PATHWEIGH: Pragmatic Weight Management in Primary Care

Sponsor

University of Colorado, Denver (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04678752

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

6,840

Enrollment

Locations

Arms

Anticipated Duration (Months)

106.9

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Weight management care path Other: Control	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6840 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Effectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial designEffectiveness-Implementation Hybrid Type 1 Study using a Stepped Wedge Cluster Randomized Trial design

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

PATHWEIGH: Pragmatic Weight Management in Primary Care

Actual Study Start Date :

Mar 17, 2020

Anticipated Primary Completion Date :

Mar 17, 2025

Anticipated Study Completion Date :

Sep 17, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Each primary care provider will administer weight loss care per their standard practice.	Other: Control 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.
Experimental: PATHWEIGH A weight management care path that support primary care both through the EHR and training for the clinicians.	Other: Weight 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

Arm

Intervention/Treatment

Active Comparator: Standard of Care

Each primary care provider will administer weight loss care per their standard practice.

Other: Control

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.

Experimental: PATHWEIGH

A weight management care path that support primary care both through the EHR and training for the clinicians.

Other: Weight 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

Outcome Measures

Primary Outcome Measures

Evaluate the implementation of PATHWEIGH and determine its effectiveness versus control clinics using standard of care (SOC) on patient weight loss [6 months]
Change from baseline

Secondary Outcome Measures

Evaluate the implementation of PATHWEIGH and determine its effectiveness versus standard of care on weight loss maintenance. [12 and 18 months]
To examine weight maintenance we will examine weight change from 6 to 12 months and 6 to 18 months. Weight loss maintenance will be defined as weight increase <10% from the 6-month weight time point.

Other Outcome Measures

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.
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.
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.
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 [6 months post intervention for each cohort through study end]
Interviews with a purposefully selected sample of providers will be conducted to measure factors that impact the implementation of PATHWEIGH.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCHealth Primary Care - Arvada West	Arvada	Colorado	United States	80007
2	UCHealth Primary Care - Quincy	Aurora	Colorado	United States	80015
3	UCHealth Executive Health Services - Anschutz Medical Campus	Aurora	Colorado	United States	80045
4	UCHealth Internal Medicine - Anschutz Medical Campus	Aurora	Colorado	United States	80045
5	UCHealth Seniors Clinic - Anschutz Medical Campus	Aurora	Colorado	United States	80045
6	UCHealth Women's Integrated Services in Health - Anschutz Medical Campus	Aurora	Colorado	United States	80045
7	UCHealth Family Medicine - Boulder	Boulder	Colorado	United States	80303
8	UCHealth CU Family Medicine - Depot Hill	Broomfield	Colorado	United States	80020
9	UCHealth Primary Care - Broomfield	Broomfield	Colorado	United States	80020
10	UCHealth Primary Care - Castle Rock	Castle Rock	Colorado	United States	80104
11	UCHealth CU Family Medicine - Centennial	Centennial	Colorado	United States	80122
12	UCHealth Primary Care and Sports Medicine Clinic - Lake Plaza	Colorado Springs	Colorado	United States	80906
13	UCHealth Primary Care - Fontanero	Colorado Springs	Colorado	United States	80907
14	UCHealth Internal Medicine - Printers Park	Colorado Springs	Colorado	United States	80910
15	UCHealth Sports Medicine Clinic - Printers Park	Colorado Springs	Colorado	United States	80910
16	UCHealth Primary Care - Academy	Colorado Springs	Colorado	United States	80918
17	UCHealth Primary Care - Rockrimmon	Colorado Springs	Colorado	United States	80919
18	UCHealth Aspen Creek Medical Center	Colorado Springs	Colorado	United States	80920
19	UCHealth Primary Care - Briargate	Colorado Springs	Colorado	United States	80920
20	UCHealth Primary Care - Chapel Hills	Colorado Springs	Colorado	United States	80920
21	UCHealth Primary Care - Scarborough	Colorado Springs	Colorado	United States	80920
22	UCHealth Primary Care - Craig	Craig	Colorado	United States	81625
23	UCHealth Primary Care - Cripple Creek	Cripple Creek	Colorado	United States	80813
24	UCHealth Primary Care - Steele Street	Denver	Colorado	United States	80206
25	UCHealth CU Internal Medicine - Garfield	Denver	Colorado	United States	80209
26	UCHealth Primary Care - Uptown	Denver	Colorado	United States	80218
27	UCHealth Internal Medicine - Lowry	Denver	Colorado	United States	80230
28	UCHealth A.F. Williams Family Medicine Clinic - Central Park	Denver	Colorado	United States	80238
29	UCHealth Primary Care - Estes Park	Estes Park	Colorado	United States	80517
30	UCHealth Primary Care - Falcon	Falcon	Colorado	United States	80831
31	UCHealth Family Medicine - Firestone	Firestone	Colorado	United States	80504
32	UCHealth Family Medicine Center - Fort Collins	Fort Collins	Colorado	United States	80524
33	UCHealth Internal Medicine - Prospect	Fort Collins	Colorado	United States	80525
34	UCHealth Internal Medicine - Snow Mesa	Fort Collins	Colorado	United States	80528
35	UCHealth Internal Medicine and Pediatric Care Clinic - Snow Mesa	Fort Collins	Colorado	United States	80528
36	UCHealth Internal Medicine - Greeley Midtown	Greeley	Colorado	United States	80538
37	UCHealth Family Medicine - Greeley	Greeley	Colorado	United States	80634
38	UCHealth Internal Medicine - Greeley	Greeley	Colorado	United States	80634
39	UCHealth CU Family Medicine - Landmark	Greenwood Village	Colorado	United States	80111
40	UCHealth Primary Care - Greenwood Village	Greenwood Village	Colorado	United States	80111
41	UCHealth Primary Care - Highlands Ranch	Highlands Ranch	Colorado	United States	80126
42	UCHealth Family Medicine - Littleton	Highlands Ranch	Colorado	United States	80129
43	UCHealth Primary Care - Sterling Ranch	Littleton	Colorado	United States	80125
44	UCHealth Primary Care - Lone Tree	Lone Tree	Colorado	United States	80124
45	UCHealth Primary Care - Yosemite	Lone Tree	Colorado	United States	80124
46	UCHealth Women's Integrated Services in Health - Lone Tree	Lone Tree	Colorado	United States	80124
47	UCHealth Family Medicine - Longmont	Longmont	Colorado	United States	80501
48	UCHealth Internal Medicine - Longmont	Longmont	Colorado	United States	80501
49	UCHealth Longmont Clinic	Longmont	Colorado	United States	80501
50	UCHealth Orchards Medical Center	Loveland	Colorado	United States	80537
51	UCHealth Family Medicine - North Loveland	Loveland	Colorado	United States	80538
52	UCHealth Internal Medicine - East Loveland	Loveland	Colorado	United States	80538
53	UCHealth Internal Medicine - Orchards	Loveland	Colorado	United States	80538
54	UCHealth Primary Care - Monument	Monument	Colorado	United States	80132
55	UCHealth Primary Care - Hilltop	Parker	Colorado	United States	80134
56	UCHealth Primary Care and Women's Wellness - Stonegate	Parker	Colorado	United States	80134
57	UCHealth Primary Care - Sterling	Sterling	Colorado	United States	80751
58	UCHealth Primary Care - Timnath	Timnath	Colorado	United States	80547
59	UCHealth Family Medicine - Westminster	Westminster	Colorado	United States	80021
60	UCHealth Family Medicine - Windsor	Windsor	Colorado	United States	80550
61	UCHealth Family Medicine - Woodland Park	Woodland Park	Colorado	United States	80863
62	Little Snake River Clinic - Managed by UCHealth Yampa Valley Medical Center	Baggs	Wyoming	United States	82321
63	UCHealth Cheyenne Medical Specialists	Cheyenne	Wyoming	United States	82009
64	UCHealth Primary Care - Cheyenne	Cheyenne	Wyoming	United States	82009

Sponsors and Collaborators

University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator: Leigh Perreault, MD, University of Colorado - Anschutz Medical Campus
Principal Investigator: Jodi S Holtrop, PhD, University of Colorado - Anschutz Medical Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT04678752

Other Study ID Numbers:

20-1954
1R18DK127003

First Posted:

Dec 22, 2020

Last Update Posted:

Jun 7, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Colorado, Denver

Obesity

Primary Care

Electronic Health Record

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Jun 7, 2022