Act in Time -Implementation of Health Promotive Work-way in Primary Care Setting (AcTi) (AcTi)

Act in Time- Implementation of Health Promotive Work-way in Primary Care Setting - Evaluation of Effect- and Implementation Process (AcTi)

The study will support implementation of a health promotive work-way in primary care setting by using external and internal facilitators, with the aim to identify effective implementation strategies and to evaluate intervention uptake. Data will be collected from multiple perspecitves.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Behavioral: health promotive work-way

Detailed Description

Insufficient physical activity, hazardous use of alcohol, tobacco use and unhealthy eating habits increase the risk of cardiovascular diseases, cancer and type 2-diabetes. Health-promoting work reduces the disease risk and mortality and should thus be integrated in clinical care processes.

Despite support by the National guideline for prevention and treatment of unhealthy life-style habits, there is a chasm to bridge when integrating evidence into clinical practise. Prerequisites for changing work-ways are often underestimated and left to the individual co-workers to full fill on their own.

Too few patients are asked about life-style habits and too few receive evidence-based measures. The measures taken may also depend on sex, language, residence and caregiver's profession. The investigators strive to support the implementation of a health-promoting way of working that includes self-reporting of life-style habits before a visit and that takes measures for those with at least one unhealthy lifestyle habit.

The aim is to identify effective implementation strategies for health-promoting efforts in the primary care. The perceptions of barriers and opportunities when changing way of working from the target groups (leaders, co-workers, patients) will be used to enhance the possibility of successful implementation. Strategies are enhanced by theories of leading change. External and internal facilitators support the implementation.

The study will evaluate the effects and the implementation process at the level of leaders, patients, co-workers, facilitators and organisation in short (4-6 months) and long term (16-18 months).

The project provides generalizable knowledge on strategies to overcome the gap between evidence and praxis, contributing to utilize an existing synthesized knowledgebase regarding health-promoting and preventative workways in a Swedish primary care setting.

It is central for the health care system to identify successful implementation strategies in order to manage their future mission.

• Study Type: Interventional
• Enrollment (Actual): 12000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Region Örebro county

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for co-workers:

• being a caregiver meeting patients and/or
• being assigned a role as internal or external facilitator in the project

Inclusion criteria for patients filling in the study specific questionnaire:

• 18 years or older
• visiting primary care units a specific time pre- or post implementation support

Inclusion criteria for personcentered processmapping:

* : having one or more unhealthy life-style habit 18 years or older

Inclusion criterina for managers:

* being a manager at a primary care unit or at higher level

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: health promotive work-way; Six primary care units that voluntarily enrolls as experimental units. The units will receive implementation support based on previous research and tailored to the specific prerequisits and context for each unit. Strategies includes involvement of target groups; informationa and interactive education;use of external and internal facilitators tarined for the purpose; systematic feedback and learning dialogs during the project. The implementation support will take approximately 12 months.	Behavioral: health promotive work-way; Clinical intervention: The patient is asked to fill in a screening form with life-style related questions. The caregiver takes adequate measures according to the recommendations of the national guideline and the filled in screeing form. The caregiver documents the measures taken. Implementation intervention as described previously: using tailored strategies to support implementation of the gudieline-based recommendations
No Intervention: Control; Six primary care centers of similar size and socioeconomic background in the population listed to each center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in S-NoMAD score (Swedish translation of NoMAD	23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring	Change from baseline S-Nomad score up to 4 to 6 months after end of study completion
Change and trend from baseline documented codes in medical records	specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity	Change from baseline (6 months), through study completion up to 6 months after end of implementation support
Change and trend from baseline documented codes in medical records	specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity	Change from baseline (6 months), through study completion up to 18 months after end of implementation support
Change in S-NoMAD score (Swedish translation of NoMAD	23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring	Change from baseline S-Nomad score up to 16 to 18 months after end of study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived clincial intervention by a study specific questionnaire	Questions related to the patients' perception on receiving the clinical intervention or not	Change from baseline up to 4 to 6 months after end of implementation support
Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.	Appropriateness, feasability, acceptability of the clinical intervention is rated on a 5-graded scale with 4 items per construct	Change from baseline in AIM,IAM and FIM up to 4 to 6 months after end of implementation support
Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.	Appropriateness, feasability, acceptability of the clinical intervention is rated on a 5-graded scale with 4 items per construct	Change from baseline in AIM,IAM and FIM up to 16 to18 months after end of implementation support

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Person centered processmapping	Structured workshop with patient representatives	At baseline
Study specific logbook	To measure fidelity, dose and reach and changes at the unit that may affect the implementation process	Through study completion, in average 16 months
Interviews to tailor strategies and evaluate implementation process	Semi-structured interview guides directed to facilitators, co-workers and managers	Interviews pre-intervention and up to 3 to 6 months after end of implementation support
Interviews to evaluate implementation support, clinical process and thoughts about up-scaling	Semi-structured interview guides directed to facilitators, co-workers and managers	Interviews pre-intervention and up to 16 to18 months after end of implementation support

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Study Director: Ylva Nilsagård, University Health Care Research Center, Region Örebro County

Publications and helpful links

General Publications

• Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.
• Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.
• Elf M, Nordmark S, Lyhagen J, Lindberg I, Finch T, Aberg AC. The Swedish version of the Normalization Process Theory Measure S-NoMAD: translation, adaptation, and pilot testing. Implement Sci. 2018 Dec 4;13(1):146. doi: 10.1186/s13012-018-0835-5.
• Wandell PE, de Waard AM, Holzmann MJ, Gornitzki C, Lionis C, de Wit N, Sondergaard J, Sonderlund AL, Kral N, Seifert B, Korevaar JC, Schellevis FG, Carlsson AC. Barriers and facilitators among health professionals in primary care to prevention of cardiometabolic diseases: A systematic review. Fam Pract. 2018 Jul 23;35(4):383-398. doi: 10.1093/fampra/cmx137.
• Nilsen P, Schildmeijer K, Ericsson C, Seing I, Birken S. Implementation of change in health care in Sweden: a qualitative study of professionals' change responses. Implement Sci. 2019 May 14;14(1):51. doi: 10.1186/s13012-019-0902-6.
• Nilsagard YE, Smith DR, Soderqvist F, Strid EN, Wallin L. Achieving health-promotion practice in primary care using a multifaceted implementation strategy: a non-randomized parallel group study. Implement Sci Commun. 2025 Apr 7;6(1):36. doi: 10.1186/s43058-025-00723-y.
• Nilsing Strid E, Wallin L, Nilsagard Y. Exploring expectations and readiness for healthy lifestyle promotion in Swedish primary health care: a qualitative analysis of managers, facilitators, and professionals. Scand J Prim Health Care. 2024 Mar;42(1):201-213. doi: 10.1080/02813432.2023.2301556. Epub 2024 Feb 7.
• Strid EN, Wallin L, Nilsagard Y. Expectations on implementation of a health promotion practice using individually targeted lifestyle interventions in primary health care: a qualitative study. BMC Prim Care. 2023 Jun 16;24(1):122. doi: 10.1186/s12875-023-02079-5.
• Strid EN, Wallin L, Nilsagard Y. Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study. JMIR Res Protoc. 2022 Aug 19;11(8):e37634. doi: 10.2196/37634.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: primary care; implementation; process evaluation
• Additional Relevant MeSH Terms: Behavior
• Other Study ID Numbers: 275301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We don't collect individual data other than in the qualitative parts and we don't have ethical approval to share that

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No