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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Chelsey Schlechter, PhD
- Номер телефона: 801-213-5704
- Электронная почта: chelsey.schlechter@hci.utah.edu
Места учебы
-
-
Utah
-
Salt Lake City, Utah, Соединенные Штаты, 84112
- Huntsman Cancer Institute at the University of Utah
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: 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.
|
|
Другой: 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.
|
|
Другой: 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).
|
|
Другой: 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.
|
|
Другой: 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.
|
|
Без вмешательства: Usual Care Only
No patient level implementation strategy.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Reach-Enroll
Временное ограничение: up to 12 months
|
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.
|
up to 12 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Reach-Offer
Временное ограничение: up to 9 months
|
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.
|
up to 9 months
|
|
Reach-Connect
Временное ограничение: up to 1 year
|
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.
|
up to 1 year
|
|
Representativeness
Временное ограничение: up to 9 months
|
This outcome measure will report Representativeness, defined as the demographics of participants compared to the CHC patient population.
|
up to 9 months
|
|
Adherence to the EBI
Временное ограничение: up to 1 year
|
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.
|
up to 1 year
|
|
Weight Loss
Временное ограничение: up to 1 year
|
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.
|
up to 1 year
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Chelsey Schlechter, PhD, Huntsman Cancer Institute/ University of Utah
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HCI184365
- 5R01CA283950-02 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .