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

NCT ID: NCT04799860

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Health Knowledge, Attitudes, Practice

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A pre-post-intervention design with control group will be used to evaluate intervention uptake and implementation process effectiveness from the perspective of managers, primary care professionals, patients, and organisation. Primary care settings in central Sweden will be supported in implementing a guideline-based health-promoting way of working including screening of life-style habits, measures taken according to evidence based recommendations and documentation. Strategies will include interactive education sessions, external and internal facilitators, audit and feedback, and tools from theories of leading change; tailored according to contextual and participant needs.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

health promotive work-way

Intervention Type BEHAVIORAL

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

Control

Six primary care centers of similar size and socioeconomic background in the population listed to each center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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


\* : 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ylva Nilsagård

Role: STUDY_DIRECTOR

University Health Care Research Center, Region Örebro County

Locations

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Region Örebro County

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 25791983 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29385438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31088483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30509289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19664226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10474547 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40197376 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38241166 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37328813 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35984700 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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275301

Identifier Type: -

Identifier Source: org_study_id