The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Abstract Background Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. Methods This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. Discussion Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. Trial registration ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

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Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial

Journal of General Internal Medicine ◽

10.1007/s11606-020-06570-y ◽

2021 ◽

Author(s):

Michele Heisler ◽

Jennifer Burgess ◽

Jeffrey Cass ◽

John F. Chardos ◽

Alexander B. Guirguis ◽

...

Keyword(s):

Clinical Practice ◽

Usual Care ◽

Health Systems ◽

Pragmatic Trial ◽

Veterans Affairs ◽

Control Group ◽

Shared Medical Appointments ◽

Site Cluster ◽

Cluster Randomized

Abstract Objective To examine whether diabetes shared medical appointments (SMAs) implemented as part of usual clinical practice in diverse health systems are more effective than usual care in improving and sustaining A1c improvements. Research Design and Methods A multi-site cluster randomized pragmatic trial examining implementation in clinical practice of diabetes SMAs in five Veterans Affairs (VA) health systems was conducted from 2016 to 2020 among 1537 adults with type 2 diabetes and elevated A1cs. Eligible patients were randomly assigned to either: (1) invitation to participate in a series of SMAs totaling 8–9 h; or (2) continuation of usual care. Relative change in A1c (primary outcome) and in systolic blood pressure, insulin starts, statin starts, and anti-hypertensive medication classes (secondary outcomes) were measured as part of usual clinical care at baseline, at 6 months and at 12 months (~7 months after conclusion of the final SMA in four of five sites). We examined outcomes in three samples of SMA participants: all those scheduled for a SMA, those attending at least one SMA, and those attending at least half of SMAs. Results Baseline mean A1c was 9.0%. Participants scheduled for an SMA achieved A1c reductions 0.35% points greater than the control group between baseline and 6-months follow up (p = .001). Those who attended at least one SMA achieved reductions 0.42 % points greater (p < .001), and those who attended at least half of scheduled SMAs achieved reductions 0.53 % points greater (p < .001) than the control group. At 12-month follow-up, the three SMA analysis samples achieved reductions from baseline ranging from 0.16 % points (p = 0.12) to 0.29 % points (p = .06) greater than the control group. Conclusions Diabetes SMAs as implemented in real-life diverse clinical practices improve glycemic control more than usual care immediately after the SMAs, but relative gains are not maintained. Our findings suggest the need for further study of whether a longer term SMA model or other follow-up strategies would sustain relative clinical improvements associated with this intervention. Trial Registration ClinicalTrials.gov ID NCT02132676

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Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments

Trials ◽

10.1186/s13063-020-4110-0 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Bethany M. Kwan ◽

L. Miriam Dickinson ◽

Russell E. Glasgow ◽

Martha Sajatovic ◽

Mark Gritz ◽

...

Keyword(s):

Study Protocol ◽

Pragmatic Trial ◽

Shared Medical Appointments ◽

Cluster Randomized

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Implementing a Pain Self-Management Protocol in Home Care: A Cluster-Randomized Pragmatic Trial

Journal of the American Geriatrics Society ◽

10.1111/jgs.14836 ◽

2017 ◽

Vol 65 (8) ◽

pp. 1667-1675 ◽

Cited By ~ 6

Author(s):

M. Carrington Reid ◽

Charles R. Henderson ◽

Melissa A. Trachtenberg ◽

Katherine L. Beissner ◽

Eileen Bach ◽

...

Keyword(s):

Home Care ◽

Pragmatic Trial ◽

Self Management ◽

Management Protocol ◽

Cluster Randomized

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GPS' PERCEPTION OF THE PATIENT ORIENTED INTERVENTIONS AS KEY ELEMENTS OF PATIENT CENTRED CARE FOR PEOPLE WITH MULTIMORBIDITY.pdf

Knowledge International Journal ◽

10.35120/kij2802561a ◽

2018 ◽

Vol 28 (2) ◽

pp. 561-565

Author(s):

Radost Assenova ◽

Levena Kireva ◽

Gergana Foreva

Keyword(s):

Chronic Conditions ◽

Patient Centered Care ◽

Self Management ◽

Multiple Chronic Conditions ◽

Positive Health ◽

Patient Centered ◽

Effective Response ◽

Patient Centred Care ◽

Centered Care ◽

Health Related

Background: Patients with multimorbidity represent a significant portion of the primary healthcare population. For healthcare providers, managing patients with multiple chronic conditions represents a challenge given the complexity and the intensity of interventions. Integrated and patient-centered care is considered an effective response to the needs of people who suffer from multiple chronic conditions. According to the literature providing patient-centered care is one of the most important interventions in terms of positive health-related outcomes for patients with multimorbidity.Aim: The aim of the study is to evaluate the GPs’ perception of patient oriented interventions as key elements of patient centred care for patients with multimorbidity.Material and methods: A cross-sectional pilot study was conducted among randomly selected 73 GPs. A direct individual anonymous survey was performed to explore the opinion of respondents about the importance of two patient-oriented interventions, each one including specific elements of patient-centered care for patients with multimorbidity. The tool was developed as a result of the scoping review performed by Smith et al. (2012;2016). A 5-point Likert scale (0-not at all, 1-little, 2-rather, 3-much, 4-very strong) was used. The data were analysed using descriptive statistics. In processing the data, the software product for statistical analyses - SPSS version 17 was performed for Windows XP.Results: Our results show that both categories - providing patient-oriented approach and self-management support interventions were highly accessed by the respondents. The most frequent categories of interventions identified in our study were Creating individualized and adapted interventions, Performing regular contacts and Reinforcing adherence. Less frequently reported elements such as Considering relatives’ needs and Developing self-management plan are still underestimated by the Bulgarian GPs.Conclusions: The acceptance and understanding of innovative patient-centered interventions adapted to patients with multimorbidity could be accepted as a good indicator for improving health-related outcomes and care for patients with multiple chronic conditions.

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A patient-centered mobile intervention to promote self-management and improve patient outcomes in chronic heart failure: The ManageHF4Life trial (Preprint)

10.2196/preprints.26185 ◽

2020 ◽

Author(s):

Michael P. Dorsch ◽

Karen B. Farris ◽

Brigid E. Rowell ◽

Scott L. Hummel ◽

Todd M. Koelling

Keyword(s):

Heart Failure ◽

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Self Care ◽

Self Management ◽

Control Group ◽

Patient Centered ◽

Self Monitoring ◽

Heart Failure Questionnaire

BACKGROUND Successful management of heart failure (HF) involves guideline based medical therapy as well as self-care behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE Evaluate the effectiveness of a mobile application intervention that enhances self-monitoring on health-related quality of life, self-management, and reduces HF readmissions. METHODS A single-center randomized controlled trial was performed. Patients greater than 45 years of age and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group used a mobile application (App). The intervention prompted daily self-monitoring and promoted self-management. The control group (No App) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and recurrent HF admissions. RESULTS Eighty-three patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF etiology. The App group had a reduced MLHFQ at 6 weeks (37.5 ± 3.5 vs. 48.2 ± 3.7, P=0.039) but not at 12 weeks (44.2 ± 4 vs. 45.9 ± 4, P=0.778) compared to No App. There was no effect of the App on the SCHFI at 6 or 12 weeks. The time to first HF admission was not statistically different between the App versus No App groups (HR 0.89, 95% CI 0.39-2.02, P=0.781) over 12 weeks. CONCLUSIONS The mobile application intervention improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on HF self-care. Further research is needed to enhance engagement in the application for a longer period of time and to determine if the application can reduce HF admissions in a larger study. CLINICALTRIAL NCT03149510

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Identifying the minimal important difference in patient-reported outcome measures in the field of people with severe mental illness: a pre–post-analysis of the Illness Management and Recovery Programme

Quality of Life Research ◽

10.1007/s11136-021-02779-4 ◽

2021 ◽

Author(s):

Titus A. A. Beentjes ◽

Steven Teerenstra ◽

Hester Vermeulen ◽

Peter J. J. Goossens ◽

Maria W. G. Nijhuis-van der Sanden ◽

...

Keyword(s):

Mental Illness ◽

Severe Mental Illness ◽

Minimal Important Difference ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Self Management ◽

Illness Management ◽

Meaningful Change ◽

Illness Management And Recovery ◽

Patient Reported

Abstract Purpose Complementary interventions for persons with severe mental illness (SMI) focus on both personal recovery and illness self-management. This paper aimed to identify the patient-reported outcome measures (PROMs) associated with the most relevant and meaningful change in persons with SMI who attended the Illness Management and Recovery Programme (IMR). Methods The effect of the IMR was measured with PROMs concerning recovery, illness self-management, burden of symptoms and quality of life (QoL). From the QoL measures, an anchor was chosen based on the most statistically significant correlations with the PROMs. Then, we estimated the minimal important difference (MID) for all PROMs using an anchor-based method supported by distribution-based methods. The PROM with the highest outcome for effect score divided by MID (the effect/MID index) was considered to be a measure of the most relevant and meaningful change. Results All PROMs showed significant pre–post-effects. The QoL measure ‘General Health Perception (Rand-GHP)’ was identified as the anchor. Based on the anchor method, the Mental Health Recovery Measure (MHRM) showed the highest effect/MID index, which was supported by the distribution-based methods. Because of the modifying gender covariate, we stratified the MID calculations. In most MIDs, the MHRM showed the highest effect/MID indexes. Conclusion Taking into account the low sample size and the gender covariate, we conclude that the MHRM was capable of showing the most relevant and meaningful change as a result of the IMR in persons with SMI.

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Harnessing COVID-Driven Technical Innovations for Improved Multi-Disciplinary Cancer Care in the Post-COVID Era: The Virtual Patient Room

Cancer Control ◽

10.1177/1073274820964800 ◽

2020 ◽

Vol 27 (1) ◽

pp. 107327482096480 ◽

Cited By ~ 1

Author(s):

Austin J. Sim ◽

Gage Redler ◽

Jeffrey Peacock ◽

Cristina Naso ◽

Stuart Wasserman ◽

...

Keyword(s):

New Technology ◽

Multidisciplinary Care ◽

Virtual Patient ◽

Paradigm Shifts ◽

Patient Room ◽

Patient Centered ◽

Team Members ◽

The Road ◽

Centered Care ◽

Virtual Visits

Emergence of the COVID-19 crisis has catalyzed rapid paradigm shifts throughout medicine. Even after the initial wave of the virus subsides, a wholesale return to the prior status quo is not prudent. As a specialty that values the proper application of new technology, radiation oncology should strive to be at the forefront of harnessing telehealth as an important tool to further optimize patient care. We remain cognizant that telehealth cannot and should not be a comprehensive replacement for in-person patient visits because it is not a one for one replacement, dependent on the intention of the visit and patient preference. However, we envision the opportunity for the virtual patient “room” where multidisciplinary care may take place from every specialty. How we adapt is not an inevitability, but instead, an opportunity to shape the ideal image of our new normal through the choices that we make. We have made great strides toward genuine multidisciplinary patient-centered care, but the continued use of telehealth and virtual visits can bring us closer to optimally arranging the spokes of the provider team members around the central hub of the patient as we progress down the road through treatment.

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