Shared Health Appointments and Reciprocal Enhanced Support

Diabetes Insipidus Clinical Trial

— SHARES  

Official title:

Peer Support to Enhance Diabetes Shared Medical Appointments: Examining Comparative Effectiveness in VA Health Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132676
• Other study ID #: IIR 15-321
• Status: Completed
• Start date: April 25, 2016
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1536
• Est. completion date: July 30, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

• at least 1 VA hospitalization with a diabetes-related International Classification Of Diseases-9 (ICD-9) code,

• at least 2 VA outpatient visits with a diabetes-related ICD-9 code, or

• At least 1 VA prescription for a glucose control medication (insulin or oral agent) or monitoring supplies

• Poor glycemic control, indicated by a HbA1c in the past 6 months or:

• at least 7.5% if age <70, or

• at least 8% if age 70+

• 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:

• Active substance abuse disorder (smoking cigarettes is not an exclusion)

• Serious psychiatric illness (bipolar disorder, dementia, schizophrenia, or personality disorders)

• Terminally ill

• Prisoner

Related Conditions & MeSH terms

• Diabetes Insipidus

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island
United States	VA Northern California Health Care System, Mather, CA	Sacramento	California
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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%.	6 months and 12 months post-enrollment
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.	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.	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).	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.	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.	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	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	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	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	6 months and 12 months post-enrollment
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).	6 months and 12 months post-enrollment
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).	6 months and 12 months post-enrollment
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).	6 months and 12 months post-enrollment
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).	6 months and 12 months post-enrollment
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).	6 months and 12 months post-enrollment