Background
Title | Content |
---|---|
Comprise some aspects also relevant in clinical trials of complex interventions. Not specific for complex interventions; exclusively focused on clinical trials (randomized controlled trials) | |
Workgroup for Intervention Development and Evaluation Research recommendations [13] | Set of criteria focusing on a comprehensive description of behavior change interventions to improve replicability |
Template for Intervention Description and Replication [14] | |
Grant et al. [16] | Set of criteria for reporting process evaluation in (cluster) randomized controlled trials of complex interventions |
Methods
Design and participants
Procedure
Results
The revised criteria list (CReDECI 2)
Item | Reported on page or in publication | |
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First stage: Development
| ||
1 | Description of the intervention’s underlying theoretical basis | |
2 | Description of all intervention components, including the reasons for their selection as well as their aims / essential functions | |
3 | Illustration of any intended interactions between different components | |
4 | Description and consideration of the context’s characteristics in intervention modelling | |
Second stage: Feasibility and piloting
| ||
5 | Description of the pilot test and its impact on the definite intervention | |
Third stage: Evaluation
| ||
6 | Description of the control condition (comparator) and reasons for the selection | |
7 | Description of the strategy for delivering the intervention within the study context | |
8 | Description of all materials or tools used delivery the intervention | |
9 | Description of fidelity of the delivery process compared the study protocol | |
10 | Description of a process evaluation and its underlying theoretical basis | |
11 | Description of internal facilitators and barriers potentially influencing the delivery of the intervention as revealed by the process evaluation | |
12 | Description of external conditions or factors occurring during the study which might have influenced the delivery of the intervention or mode of action ( how it works) | |
13 | Description of costs or required resources for the delivery of the intervention |
First stage: development
Example [20]: “We developed a multifaceted intervention comprising care plans for both the practices and the patients (…). By exploring practitioners’ and patients’ views (…), we determined the duration and intensity of training within the practices and the frequency of patient recall. (…) cognitive theory [Ref] was the main psychological theory used to develop the training in behavior change, design the booklet for intervention patients (Ref), and inform the development of tailored plans for patient care. According to this theory, building patients’ or and facilitating patients in setting goals and making action plans are central to the optimal management of chronic disease”.
Intervention | Description | Basis of rationale |
---|---|---|
Declaration
| • Declaration confirming the nursing home’s dedication to the intervention’s objectives, i.e. the avoidance of physical restraints signed by head nurses and/or directors of each nursing home | • Proven strategy in previous studies
(Ref)
|
Structured 90-minute information program for all nursing staff
| • Definition of physical restraints | • Cochrane review
(Ref)
|
• Desired and unwanted effects of physical restraints | • Theory of planned behavior
(Ref)
| |
• Legal aspects of physical restraint use | • Acknowledging perceived barriers, current practice culture, and concerns and emotional responses of nursing staff by using different educational strategies, e.g. working with case vignettes and small group work
(Ref)
| |
• Guideline development and recommendations | ||
• Nurses’ subjective attitudes and experiences | ||
• Alternative approaches focusing on physical restraints avoidance as most important alternative | • … | |
External structured 1-day intensive training workshop for nominated key nurses from different nursing homes
| • Advanced version of 90-min session | • Key nurses to support reduction of physical restraints
(Ref)
|
• In-depth work with the guideline | • All aspects referred to in the above box | |
• Exchange and discussion between nurses from different nursing homes | ||
• Group presentation and discussion of individual barriers and facilitators of physical restraints reduction | ||
• … |
Example [23]: “A structured single information session of approximately 90 minutes will be provided for each cluster of the intervention group, so that at best all nurses will be informed. The information programme intends to sensitise nurses about the matter of physical restraints and the message of the guidance by addressing their subjective attitudes and experiences. By means of interactive training sequences nurses are motivated to discuss and develop alternative approaches. As supporting materials they receive a short version of the guidance and reminders like posters, pens, mugs, and note pads”.
Example [20]: “We recruited general practices from two different healthcare systems in Ireland. The Republic of Ireland has a mixed healthcare system and Northern Ireland is served by the UK National Health Service (…). Key features of healthcare systems in Northern Ireland and Republic of Ireland: (…)”.
Second stage: feasibility and piloting
Example [24]: “Problems were also identified through testing the process of plan production and delivery (…). Two substantial changes were made including the addition of a carer component and the introduction of manual checking procedures to ensure that all patient information provided in the plans is correct and all related secondary prevention advice is appropriate”.
Third stage: evaluation
Example [20]: “Usual care (…) in Northern Ireland involved a system for annual review of blood pressure, cholesterol concentration, smoking status, and prescribed drugs, in accordance with the criteria specified within the NHS general practitioner contract quality and outcomes framework for the management of coronary heart disease”.
Example [25]: “The training was standardized by using the same training materials: the trainers (the research general practitioner and research nurse in each center) adhered to a single training protocol, and training delivery was planned and rehearsed jointly by all trainers using role play and peer review (Ref)”.
-
Provision of the guideline’s 16-page short version for all nursing staff,
-
Provision of the guideline’s 16-page short version for legal guardians and relatives focusing on legal aspects,
-
Provision of a leporello-style flyer for relatives and other visitors with information about the project’s main objectives.
-
Provision of posters with the intervention’s logo and slogan (‘Dare more freedom’),
-
Provision of pencils and post-its with the intervention’s logo for all nurses attending the educational session
-
Provision of mugs with the intervention’s logo for key nurses’.
Example [26]: “The training and intervention were delivered as planned for the general practitioners, practice nurses, and peer supporters in the protocol. All intervention and control practices implemented structured diabetes care as planned. All the practices and 28 out of the 29 peer supporters were followed up, though only 23 of the peer supporters were retained in their role. The main concern regarding the delivery and receipt of treatment, that is, the intervention, was the low attendance at the group meetings. Participants in the intervention group attended a mean of five peer support meetings, and 18% never attended a meeting and therefore had no exposure to the intervention. This was despite repeated phone calls from practice nurses and a call from the study manager to all nonattenders after the third round of meetings”.
Example [28]: “We preplanned a process evaluation for our newly developed fall-prevention program (…). Because of the frailty of our population, we tried to assess as many variables as possible with simple questionnaires or registration forms. In addition, we performed short semistructured interviews among participants and instructors to gather information about their experiences and thoughts”.(see Table 4).Table 4Table (excerpt)
Process Measures Process Variables 1. Quality of delivery of the interventional components 1a. The part of each component and the complete intervention delivered by instructors; b. Satisfaction with delivery 2. Barriers and facilitators for delivery of interventional components 2. Reasons for diverging from, or applying (planned) components 3. Adherence to interventional components 3a. Number of sessions followed; b. Intervention components (partly) followed; c. Compliance to individual recommendations; d. Homework adherence 4. Barriers and facilitators for adherence to interventional components 4. Motivation for (lack of) attendance and compliance 5. Experience of participants and instructors with interventional components 5a. Perceived benefit; b. Strong and weak aspects of the interventional components (structure and content), and the total intervention”
Example [22]: “The qualitative analysis of 40 in-depth interviews with nominated key nurses and head nurses identified important facilitators of and barriers to reducing prevalence of physical restraint use. Potential facilitators were supportive attitudes among head nurses; in-house quality circles with case discussion; counselling and education of relatives; and explicit and qualified information for judges, legal guardians, and physicians. Important barriers were negative experiences of nurses, concerns and uncertainties of relatives and legal guardians, and organizational problems (for example, staff fluctuation).”
Example [29]: “In March 2004, the Committee on Safety of Medicines wrote to all doctors in the United Kingdom to advise against the prescription of risperidone and olanzapine in patients with dementia. The effect of this communication, which might have been expected to result in discontinuation of neuroleptics in a large number of participants in both arms of the trial, was only modest. Differences in the proportion of patients receiving neuroleptics at each review (…) between the groups were sustained over the year, and similarly affected by the ruling of the Committee on Safety of Medicines.”
Example [30]: “The average direct cost of the intervention, including nurse time and psychiatrist supervision (but not the cost of nurse training or screening for depression), was £261.65 per patient. Patients who received the intervention also had slightly greater costs for healthcare than did those who had usual care (£175.33 versus £151.44, difference £23.89) and for antidepressant drugs (£70.11 versus £20.79, difference £49.32). The total average extra cost of the intervention was therefore £334.86 (95% confidence interval £276 to £393) per patient over 6 months (…).”