Clinical trial NCT03181295: Screening While You Wait: An Intervention to Facilitate Exercise in Primary Care
Official title: Screening While You Wait: A Technology-based Intervention to Facilitate Actionable Exercise Prescriptions in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Family Medicine
Primary Care
Exercise prescriptions
Technology
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2017-06-08
Enrollment: 537
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single-centre, pilot step wedge trial, with graduated, random intervention roll-out across the clinical setting in four steps
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite knowing that exercise improves health, primary care providers (PCPs) do not regularly assess physical activity (PA) levels or use proven techniques to help patients to increase their PA levels. Studies have shown that PCPs don't talk to patients about their PA levels because they don't feel they have adequate knowledge or resources to help their patients. Additionally they don't feel they have time to provide personalized advice regarding PA.

This study will use tablet computers and email to engage patients in contemplating their own PA levels and starting conversations with their PCPs. Electronic surveys delivered via tablets and email prior to periodic health reviews will be used to support customized, patient-centred health care. The patient's survey responses will be used to develop a printable 'toolkit' with individualized PA recommendations, a personalized exercise prescription (Rx), as well as patient-specific educational and community resources. The exercise Rx and resources can be edited by the PCP based on the resulting discussion between patient and PCP.

The overarching aim of this study is to determine how the use of technology in family doctors' offices can help patients to engage with their PCPs regarding PA and ultimately increase their PA levels.

Detailed description: The study will take place at the academic Women's College Hospital (WCH) Family Practice (FP) in Toronto, Canada. The clinic provides over 50,000 patient visits per year and is split into four sub-teams for operational purposes. These teams have unique members with no crossover of PCPs. Patients typically see their own PCP for planned care visit (e.g., preventative care and chronic disease management) but access any PCP available when more acute issues arise.

The PA surveys are administered via Ocean by CognisantMD. Ocean connects patients, PCPs, and researchers using secure surveys on tablets in the FP waiting room and online patient surveys that integrate with WCH FP Electronic Medical Records.

This is a pilot step wedge trial, with graduated, random intervention roll-out across the clinical setting in four steps over five time intervals. Eligible patients presenting to the clinic during the study period will be allocated to intervention or control depending on whether the PCP they have booked to see has had the intervention 'turned-on'. The order determining when each PCP and his or her team change from control to intervention is randomly assigned. This design was chosen to avoid the risk of intervention contamination and to enable logistics of implementation. The teams will receive the control and intervention according to the following schedule:

Time Interval 1: Team A-D Control Time Interval 2: Team A Intervention, Team B-D Control Time Interval 3: Team A+B Intervention, Team C+D Control Time Interval 4: Team A-C Intervention, Team D Control Time Interval 5: Team A-D Intervention

Eligibility criteria: Family physicians (and the patients they care for) are eligible for the study if they are active staff at WCH FP and have consented to participating.

Participating family physicians will assist in identifying potential participants and confirm that patients are appropriate participants for a study of this nature.

Patient inclusion criteria:

* Adult WCH FP patients aged 18-79
* Attending a PHR - formerly known as a 'complete physical' examination

Patient exclusion criteria:

* Non-English speaking patients (due to inability to translate the study materials at the pilot-phase)
* Patients with dementia or cognitive impairment (due to the burden of completing survey materials potentially outweighing the uncertain benefit of intervention)
* Patients who have a major ongoing illness (due to the possibility of their injury/illness interfering with their PA capabilities)
* Patients who are pregnant (due to limitations in modifying PA level between baseline and follow-up)

Primary outcomes:
measure: Metabolic Equivalent of Task-minutes per week
timeFrame: 4 months post-intervention
Secondary outcomes:
measure: Measures of motivation (based on the Health Action Process Approach)
timeFrame: 4 months post-intervention
measure: Measures of self-efficacy (based on the Health Action Process Approach)
timeFrame: 4 months post-intervention
measure: Proportion of eligible patients providing outcome data
timeFrame: 4 months post-intervention
measure: Proportion of eligible patients provided the exercise Rx
timeFrame: 0-2 weeks post-intervention
measure: Estimated time spent on PA
timeFrame: 0-2 weeks post-intervention
measure: Satisfaction with PA advice
timeFrame: 0-2 weeks post-intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital Family Practice
state: Ontario
Study officials:
affiliation: Family Doctor and Research Scientist
name: Noah Ivers
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lippke S, Ziegelmann JP, Schwarzer R. Initiation and Maintenance of Physical Exercise: Stage-Specific Effects of a Planning Intervention. Research in Sports Medicine 12: 221-240, 2004.
citation: Lippke S, Schwarzer R, Ziegelmann JP, Scholz U, Schuz B. Testing stage-specific effects of a stage-matched intervention: a randomized controlled trial targeting physical exercise and its predictors. Health Educ Behav. 2010 Aug;37(4):533-46. doi: 10.1177/1090198109359386. Epub 2010 Jun 14.
citation: Schwarzer R, Lippke S, Luszczynska A. Mechanisms of health behavior change in persons with chronic illness or disability: the Health Action Process Approach (HAPA). Rehabil Psychol. 2011 Aug;56(3):161-70. doi: 10.1037/a0024509.
citation: Agarwal P, Kithulegoda N, Bouck Z, Bosiak B, Birnbaum I, Reddeman L, Steiner L, Altman L, Mawson R, Propp R, Thornton J, Ivers N. Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial. J Med Internet Res. 2020 Feb 14;22(2):e15424. doi: 10.2196/15424.