Testing the Impact of the MOHR Follow-up Support
Testing the Impact of the My Own Health Report Intervention With 3 Distinct Options for Structured Follow-up as Compared to a Control Condition
調査の概要
状態
詳細な説明
In previous pilot studies was found that patients in clinics randomized to the MOHR intervention vs. control significantly improved physical activity (p < 0.001) and diet risk behaviors (p < 0.001), as well as other risk factors. However, two gaps were identified. First, clinic partners voiced a need for a more flexible menu of delivery options to feasibly adopt and sustain the intervention. Second, to achieve sustained behavior change, particularly for those with unmet social needs, clinics need to provide structured follow-up. Structured follow-up bundles are part of the ERIC strategy of "enhance uptake and adherence (among patients)" and "technical assistance." In other work, additional reminders and resources improved outcomes of goal-setting interventions in general and among those with unmet social needs, so the study team operationalized these to be delivered either electronically (Reminder and Resources (R2) Message) or by a person (R2 Navigation). To fill these two gaps, we engaged with a subset of both UCHealth and rural primary care clinics and patient advisors to co-develop a menu of delivery options for the MOHR intervention and also a menu of options for the R2 Message and R2 Navigation strategy bundles.
In a randomized comparative effectiveness-implementation trial the study team will enroll 1,000 adult patients with two or more cancer risks (including both insufficient physical activity and fruit/vegetable intake). The study team will evaluate the outcomes of R2 Message and R2 Navigation alone or in combination. Key outcomes include: 1) improvement in behavioral risk factors, 2) representative engagement with R2 Message and R2 Navigation, and 3) improvement in practice value outcomes, including patient experience ratings.
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：Principal Investigator
- 電話番号：(303) 724-2268
- メール：amy.huebschmann@cuanschutz.edu
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- 募集
- University Of Colorado Hospital
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コンタクト：
- Rebekah Gomes
- 電話番号：303-724-3115
- メール：rebekah.gomes@cuanschutz.edu
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主任研究者：
- Amy Huebschmann
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Denver、Colorado、アメリカ、80206
- 募集
- UCHealth Cherry Creek Medical Center
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コンタクト：
- Rebekah Gomes
- 電話番号：303-724-3115
- メール：rebekah.gomes@cuanschutz.edu
-
主任研究者：
- Amy Huebschmann
-
Denver、Colorado、アメリカ、80045
- 募集
- UCHealth Women's Integrated Services in Health (WISH)
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コンタクト：
- Rebekah Gomes
- 電話番号：303-724-3115
- メール：rebekah.gomes@cuanschutz.edu
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Denver、Colorado、アメリカ、80230
- 募集
- UCHealth Internal Medical Clinic - Lowry
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コンタクト：
- Rebekah Gomes
- 電話番号：303-724-3115
- メール：rebekah.gomes@cuanschutz.edu
-
主任研究者：
- Amy Huebschmann
-
Lone Tree、Colorado、アメリカ、80124
- 募集
- UCHealth Lone Tree Medical Center
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コンタクト：
- Rebekah Gomes
- 電話番号：303-724-3115
- メール：rebekah.gomes@cuanschutz.edu
-
主任研究者：
- Amy Huebschmann
-
Westminster、Colorado、アメリカ、80021
- 募集
- UCHealth Family Medicine - Westminster
-
コンタクト：
- Rebekah Gomes
- 電話番号：303-724-3115
- メール：rebekah.gomes@cuanschutz.edu
-
主任研究者：
- Amy Huebschmann
-
-
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:
- Adults, aged 18 years and older.
- Completion of the MOHR health risk assessment and goal-setting tool
- Score in the "at-risk" range on both of the following cancer risk assessments: 1) Physical activity risk: less than 150 minutes per week of moderate to vigorous physical activity; Diet risk: Less than 5 servings daily of combined fruit/vegetables
- Patient at one of the participating clinics
Exclusion Criteria:
- Incomplete or no MOHR assessment
- Language preference/proficiency other than English or Spanish
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. Examples include - Indices of advanced illness and frailty, such as dementia (ICD-10 codes F01.50, F01.51, F02.80, F02.81, F03.90, F03.91, F10.27, F10.97, G31.09, G31.83 or dementia medication of Donepezil • Galantamine • Rivastigmine, Memantine, or Donepezil-memantine)).
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：並列代入
- 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 |
|---|---|
|
アクティブコンパレータ：Control Arm
Standardized version of usual care
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Regular (standard) care provided by healthcare provider team
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実験的：R2 Message Only
Reminder and Resources Messages sent to patient
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Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using messages sent to patients.
|
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実験的：R2 Navigation only
Reminder and Resources provided to patient via health navigator
|
Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using health navigators calling the patients.
|
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実験的：R2 Message + R2 Navigation
Both reminder and resources messages and navigation provided to the patient
|
Regular (standard) care provided by healthcare provider team
Patients will be provided reminders and resources using messages sent to patients.
Patients will be provided reminders and resources using health navigators calling the patients.
|
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 |
|---|---|---|
|
Number of MOHR risk factors
時間枠：From enrollment to the follow-up survey timepoint at 2 months.
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Primary effectiveness outcome measured on scale from -6 to +6 as change of the number of risk factors improved.
MOHR questions are organized into 6 risk areas: 1) intake of fruits and vegetables; 2) high sugar beverages; 3) fast food; 4) physical activity; 5) stress; and 6) sleep.
Each risk factor is evaluated as low risk, medium risk, or high risk.
Level of improvement in risk factors outcome will be a count score from -6 to 6 (any improvement or decrement in level of risk in each factor will count as 1 or -1).
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From enrollment to the follow-up survey timepoint at 2 months.
|
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REACH - specifically representative engagement
時間枠：From enrollment to the follow-up survey timepoint at 6 months.
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Primary implementation outcome.
Representative engagement: Engagement during the follow-up period involves interactions over time of the participant with either or both a navigator or text messages .
Engagement will be assessed percent of navigator calls completed (maximum of 12 over 6 months) and percent of text messages successfully sent (maximum of 60 over 6 months).
To assess whether engagement is representative our primary assessments will be if there is differential engagement across conditions (e.g., an interaction effect) based on 1) number of baseline social needs, 2) Latine vs. non Latine ethnicity or 3) digital literacy.
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From enrollment to the follow-up survey timepoint at 6 months.
|
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Patient experience
時間枠：From enrollment to the follow up survey time point at 6 months.
|
Primary practice value outcome measured by change in mean score on Patient Assessment of Quality-of-Care subscales of goal setting/tailoring and follow-up/coordination (PACIC).
Scale ranges from almost never (indicating the worst patient experience) to almost always (indicating the best patient experience).
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From enrollment to the follow up survey time point at 6 months.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 25-0224.cc
- 1R01CA282292-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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