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

Health Knowledge, Attitudes, Practice Clinical Trial

— AcTi)  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04799860
• Other study ID #: 275301
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

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

Locations

Country	Name	City	State
Sweden	Region Örebro County	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

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. — View Citation

Elf M, Nordmark S, Lyhagen J, Lindberg I, Finch T, Åberg 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. — View 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. Review. — View 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. — View 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. — View Citation

Wändell PE, de Waard AM, Holzmann MJ, Gornitzki C, Lionis C, de Wit N, Søndergaard J, Sønderlund 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 4 to 6 months after end of implementation support
Other	Person centered processmapping	Structured workshop with patient representatives	At baseline
Other	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
Primary	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, through study completion up to 4 to 6 months after end of implementation support
Primary	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
Secondary	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
Secondary	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