Enhancing Self-Management Support in Diabetes Through Patient Engagement (EE-CTH)
The Patient Centered Medical Home (PCMH) and the Chronic Care Model (CCM) are complementary clinical intervention frameworks that are commonly invoked to support better type 2 diabetes (T2DM) outcomes in primary care. Self-management Support (SMS) is a core component of both the PCMH and CCM, and focuses on the central role of patients in managing their illness by engaging with and adopting healthy behaviors that promote optimal clinical outcomes. Despite its recognized importance, SMS programs for diabetes continue to demonstrate limited effectiveness in the real-world of primary care.
SMS is comprised of two complementary and interactive components: (1) patient engagement (e.g., the process of eliciting and responding to patients emotions and motivations related to health behaviors), and (2) behavioral change tools (e.g., selecting specific goals, creating action plans). While several sophisticated SMS programs have been developed for T2DM, the vast majority are designed with a narrow focus on behavioral change tools, largely ignoring unique aspects of the patient context that drive and maintain health behavior. Considerable clinical research suggests that the addition of a structured, evidenced-based program of patient engagement can maximize the effectiveness of SMS programs for patients with T2DM in primary care.
To date there has been no systematic study of the degree to which fully integrating enhanced patient engagement as part of SMS will increase the initiation and maintenance of behavior change over time, and for which kinds of patients enhanced patient engagement is essential. To address this gap, the investigators will compare a state-of-the-art, evidence-based SMS behavior change tool program, called Connection to Health (CTH), with an enhanced CTH program that includes a practical, time-efficient patient engagement protocol, to create a program with an integrated and comprehensive approach to SMS, called "Enhanced Engagement CTH" (EE-CTH). The current study will directly test the added benefit of EE-CTH to CTH with regard to self-management behaviors and glycemic control in resource-limited community health centers, where vast numbers of patients with T2DM from ethnically diverse and medically vulnerable populations receive their care. The investigators will use an effectiveness-implementation hybrid design, employing the "Reach Effectiveness Adoption Implementation Maintenance" (RE-AIM) framework to test these two SMS programs for T2DM. This will provide critical information that will support dissemination and implementation of effective SMS programs in resource-limited primary care settings, serving diverse and medically vulnerable populations with much to gain from improved SMS.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a two-arm, 14 month pragmatic cluster randomized trial to evaluate the added benefit of EE-CTH relative to CTH for patients with T2DM in primary care.
Primary care practices (not patients) will be randomly assigned to receive and deliver CTH or EE-CTH in an innovative effectiveness-implementation hybrid design. Using the RE-AIM framework, the investigators will evaluate program effectiveness in a real world setting, while at the same time gathering information on program reach, adoption, implementation and maintenance. CTH and EE-CTH practice trainings and delivery will each follow separate and standardized protocols, with support provided to practices through staff training, ongoing supervision and case presentations, and a practice improvement team assisted by a practice facilitator to address issues of staffing and patient flow. Practice training and facilitation notes, in conjunction with feedback from patient advisory councils, will be captured and integrated to identify barriers and facilitators to the implementation process and inform dissemination efforts. Beyond the requirements of the study, practices will be permitted to use EE-CTH or CTH with other patients as wished, which will enable the investigators to document the program's reach within the practice. Patients in both study arms will receive the intervention at a minimum of two primary care appointments (baseline and follow-up between 6 and 12 months).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94143
- University of California, San Francisco
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Type 2 diabetes;
- Diagnosed and receiving care at participating practices for at least 12 months;
- Able to read in English or Spanish (at least 6th grade level).
Exclusion Criteria:
- Not meeting all inclusion criteria
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Connection to Health (CTH)
CTH is a comprehensive SMS program that focuses on behavior change.
CTH utilizes web-based interactive behavior change technology, based on a logic model of behavior and maintenance that is informed by social-cognitive and social ecological theories.
Prior to diabetes visits with a clinician, health educator, or care manager, patients complete a pre-visit CTH assessment at their practice through a tablet computer or computer kiosk.
CTH assesses multiple diabetes management behaviors (diet, physical activity, medication adherence, alcohol and tobacco use, stress, mood) using brief assessment measures, each with cut-points highlighting areas of deficit.
Action planning plays a central role, through a web-based platform that allows the patient and health care team to select and set goals collaboratively.
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CTH is a comprehensive SMS program that focuses on behavior change.
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Expérimental: Enhanced Engagement Protocol for CTH (EE-CTH)
EE-CTH seamlessly integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol specifically designed to enhance patient engagement in SMS activities.
Key components of MI have been incorporated into a practical and systematic engagement protocol that includes: (1) acknowledging the patient's point of view; (2) identifying and labeling the patient's ambivalence (both the good reasons for making the change and the good reasons for not making the change); (3) evaluating whether change is really worth the effort; (4) identifying, reflecting and labeling accompanying feelings and concerns about change; and (5) establishing a small and meaningful goal by the end of the encounter.
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EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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HbA1c (glycated haemoglobin)
Délai: Change from baseline to follow-up (6 to 12 months)
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Percentage HbA1c
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Change from baseline to follow-up (6 to 12 months)
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High fat food
Délai: Change from baseline to follow-up (6 to 12 months)
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Amount of high fat food consumed weekly adapted from the Summary of Diabetes Self-Care Activities
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Change from baseline to follow-up (6 to 12 months)
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Physical activity
Délai: Change from baseline to follow-up (6 to 12 months)
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Number of minutes of participation in physical activity from the International Physical Activity Questionnaire
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Change from baseline to follow-up (6 to 12 months)
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Number of days missed medications
Délai: Change from baseline to follow-up (6 to 12 months)
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Number of days missed missing one or more medications in the past 14 days
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Change from baseline to follow-up (6 to 12 months)
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Medication adherence
Délai: Change from baseline to follow-up (6 to 12 months)
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Frequency of reasons for missing medications.
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Change from baseline to follow-up (6 to 12 months)
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Fruit and vegetable intake
Délai: Change from baseline to follow-up (6 to 12 months)
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Number of daily fruit and vegetable servings adapted from the Summary of Diabetes Self-Care Activities
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Change from baseline to follow-up (6 to 12 months)
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Sugar-sweetened beverages
Délai: Change from baseline to follow-up (6 to 12 months)
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Number of daily sugar-sweetened beverages from the Starting the Conversation Measure
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Change from baseline to follow-up (6 to 12 months)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Health-related distress
Délai: Change from baseline to follow-up (6 to 12 months)
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Modified from the Diabetes Distress Scale
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Change from baseline to follow-up (6 to 12 months)
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Depression symptoms
Délai: Change from baseline to follow-up (6 to 12 months)
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Patient Health Questionnaire (PHQ8) Score
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Change from baseline to follow-up (6 to 12 months)
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Weight
Délai: Change from baseline to follow-up (6 to 12 months)
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Weight (pounds)
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Change from baseline to follow-up (6 to 12 months)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Danielle M Hessler, Ph.D., University of California, San Francisco
Publications et liens utiles
Publications générales
- Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
- 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.
- Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med. 2008 May-Jun;6(3):246-52. doi: 10.1370/afm.842.
- Paxton AE, Strycker LA, Toobert DJ, Ammerman AS, Glasgow RE. Starting the conversation performance of a brief dietary assessment and intervention tool for health professionals. Am J Prev Med. 2011 Jan;40(1):67-71. doi: 10.1016/j.amepre.2010.10.009.
- Hessler D, Fisher L, Dickinson M, Dickinson P, Parra J, Potter MB. The impact of enhancing self-management support for diabetes in Community Health Centers through patient engagement and relationship building: a primary care pragmatic cluster-randomized trial. Transl Behav Med. 2022 Oct 7;12(9):909-918. doi: 10.1093/tbm/ibac046.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15-17033
- R18DK108039-05 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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