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Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study.

ABSTRACT: INTRODUCTION:Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in 'how to' make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, including mental health and behavioural change strategies, based on a person's needs. A new, multidisciplinary, person-centred and evidence-based and practice-based programme has been created to address these needs. This proposal aims to evaluate the feasibility and implementation of this programme and to determine changes in participant-directed and clinical outcomes through a pilot study. METHODS AND ANALYSIS:A pragmatic mixed methods design will be used to study multiple dimensions of the year-long healthy lifestyles programme. The pilot study includes a randomised controlled trial, with 30 participants randomised to either the programme or to a comparator arm, and qualitative components to determine the feasibility of the programme, including recruitment and retention, data missing rates and resources needed to run this programme. Changes in participant-directed and clinical outcomes will be measured. Descriptive statistics, t-tests and repeated measures analysis of variance (ANOVA) for within group comparisons and generalised estimating equations for between group analyses will be used. Qualitative interviews of programme staff and healthcare providers and family focus groups will be used to further enhance the findings and improve the programme. ETHICS AND DISSEMINATION:Approval from the Hamilton Integrated Research Ethics Board (HiREB) has been obtained. Informed consent will be obtained prior to enrolling any participant into the study. Participant IDs will be used during data collection and entry. Peer-reviewed publications and presentations will target researchers, health professionals and stakeholders. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Identifier: NCT03258138.HiREB project number: 3793.

SUBMITTER: Alvarez E

PROVIDER: S-EPMC6797346 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study.

Alvarez Elizabeth E Qutob Majdi M Mbuagbaw Lawrence L Lavis John J Lokker Cynthia C Walli-Attaei Marjan M Samaan Zainab Z Sutton Arielle A Singh Japteg J Feeny David D Fortuna John J

BMJ open 20191016 10

<h4>Introduction</h4>Rates of chronic conditions, such as diabetes, cardiovascular disease and obesity are increasing in Canada and internationally. There are effective lifestyle interventions that are known to improve chronic conditions. However, there is often a gap in 'how to' make lifestyle changes. Mental health and other determinants of health play a role in the development and progression of chronic conditions. Changing habits takes time and requires the use of multiple techniques, includ ...[more]

PMID: 31619429

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Project description:BackgroundEfficacy of exercise to improve motor symptoms in Parkinson's Disease (PD) has been established in multiple clinical trials. The Pedaling for Parkinson's ™ (PFP) program is an existing community-based cycling intervention for individuals with PD. Although PFP program design was informed by in-laboratory efficacy studies, the implementation and effectiveness of the program in the community have not been studied. This feasibility study explores implementation and effectiveness of PFP utilizing the RE-AIM implementation evaluation framework.MethodsThis was a pragmatic open-label multi-site study. First, community-based gyms were recruited to implement the PFP protocol with enhanced multi-modal training and support. Second individuals with Hoehn and Yahr stage I-III idiopathic PD were recruited to participate. Reach, effectiveness (both clinical scores and participant enjoyment), adoption, implementation (gym and participant fidelity, cost), and maintenance (sustainability) were assessed. Tracking of adverse events was used to monitor safety of the intervention.ResultsReach was moderate: 59% of participants who expressed interest opted to participate. No effectiveness outcomes demonstrated a significant change from pre to post; however, the program was highly enjoyable (96% of participants who started classes enjoyed the program and 87% wished to continue). Adoption was poor with only four out of 34 gyms participating. The program had poor gym and moderate participant fidelity. The program was maintained for at least 4 months across all sites. The program was implemented safely.ConclusionBarriers to implementation of nonpharmacologic interventions such as exercise protocols limit reach and availability of these interventions to patients. Pilot studies are needed to inform and direct further implementation efforts. Our pilot study suggests the PFP cycling intervention should be modified prior to attempts at widespread implementation. Modifications made by gyms in this study suggest adaptations to the protocol that may increase fidelity and effectiveness.

Project description:BackgroundMultimorbidity, the co-existence of 2+ (or 3+) chronic diseases in an individual, is an increasingly common global phenomenon leading to reduced quality of life and functional status, and higher healthcare service use and mortality. There is an urgent need to develop and test new models of care that incorporate the components of multimorbidity interventions recommended by international organizations, including care coordination, interdisciplinary teams, and care plans developed with patients that are tailored to their needs and preferences.PurposeTo determine the effectiveness of a 6-month, community-based, multimorbidity intervention compared to usual home care services for community-dwelling older adults (age 65+ years) with multimorbidity (3+ chronic conditions) that were newly referred to and receiving home care services.MethodsA pragmatic, parallel, two-arm randomized controlled trial evaluated the intervention, which included in-home visits by an interdisciplinary team, personal support worker visits, and monthly case conferences. The study took place in two sites in central Ontario, Canada. Eligible and consenting participants were randomly allocated to the intervention and control group using a 1:1 ratio. The participants, statistician/analyst, and research assistants collecting assessment data were blinded. The primary outcome was the Physical Component Summary (PCS) score of the 12-Item Short-Form health survey (SF-12). Secondary outcomes included the SF-12 Mental Component Summary (MCS) score, Center for Epidemiological Studies of Depression (CESD-10), Generalized Anxiety Disorder (GAD-7), Self-Efficacy for Managing Chronic Disease, and service use and costs. Analysis of covariance (ANCOVA) tested group differences using multiple imputation to address missing data, and non-parametric methods explored service use and cost differences.Results59 older adults were randomized into the intervention (n = 30) and control (n = 29) groups. At baseline, groups were similar for the primary outcome and number of chronic conditions (mean of 8.6), but the intervention group had lower mental health status. The intervention was cost neutral and no significant group differences were observed for the primary outcome of PCS from SF-12 (mean difference: -4.94; 95% CI: -12.53 to 2.66; p = 0.20) or secondary outcomes.ConclusionWe evaluated a 6-month, self-management intervention for older adults with multimorbidity. While the intervention was cost neutral in comparison to usual care, it was not found to improve the PCS from SF-12 or secondary health outcomes. Recruitment and retention challenges were significant obstacles limiting our ability to assess intervention effectiveness. Yet, the intervention was grounded in internationally-endorsed recommendations and implemented in a practice setting (home care) viewed as a key upstream resource fostering independence in older adults. These features collectively support the identification of ways to recruit/retain older adults and test alternative implementation strategies for interventions that are based on sound principles of multimorbidity management.

Project description:BACKGROUND:The Pragmatic Trial of Video Education in Nursing Homes (PROVEN) is one of the first large pragmatic randomized clinical trials (pRCTs) to be conducted in U.S. nursing homes (N = 119 intervention and N = 241 control across two health-care systems). The trial aims to evaluate the effectiveness of a suite of videos to improve advance care planning (ACP) for nursing home patients. This report uses mixed methods to explore the optimal and suboptimal conditions necessary for implementation fidelity within pRCTs in nursing homes. METHODS:PROVEN's protocol required designated facility champions to offer an ACP video to long-stay patients every 6 months during the 18-month implementation period. Champions completed a video status report, stored within electronic medical records, each time a video was offered. Data from the report were used to derive each facility's adherence rate (i.e., cumulative video offer). Qualitative interviews held after 15 months with champions were purposively sampled from facilities within the highest and lowest adherence rates (i.e., those in the top and bottom quintiles). Two researchers analyzed interview data thematically using a deductive approach based upon six domains of the revised Conceptual Framework for Implementation Fidelity (CFIF). Matrices were developed to compare coded narratives by domain across facility adherence status. RESULTS:In total, 28 interviews involving 33 champions were analyzed. Different patterns were observed across high- versus low-adherence facilities for five CFIF domains. In low-adherence nursing homes, (1) there were limited implementation resources (Context), (2) there was often a perceived negative patient or family responsiveness to the program (Participant Responsiveness), and (3) champions were reticent in offering the videos (Recruitment). In high-adherence nursing homes, (1) there was more perceived patient and family willingness to engage in the program (Participant Responsiveness), (2) champions supplemented the video with ACP conversations (Quality of Delivery), (3) there were strategic approaches to recruitment (Recruitment), and (4) champions appreciated external facilitation (Strategies to Facilitate Implementation). CONCLUSIONS:Critical lessons for implementing pRCTs in nursing homes emerged from this report: (1) flexible fidelity is important (i.e., delivering core elements of an intervention while permitting the adaptation of non-core elements), (2) reciprocal facilitation is vital (i.e., early and ongoing stakeholder engagement in research design and, reciprocally, researchers' and organizational leaders' ongoing support of the implementation), and (3) organizational and champion readiness should be formally assessed early and throughout implementation to facilitate remediation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02612688. Registered on 19 November 2015.

Project description:BackgroundFrail older patients are at risk of experiencing a decline in physical and cognitive function unrelated to the reason for admission. The Elder-Friendly Care (EFC) program was designed to improve the care, experiences, and outcomes of frail older adults. The project supported 8 Early Adoption Sites (EAS) in a large Canadian healthcare organization by providing multiple strategies, educational opportunities, and resources. The purpose of this study was to assess the usefulness of EFC educational materials and resources, staff practice changes and perceptions in pilot sites, and readiness for scale and spread.MethodsThe study was conducted from May 2017 to June 2018 using a mixed-methods approach incorporating the Kirkpatrick Model of Training/Evaluation. A total of 76 Direct Care Staff participated in the staff survey, which assessed their awareness of, satisfaction with, and utilization of EFC principles, resources, and practices. Additionally, 12 interviews were conducted with staff who were directly involved in site implementation of EFC.ResultsMost survey participants were aware (86%, n = 63) of the EFC program, and 85% (n = 41) indicated they or their site/unit had implemented EFC. Out of these 41 participants, the most common practice changes identified were: incorporating alternatives to restraint (81%, n = 33), decreased use of pharmacological restraint (78%, n = 32), and patient and family care planning (76%, n = 31). Participants that attended all 3 EFC Learning Workshops (LWs) were significantly more likely to recommend the EFC Toolkit to others (87% versus 40%; χ2 = 8.82, p < 0.01) compared to participants attending less than 3 EFC LWs. Interview participants indicated that the program was well structured and flexible as sites/units could adopt changes that suited their individual sites, needs, contexts, and challenges.ConclusionsThe educational materials and resources used for the EFC project are useful and appreciated by the Direct Care Staff. Further, participants perceive the EFC intervention as effective in creating positive practice change and useful in reducing hospital-related complications for older patients. Future implementation will investigate the impact of EFC on system-level outcomes in acute care.

Project description:BackgroundMore than 90% of antibiotics are prescribed in primary care, but 50% may be unnecessary. Reducing unnecessary antibiotic overuse is needed to limit antimicrobial resistance. We conducted a pragmatic trial of a primary care provider-focused antimicrobial stewardship intervention to reduce antibiotic prescriptions in primary care.MethodsPrimary care practitioners from six primary care clinics in Toronto, Ontario were assigned to intervention or control groups to evaluate the effectiveness of a multi-faceted intervention for reducing antibiotic prescriptions to adults with respiratory and urinary tract infections. The intervention included provider education, clinical decision aids, and audit and feedback of antibiotic prescribing. The primary outcome was total antibiotic prescriptions for these infections. Secondary outcomes were delayed prescriptions, prescriptions longer than 7 days, recommended antibiotic use, and outcomes for individual infections. Generalized estimating equations were used to estimate treatment effects, adjusting for clustering by clinic and baseline differences.ResultsThere were 1682 encounters involving 54 primary care providers from January until May 31, 2019. In intervention clinics, the odds of any antibiotic prescription was reduced 22% (adjusted Odds Ratio (OR) = 0.78; 95% Confidence Interval (CI) = 0.64.0.96). The odds that a delay in filling a prescription was recommended was increased (adjusted OR=2.29; 95% CI=1.37, 3.83), while prescription durations greater than 7 days were reduced (adjusted OR=0.24; 95% CI=0.13, 0.43). Recommended antibiotic use was similar in control (85.4%) and intervention clinics (91.8%, p=0.37).ConclusionsA community-based, primary care provider-focused antimicrobial stewardship intervention was associated with a reduced likelihood of antibiotic prescriptions for respiratory and urinary infections, an increase in delayed prescriptions, and reduced prescription durations.Trial registrationclinicaltrials.gov ( NCT03517215 ).

Project description:Background: There is growing evidence demonstrating the benefits of intradialytic cycling. However, there are relatively few centers where this practice has been adopted with no reports from hemodialysis units in rural, remote, and northern locations. Maintaining mobility and quality of life for patients on kidney replacement therapy living in remote northern communities is inhibited by inclement weather and lack of access to resources and infrastructure that support physical activity. The integration of intradialytic cycling during hemodialysis offers patients a form of safe physical activity year-round. Objective: This study focuses on better understanding the feasibility and acceptability of implementing intradialytic cycling in a remote northern geographical context. Design: A feasibility study using a mixed-methods explanatory design was adopted for this study. Setting: The research is conducted in Prince George, British Columbia. Participants: The participants are patients attending a community-based dialysis unit in remote northern British Columbia and health professionals working in the same facility. Methods: Quantitative measures were captured through cycling logbooks and quality of life measure, and qualitative data were obtained through semi-structured interviews and analyzed using thematic analysis. Results: Six (43%) eligible patients used leg ergometers more than once for a median of 2.5 (interquartile range: 1-4) months and 87% of hemodialysis sessions. Participants cycled for a median of 65 (interquartile range: 39-76) minutes per session, with frequent variability noted between participants and different hemodialysis sessions for the same participant. Nine patients completed the European Quality of Life Health Questionnaire prestudy, with 5 (56%) also completing it poststudy. Interviews with 9 patients, 4 nurses, and 1 physiotherapist led to the identification of themes instrumental to implementation: a supportive community dialysis unit, shared responsibility, knowledge of patients/providers, and benefits associated with engagement. Themes that were identified as being key to acceptability in this remote dialysis unit were trust, connection, and engagement through common values. Limitations: Due to dialysis unit size, we had a small number of participants. Conclusions: This study demonstrates the feasibility of implementing best practice in a remote community and provides insight into the elements of context and participation that contribute to acceptability in the implementation of intradialytic cycling.

Project description:BackgroundThe Cardiovascular Health Awareness Program (CHAP) uses volunteers to provide cardiovascular disease (CVD) and diabetes screening in a community setting, referrals to primary care providers, and locally available programs targeting lifestyle modification. CHAP has been adapted to target older adults residing in social housing, a vulnerable segment of the population. Older adults living in social housing report poorer health status and have a higher burden of a multitude of chronic illnesses, such as CVD and diabetes. The study objective is to evaluate whether there is a reduction in unplanned CVD-related Emergency Department (ED) visits and hospital admissions among residents of social seniors' housing buildings receiving the CHAP program for 1 year compared to residents in matched buildings not receiving the program.Methods/designThis is a pragmatic, cluster randomized controlled trial in community-based social (subsidized) housing buildings in Ontario and Quebec. All residents of 14 matched pairs (intervention/control) of apartment buildings will be included. Buildings with 50-200 apartment units with the majority of residents aged 55+ and a unique postal code are included. All individuals residing within the buildings at the start of the intervention period are included (intention to treat, open cohort). The intervention instrument consists of CHAP screens for high blood pressure using automated blood pressure monitors and for diabetes using the Canadian Diabetes Risk (CANRISK) assessment tool. Monthly drop-in sessions for screening/monitoring are held within a common area of the building. Group health education sessions are also held monthly. Reports are sent to family doctors, and attendees are encouraged to visit their family doctor. The primary outcome measure is monthly CVD-related ED visits and hospitalizations over a 1-year period post randomization. Secondary outcomes are all ED visits, hospitalizations, quality of life, cost-effectiveness, and participant experience.DiscussionIt is anticipated that CVD-related ED visits and hospitalizations will decrease in the intervention buildings. Using the volunteer-led CHAP program, there is significant opportunity to improve the health of older adults in social housing.Trial registrationClinicalTrials.gov,NCT03549845. Registered on 15 May 2018. Updated on 21 May 2019.

Dataset Information

Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study.

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Feasibility and implementation of a healthy lifestyles program in a community setting in Ontario, Canada: protocol for a pragmatic mixed methods pilot study.

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