Integrating pediatric TB services into child healthcare services in Africa: study protocol for the INPUT cluster-randomized stepped wedge trial

Abstract Background In the Netherlands, suicide rates showed a sharp incline and this pertains particularly to the province of Noord-Brabant, one of the southern provinces in the Netherlands. This calls for a regional suicide prevention effort. Methods/design Study protocol. A regional suicide prevention systems intervention is implemented and evaluated by a stepped wedge trial design in five specialist mental health institutions and their adherent chain partners. Our system intervention is called SUPREMOCOL, which stands for Suicide Prevention by Monitoring and Collaborative Care, and focuses on four pillars: 1) recognition of people at risk for suicide by the development and implementation of a monitoring system with decision aid, 2) swift access to specialist care of people at risk, 3) positioning nurse care managers for collaborative care case management, and 4) 12 months telephone follow up. Eligible patients are persons attempting suicide or expressing suicidal ideation. Primary outcome is number of completed suicides, as reported by Statistics Netherlands and regional Public Health Institutes. Secondary outcome is number of attempted suicides, as reported by the regional ambulance transport and police. Suicidal ideation of persons registered in the monitoring system will, be assessed by the PHQ-9 and SIDAS questionnaires at baseline and 3, 6, 9 and 12 months after registration, and used as exploratory process measure. The impact of the intervention will be evaluated by means of the RE-AIM dimensions reach, efficacy, adoption, implementation, and maintenance. Intervention integrity will be assessed and taken into account in the analysis. Discussion The present manuscript presents the design and development of the SUPREMOCOL study. The ultimate goal is to lower the completed suicides rate by 20%, compared to the control period and compared to other provinces in the Netherlands. Moreover, our goal is to provide specialist mental health institutions and chain partners with a sustainable and adoptable intervention for suicide prevention. Trial registration Netherlands Trial Register under registration number NL6935 (5 April 2018). This is the first version of the study protocol (September 2019).

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Implementation of a Cost-Effective Physical Therapy Approach (Coach2Move) to Improve Physical Activity in Community-Dwelling Older Adults With Mobility Problems: Protocol for a Cluster-Randomized, Stepped Wedge Trial

Physical Therapy ◽

10.1093/ptj/pzz183 ◽

2019 ◽

Vol 100 (4) ◽

pp. 653-661 ◽

Cited By ~ 1

Author(s):

Ward Heij ◽

Steven Teerenstra ◽

Lieke Sweerts ◽

J Bart Staal ◽

Maria W G Nijhuis-van der Sanden ◽

...

Keyword(s):

Physical Activity ◽

Older Adults ◽

Physical Therapy ◽

Physical Therapist ◽

Community Dwelling ◽

Stepped Wedge ◽

Cluster Randomized ◽

Community Dwelling Older Adults ◽

Stepped Wedge Trial ◽

Insight Into

Abstract Background Coach2Move is a personalized treatment strategy by physical therapists to elicit physical activity in community-dwelling older adults with mobility problems. Objective The primary objective of this study is to assess the effectiveness and cost-effectiveness of the implementation of Coach2Move compared with regular care physical therapy in daily clinical practice. Design, Setting, Participants, and Intervention A multicenter cluster-randomized stepped wedge trial is being implemented in 16 physical therapist practices (4 clusters of 4 practices in 4 steps) in the Netherlands. The study aims to include 400 older adults (≥70 years) living independently with mobility problems and/or physically inactive lifestyles. The intervention group receives physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapist care. Measurements Measurements are taken at baseline and 3, 6, and 12 months after the start of treatment. The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test). Trial success can be declared if at least 1 parameter improves while another does not deteriorate. Secondary outcomes are level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5 L), and health care expenditures. Multilevel linear regression analyses are used to compare the outcomes between treatment groups according to an intention-to-treat approach. Alongside the trial, a mixed-methods process evaluation is performed to understand the outcomes, evaluate therapist fidelity to the strategy, and detect barriers and facilitators in implementation. Limitations An important limitation of the study design is the inability to blind treating therapists to study allocation. Discussion The trial provides insight into the effectiveness and cost-effectiveness of the Coach2Move strategy compared with usual care. The process evaluation provides insight into influencing factors related to outcomes and implementation.

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