN06180958

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Patient, staffing and health centre factors associated with annual testing for sexually transmissible infections in remote primary health centres

Sexual Health ◽

10.1071/sh16123 ◽

2017 ◽

Vol 14 (3) ◽

pp. 274 ◽

Cited By ~ 3

Author(s):

Belinda Hengel ◽

Handan Wand ◽

James Ward ◽

Alice Rumbold ◽

Linda Garton ◽

...

Keyword(s):

Aboriginal People ◽

Health Workers ◽

Health Centre ◽

Randomised Trial ◽

Laboratory Data ◽

Aboriginal Health ◽

Guideline Recommendation ◽

Cluster Randomised Trial ◽

Factors Associated ◽

Sexually Transmissible Infections

Background: In high-incidence Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) settings, annual re-testing is an important public health strategy. Using baseline laboratory data (2009–10) from a cluster randomised trial in 67 remote Aboriginal communities, the extent of re-testing was determined, along with the associated patient, staffing and health centre factors. Methods: Annual testing was defined as re-testing in 9–15 months (guideline recommendation) and a broader time period of 5–15 months following an initial negative CT/NG test. Random effects logistic regression was used to determine factors associated with re-testing. Results: Of 10 559 individuals aged ≥16 years with an initial negative CT/NG test (median age = 25 years), 20.3% had a re-test in 9–15 months (23.6% females vs 15.4% males, P < 0.001) and 35.2% in 5–15 months (40.9% females vs 26.5% males, P < 0.001). Factors independently associated with re-testing in 9–15 months in both males and females were: younger age (16–19, 20–24 years); and attending a centre that sees predominantly (>90%) Aboriginal people. Additional factors independently associated with re-testing for females were: being aged 25–29 years, attending a centre that used electronic medical records, and for males, attending a health centre that employed Aboriginal health workers and more male staff. Conclusions: Approximately 20% of people were re-tested within 9–15 months. Re-testing was more common in younger individuals. Findings highlight the importance of recall systems, Aboriginal health workers and male staff to facilitate annual re-testing. Further initiatives may be needed to increase re-testing.

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Process evaluation of a workplace-based health promotion and exercise cluster-randomised trial to increase productivity and reduce neck pain in office workers: a RE-AIM approach

BMC Public Health ◽

10.1186/s12889-020-8208-9 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Alyssa Welch ◽

Genevieve Healy ◽

Leon Straker ◽

Tracy Comans ◽

Shaun O’Leary ◽

...

Keyword(s):

Health Promotion ◽

Neck Pain ◽

Process Evaluation ◽

Randomised Trial ◽

Office Workers ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Increase Productivity

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Pilot Implementation of Adapted-Family Diabetes Self-Management Education Into a Clinical Setting

Journal of Primary Care & Community Health ◽

10.1177/2150132720931289 ◽

2020 ◽

Vol 11 ◽

pp. 215013272093128

Author(s):

Pearl A. McElfish ◽

Christopher R. Long ◽

Aaron J. Scott ◽

Jonell S. Hudson ◽

Lauren Haggard-Duff ◽

...

Keyword(s):

Blood Pressure ◽

Type 2 Diabetes ◽

Clinical Setting ◽

Management Education ◽

Health Workers ◽

Family Members ◽

Self Management ◽

Biometric Data ◽

Pilot Implementation

Objectives: Marshallese are a Pacific Islander community that experience a disproportionate rate of type 2 diabetes. The purpose of this study is to evaluate the preliminary effectiveness and feasibility of an Adapted-Family Diabetes Self-Management Education (DSME) intervention among Marshallese adults diagnosed with type 2 diabetes and their family members when delivered in a clinical setting. Methods: Marshallese patients (primary participants) with type 2 diabetes (n = 10) and their family members (n = 10) enrolled in a pilot study deigned to evaluate an Adapted-Family DSME curriculum conducted by community health workers and a certified diabetes educator in a clinical setting. Primary and family participants’ health information and biometric data (HbA1c, blood pressure, cholesterol, and body mass index) were collected at preintervention and 12 weeks postintervention. Results: All 10 primary participants and 8 of the family members received all 10 hours of the education intervention. Nine of the 10 primary participants and 8 of the 10 family members completed the pre- and postintervention data collection events. Primary participants demonstrated a mean decrease in HbA1c of 0.7%, from pre- to postintervention, as well as improved blood pressure and cholesterol. Family members demonstrated minor improvements in HbA1c and blood pressure. Conclusions: Results suggest preliminary effectiveness and feasibility of the Adapted-Family DSME in a clinic setting and will inform implementation of a fully powered study.

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Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India

BMJ Open ◽

10.1136/bmjopen-2018-027841 ◽

2019 ◽

Vol 9 (5) ◽

pp. e027841 ◽

Cited By ~ 1

Author(s):

Nikhil Srinivasapura Venkateshmurthy ◽

Kevin Mc Namara ◽

Harriet Koorts ◽

Sailesh Mohan ◽

Vamadevan S Ajay ◽

...

Keyword(s):

Mixed Methods ◽

Process Evaluation ◽

Randomised Trial ◽

Intervention Development ◽

Health Department ◽

Uncontrolled Hypertension ◽

Cluster Randomised Trial ◽

Care Coordinator ◽

Cluster Randomised ◽

Number Of Patients

IntroductionIndia has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled ‘m-Power Heart Project’ is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial’s process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research.Methods and analysisThe process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick’s model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelliet al’s framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc.Ethics and disseminationEthical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations.Trial registration numberNCT03164317; Pre-results.

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Effects of the Preschool-Based Family-Involving DAGIS Intervention on Family Environment: A Cluster Randomised Trial

Nutrients ◽

10.3390/nu12113387 ◽

2020 ◽

Vol 12 (11) ◽

pp. 3387

Author(s):

Carola Ray ◽

Rejane Figueiredo ◽

Riikka Pajulahti ◽

Henna Vepsäläinen ◽

Elviira Lehto ◽

...

Keyword(s):

Family Environment ◽

Interaction Effect ◽

Repeated Measures ◽

Randomised Trial ◽

Intervention Group ◽

Cluster Randomised Trial ◽

Control Group ◽

Intervention Effects ◽

Role Modelling ◽

The Family

Interventions promoting young children’s healthy energy balance-related behaviours (EBRBs) should also examine changes in the family environment as this is an important determinant that may affect the effectiveness of the intervention. This study examines family environmental effects of the Increased Health and Wellbeing in Preschools (DAGIS) intervention study, and whether these effects differed when considering three parental educational level (PEL) groups. The DAGIS intervention was conducted in preschools and involving parents in Southern Finland from September 2017 to May 2018. It was designed as a randomised trial, clustered at preschool-level. Parents of 3–6-year-olds answered questionnaires recording PEL, parental role modelling for EBRBs, and the family environment measured as EBRBs availability and accessibility. Linear Mixed Models with Repeated Measures were used in order to detect intervention effects. Models included group by time interactions. When examining intervention effects separated by PEL groups, models with three-level interactions (group × time-points × PEL) were evaluated. There was an interaction effect for the availability of sugary everyday foods and drinks (p = 0.002). The analyses showed that the control group increased availability (p = 0.003), whereas in the intervention group no changes were detected (p = 0.150). In the analysis separated by PEL groups, changes were found only for the accessibility of sugary treats at home; the high PEL control group increased the accessibility of sugary treats (p = 0.022) (interaction effect: p = 0.027). Hence, results suggest that the DAGIS multicomponent intervention had a limited impact on determinants for children’s healthy EBRBs, and no impact was found in the low PEL group.

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