Glucose to Goal: A Model to Support Diabetes Management in Primary Care
2018年4月6日 更新者:Linda Siminerio、University of Pittsburgh
Diabetes education is a very important part of diabetes care.
Most people with diabetes receive care in primary care practices where diabetes education is not always available.
This project tests a model designed to improve access to diabetes education services.
調査の概要
詳細な説明
Evidence that diabetes self-management education (DSME) can improve health outcomes has repeatedly been shown and is considered to be a critical component of care.
Diabetes educators are highly skilled at addressing diabetes-related clinical and behavioral needs through DSME, but engagement with diabetes educators is underutilized.
It has been suggested that poor referral practices and the way in which DSME service is delivered are the problems.
Most patients receive diabetes care in primary care yet most DSME programs are distinctly separate from primary care practice.
This limits care coordination and diabetes educator access to amenities currently available to primary care.
Efforts are underway to change the US health care paradigm with a focus on quality in primary care that includes practice redesign, population management, and communication through electronic medical records.
The purpose of this application is to evaluate the deployment of Glucose to Goal, a model relying on a systematic redesign of practice that links diabetes educators services with primary care.
This will be compared to the traditional process for DSME delivery, without the direct connection to primary care processes, for an eighteen month period.
The hypothesis is that the proportion of primary care provider referrals and patient utilization of diabetes educator services from primary care practices participating in Glucose to Goal will be higher compared to those associated with traditional DSME.
It is anticipated that this model will appeal to primary care providers, demonstrate a feasible approach to offering diabetes education in the current health environment, and set the stage for future testing of the model, namely its impact on meaningful improvements on diabetes outcomes and cost-effectiveness.
研究の種類
介入
入学 (実際)
4994
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC Community Medicine, Inc.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Clinical diagnosis of type 2 diabetes
- Patients referred to diabetes self-management education by their primary care provider
- Able to read and write English
Exclusion Criteria:
- Clinical diagnosis of type 1 or gestational diabetes
- Unable to speak or read English
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:支持療法
- 割り当て:非ランダム化
- 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 |
|---|---|
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実験的:Glucose to Goal
Three diabetes educators will be assigned to the Glucose to Goal/experimental arm.
The educators will each identify two primary care practices of mid to large size to participate in the Glucose to Goal intervention.
Patients will not be formally recruited or enrolled.
Rather, information documented in the electronic medical record system will be extracted to evaluate patient-level outcomes.
Based on a random sampling of mid to large size primary care practices in study communities, an estimated 2,200 patients with diabetes per study group will meet eligibility criteria for DSME referral.
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The Glucose to Goal intervention applies elements of the Patient Centered Medical Home (i.e., practice design, decision support, population management, etc) to diabetes education services and operationalizes the current DSME objectives in the primary care setting.
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他の:Control Group
Two usual care diabetes educators will each identify three primary care practices of mid to large size to include in the control arm and participate in the usual care intervention.
Uneven group assignment accounts for the amount of time (one day equivalent/per week) that the intervention diabetes educators will devote to each primary care practice versus the full-time availability of the usual care diabetes educators to see patients at the outpatient, hospital-based program.
Like the experimental arm, an estimated 2,200 patients with diabetes will meet eligibility criteria for DSME referral.
Patients will not be formally recruited or enrolled into the control arm; data will be extracted from the electronic medical record system to evaluate patient-level outcomes.
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The control group will follow the traditional DMSE delivery model, which includes primary care providers referring patients to an outpatient, hospital-based diabetes educator for DSME, but in a passive manner (i.e., without proactive patient identification), which is the usual process for referrals.
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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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Provider referral
時間枠:Monitor continuously across 18 months
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The proportion of provider referrals for DSME divided by the total number of patients eligible for a referral.
Patients will be considered eligible for referral if they were seen by their primary care provider during the intervention period and the provider did not contraindicate DSME for any reason.
Referrals (eligibility for and made) will be tracked through electronic medical record review.
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Monitor continuously across 18 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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Patient participation
時間枠:Monitor continuously across 18 months
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Patient participation will be reported as the proportion of patients who participate in DSME divided by the total number of eligible patients from each participating primary care practice during the study period and will take into account patterns and frequency of visits.
Patients will be considered eligible if they have received a referral to DSME from their primary care provider.
Patients will be offered the opportunity to meet with the diabetes educator for a series of DSME visits and these visits will occur in individual or group format, depending on space, scheduling, etc.
The number and content of the visits will be patient-centered (driven by the patient).
Patients eligible for and participating in DSME will be tracked through electronic medical record review.
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Monitor continuously across 18 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Primary care practice satisfaction with implementation process
時間枠:Baseline, 9 months, 18 months
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The research team will collect data on the implementation process at the primary care practice orientation and team huddles at the mid-point and end of the intervention.
During the practice orientation, the manner in which practices negotiate adoption of the key features of Glucose to Goal will be documented.
With the assistance of trained qualitative researchers, mid and end point team huddles will be conducted using a focus group format to review experiences, examine challenges and barriers, identify best practices, and gauge provider and diabetes educator satisfaction.
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Baseline, 9 months, 18 months
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Hemoglobin A1c
時間枠:As available across 18 months
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In preparation for a larger scale, longitudinal study testing the effectiveness of the Glucose to Goal model on diabetes control, hemoglobin A1c values and other key diabetes markers (i.e., lipid panels, blood pressure) that are documented in the electronic medical record system during the study period will be extracted and analyzed.
Dates and frequency of tests, absolute values, and whether values were within recommended target ranges will be documented.
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As available across 18 months
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Problem Assessment in Diabetes-5 (PAID-5)
時間枠:As available across 18 months
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PAID is a measure of psychosocial adjustment and diabetes emotional distress.
Psychometric reports to date on PAID have shown it to have consistently high internal and test-retest reliability; correlate strongly with a wide range of theoretically related constructs such as general emotional distress, depression, diabetes self-care behaviors, diabetes coping, and health beliefs; and be a statistically significant predictor of glycemic control (Polonsky et al, 1995).
The 5-item version (McGuire et al, 2010) will be administered at DSME visits.
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As available across 18 months
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Diabetes Empowerment Scale - Short Form (DES-SF)
時間枠:As available across 18 months
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To allow for a brief overall assessment of diabetes-related psychosocial self-efficacy, the DES-SF, an 8-item scale, was developed based on the original 37-item DES (Anderson et al, 2003).
DES-SF items address participants' perceived ability to assess readiness to change, set/reach goals, overcome barriers, cope with emotions, manage stress, obtain support, motivation, and make cost/benefit decisions.
The DES-SF will be administered at DSME visits.
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As available across 18 months
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Summary of Diabetes Self-care Activities Measure (SDSCA)
時間枠:As available across 18 months
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This instrument will be used to evaluate self-care with questions about number of days in a week that the participant reports self-care behaviors related to general diet, specific diet, exercise, blood glucose testing, foot care, and smoking.
Correlations with other measures of diet and exercise generally support validity of SDSCA subscales (Toobert et al, 2000).
The SDSCA will be administered at DSME visits.
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As available across 18 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Linda Siminerio, RN, PhD, CDE、University of Pittsburgh
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
- Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
- McGuire BE, Morrison TG, Hermanns N, Skovlund S, Eldrup E, Gagliardino J, Kokoszka A, Matthews D, Pibernik-Okanovic M, Rodriguez-Saldana J, de Wit M, Snoek FJ. Short-form measures of diabetes-related emotional distress: the Problem Areas in Diabetes Scale (PAID)-5 and PAID-1. Diabetologia. 2010 Jan;53(1):66-9. doi: 10.1007/s00125-009-1559-5. Epub 2009 Oct 20.
- Anderson RM, Fitzgerald JT, Gruppen LD, Funnell MM, Oh MS. The Diabetes Empowerment Scale-Short Form (DES-SF). Diabetes Care. 2003 May;26(5):1641-2. doi: 10.2337/diacare.26.5.1641-a. No abstract available.
- Krall JS, Kanter JE, Ruppert KM, Arena VC, Solano FX, Siminerio LM. Effect of a Primary Care-Based Diabetes Education Model on Provider Referrals and Patient Participation. Sci Diabetes Self Manag Care. 2021 Feb;47(1):74-84. doi: 10.1177/0145721720981840.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年4月1日
一次修了 (実際)
2017年12月1日
研究の完了 (実際)
2017年12月31日
試験登録日
最初に提出
2016年3月1日
QC基準を満たした最初の提出物
2016年3月16日
最初の投稿 (見積もり)
2016年3月22日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月10日
QC基準を満たした最後の更新が送信されました
2018年4月6日
最終確認日
2018年4月1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。