Trial Outcomes & Findings for Shared Health Appointments and Reciprocal Enhanced Support (NCT NCT02132676)
NCT ID: NCT02132676
Last Updated: 2020-09-02
Results Overview
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%.
COMPLETED
1536 participants
6 months and 12 months post-enrollment
2020-09-02
Participant Flow
Participant milestones
| Measure |
Usual Care
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Overall Study
STARTED
|
727
|
809
|
|
Overall Study
COMPLETED
|
727
|
809
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shared Health Appointments and Reciprocal Enhanced Support
Baseline characteristics by cohort
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
Total
n=1536 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
67.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
707 Participants
n=5 Participants
|
782 Participants
n=7 Participants
|
1489 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
85 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
536 Participants
n=5 Participants
|
545 Participants
n=7 Participants
|
1081 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
A1c
|
8.9 percent
STANDARD_DEVIATION 1.3 • n=5 Participants
|
9.1 percent
STANDARD_DEVIATION 1.5 • n=7 Participants
|
9.0 percent
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
SBP
|
137.7 mmHg
STANDARD_DEVIATION 15.2 • n=5 Participants
|
136.2 mmHg
STANDARD_DEVIATION 13.4 • n=7 Participants
|
136.8 mmHg
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
On insulin
|
255 Participants
n=5 Participants
|
385 Participants
n=7 Participants
|
640 Participants
n=5 Participants
|
|
On statin
|
470 Participants
n=5 Participants
|
603 Participants
n=7 Participants
|
1073 Participants
n=5 Participants
|
|
Classes of anti-hypertensive meds
|
2.2 number of classes of antihypertensives
STANDARD_DEVIATION 1.3 • n=5 Participants
|
2.4 number of classes of antihypertensives
STANDARD_DEVIATION 1.2 • n=7 Participants
|
2.3 number of classes of antihypertensives
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Primary Care Physician (PCP) in-person visits in past 8 months
|
3.2 number of in-person PCP visits
STANDARD_DEVIATION 3.4 • n=5 Participants
|
3.4 number of in-person PCP visits
STANDARD_DEVIATION 3.1 • n=7 Participants
|
3.3 number of in-person PCP visits
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
PCP phone visits in past 8 months
|
0.7 number of PCP phone visits
STANDARD_DEVIATION 1.5 • n=5 Participants
|
0.7 number of PCP phone visits
STANDARD_DEVIATION 1.2 • n=7 Participants
|
0.7 number of PCP phone visits
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Nurse case manager in-person visits in past 8 months
|
0.2 number of RNCM in-person visits
STANDARD_DEVIATION 0.8 • n=5 Participants
|
0.2 number of RNCM in-person visits
STANDARD_DEVIATION 0.7 • n=7 Participants
|
0.2 number of RNCM in-person visits
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Nurse case manager phone visits in past 8 months
|
0.3 number of RNCM phone visits
STANDARD_DEVIATION 0.9 • n=5 Participants
|
0.3 number of RNCM phone visits
STANDARD_DEVIATION 0.9 • n=7 Participants
|
0.3 number of RNCM phone visits
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Endocrinology in-person visits in past 8 months
|
0.2 number of Endocrinology in-person visits
STANDARD_DEVIATION 0.8 • n=5 Participants
|
0.3 number of Endocrinology in-person visits
STANDARD_DEVIATION 0.8 • n=7 Participants
|
0.3 number of Endocrinology in-person visits
STANDARD_DEVIATION 0.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those with A1c values documented in the electronic health record (EHR) during the evaluation windows were included in the number analyzed
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%.
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Change in Glycemic Control
Baseline
|
8.92 % glycolated hemoglobin
Standard Deviation 1.31
|
9.12 % glycolated hemoglobin
Standard Deviation 1.48
|
|
Change in Glycemic Control
6-Months
|
8.26 % glycolated hemoglobin
Standard Deviation 1.47
|
8.16 % glycolated hemoglobin
Standard Deviation 1.37
|
|
Change in Glycemic Control
12-Months
|
8.15 % glycolated hemoglobin
Standard Deviation 1.50
|
8.15 % glycolated hemoglobin
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those with SBP values documented in the EHR during the evaluation windows were included in the number analyzed
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.
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP)
Baseline
|
139.6 mmHg
Standard Deviation 18.9
|
137.2 mmHg
Standard Deviation 17.5
|
|
Change in Systolic Blood Pressure (SBP)
6-Moths
|
139.6 mmHg
Standard Deviation 20.5
|
136.2 mmHg
Standard Deviation 18.7
|
|
Change in Systolic Blood Pressure (SBP)
12-Months
|
139.3 mmHg
Standard Deviation 19.7
|
137.4 mmHg
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentThe 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.
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Insulin Starts
Baseline
|
255 Participants
|
385 Participants
|
|
Insulin Starts
6-Months
|
247 Participants
|
418 Participants
|
|
Insulin Starts
12-Months
|
246 Participants
|
406 Participants
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentMajor 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).
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Emergency Department (ED) Visits
12-Months
|
0.50 number of ED visits
Standard Deviation 1.26
|
0.60 number of ED visits
Standard Deviation 1.31
|
|
Emergency Department (ED) Visits
Baseline
|
0.51 number of ED visits
Standard Deviation 1.24
|
0.54 number of ED visits
Standard Deviation 1.16
|
|
Emergency Department (ED) Visits
6-Months
|
0.42 number of ED visits
Standard Deviation 1.04
|
0.68 number of ED visits
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentThe 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.
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Statin Starts
Baseline
|
470 Participants
|
603 Participants
|
|
Statin Starts
6-Months
|
456 Participants
|
617 Participants
|
|
Statin Starts
12-Months
|
446 Participants
|
608 Participants
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those participants who were on at least one anti-hypertensive med during the evaluation windows were included in the number analyzed
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.
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Change in Number of Classes of Anti-hypertensive Meds
Baseline
|
2.23 Number of classes of anti-hypertensives
Standard Deviation 1.27
|
2.38 Number of classes of anti-hypertensives
Standard Deviation 1.21
|
|
Change in Number of Classes of Anti-hypertensive Meds
6-Months
|
2.31 Number of classes of anti-hypertensives
Standard Deviation 1.28
|
2.38 Number of classes of anti-hypertensives
Standard Deviation 1.19
|
|
Change in Number of Classes of Anti-hypertensive Meds
12-Months
|
2.28 Number of classes of anti-hypertensives
Standard Deviation 1.19
|
2.39 Number of classes of anti-hypertensives
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed
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
Outcome measures
| Measure |
Usual Care
n=448 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Change in Patient-reported Satisfaction With VA Care
Baseline
|
4.58 units on a scale
Standard Deviation 1.04
|
—
|
|
Change in Patient-reported Satisfaction With VA Care
6-Months
|
4.97 units on a scale
Standard Deviation 0.98
|
—
|
|
Change in Patient-reported Satisfaction With VA Care
12-Months
|
4.88 units on a scale
Standard Deviation 1.08
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed
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
Outcome measures
| Measure |
Usual Care
n=451 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Change in Patient-reported Diabetes Distress
Baseline
|
2.43 units on a scale
Standard Deviation 1.02
|
—
|
|
Change in Patient-reported Diabetes Distress
6-Months
|
2.19 units on a scale
Standard Deviation 0.99
|
—
|
|
Change in Patient-reported Diabetes Distress
12-Months
|
2.03 units on a scale
Standard Deviation 0.93
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed
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
Outcome measures
| Measure |
Usual Care
n=446 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Change in Patient-reported Degree of Diabetes Support
Baseline
|
3.77 units on a scale
Standard Deviation 1.30
|
—
|
|
Change in Patient-reported Degree of Diabetes Support
6-Months
|
4.29 units on a scale
Standard Deviation 1.25
|
—
|
|
Change in Patient-reported Degree of Diabetes Support
12-Months
|
4.09 units on a scale
Standard Deviation 1.37
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those who completed each timepoint's survey and responded to the relevant scale items were included in the number analyzed
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
Outcome measures
| Measure |
Usual Care
n=449 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Change in Patient-reported Degree of Self-Efficacy
Baseline
|
4.51 units on a scale
Standard Deviation 1.05
|
—
|
|
Change in Patient-reported Degree of Self-Efficacy
6-Months
|
4.84 units on a scale
Standard Deviation 1.02
|
—
|
|
Change in Patient-reported Degree of Self-Efficacy
12-Months
|
4.87 units on a scale
Standard Deviation 1.05
|
—
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentMajor 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).
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Hospitalizations
Baseline
|
0.12 number of hospitalizations
Standard Deviation 0.46
|
0.10 number of hospitalizations
Standard Deviation 0.36
|
|
Hospitalizations
6-Months
|
0.12 number of hospitalizations
Standard Deviation 0.52
|
0.15 number of hospitalizations
Standard Deviation 0.56
|
|
Hospitalizations
12-Months
|
0.14 number of hospitalizations
Standard Deviation 0.55
|
0.12 number of hospitalizations
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentPopulation: Only those participants who had at least one hospitalization during the evaluation windows were included in the number analyzed
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).
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=810 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Length of Hospitalizations
Baseline
|
6.1 days
Standard Deviation 12.7
|
3.1 days
Standard Deviation 3.2
|
|
Length of Hospitalizations
6-Months
|
12.7 days
Standard Deviation 33.2
|
6.3 days
Standard Deviation 9.3
|
|
Length of Hospitalizations
12-Months
|
7.3 days
Standard Deviation 9.2
|
8.6 days
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentMajor 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).
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
PCP Visits
Baseline
|
1.65 number of PCP visits
Standard Deviation 1.47
|
1.57 number of PCP visits
Standard Deviation 1.30
|
|
PCP Visits
6-Months
|
1.04 number of PCP visits
Standard Deviation 1.20
|
1.42 number of PCP visits
Standard Deviation 1.37
|
|
PCP Visits
12-Months
|
1.11 number of PCP visits
Standard Deviation 1.19
|
1.38 number of PCP visits
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentMajor 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).
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Nurse Case Manager Visits
Baseline
|
0.40 number of RNCM visits
Standard Deviation 1.12
|
0.42 number of RNCM visits
Standard Deviation 1.09
|
|
Nurse Case Manager Visits
6-Months
|
0.08 number of RNCM visits
Standard Deviation 0.38
|
0.29 number of RNCM visits
Standard Deviation 0.86
|
|
Nurse Case Manager Visits
12-Months
|
0.18 number of RNCM visits
Standard Deviation 0.74
|
0.23 number of RNCM visits
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 6 months and 12 months post-enrollmentMajor 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).
Outcome measures
| Measure |
Usual Care
n=727 Participants
Randomly selected sample of those not offered participation in a Shared Medical Appointment (SMA)
|
Active Treatment
n=809 Participants
All those scheduled for a Shared Medical Appointment (SMA), regardless of whether an SMA was actually attended
|
|---|---|---|
|
Endocrinology Visits
Baseline
|
0.18 number of Endocrinology visits
Standard Deviation 0.69
|
0.21 number of Endocrinology visits
Standard Deviation 0.64
|
|
Endocrinology Visits
6-Months
|
0.15 number of Endocrinology visits
Standard Deviation 0.68
|
0.20 number of Endocrinology visits
Standard Deviation 0.61
|
|
Endocrinology Visits
12-Months
|
0.15 number of Endocrinology visits
Standard Deviation 0.62
|
0.21 number of Endocrinology visits
Standard Deviation 0.63
|
Adverse Events
Usual Care
Active Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michele Heisler
VA Ann Arbor Healthcare System Center for Clinical Management & Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place