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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Chelsey Schlechter, PhD
- 電話番号：801-213-5704
- メール：chelsey.schlechter@hci.utah.edu
研究場所
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Utah
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Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute at the University of Utah
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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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他の：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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他の：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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他の：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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他の：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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介入なし：Usual Care Only
No patient level implementation strategy.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reach-Enroll
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reach-Offer
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Chelsey Schlechter, PhD、Huntsman Cancer Institute/ University of Utah
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Ask-Advise-Connect (AAC)の臨床試験
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Chinese University of Hong Kong募集