Clinical trial NCT04799860: Act in Time -Implementation of Health Promotive Work-way in Primary Care Setting (AcTi)
Official title: Act in Time- Implementation of Health Promotive Work-way in Primary Care Setting - Evaluation of Effect- and Implementation Process (AcTi)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Keywords: implementation
primary care
process evaluation
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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 and organisation.

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.

Eligibility criteria: Inclusion Criteria for co-workers:

* being a caregiver meeting patients and/or
* being assigned a role as internal 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

Primary outcomes:
measure: Change and trend from baseline documented codes in medical records
timeFrame: Change from baseline, through study completion up to 4 to 6 months after end of implementation support
measure: Change in S-NoMAD score (Swedish translation of NoMAD
timeFrame: Change from baseline S-Nomad score up to 4 to 6 months after end of study completion
Secondary outcomes:
measure: Change in perceived clincial intervention by a study specific questionnaire
timeFrame: Change from baseline up to 4 to 6 months after end of implementation support
measure: Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.
timeFrame: Change from baseline in AIM,IAM and FIM up to 4 to 6 months after end of implementation support
Other outcomes:
measure: Interviews to tailor strategies and evaluate implementation process
timeFrame: Interviews pre-intervention and up to 4 to 6 months after end of implementation support
measure: Person centered processmapping
timeFrame: At baseline
measure: Study specific logbook
timeFrame: Through study completion, in average 16 months
Locations:
city: Örebro
country: Sweden
facility: Region Örebro County
Study officials:
affiliation: University Health Care Research Center, Region Örebro County
name: Ylva Nilsagård
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.