Obesity
Conditions
Keywords
Obesity, Primary Care, Electronic Health Record
Brief summary
The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews.
Detailed description
This study will investigate how PATHWEIGH, a weight management tool built into the EPIC electronic health record, in combination with clinician and staff training on the use of PATHWEIGH as a tool, education on effective weight management practices, and practice facilitation to support implementation can facilitate weight loss and maintenance for primary care patients. The study examines patient weight loss and maintenance, associated predictors (patient health characteristics and demographics), and contextual factors in the practice environment that influence the intervention's adoption, implementation, and sustainability. This will be achieved through a mixed methods implementation study including collection and analysis of de-identified clinical data, surveys, observations, and interviews. This study is being conducted because despite obesity being the leading cause of preventable death in the U.S. and a major risk factor for disease, people with any degree of overweight or obesity are rarely offered anything other than lifestyle advice, rather than more rigorous and evidence-based weight management strategies. Poor reimbursement for weight-related visits, competing priorities, lack of appropriate tools, and limited time in visits also prevent more widespread use of weight management interventions. PATHWEIGH helps primary care clinicians and teams prioritize weight management with their patients when appropriate and ensures that they have the tools and knowledge handy to do so effectively. As part of the assessment of the PATHWEIGH intervention, the study will identify predictors of patient weight loss and weight loss maintenance using mediator and moderator analysis. Relevant factors (patient demographics, health metrics (e.g. vital signs, anthropometrics, comorbidities), behaviors and goals, provider age, sex, years and % time practicing, and clinic information (e.g. size, location, culture scale)) will be evaluated by including interaction terms between the treatment variable and possible moderating variables in outcome regression models .
Interventions
OTHERWeight management care path
* Documentation and data capture built in the Electronic Health Record * Clinical data support that suggests weight loss approach(es) * Tracking of weight loss progress and weight loss maintenance during patient visits to guide the patient-clinician conversation * Diagnosis and billing in EHR automatically adds the diagnosis of overweight or obesity and links the most common weight-related co-morbidities to ensure adequate provider reimbursement * Evidence-based online training on weight management for clinicians * Practice quality improvement and training for use of PATHWEIGH for weight-prioritized visits through practice coaches/facilitators * Consultation support by practice facilitators with implementing PATHWEIGH and by obesity providers for clinicians with creating patient treatment plans
OTHERControl
Within primary care the option to select Obesity brief HPI, this is a brief historical intake of a patient's weight - when either they or their clinician decides to have a weight-prioritized visit. It is intended to initiate a discussion regarding potential strategies for weight loss (often eat less, exercise more). The provider has the discretion to augment or add support as they see fit.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
Clinician Inclusion Criteria: * Affiliated with a participating primary care practice * Provide care for adult patients (\>=18 years old) Patient Inclusion Criteria: * All adult patients (age \>18 years) * BMI \>25 kg/m2 * Appointment at a primary care clinic participating in the study Patient
Exclusion criteria
* Unable to participate in weight loss treatment due to factors such as cognitive deficits, non-home residence, or limited life expectancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient weight trajectories over the 6 months after the initial weight measured in the usual care and intervention phases | 0 to 6 months | Change in patient weight trajectories 0-6 months after the initial weight measurement in the usual care and intervention phases. |
| Patient weight maintenance, as measured by patient weight trajectories from 6 to 18 months after the initial weight measurement, in the usual care and intervention phases | 6 to 18 months | Change in patient weight trajectories from 6 to 18 months after the initial weight measurement in the usual care and intervention phases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient weight maintenance, as measured by patient weight trajectories from 6 to 18 months after the initial weight measurement, in the usual care and intervention phases stratified by those received vs. did not receive discernible weight-related care | 6 to 18 months | Change in weight from 6 to 18 months after the initial weight measurement in the usual care and intervention phases stratified by those who did and did not receive discernible weight related care. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative assessment of adoption of the intervention by medical providers. | 1 year post intervention start/cohort | Qualitative interviews of a purposefully selected sample of providers will be conducted to understand reasons and barriers to adoption of PATHWEIGH. |
| Implementation - The intervention agents' fidelity to the various elements of the intervention's protocol including consistency of delivery as intended and the time and cost of the intervention | Every 6 months for 5 years | The number of medical providers who provided the PATHWEIGH intervention to patients correctly (meeting fidelity criteria) which will be abstracted from the medical record. |
| Reach - The representativeness of individuals who participate in the trial. | Baseline and each 1 year step after | Individual participants enrolled on the trial versus the number of patients eligible for the trial will be assessed within the electronic medical record. |
| Maintenance - The extent to which the intervention becomes part of practice | 1 year post intervention start cohort up till year 5 of the study | Each practice will be evaluated for the extent to which they continue to use the PATHWEIGH intervention via medical record review indicating intervention use amongst eligible patients. |
| Maintenance - The proportion of patients that maintained weight loss at 18 months post enrollment. | 18 months post enrollment | Patients will be weighed and the difference from initial weight-prioritized visit. |
| Qualitative assessment of the reach of patient recruitment | 6 months post intervention start | Interviews with a purposefully selected sample of patients to measure factors that impact patient recruitment to the study. |
| Adoption - The representativeness of providers who initiate the intervention | Baseline and at each 1 year step | The proportion of medical providers who provide the PATHWEIGH intervention to patients over medical providers who were eligible but chose not to provide the PATHWEIGH intervention will be calculated overall and within each participating clinic. |
Countries
United States
Outcome results
None listed