Article Text
Abstract
Promotion of physical activity by health professionals can increase physical activity participation among patients, however, implementing physical activity promotion within hospital systems is lacking. The Promotion of Physical Activity by Health Professionals (PROMOTE-PA) study is a hybrid type I effectiveness-implementation cluster randomised controlled trial evaluating the effectiveness of support for physical activity promotion by health professionals on physical activity participation of patients. Health professionals delivering outpatient healthcare services within four local health districts and one specialty health network in New South Wales, Australia will be included. The target patient population is children (5–17 years) and adults (18+ years) who are willing to receive additional support to be more physically active. The evidence-based intervention is brief physical activity promotion informed by the ‘5As’ physical activity counselling model and behavioural theory, embedded into routine clinical practice. Our multi-faceted strategy to support implementation of physical activity promotion was developed based on preliminary research and consultation with key stakeholders. The implementation strategy includes education and training as well as a selection of the following (tailored to each clinical team): community referral strategies, experts and clinical mentors, and clinical champions. 30 outpatient clinical teams will be randomised to receive the implementation strategy immediately or after a 3-month delay (waitlist control). Each team will seek to recruit 10–30 patients (n=approx. 720) to report moderate-vigorous physical activity (minutes per week, primary outcome), frequency of balance and strength exercise, mobility, and quality of life at baseline, 3-month and 6-month post patient recruitment. This study aims to address the increasing burden of physical inactivity in a high-risk population using the existing health workforce.
Trial registration number Australian and New Zealand Clinical Trials Registry (ACTRN12623000920695).
- Preventive counselling
- Physical performance
- Weight management
Data availability statement
No data are available. Not applicable.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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WHAT IS ALREADY KNOWN ON THIS TOPIC
Promotion of physical activity by health professionals could have a role in addressing global inactivity but evidence to guide real-world implementation is limited.
WHAT THIS STUDY ADDS
This study will evaluate the effectiveness of support for physical activity promotion by health professionals on physical activity participation of their patients.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Embedding physical activity promotion into routine clinical practice is a potentially efficient intervention to reduce chronic disease and enhance health using the existing health workforce.
Introduction
Low physical activity (PA) is a major public health issue leading to 5.3 million avoidable deaths each year.1 Almost one in two Australians (43%) do not meet current PA guidelines and there is no sign of improvement over time.2 People with disability and older adults face additional barriers to PA participation.3 There is an urgent need to develop and evaluate interventions that can be implemented at scale.4
PA promotion aims to change behaviour to prevent chronic conditions. Interventions that incorporate behaviour change techniques (identifying barriers, self-monitoring, goal setting and feedback) increase PA in the general population5 6 and people with disabilities.7 Brief interventions such as the 5As approach (Assess, Advise, Agree, Assist and Arrange)8 can improve PA when delivered by health professionals, but evidence within hospital settings is limited.9
The WHO recommends that health professionals promote PA within routine care.10 Health professionals have a strong interest in supporting their patients to be more active.11 12 However, health professional surveys,11 12 patient surveys13 14 and medical record audits13 indicate that PA promotion is not routinely delivered. Common barriers include a lack of resources, time, knowledge, skills, incentives, and limited knowledge and trust of existing community PA opportunities.15
The Promotion of Physical Activity by Health Professionals (PROMOTE-PA) study aims to address these evidence-practice gaps. We will deliver a multi-faceted implementation strategy supporting teams of outpatient health professionals to implement PA promotion into routine care. The purpose of this study is to test the effectiveness of the PA promotion intervention delivered by health professionals with support from researchers. We will also gather observational data on implementation outcomes and determinants. Effectiveness questions include:
Does PA promotion by health professionals with support from researchers, increase participation in self-reported moderate-vigorous PA (primary outcome), balance or strength exercise compared with usual care among people who receive outpatient health services?
Does PA promotion by health professionals with support from researchers, improve self-reported mobility and quality of life compared with usual care among people who receive outpatient health services?
Our hypothesis is that patients receiving care from health professionals who have received support will be more physically active (primary hypothesis) and have greater self-reported mobility and quality of life, than patients receiving care from health professionals who have not yet received support.
Methods
Design
We will undertake a cluster randomised controlled superiority trial with two parallel groups, 30 clusters and approximately 720 participants (figure 1). The study will use an effectiveness-implementation hybrid type I design, with a primary focus on effectiveness. The study design is guided by the Consolidated Standards of Reporting Trials: extension to cluster randomised controlled trials,16 and reported according to the Standard Protocol Items: Recommendations for Interventional Trials17 and the Template for Intervention Description and Replication (TIDieR) framework.18
This protocol describes the effectiveness components of the PROMOTE-PA study. The protocol for exploration of processes, implementation outcomes and determinants, and the economic evaluation will be described in a separate paper.
Consumer and health professional input
This study was codesigned with our clinical/health service manager investigators (BR, DT, MJ, SG, KW) and community PA representatives (PH, JW). The implementation strategies were developed and refined with local health professional input, including managers and senior and junior health professionals, via semi-structured interviews and focus groups during part I of this study (manuscripts in preparation) as well as previous surveys,19 20 interviews15 and consultations21 with health professionals.
A PROMOTE-PA consumer advisory group has been established for this study and comprises four consumer volunteers who have provided feedback on development of study information and consent forms, participant surveys and educational resources for patients. This feedback has been used to further develop trial information and consent forms. The group will meet 3–4 times per year for the duration of the trial.
Study sites and participant groups
This study will recruit through outpatient healthcare services across four Local Health Districts (Sydney, Western Sydney, South Western Sydney and South Eastern Sydney) and Sydney Children’s Hospital Network within New South Wales, Australia. The local health districts include 15 public hospitals and the Sydney Children’s Hospital Network includes 2 public hospitals. Private practices offering similar outpatient services to target patient groups may also be recruited.
Health professional inclusion criteria
Healthcare teams that provide a service for outpatients to the target patient groups will form each of the 30 clusters. Teams that have at least one interested health professional will be recruited, with the size of clinical teams likely to differ. Examples of clinical teams include physiotherapy outpatients, rheumatology outpatients and outpatient rehabilitation.
Health professional participants will be eligible if they:
Are providing outpatient services within a participating clinical team.
Have the scope to include PA promotion in their practice, including physiotherapists, occupational therapists, geriatricians, rehabilitation physicians, rheumatologists, endocrinologists, surgeons, oncologists, haematologists, sports physicians, exercise physiologists or nurses.
Provide informed consent and have the willingness and capacity to meet study requirements.
Patient inclusion criteria
Eligible patients will be identified by the treating health professional in each cluster. Formal informed consent and study recruitment will be undertaken by the research team. Patient participants will be eligible if they are adults (aged 18+ years) or school-aged children (aged 5–17 years) attending a participating service and who are willing to receive additional support to be more physically active; agree to complete study surveys; have no contra-indications to increase PA; and have sufficient language capabilities to respond to written or verbal questionnaires in English, Arabic or Vietnamese. Potential participants will be excluded if they have: a medical condition precluding PA/exercise; a progressive neurological disease that severely affects function; or other conditions affecting study participation for example, delirium, terminal illness, severe psychiatric disorders.
Recruitment and randomisation
Clinical teams
30 clinical teams will be recruited as clusters and randomised to either the early implementation support group (who will receive the multi-faceted implementation strategy immediately) or the delayed implementation support group (who will receive support after 3 months or once they have recruited their anticipated quota of patients). Eligible clinical teams will be identified by the Investigators in collaboration with clinical managers. The investigators will present the study protocol to the clinical team (via face-to-face or online meetings) and provide study brochures and participant information. The Head of Department or other contact person will then liaise with staff regarding interest and eligibility to participate. Health professionals who agree to participate will provide informed consent prior to the team being randomised. Health professionals who join the team during the study can also consent and participate.
Clinical teams will undertake a ‘service mapping’ process to tailor implementation strategies to their service. The service mapping process consists of two phases: phase I (before randomisation) and phase II (after randomisation, either immediately for the early implementation support group or after participant recruitment for the delayed implementation support group). For phase I, the research team will work with team leaders to identify team members, clinical processes and the patient journey. For phase II, the research team will work with clinical teams and managers to identify readiness for change, current PA promotion practices, barriers and facilitators to PA promotion, as well as the implementation strategies and PA promotion interventions to be delivered. A tailored implementation plan will be developed and documented for each team.
Following phase I service mapping, clinical teams will be randomised to receive the supported implementation strategy immediately or after a delay. The randomisation schedule will be generated in STATA statistical software and uploaded into Research Data Electronic Capture (REDCap) data management software. The randomisation schedule includes stratified block randomisation with randomly selected block size using two dichotomous variables: (a) anticipated number of occasions of service (services likely to provide 1–2 occasions of service per patient during study period vs services likely to provide on average 3 or more occasions of service) and (b) patient population (adults or paediatrics). When there is a team(s) to randomise, the study coordinator will enter the team into REDCap to generate group allocation. To ensure concealed allocation, research staff who are responsible for generating the schedule and uploading it into REDCap will not be involved in recruiting teams.
Patient-participants
Consecutive new patients of participating health professionals will be invited to participate by their treating health professional. Eligible patients will be provided with a written information sheet and encouraged to discuss their participation with family. The research team will then follow-up with patients by phone to seek informed consent. For participants aged 5–17 years, initial contact will be made with the parent/carer to consider the study. A child-friendly version of the study information will also be offered to children/young people who are considering participating. Written, informed consent will be given by the parent/carer for all participants aged 5–17 years, with children aged 13–17 years also able to provide assent to participate.
Interventions
As this is a hybrid type I implementation effectiveness trial, two components are being investigated; (a) evidence-based intervention (PA promotion) delivered by health professionals to their patients within their routine care with support from the research team (primary question) and (b) implementation strategies delivered by researchers to support health professionals in incorporating PA promotion into their routine care. Figure 2 provides an overview of implementation strategies and PA interventions for this study.
PA promotion intervention within routine care
The PA promotion intervention in this study is underpinned by theoretical models of behaviour change (Capability, Opportunity, Motivation-Behaviour model,22 Self Determination Theory23 and Social Cognitive Theory).24 It also uses motivational interviewing, which incorporates behaviour change techniques, and has been shown to increase PA in the general population6 as well as people with physical disabilities.7
The model for PA promotion in this study is informed by the ‘5As’ Physical Activity Promotion Model.8 The PA promotion intervention (figure 2) will be embedded into routine clinical care by health professionals and includes:
Assess: all health professionals will be encouraged to assess their patients’ PA participation and influences on this, provide brief advice and implement one or more of the PA approaches as per that team’s implementation plan.
Additional actions may include any of the following (depending on the team’s patient groups, clinical setting and capacity):
Advise: provide advice regarding the benefits of PA and make specific recommendations on suitable opportunities.
Agree: collaboratively set goals and develop an action plan.
Assist: collaboratively identify barriers and potential solutions and set up a self-monitoring strategy.
Arrange: arrange referral to a community PA programme and/or the PROMOTE-PA Linkage Programme, discuss social support and follow-up.
For teams that have limited capacity to incorporate all five elements of 5As model, eligible patients will be referred by their health professional to the PROMOTE-PA Linkage Programme. The PROMOTE-PA Linkage Programme will be developed specifically for this study and delivered by trained staff within the research team. This programme will provide:
Assessment: an initial session of up to 1 hour from an experienced physiotherapist or exercise physiologist to identify what support they may need/want to be more active. This session may be provided via phone call or video call.
Tailored advice about suitable PA opportunities or ways to incorporate PA into one’s day.
Development of an individualised plan that may include referral to local opportunities/services.
An optional second session to discuss the plan and provide additional support to help patients get started and stay active.
Additional PA referral options, including new models of service delivery, will also be developed where indicated to support patients transitioning from hospital-based to community-based PA opportunities. Table 1 describes the PA promotion interventions that could be delivered by health professionals in this study according to the TIDieR framework.
Implementation strategies
The implementation strategies have been selected to address barriers described in the literature as well as barriers specific to each team. Health professionals in the early implementation support group will be offered strategies to support and train them to incorporate PA promotion into their routine practice. All teams in the early implementation support group will receive access to an online resource hub, with additional strategies offered as indicated. Table 2 provides an overview of the implementation strategies to be offered in this study (tailored to each team).
Outcome measures
As a hybrid type I study, patient-level effectiveness outcomes will be measured while collecting data on implementation outcomes and determinants. All effectiveness outcomes as well as demographic information will be assessed at baseline to enable a description of patients’ baseline characteristics and to obtain values to enter as covariates in the models, comparing groups at follow-up. At the time of consent, the research team member will send patients either a link to complete the electronic survey or a paper survey. Surveys will be completed independently by participants or assisted by research staff over the telephone who are blinded to team allocation. Follow-up effectiveness outcomes will be collected via surveys at 3-month and 6-month postrandomisation. Patients will be followed up by blinded research staff if follow-up surveys are not completed within 1 week. For participants aged 5–17 years, questionnaires will be completed by the parent/proxy together with the child, or by self-report for older children/adolescents as they are able.
Primary effectiveness outcome
The primary effectiveness outcome is self-reported time (hours/week) spent in moderate-vigorous PA over the last 7 days at 3 months (primary endpoint) and 6 months from baseline. This will be measured using a modified version of the Physical Activity Vital Sign, a self-reported survey consisting of two items assessing the number of days and minutes per day spent in moderate-vigorous PA over the past 7 days.25 For participants aged 5–17 years, this measure will be completed by proxy-report for younger children and by self-report for older children/adolescents as able. This measure has demonstrated acceptable reliability and validity among adolescents26 and adults not currently meeting PA guidelines.27
Secondary effectiveness outcomes
Physical activity
additional questions assessing adherence with other aspects of the WHO PA guidelines will be collected. These questions will assess the self-reported number of days per week participating in muscle strengthening activity and in balance/functional training (participants aged 18+ years)25 and the number of days per week active for more than 60 min using the Patient-centred Assessment and Counselling for Exercise measure (participants aged 5–17 years).26 The three most common types of PA that participants engage in will also be recorded.
Patient-Reported Outcomes Measurement Information System
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) profile V.2.1 Physical Function domain will assess physical functioning of participants aged 18+ years. The Physical Function domain includes four items, each rated on a 5-point scale. The physical function domain score will be generated (raw and T-score). The PROMIS Parent Proxy Mobility Short Form 8a will be used for participants aged 5–17 years and consists of eight mobility items rated on a 5-point scale. Preliminary evidence supports the reliability and validity of the PROMIS tool.28
Global perceived change in PA and mobility
Global perceived change in PA and mobility will each be assessed by a single question asking participants to rate their current PA and mobility levels now compared with 3 months ago. Each item is ranked on a 10-point scale from −5 (a lot worse) to +5 (a lot better). Global rating of change scales have adequate test–retest reliability, face validity and construct validity.29
EuroQOL-5D (EQ5D-5L)
Utility-based quality of life will be measured using the EQ5D-5L (adults aged 18+ years) or the EQ5D-Y Proxy report (children and adolescents aged 5–17 years). The EQ5D-5L is a 5-item quality of life scale measuring the domains of mobility, self-care, usual activities, pain or discomfort and anxiety or depression. Each item is rated on a 5-point scale ranging from no problems to extreme problems. The EQ5D-5L also includes a visual analogue scale asking participants to rate their current health status from 0 (worst imaginable) to 100 (best imaginable). The EQ5D-5L and EQ5D-Y provide five domain scores, a visual analogue scale score (0–100) and overall health utility score.30 31
Strategies to include culturally and linguistically diverse patients
This study will include targeted approaches to include participants from Arabic and Vietnamese backgrounds, two common backgrounds in the Sydney region. Consultation with staff from the District Multicultural Health Services across the health districts has informed our targeted approaches to include diverse participants. Participant information, consent forms and effectiveness outcome measures will be provided to patients in their preferred language of English, Arabic or Vietnamese. Arabic and Vietnamese translations of the patient surveys will be used. Training resources for health professionals also include advice and resources for delivering PA promotion to people from diverse backgrounds.
Data analysis and management
Sample size
Recruitment of 720 patients across 30 clusters (average 24 participants per cluster) will be sufficient to detect a weekly absolute between-group difference of 75 min in moderate-vigorous PA (assuming 180 min in the early implementation support group and 105 min in the delayed implementation support group, SD=204 min). This calculation used 80% power, alpha=0.05, intraclass correlation=0.05 and allowed for a 20% dropout rate. Calculations were undertaken using clustersampsi in Stata V.16. A previous study investigating the effect of digitally enabled interventions to target PA and mobility problems postrehabilitation found a mean between-group difference of 1.8 hours/week (95% CI 0.6 to 3.0) in the walking activity subscale of the Incidental and Planned Exercise Questionnaire.32
Data management
Patient screening will be collected on encrypted Excel spreadsheets for each clinical team and saved on the health service password protected drive. All paper-based patient data will be entered on a password protected REDCap database33 34 with license held by The University of Sydney. Access to this database will only include the chief investigator and required members of the research team. Patient and health professional participants will be given the option to complete surveys electronically or on paper. For electronic completion, unique survey links will be sent to participants to complete their survey directly into REDCap. For paper completion, data will be entered by a member of the research team, and a random sample of surveys (10% of completed paper surveys) will be double checked by a second member of the research team. If any errors are found a further 10% will be checked. Survey questions will use data validation in REDCap where possible.
A Data Safety and Monitoring Board has been established for this study and comprises three clinical and academic members external to the study team who will meet in the occurrence of a serious adverse event, defined as an unwanted and usually harmful outcome (eg, injurious fall, seizure, cardiac event).35 The event may or may not be related to the intervention, but it occurs while the person is participating in the intervention for example, while they are being physically active.
Patient-level effectiveness outcomes
The planned quantitative analysis has been designed by CS and LH, overseen by the study statistician (KR). Primary analyses will be pre-planned and conducted while masked to group allocation. To account for correlation among individuals within clusters, all statistical models will use a generalised estimating equations approach with an exchangeable correlation structure.
The primary analysis will evaluate the effect of PA promotion on the self-reported PA of patients, with moderate-vigorous PA as the primary outcome. The main intention-to-treat dataset will include all patients recruited into the study irrespective of the amount of PA promotion they received. For continuous outcomes, multiple linear regression will be used with group (early implementation support vs delayed implementation support) as the primary independent variable and baseline scores as a covariate. Binary logistic regression will compare groups on dichotomous outcome measures with group as primary independent variable. We will also conduct a planned subgroup analysis for paediatric participants aged 5–17 years to investigate the effect of PA promotion on PA among children and young people.
Discussion
This study tests a potentially efficient intervention to increase PA participation using the health workforce. There is strong evidence to support this intervention. The WHO’s Global Action Plan on Physical Activity 2018–2030 supports PA promotion by health professionals as one of its 20 policy actions to achieve a 15% relative reduction in the global prevalence of physical inactivity by 2030.10
There are several minor risks in this study. The extra time required to administer the intervention could place undue stress on health professionals or compromise care to patients (participating or other). To minimise this risk, the implementation strategies and PA promotion interventions will be tailored for each team. Contamination between health professionals in early and delayed implementation clusters could occur. We have selected a cluster trial rather than an individually randomised controlled trial to reduce this risk, however clinical staff could move between clinical teams in unforeseen circumstances. In this instance the health professional will still be welcome to participate in implementation strategies, however, they will not recruit any patients and will be asked not to share resources.
The benefits of PA are known, yet only 17% of PA studies are implementation or scale-up studies.36 By using the hybrid type I design to test the effectiveness of the PA promotion intervention while gathering implementation data, our study will provide essential information about how this intervention can be adopted and delivered in a real-world setting. This will provide direct evidence to policymakers regarding if—and how—the intervention can be implemented and scaled up to improve PA participation.
Data availability statement
No data are available. Not applicable.
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants and was approved by Sydney Local Health District Human Research Ethics Committee (2023/ETH01101). Participants gave informed consent to participate in the study before taking part.
Acknowledgments
The authors wish to thank the consumer volunteers within the Institute for Musculoskeletal Health for providing feedback on study documents. The authors also wish to thank the consumer and health professional volunteers involved in developing educational resources for patients and health professionals.
References
Footnotes
X @mnoetel
Contributors CS, LH and AT conceived the study. CS, LH, AT, LAH, MP, KH, PP, AH, MN, AB, CL, BJS, GC, GD, KW and LR received funding to conduct this study. LH designed the multi-faceted implementation strategy and evidence-based intervention with CS, AT, JNB, KP and RS with input from other authors. JNB, KP, CS, RS and LH designed the study protocol and resources with input from all authors. JNB drafted the manuscript and all authors provided critical review. All authors approved the final manuscript version. CS is the guarantor of this manuscript.
Funding This study is funded under the NHMRC 2021 Partnership Project Grant Scheme (2011157). MP and CS receive salary from an Australian National Health and Medical Research Council Fellowship. AT is supported by a University of Sydney Robinson Fellowship. BW is supported by a Research Training Programme Stipend Scholarship.
Competing interests No, there are no competing interests.
Provenance and peer review Not commissioned; externally peer reviewed.