scholarly journals Users’ Perspectives, Opportunities, and Barriers of the Strengthen Your Ankle App for Evidence-Based Ankle Sprain Prevention: Mixed-Methods Process Evaluation for a Randomized Controlled Trial

2018 ◽  
Vol 5 (2) ◽  
pp. e13 ◽  
Author(s):  
Miriam van Reijen ◽  
Marianne Asscheman ◽  
Ingrid Vriend ◽  
Willem van Mechelen ◽  
Evert Verhagen
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Ankle Sprain ◽  
Controlled Trial ◽  
Evidence Based ◽  
Randomized Controlled

scholarly journals Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study

2021 ◽  
Vol 18 (11) ◽  
pp. 5778
Author(s):  
Janet K. Sluggett ◽  
Georgina A. Hughes ◽  
Choon Ean Ooi ◽  
Esa Y. H. Chen ◽  
Megan Corlis ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Outcome Evaluation ◽  
Cluster Randomized Controlled Trial ◽  
Residential Aged Care ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The One

Complex medication regimens are highly prevalent, burdensome for residents and staff, and associated with poor health outcomes in residential aged care facilities (RACFs). The SIMPLER study was a non-blinded, matched-pair, cluster randomized controlled trial in eight Australian RACFs that investigated the one-off application of a structured 5-step implicit process to simplify medication regimens. The aim of this study was to explore the processes underpinning study implementation and uptake of the medication simplification intervention. A mixed methods process evaluation with an explanatory design was undertaken in parallel with the main outcome evaluation of the SIMPLER study and was guided by an established 8-domain framework. The qualitative component included a document analysis and semi-structured interviews with 25 stakeholders (residents, family, research nurses, pharmacists, RACF staff, and a general medical practitioner). Interviews were transcribed verbatim and reflexively thematically content analyzed. Descriptive statistics were used to summarize quantitative data extracted from key research documents. The SIMPLER recruitment rates at the eight RACFs ranged from 18.9% to 48.6% of eligible residents (38.4% overall). Participation decisions were influenced by altruism, opinions of trusted persons, willingness to change a medication regimen, and third-party hesitation regarding potential resident distress. Intervention delivery was generally consistent with the study protocol. Stakeholders perceived regimen simplification was beneficial and low risk if the simplification recommendations were individualized. Implementation of the simplification recommendations varied between the four intervention RACFs, with simplification implemented at 4-month follow-up for between 25% and 86% of residents for whom simplification was possible. Good working relationships between stakeholders and new remunerated models of medication management were perceived facilitators to wider implementation. In conclusion, the one-off implicit medication simplification intervention was feasible and generally delivered according to the protocol to a representative sample of residents. Despite variable implementation, recommendations to simplify complex regimens were valued by stakeholders, who also supported wider implementation of medication simplification in RACFs.

scholarly journals A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS)

2020 ◽  
Author(s):  
Tonje Fyhn ◽  
Kari Ludvigsen ◽  
Silje E Reme ◽  
Frederieke Schaafsma
Keyword(s):  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Work Rehabilitation ◽  
Individual Placement And Support ◽  
Randomized Controlled ◽  
Fidelity Scale ◽  
Individual Placement

Abstract Background: Individual Placement and Support (IPS) is an evidence-based work rehabilitation program helping people with moderate to severe mental illness to obtaini ordinary employment. Although IPS has proven superior to other work rehabilitation programs, in many studies, the majority of the participants remains unemployed. Structured process evaluations of IPS that use mixed methods are scarce, although they could identify implementation aspects that may enhance its effect. The aim of the current study is to assess reach, fidelity, and identify barriers and facilitators to implement IPS. Methods: The process evaluation was conducted alongside a randomized controlled trial including six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness. Mixed methods were used in the process evaluation, including focus group interviews with service providers, individual interviews and survey data from participants, and fidelity reviews using the validated IPS Fidelity Scale. Results: The intervention reached the intended target group. All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 89-108, SD 7). Certain fidelity items indicated implementation issues related to employer contact, community-based services, and integration with health services. Survey data showed that less than half of the participants regarded their illness as a barrier for participating in IPS and that freedom of disclosure was important. Participant interviews gave further insight into the role of the IPS specialist, emphasizing their availability and consistent job focus. Conclusions: Indications of implementation challenges across centers during the first year suggest special attention should be given to these aspects in an early phase to ensure higher fidelity from the start and thus enhance the effectiveness of IPS. The IPS specialist played an important role for participants, and was described as positive, pushing in a positive way, and encouraging. More knowledge on the characteristics of successful IPS specialists could further enhance the effectiveness of the intervention. Trial Registration: The study was registered on clinicaltrials.gov prior to the inclusion period (reg.no: NCT01964092, registered 17/07/2013, https://clinicaltrials.gov/ct2/show/NCT01964092).

scholarly journals App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation (Preprint)

2020 ◽  
Author(s):  
Charlotte Diana Nørregaard Rasmussen ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Barbara I Nicholl ◽  
Frances S Mair ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Mixed Methods ◽  
Usual Care ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Self Management ◽  
Low Back ◽  
Randomized Controlled

BACKGROUND Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. OBJECTIVE This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. METHODS The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. RESULTS The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. CONCLUSIONS This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. CLINICALTRIAL ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/20308

scholarly journals A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS)

2020 ◽  
Author(s):  
Tonje Fyhn ◽  
Kari Ludvigsen ◽  
Silje E Reme ◽  
Frederieke Schaafsma
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Community Based ◽  
Individual Placement And Support ◽  
Randomized Controlled ◽  
Employment Specialist ◽  
Community Based Services ◽  
Individual Placement

Abstract Background The effect of Individual Placement and Support (IPS) has been widely documented, but in many studies, the majority of participants remains unemployed. Structured process evaluations that use mixed methods are scarce, although they could identify components that may enhance the effect of IPS. The aim of the current study is to provide a description of a structured mixed methods process evaluation of IPS in Norway. Methods The process evaluation was conducted alongside a randomized controlled trial including six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness. Mixed methods were used in the process evaluation, and outcome measures were reach, barriers and facilitators, and fidelity. Results The intervention reached the intended target group. All centers reached fair to good fidelity within the project period. Certain fidelity items seemed to indicate implementation issues related to employer contact, community-based services, and integration with health services. Less than half of the participants regarded their illness as a barrier for participation in IPS. Participants were overall satisfied and found the intervention useful, emphasizing the availability of the employment specialist and their consistent job focus, as well as the freedom to disclose their illness or not. Conclusions Certain fidelity items indicated implementation issues during the first year, namely providing community-based services, ensuring quality in employer contact, and integration with health treatment. The employment specialist clearly played an important role for participants. Most participants described this relationship as positive, empowering, and encouraging. Trial Registration The study was registered on clinicaltrials.gov prior to the inclusion period (reg.no: NCT01964092, registered 17/07/2013, https://clinicaltrials.gov/ct2/show/NCT01964092 ).

scholarly journals Electronic Health Program to Empower Patients in Returning to Normal Activities After Colorectal Surgical Procedures: Mixed-Methods Process Evaluation Alongside a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Chantal M den Bakker ◽  
Judith AF Huirne ◽  
Frederieke G Schaafsma ◽  
Charlotte de Geus ◽  
Hendrik J Bonjer ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Surgical Procedures ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Data Points ◽  
Qualitative Part

BACKGROUND Long-term recovery takes longer than expected despite improved surgical techniques and Enhanced Recovery After Surgery programs. An electronic health (eHealth) care program (“ikherstel”) was developed to partially substitute perioperative care for patients undergoing colorectal surgical procedures. Successfully tested eHealth programs are not always implemented in usual care, and it is, therefore, important to evaluate the process to optimize future implementation. OBJECTIVE The aim of this study was to evaluate whether the eHealth intervention was executed as planned. METHODS A mixed-methods process evaluation was carried out alongside a multicenter randomized controlled trial (RCT). This evaluation was performed using the Linnan and Steckler framework for the quantitative part of this study, measuring the components reach, dose delivered, dose received, fidelity, and participants’ attitudes. Total implementation scores were calculated using the averaging approach, in which the sum of all data points is divided by the number of data points and the total adherence to the protocol is measured. For the qualitative part, the Unified Theory of Acceptance and Use of Technology framework was used. The quantitative data were based on participants’ questionnaires, a logistic database, a weblog, and participants’ medical files and were obtained by performing semistructured interviews with participants of the RCT. RESULTS A total of 151 participants of 340 eligible patients were included in the RCT, of which 73 participants were allocated to the intervention group. On the basis of the quantitative process data, total implementation scores for the website, mobile app, electronic consult, and activity tracker were 64%, 63%, 44%, and 67%, respectively. Participants in the qualitative part experienced the program as supportive and provided guidance on their recovery process after colorectal surgery. Most frequently mentioned barriers were the limited interaction with and feedback from health care professionals and the lack of tailoring of the convalescence plan in case of a different course of recovery. CONCLUSIONS The intervention needs more interaction with and feedback from health care professionals and needs more tailored guidance in case of different recovery or treatment courses. To ensure a successful implementation of the program in daily practice, some adjustments are required to optimize the program in a blended care form. CLINICALTRIAL Netherlands Trial Registry NTR5686; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC= 5686 (Archieved by WebCite at http://www.webcitation.org/75LrJaHrr)

scholarly journals A structured mixed method process evaluation of a randomized controlled trial of Individual Placement and Support (IPS)

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Tonje Fyhn ◽  
Kari Ludvigsen ◽  
Silje E. Reme ◽  
Frederieke Schaafsma
Keyword(s):  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Work Rehabilitation ◽  
Individual Placement And Support ◽  
Randomized Controlled ◽  
Fidelity Scale ◽  
Individual Placement

Abstract Background Individual Placement and Support (IPS) is an evidence-based work rehabilitation program helping people with moderate to severe mental illness to obtain ordinary employment. Although IPS has proven superior to other work rehabilitation programs, in many studies, the majority of the participants remain unemployed. Structured process evaluations of IPS that use mixed methods are scarce, although they could identify implementation aspects that may enhance its effect. The aim of the current study is to assess reach, fidelity, and identify barriers and facilitators to implement IPS. Methods The process evaluation was conducted alongside a randomized controlled trial including six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness. Mixed methods were used in the process evaluation, including focus group interviews with service providers, individual interviews and survey data from participants, and fidelity reviews using the validated IPS Fidelity Scale. Results The intervention reached the intended target group. All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97–109, SD 8.1) (see Table 5). Certain fidelity items indicated implementation issues related to employer contact, community-based services, and integration with health services. Survey data showed that less than half of the participants regarded their illness as a barrier for participating in IPS and that freedom of disclosure was important. Participant interviews gave further insight into the role of the IPS specialist, emphasizing their availability and consistent job focus. Conclusions Indications of implementation challenges across centers during the first year suggest special attention should be given to these aspects in an early phase to ensure higher fidelity from the start and thus enhance the effectiveness of IPS. The IPS specialist played an important role for participants and was described as positive, pushing in a positive way, and encouraging. More knowledge on the characteristics of successful IPS specialists could further enhance the effectiveness of the intervention. Trial registration The study was registered on clinicaltrials.gov prior to the inclusion period (reg.no: NCT01964092, registered 17/07/2013).

scholarly journals A Mixed Methods Process Evaluation of a Clustered-Randomized Controlled Trial to Determine the Effects of Community-Based Dietary Sodium Reduction in Rural China

2021 ◽  
Vol 8 ◽  
Author(s):  
Hongling Chu ◽  
Jing Zhang ◽  
Michael D. Fetters ◽  
Wenyi Niu ◽  
Huijuan Li ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Process Evaluation ◽  
Quantitative Data ◽  
Administrative Support ◽  
Rural China ◽  
Contextual Factors ◽  
Controlled Trial ◽  
Sodium Reduction ◽  
Randomized Controlled

Purpose: A clustered-randomized controlled trial was conducted to determine the effects of a sodium reduction program in 120 rural villages in Northern China. This mixed-methods process evaluation was used to investigate the implementation and to evaluate the feasibility of the complex intervention to translate the findings from clinical study to the real world.Methods: A convergent mixed-methods process evaluation design was used in this study. Quantitative data were collected from activity logs and routine study records. Qualitative data were collected from 53 project stakeholders and 45 villagers from 10 intervention villages. Thematic analysis of qualitative interviews facilitated integration with the descriptive quantitative data analysis based on theory-informed domains of fidelity, delivery, reach, receipt, and contextual factors of intervention from a process evaluation framework.Results: The intervention was implemented with high fidelity, delivery, reach, and receipt. A total of 5,450 sheets of posters, 31,400 calendars, and 78,000 sheets of stickers were delivered as planned, and 11 promotion activities were conducted in each village. Contextual factors hindering full uptake of the intervention included preference for salty taste, higher cost of low-sodium salt, and low education levels of villagers. Other contextual factors, positive policy support, administrative support, and staff enthusiasm were the facilitators for implementation.Conclusions: This multifaceted intervention was implemented well and effectively in rural China. This process evaluation has indicated that conducting health education interventions in rural areas requires policy and administrative support, enthusiastic staff, easy-to-understand health education materials and activities, and key persons, but tempered expectations as behavior change requires time. This project demonstrates the feasibility and benefits of using mixed-methods process evaluation in large-scale studies.

scholarly journals App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation

10.2196/20308 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e20308
Author(s):  
Charlotte Diana Nørregaard Rasmussen ◽  
Malene Jagd Svendsen ◽  
Karen Wood ◽  
Barbara I Nicholl ◽  
Frances S Mair ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Mixed Methods ◽  
Usual Care ◽  
Process Evaluation ◽  
Controlled Trial ◽  
Self Management ◽  
Low Back ◽  
Randomized Controlled

Background Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. Objective This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. Methods The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. Results The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. Conclusions This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. Trial Registration ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288 International Registered Report Identifier (IRRID) DERR1-10.2196/20308

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