Condition category
Not Applicable
Date applied
10/01/2016
Date assigned
12/01/2016
Last edited
24/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
‘Physical activity on Prescription’ (FaR) is a method used in Swedish healthcare to promote healthy physical activity in patients, for both the prevention and treatment of lifestyle-related health conditions. FaR has been recommended to be used by licensed healthcare professionals in primary healthcare, but also in other healthcare services. Despite scientific support for the method and major information and education campaigns, it is used to a limited extent in the healthcare sector. We have developed an intervention to support primary healthcare professionals to implement FaR in everyday patient consultations. The aim of this study is to explore the feasibility and acceptability of this intervention, as well as the feasibility of methods for data collection and evaluation of the intervention, for a forthcoming larger study.

Who can participate?
At each participating primary healthcare center, all licensed healthcare professionals having consultations with adult patients who may have a need for increased level of physical activity, as well as the healthcare center management (the manager and possibly others in supervisory positions).

What does the study involve?
The intervention is conducted at each healthcare center. In all, three seminars are conducted with the whole healthcare center staff and management. At the introductory half-day seminar, all healthcare staff are presented to the intervention. An inspiring lecture on health-promoting physical activity and FaR is provided by an external expert in the field, and an educational lecture is also given to provide detailed information on the FaR method, with easy applicable guidance on how to prescribe FaR. Statistics from the patient record system on current FaR prescriptions at the healthcare center are presented. The FaR coordinators and healthcare center manager present a local routine for FaR. The suggestion is discussed and possibly adjusted based on the staff’s comments. There are two one-hour follow-up seminars two and six months after the first seminar. The seminars focus on reflection and feedback on the procedures and components of the intervention, by exploring experiences of using the local routine for FaR prescriptions, using the FaR method in patient consultations, and barriers or facilitators for prescribing FaR. The local routine is changed if necessary. Data is collected from patient records, questionnaires and interviews (focus groups and individual interviews) with healthcare staff and management.

What are the possible benefits and risks of participating?
Participants will gain in-depth knowledge about using the FaR method and will develop their skills for treating patients' unhealthy lifestyle behaviours and improving their quality of life. There are no foreseeable risks or disadvantages of participating.

Where is the study run from?
Three primary healthcare centres in Dalarna County Council and Region Gävleborg (Sweden)

When is the study starting and how long is it expected to run for?
September 2015 to December 2017

Who is funding the study?
1. Regional Research Council for the County Councils in Uppsala-Örebro-region (Sweden)
2. Center for Clinical Research Dalarna, County Council of Dalarna (Sweden)

Who is the main contact?
Dr Catharina Gustavsson

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catharina Gustavsson

ORCID ID

http://orcid.org/0000-0002-8709-4446

Contact details

Center for Clinical Research Dalarna
Nissers väg 3
Falun
SE-79182
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Feasibility study of an implementation intervention for facilitating primary healthcare staff's use of the method FaR ‘Physical activity on Prescription’ for supporting health promoting physical activity in patient encounters

Acronym

Study hypothesis

A theoretically based implementation strategy (a multi-faceted intervention approach based on four implementation methods that each have some scientific support) is feasible and acceptable for the implementation of the method ‘FaR’ in primary healthcare as measured by healthcare staff's use and perceived usefulness of ‘FaR’.

Ethics approval

Uppsala ethics committee, 13/01/2016, ref: 2015/506

Study design

Feasibility study with before-and-after design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Healthcare professionals' behavior change in clinical practice

Intervention

Feasibility study with before-and-after design with focus on exploring an implementation intervention directed to healthcare professionals in primary healthcare centers, where a combination of methods to support the implementation of FaR are explored for feasibility and acceptance. The study includes components of ‘participatory research’ and ‘co-production’ by participant involvement throughout the intervention process.

A theoretically based implementation strategy (a multi-faceted intervention approach based on four implementation methods that each have some scientific support) aimed to support healthcare professionals in primary healthcare to implement an evidence-based approach to health-promoting physical activity, FaR, in everyday patient consultations. The multi-faceted intervention strategy is based on four methods: ‘Tailoring to address barriers to change’, ‘Educational outreach’, ‘Local champions’, ‘Audit and feedback’.

The intervention is conducted at each healthcare center, preceded by three preparatory meetings for the formation of a working team consisting of the healthcare center manager, the local FaR coordinators (one to three persons), a researcher (the study principal investigator PI) and an observer (study research assistant). The working team will prepare a plan for a local routine for FaR tailored to local conditions. In all, three seminars are conducted with the whole healthcare center staff and management; an introductory half-day seminar and two follow-up one-hour seminars during six months. The study researcher (PI) surveys the intervention process at working team meetings and all seminars. A research assistant participates as an observer and documents the intervention process (by observation protocols/checklists).

1. First preparatory working team meeting before the first seminar: healthcare center manager, a researcher and an observer meet and agree on the conditions and plan for the healthcare center participation.

2. Second preparatory working team meeting before the first seminar: a working team consisting of local FaR coordinators (from the healthcare staff) and healthcare center manager meet the researcher (with an observer present). The working team is presented to the task to produce a proposal for a local routine for FaR tailored to local conditions.

3. Third preparatory working team meeting before the first seminar: the working team presents a suggested local routine for FaR for the researcher (the observer is present but not active).

4. Introductory half-day seminar: all healthcare staff at the healthcare center are present and are presented to the intervention. An inspiring lecture on health promoting physical activity and FaR is provided by an external ‘expert’ in the field, and an educational lecture is also given to provide detailed information on the FaR method, with easy applicable guidance on how to prescribe FaR, by entailing each component in the method. Statistics from the patient record system on current FaR-prescriptions at the healthcare center is presented, likewise a routine for further recurrent feedback of the healthcare center's FaR prescriptions. The FaR coordinators and healthcare center manager presents a local routine for FaR. The suggestion is discussed and possibly adjusted based on the staff’s comments. The FaR coordinators are presented as in charge of undertaking monthly follow-ups at workplace meetings on statistics on FaR-prescriptions, respectively discuss the local routine for FaR and if needed make revisions.

5-6. One-hour follow-up seminars: at two and six months after the first seminar. The seminars focus on reflection and feedback on the procedures and components of the intervention, by exploring experiences of using the local routine for FaR-prescriptions, feedback on FaR-prescriptions by statistics at workplace meeting, using the FaR-method in patient consultations, and barriers or facilitators for prescribing FaR. The local routine is revised if needed.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

This is a pilot study with the primary aim to explore the feasibility and acceptability of the intervention, not to evaluate an ‘a priori’ primary outcome measure. Study evaluation will be targeting the implementation process and mechanisms of change.

Baseline measurement: the healthcare staff's use of and attitudes toward prescribing FaR (i.e. appreciation of the content, objective and evidence base for the method, as well as trust in the effects of the method, etc) will be measured by a questionnaire prior to the intervention. Also the quality of the FaR-prescriptions (i.e. the use of the five components included in FaR) will be measured by the questionnaire to the healthcare staff.

Follow-up measurements: of healthcare staff's use of and attitudes towards FaR, as well as of the quality of FaR-prescriptions is done through questionnaires and semi-structured interviews (focus groups, respectively individual interviews) after the intervention, i.e. at the last intervention seminar (just before 6 months), respectively, at 6 months after the intervention.

Process evaluation: observation protocols at all intervention seminars/workshops including checklists of intervention components and notations of deviation from the intervention protocol.

Secondary outcome measures

Data will also be collected for the purpose of evaluating methods for data collection in a full-scale randomized controlled study on the outcome measure: effects on behaviour change in prescribing FaR.

Baseline measurement: The quantity of FaR-prescriptions (i.e. the number of registered prescriptions) at each primary healthcare center will be registered during a month prior to the intervention, through statistics from the patient medical records.

Follow-up measurements: of the quantity of FaR-prescriptions for every month throughout the year, i.e. until one year after the intervention. To eliminate seasonal variations in FaR-prescriptions, measurement and comparison will be undertaken between the same months in two consecutive years; for example April 2016 will be compared to April 2017. Data collection will be completed a year after the intervention.

Overall trial start date

01/09/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

At each participating primary healthcare center, all licensed healthcare professionals having consultations with adult patients who may have a need for increased level of health-promoting physical activity, as well as the healthcare center management (the manager and possibly others in supervisory positions), participate in the intervention.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Three primary healthcare centres. Centre one: 30 licensed healthcare professionals. Centre two: 20 licensed healthcare professionals. Centre three: 15 licensed healthcare professionals.

Participant exclusion criteria

None

Recruitment start date

01/02/2016

Recruitment end date

20/03/2016

Locations

Countries of recruitment

Sweden

Trial participating centre

Dalarna County Council, the primary healthcare organization
Center for Clinical Research Dalarna Nissers väg 3
Falun
SE-79182
Sweden

Trial participating centre

County Council Region Gävleborg, the primary healthcare organization
SE-79182
Sweden

Sponsor information

Organisation

Center for Clinical Research Dalarna, County Council of Dalarna (Sweden)

Sponsor details

Nissers väg 3
Falun
SE-79182
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Regional Research Council for the County Councils in Uppsala-Örebro-region (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Center for Clinical Research Dalarna, County Council of Dalarna (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Data collection will be completed a year after the start of the intervention (estimated finished the third quarter of 2017). Final data analysis and report writing will be undertaken during the third and fourth trimester of 2017.
The pilot study is planned to produce two publications in peer-reviewed journals:
1. Exploring the feasibility and acceptability of the intervention
2. Evaluation of methods for measuring the process and effects of the implementation intervention on: a) healthcare staff attitudes to working with the FaR method, respectively, b) the quantity and quality of prescribing FaR, up to 6 months after the intervention.

Intention to publish date

30/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/02/2016: Ethics approval information has been added.