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The purpose of this study is to evaluate the effectiveness of a peer-to-peer program (P2P) in addition to Shared Medical Appointments (SMAs) compared to SMAs alone for the treatment of diabetes in five VA health systems, and to study the implementation process in order to gather information required to disseminate the program more broadly in the VHA system.
Providers are often unable to communicate as frequently as needed with diabetes patients who have poor risk factor control and face significant self-management challenges. Moreover, many VA patients face barriers to attending frequent face-to-face visits. This project will evaluate the implementation of a novel program found in a recent VA randomized, controlled trial to significantly improve VA patients' diabetes-specific social support, insulin starts, and glycemic control compared to usual nurse care management. The program uses periodic group sessions in conjunction with calls between paired patients with diabetes to promote more effective care management as well as peer-to-peer (P2P) communication among diabetes patients who both have poor glycemic control and are working on similar care goals. "Peer buddies" are encouraged to talk by phone at least weekly to provide mutual support and share their progress on meeting their self-management goals. The goal of this service is to enhance the effect of shared medical appointments (SMAs), a service model demonstrated to be effective in improving outcomes among patients with diabetes and other chronic conditions and now being widely implemented in VA. Based on the success of the efficacy trial of this intervention, the investigators now seek to evaluate a wider-scale implementation of this program. During implementation of the P2P program in conjunction with shared medical appointments (SMAs) in five diverse VA facilities, the investigators will evaluate the effectiveness of SMAs alone and SMAs+P2P compared to usual care, and study the implementation process in order to gather information required to disseminate the program more broadly in Veterans Health Administration (VHA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | All those scheduled for a Shared Medical Appointment (SMA), regardless of whether the Peer to Peer (P2P) program was offered. | ||
| Usual Care | The randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycemic Control | Glycemic control (measured by Hemoglobin A1c) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values of A1c, the investigators will also examine the change in the percentage of patients with an average A1c > 8%. | 6 months and 12 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | Systolic blood pressure (SBP) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values, the investigators will also examine the change in percentage of patients with an average SBP > 140. |
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Inclusion Criteria:
Veterans enrolled into diabetes Shared Medical Appointments (SMAs) at participating sites, and a random subset of those meeting criteria for diabetes SMAs who have not yet participated:
Veteran receiving care at a participating VA Medical Center
Meets at least one of the following criteria in the past 2 years;
Poor glycemic control, indicated by a HbA1c in the past 6 months or:
Has a current address and telephone number listed in VA databases
Is competent to provide informed consent
Can communicate in English and by telephone
Able to participate in an outpatient program
Exclusion Criteria:
For no intervention control group:
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VA outpatients with uncontrolled diabetes receiving care at a participating VA Medical Center during implementation of a P2P program for diabetes management in conjunction with SMAs
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| Name | Affiliation | Role |
|---|---|---|
| Mary Ellen M Heisler, MD MPA | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States | ||
| VA Northern California Health Care System, Mather, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28549471 | Background | Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Jeffery SM, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial. Trials. 2017 May 26;18(1):239. doi: 10.1186/s13063-017-1959-7. | |
| 29981568 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA) |
| FG001 | Active Treatment | All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA) |
| BG001 | Active Treatment | All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycemic Control | Glycemic control (measured by Hemoglobin A1c) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values of A1c, the investigators will also examine the change in the percentage of patients with an average A1c > 8%. | Only those with A1c values documented in the electronic health record (EHR) during the evaluation windows were included in the number analyzed | Posted | Mean | Standard Deviation | % glycolated hemoglobin | 6 months and 12 months post-enrollment |
|
For each enrolled patient, adverse event data were collected from enrollment through 1 year 3 months post-enrollment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michele Heisler | VA Ann Arbor Healthcare System Center for Clinical Management & Research | 734-845-3502 | mheisler@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2020 | Jun 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003919 | Diabetes Insipidus |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 6 months and 12 months post-enrollment |
| Insulin Starts | The number of participants who are not on insulin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA. | 6 months and 12 months post-enrollment |
| Emergency Department (ED) Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | 6 months and 12 months post-enrollment |
| Statin Starts | The number of participants who are not on a statin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA. | 6 months and 12 months post-enrollment |
| Change in Number of Classes of Anti-hypertensive Meds | Change in antihypertensive use (number of classes of prescribed anti-hypertensives) in each group will be assessed at baseline and following the 6 and 12-month post-enrollment evaluation periods. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA. | 6 months and 12 months post-enrollment |
| Change in Patient-reported Satisfaction With VA Care | Patients' satisfaction with VA care will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: VA Healthcare Satisfaction Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome | 6 months and 12 months post-enrollment |
| Change in Patient-reported Diabetes Distress | Patients' level of diabetes distress will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Diabetes Distress Scale Scale ranges: 1-5 (Not a Problem=1, Minor Problem=2, Moderate Problem=3, Somewhat Serious Problem=4, Serious Problem=5) Direction of range: Lower score indicates a better outcome | 6 months and 12 months post-enrollment |
| Change in Patient-reported Degree of Diabetes Support | Patients' degree of diabetes support will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Diabetes Support Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome | 6 months and 12 months post-enrollment |
| Change in Patient-reported Degree of Self-Efficacy | Patients' degree of self-efficacy will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Williams Self-Efficacy Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome | 6 months and 12 months post-enrollment |
| Hospitalizations | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | 6 months and 12 months post-enrollment |
| Length of Hospitalizations | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | 6 months and 12 months post-enrollment |
| PCP Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | 6 months and 12 months post-enrollment |
| Nurse Case Manager Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | 6 months and 12 months post-enrollment |
| Endocrinology Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | 6 months and 12 months post-enrollment |
| Sacramento |
| California |
| 95655 |
| United States |
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908 | United States |
| Kowalski CP, Veeser M, Heisler M. Formative evaluation and adaptation of pre-and early implementation of diabetes shared medical appointments to maximize sustainability and adoption. BMC Fam Pract. 2018 Jul 7;19(1):109. doi: 10.1186/s12875-018-0797-3. |
| 33532956 | Derived | Heisler M, Burgess J, Cass J, Chardos JF, Guirguis AB, Strohecker LA, Tremblay AS, Wu WC, Zulman DM. Evaluating the Effectiveness of Diabetes Shared Medical Appointments (SMAs) as Implemented in Five Veterans Affairs Health Systems: a Multi-site Cluster Randomized Pragmatic Trial. J Gen Intern Med. 2021 Jun;36(6):1648-1655. doi: 10.1007/s11606-020-06570-y. Epub 2021 Feb 2. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| A1c | Mean | Standard Deviation | percent |
|
| SBP | Mean | Standard Deviation | mmHg |
|
| On insulin | Count of Participants | Participants |
|
| On statin | Count of Participants | Participants |
|
| Classes of anti-hypertensive meds | Mean | Standard Deviation | number of classes of antihypertensives |
|
| Primary Care Physician (PCP) in-person visits in past 8 months | Mean | Standard Deviation | number of in-person PCP visits |
|
| PCP phone visits in past 8 months | Mean | Standard Deviation | number of PCP phone visits |
|
| Nurse case manager in-person visits in past 8 months | Mean | Standard Deviation | number of RNCM in-person visits |
|
| Nurse case manager phone visits in past 8 months | Mean | Standard Deviation | number of RNCM phone visits |
|
| Endocrinology in-person visits in past 8 months | Mean | Standard Deviation | number of Endocrinology in-person visits |
|
| OG001 | Active Treatment | All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended |
|
|
| Secondary | Change in Systolic Blood Pressure (SBP) | Systolic blood pressure (SBP) in each group will be assessed by the comparison of an average of the values obtained during routine outpatient clinical practice in 6-month windows preceding baseline and following the 6 and 12-month post-enrollment evaluation periods. In addition to measuring absolute values, the investigators will also examine the change in percentage of patients with an average SBP > 140. | Only those with SBP values documented in the EHR during the evaluation windows were included in the number analyzed | Posted | Mean | Standard Deviation | mmHg | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Insulin Starts | The number of participants who are not on insulin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA. | Posted | Count of Participants | Participants | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Emergency Department (ED) Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | Posted | Mean | Standard Deviation | number of ED visits | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Statin Starts | The number of participants who are not on a statin at baseline and are started on insulin during the 6 and 12-month post-enrollment periods will be totaled and compared for the SMA group and the no intervention control group. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA. | Posted | Count of Participants | Participants | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Change in Number of Classes of Anti-hypertensive Meds | Change in antihypertensive use (number of classes of prescribed anti-hypertensives) in each group will be assessed at baseline and following the 6 and 12-month post-enrollment evaluation periods. For the no intervention control group, baseline will be the date they are identified by the data manager. For the SMA group, baseline will be the date of the first SMA. | Only those participants who were on at least one anti-hypertensive med during the evaluation windows were included in the number analyzed | Posted | Mean | Standard Deviation | Number of classes of anti-hypertensives | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Change in Patient-reported Satisfaction With VA Care | Patients' satisfaction with VA care will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: VA Healthcare Satisfaction Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome | Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed | Posted | Mean | Standard Deviation | units on a scale | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Change in Patient-reported Diabetes Distress | Patients' level of diabetes distress will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Diabetes Distress Scale Scale ranges: 1-5 (Not a Problem=1, Minor Problem=2, Moderate Problem=3, Somewhat Serious Problem=4, Serious Problem=5) Direction of range: Lower score indicates a better outcome | Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed | Posted | Mean | Standard Deviation | units on a scale | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Change in Patient-reported Degree of Diabetes Support | Patients' degree of diabetes support will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Diabetes Support Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome | Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed | Posted | Mean | Standard Deviation | units on a scale | 6 months and 12 months post-enrollment |
|
|
|
| Secondary | Change in Patient-reported Degree of Self-Efficacy | Patients' degree of self-efficacy will be assessed through surveys at baseline and 6 and 12 months post-enrollment for the SMA group. The following relates to the scale used: Scale name: Williams Self-Efficacy Scale Scale ranges: 1-6 (Strongly Disagree=1, Disagree=2, Slightly Disagree=3, Slightly Agree=4, Agree=5, Strongly Agree=6) Direction of range: Higher score indicates a better outcome | Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed | Posted | Mean | Standard Deviation | units on a scale | 6 months and 12 months post-enrollment |
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| Secondary | Hospitalizations | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | Posted | Mean | Standard Deviation | number of hospitalizations | 6 months and 12 months post-enrollment |
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| Secondary | Length of Hospitalizations | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | Only those participants who had at least one hospitalization during the evaluation windows were included in the number analyzed | Posted | Mean | Standard Deviation | days | 6 months and 12 months post-enrollment |
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| Secondary | PCP Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | Posted | Mean | Standard Deviation | number of PCP visits | 6 months and 12 months post-enrollment |
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| Secondary | Nurse Case Manager Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | Posted | Mean | Standard Deviation | number of RNCM visits | 6 months and 12 months post-enrollment |
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| Secondary | Endocrinology Visits | Major utilization events (admissions, bed days of care, and outpatient visits) will be collected from electronic medical records. Outpatient visits will be limited to those clinics most likely to be impacted by the intervention (e.g., primary care visits, diabetes specialty visits, and nurse visits). | Posted | Mean | Standard Deviation | number of Endocrinology visits | 6 months and 12 months post-enrollment |
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| 0 |
| 727 |
| 0 |
| 727 |
| 0 |
| 727 |
| EG001 | Active Treatment | All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended | 0 | 809 | 0 | 809 | 0 | 809 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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