Partnership to Reduce Obesity in Community Health Center Patients (SMARTLife Utah)
The long-term objective of SMARTLife Utah is to increase the reach of existing digital EBIs for obesity among patients of Community Health Centers (CHCs). SMARTLife Utah will be conducted in up to 11 Community Health Center (CHC) systems, consisting of 38 primary care clinics. SMARTLife Utah is a hybrid Type III effectiveness-implementation design, utilizing a pragmatic, multilevel, three-phase Sequential Multiple Assignment Randomized Trial (SMART). SMARTLife Utah leverages ubiquitous health information technology(HIT)/telehealth for both the implementation strategies and Evidence-Based Intervention (EBI) delivery in order to address barriers for engaging in EBIs.
Implementation strategies target two different levels to increase the reach of EBIs:
- a clinic-level HIT implementation strategy that includes enhanced system supports at the point of care; and
- patient-level implementation strategies that provide repeated opportunities to enroll in EBIs, as well as motivation/practical problem-solving to facilitate enrollment.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Approximately 40% of U.S. adults have obesity (BMI>30), and excess body weight is associated with at least 13 different cancers and 5% and 11% of cancer cases in men and women, respectively. Evidence-Based Interventions (EBIs) that address excess body weight, physical inactivity, and poor diet are effective in promoting weight loss and reducing cancer risk, but are grossly underutilized. Digital EBI delivery modalities have yielded outcomes comparable to in-person programs. As such, the long-term objective of SMARTLife Utah is to increase the reach of existing digital EBIs for obesity among patients of Community Health Centers (CHCs).
SMARTLife Utah will be conducted in up to 11 Community Health Center (CHC) systems, consisting of 38 primary care clinics. SMARTLife Utah is a hybrid type III effectiveness - implementation design, using a pragmatic, multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART). SMARTLife Utah leverages ubiquitous health information technology (HIT)/telehealth for both the implementation strategies and EBI delivery in order to address barriers of engaging in EBIs.
Implementation strategies target two different levels to increase the reach of EBIs:
- a clinic-level HIT implementation strategy that includes enhanced system supports at the point of care; and,
- patient-level implementation strategies that provide repeated opportunities to enroll in EBIs, as well as motivation/practical problem-solving to facilitate enrollment.
The scientific premise of SMARTLife Utah is based on:
- Evidence that EBIs for obesity are effective but underutilized,
- Recommendations to scale up EBI reach and reduce inequities utilizing technology-based programs,
- Data demonstrating that HIT implementation strategies can dramatically increase engagement with EBIs and fit within existing clinical systems,
- Data indicating that text messaging can increase the reach of EBIs, and
- Prior research has highlighted the effectiveness of telehealth-based patient navigation in improving the reach of EBIs.
SMARTLife Utah will provide critical data regarding the impact of pragmatic and scalable multilevel implementation strategies designed to increase the uptake of EBIs for obesity among patients of CHCs. It will also advance the field of dissemination and implementation science by testing key constructs hypothesized to influence implementation and effectiveness using a comprehensive conceptual framework.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chelsey Schlechter, PhD
- Número de teléfono: 801-213-5704
- Correo electrónico: chelsey.schlechter@hci.utah.edu
Ubicaciones de estudio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute at the University of Utah
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 18 years old or older
- BMI ≥ 30
- Speak either English or Spanish
- Present at the participating clinic
- Valid cell phone number in the electronic health record (EHR)
- EHR indicates they have not opted out of receiving text messages from the clinic
Exclusion Criteria:
- Currently pregnant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: AAC Only
Ask-Advise-Connect (AAC) will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. |
A Health Information Technology (HIT) intervention that consists of an Electronic Health Record (EHR)-based point of care assessment of height/weight for BMI (ASK).
If BMI ≥ 30, clinic staff are prompted to ADVISE via a standardized script and automatically CONNECT interested patients to the Evidence-Based Interventions (EBIs) through electronic referral.
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Otro: AAC + CO
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. A Clinic-level implementation strategy only (CO) for the 12 months following each individual's clinic visit. |
A Health Information Technology (HIT) intervention that consists of an Electronic Health Record (EHR)-based point of care assessment of height/weight for BMI (ASK).
If BMI ≥ 30, clinic staff are prompted to ADVISE via a standardized script and automatically CONNECT interested patients to the Evidence-Based Interventions (EBIs) through electronic referral.
No patient level implementation strategy.
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Otro: AAC + TM
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. Text Messaging (TM) consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all). |
A Health Information Technology (HIT) intervention that consists of an Electronic Health Record (EHR)-based point of care assessment of height/weight for BMI (ASK).
If BMI ≥ 30, clinic staff are prompted to ADVISE via a standardized script and automatically CONNECT interested patients to the Evidence-Based Interventions (EBIs) through electronic referral.
Bidirectional text messages, which include a simple response that directly connects individuals to the EBI in a variety of ways (phone, website, or callback from EBI).
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Otro: AAC + TM + TM-Cont
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with Usual Care (UC) for 3 months, then AAC for 9 months during the Stepped Wedge (SW) Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (i.e., up to 6 texts in all). TM Continued (TM-Cont) will consist of a monthly text message that includes a simple one-touch response to connect during months 6-12 following each individual's clinic visit (i.e., up to 6 texts). |
A Health Information Technology (HIT) intervention that consists of an Electronic Health Record (EHR)-based point of care assessment of height/weight for BMI (ASK).
If BMI ≥ 30, clinic staff are prompted to ADVISE via a standardized script and automatically CONNECT interested patients to the Evidence-Based Interventions (EBIs) through electronic referral.
Bidirectional text messages, which include a simple response that directly connects individuals to the EBI in a variety of ways (phone, website, or callback from EBI).
Bidirectional text messages, which include a simple one-touch response that directly connects individuals to the EBI in a variety of ways (phone, website, or callback from EBI).
No additional patient-level implementation strategy.
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Otro: AAC + TM + TM+MAPS
AAC will be implemented across all clinics and evaluated using a stepped wedge design. CHCs randomized to Wedge 1 will continue with UC for 3 months, then AAC for 9 months during the SW Evaluation period. CHCs randomized to Wedge 2 will continue with UC for 6 months, then AAC for 6 months during the SW Evaluation period. CHCs will continue AAC implementation 3 months after the SW evaluation. CHCs randomized to Wedge 3 will continue with UC for 6 months, then AAC for 3 months during the SW Evaluation period. CHCs will continue AAC implementation 6 months after the SW evaluation. TM consists of a monthly bidirectional text message for 6 months following each individual's clinic visit (up to 6 texts). Continued TM plus Motivation And Problem Solving (TM+MAPS) will consist of a monthly text message plus up to 2 brief telephone calls from patient navigators during months 6-12 following each individual's clinic visit (up to 6 texts and 2 calls). |
A Health Information Technology (HIT) intervention that consists of an Electronic Health Record (EHR)-based point of care assessment of height/weight for BMI (ASK).
If BMI ≥ 30, clinic staff are prompted to ADVISE via a standardized script and automatically CONNECT interested patients to the Evidence-Based Interventions (EBIs) through electronic referral.
Bidirectional text messages, which include a simple response that directly connects individuals to the EBI in a variety of ways (phone, website, or callback from EBI).
Text messages plus telephone health coach calls.
MAPS is an empirically validated behavioral approach that has been demonstrated to facilitate change, including enrollment with EBIs.
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Sin intervención: Usual Care Only
No patient level implementation strategy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reach-Enroll
Periodo de tiempo: up to 12 months
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This outcome measure will report Reach-Enroll, defined as the number of eligible patients who officially enroll in the EBI divided by the total number of eligible patients.
Patients are eligible if they are ≥ 18 years, have a clinic visit during the AAC implementation period, and have a BMI ≥ 30.
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up to 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Reach-Offer
Periodo de tiempo: up to 9 months
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This outcome measure will report Reach-Offer, defined as the number of eligible clinical encounters in which AAC is performed, divided by the total number of eligible encounters.
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up to 9 months
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Reach-Connect
Periodo de tiempo: up to 1 year
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This outcome measure will report Reach-Connect, defined as the number of eligible individuals who accept connection to the EBI divided by the total number of individuals offered connection via AAC or patient implementation strategies.
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up to 1 year
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Representativeness
Periodo de tiempo: up to 9 months
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This outcome measure will report Representativeness, defined as the demographics of participants compared to the CHC patient population.
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up to 9 months
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Adherence to the EBI
Periodo de tiempo: up to 1 year
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To assess EBI effectiveness for 12 months following EBI enrollment.
This outcome measure will report patient adherence, defined as the number of participants who complete the EBI divided by the number of participants who enroll in the EBI.
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up to 1 year
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Weight Loss
Periodo de tiempo: up to 1 year
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To assess EBI effectiveness for 12 months following EBI enrollment.
This outcome measure will report the mean weight loss of participants who enroll in the EBI.
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up to 1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chelsey Schlechter, PhD, Huntsman Cancer Institute/ University of Utah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HCI184365
- 5R01CA283950-02 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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