Copen-SCALE: Scaling up an effective intervention to childcare institutions in Copenhagen

Pain-related sickness absence within the last three months measured using a questionnaire at baseline and follow-up (approx. 6-8 months after the intervention start). Participants will be asked to answer the following categories: 0 days, 1-5 days, 6-10 days, 11-15 days and above 15 days.

Evaluation of implementation
The primary outcome for implementation will be the fidelity of the intervention. Fidelity will be measured as:
1. Adherence, defined as the proportion of program components that were delivered compared to the number prescribed in the intervention protocol, measured using a short questionnaire survey for the consultants after completing each intervention activity
2. Exposure, defined as the number of sessions, measured using the consultant’s intervention logs registered throughout the study period
3. Quality of delivery measured using the following questions for the consultants after completing each intervention activity:
3.1. “Regarding today, to which extent have you contributed to… [To a very large extent (100)/to a large extent (100)/somewhat (50)/to a small extent (0)/to a very small extent (0)]
...the participants’ commitment and motivation?
..ensuring the employees’ participation in the activity?
..adapting the activity to the needs of the participants?
..maintaining the participants’ attention?
3.2. Suppose that your performance, at its best, is equal to 10 points. How would you rate your performance today? [0–10 (0 = not capable to perform; 10 = best performance) (0–4 were scored 0, 5–7 were scored 50, 8–10 were scored 100)]
4. Participant responsiveness measured using the following question for the consultants after completing each intervention activity:
4.1. To which extent are the participants committed and motivated? [To a very large extent (100)/to a large extent (100)/somewhat (50)/to a small extent (0)/to a very small extent (0)]

The following secondary outcome measures will be assessed at baseline and follow-up (approx. 6-8 months):
1. Frequency of pain in any body region (except the head) within the last three months measured using a questionnaire
2. Worst pain in neck/shoulder and lower back within the last three months measured using a Numeric Pain Rating Scale (NPRS) from 0-10
3. Pain duration within the last seven days measured using a modified version of the Nordic Musculoskeletal Questionnaire (NMQ)
4. Average pain intensity in neck/shoulder and lower back within the last seven days measured using an NPRS from 0-10 (NMQ)
5. Pain-related work interference measured using a modified version of the NMQ
6. Pain-related health literacy levels measured using a modified version of the Health Literacy Questionnaire (HLQ)
7. Fear-avoidance beliefs measured using two questions from the Örebro Musculoskeletal Pain Questionnaire (OMPQ)
8. Perceived physical exertion at work measured using the BORG-10 Rating of Perceived Exertion (RPE) scale
9. Meaning in work measured using a question from the Danish Psychosocial Questionnaire.

Evaluation of cost-effectiveness
A cost-effectiveness evaluation will be made with the following outcomes:
1. Sickness absence will be collected from workplace registers. Data will be collected from one year before the intervention (2023) until the last childcare institution has finished the intervention (in 2027).
2. Productivity costs will be measured using a modified version of the iMTA Productivity Cost Questionnaire (iPCQ) at baseline and follow-up. Costs will be collected during the implementation of the intervention and will include:
2.1. Staff time: Employees’ and managers’ participation in intervention activities, measured using registration of participation in activities that are not directly part of daily work (e.g. a workshop/meeting for planning the activities)
2.2. Employees’ and managers’ costs will subsequently be valued based on their average yearly gross salaries, including overhead costs measured using intervention activity time recorded in hours and personnel records
2.3. Consultants’ time: The time spent on implementing the intervention by the consultants will be registered. Their costs will be based on their usual consultant fees using costs recorded and provided by the consultants
2.4. Consumables: Materials (print-outs and posters etc.) as well as fruit/snacks/coffee at meetings will be recorded be measured using invoices.

Secondary outcomes for implementation are acceptability, appropriateness, feasibility, adoption, penetration and sustainability:
1. Acceptability, appropriateness and feasibility measured using semi-structured interviews guided by the Theoretical Framework of Acceptability (TFA) with selected participants during follow-up
2. Adoption and recruitment logs will be reviewed to measure the characteristics and number of institutions that actively participated in contrast to those that were eligible for participation. The pertinent characteristics, encompassing type (public/private) and size (employee count, unit count), will be extracted from municipal registers.
3. Penetration and Sustainability will be measured using purposive sampling qualitative methods to ensure representation from both low- and high-performing childcare institutions, including interviews with a representative cohort of childcare workers and managers conducted after the implementation of the Copen-SCALE intervention (approx. 6-12 months after ended intervention)

Evaluation of adaptation
Adaptations to the intervention at the institutional level measured using FRAME-IS framework document analysis, focus groups with consultants, and observations at random participating institutions during the intervention period and/or at follow-up