Act in Time- Implementation of Health Promotive Work-way in Primary Care Setting - Evaluation of Effect- and Implementation Process (AcTi)
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Sponsor: Region Örebro County

 
Study protocol and statistical analysis plan  
Act in Time -Implementation of Health Promotive Work-way in Primary Care Setting 
(Acti) ID: 275301 
Date: 2025-12-09 
 
There is growing evidence that noncommunicable diseases (NCDs) can be attributable 
to unhealthy lifestyle habits. However, there has been little application of this knowledge 
in primary health care (PHC). This study aims to evaluate the process and outcomes of a 
multifaceted implementation strategy for a healthy lifestyle-promoting practice in a PHC 
setting. This practice is based on national guidelines targeting unhealthy lifestyle habits 
with a potential risk for NCDs.  
A pre-post implementation study design with a control group is used in a PHC setting in 
central Sweden. The implementation process and outcomes will be assessed using a 
mix of qualitative and quantitative methods. Core components in the implementation 
strategy are external and internal facilitators in line with the integrated-Promoting Action 
on Research Implementation in Health Services (i-PARIHS) framework and the Astrakan 
change leadership model. The implementation strategies will be prioritized and adapted 
through discussions with the involved stakeholders. 
A strategic sample of up to 6 PHC centers will be included as intervention centers, 
which will receive a 12-month multifaceted implementation strategy. Up to 6 matched 
PHC centers will serve as controls. 
Data will be collected at baseline, during the implementation phase, and up to 18 
months after ending of the implementation intervention. Questionnaires will be sent to 
roughly 500 patients in every PHC center and 200 health care professionals before and 
after implementation. In addition, purposeful sampling will be used for interviews and 
focus group discussions with managers at different levels, health care professionals, 
patient representatives, and internal and external facilitators. Use of data from medical 
records and activity logs will be an additional data source. For rigorous process 
evaluations, data will be collected before, during, and after accomplishing the 
implementation strategy.  
 
 
 
 

An overview of data collection including the timeline, target group, and methodology. 
 
 
Quantitative data will be analyzed using SPSS Statistics for Windows (version 27.0, IBM 
Corp). Data from patients’ questionnaires and medical records and HCPs’ 
questionnaires will be analyzed using generalized linear mixed models. Fixed effects will 
include intervention, month, and sex, whereas random effects will include nested 
patients at PHC intervention centers. Model checking will involve the inspection of 
residual and autocorrelation plots. To determine statistical significance, a P value of 
value of 0.05 will be considered. CIs will be adjusted for simultaneous inference where 
several contrasts are presented. 
All qualitative data will be audio-recorded and transcribed verbatim. Qualitative content 
analysis will be used, both inductively and deductively.