Trial Outcomes & Findings for Improving Chronic Disease Management With Pieces (NCT NCT02587936)
NCT ID: NCT02587936
Last Updated: 2024-04-02
Results Overview
Hospitalization rates at 12 months for all study participants, capturing all cause unplanned hospitalizations including both regular hospitalizations as currently defined by CMS and observation status overnight. Hospitalizations will be ascertained from Electronic Health Record of each participating healthcare system with assistance from Pieces.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18268 participants
Primary outcome timeframe
12 months
Results posted on
2024-04-02
Participant Flow
The study is a pragmatic trial with the participating primary care practices randomized to Intervention or Usual care group
Participants must meet study criteria to include 1. Confirmed diagnosis of triad CKD, DM, and Hypertension 2. Be followed in one of the primary care clinics of the participating health system 3. Should have completed a clinic visit/ Lab no more than 2 years prior to enrollment visit
Unit of analysis: Primary care practices
Participant milestones
| Measure |
Intervention
Group to receive Collaborative model of primary care and subspecialty care enhanced by Pieces and Practice Facilitator
Collaborative Model of Primary care and Subspecialty care: Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
|
Usual Care
Group to receive usual care
|
|---|---|---|
|
Overall Study
STARTED
|
9730 71
|
8538 70
|
|
Overall Study
COMPLETED
|
5508 71
|
5492 70
|
|
Overall Study
NOT COMPLETED
|
4222 0
|
3046 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Chronic Disease Management With Pieces
Baseline characteristics by cohort
| Measure |
Intervention
n=5508 Participants
Group to receive Collaborative model of primary care and subspecialty care enhanced by Pieces and Practice Facilitator
Collaborative Model of Primary care and Subspecialty care: Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
|
Usual Care
n=5492 Participants
Group to receive usual care
|
Total
n=11000 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2550 Participants
n=5 Participants
|
2541 Participants
n=7 Participants
|
5091 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2958 Participants
n=5 Participants
|
2951 Participants
n=7 Participants
|
5909 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1129 Participants
n=5 Participants
|
944 Participants
n=7 Participants
|
2073 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3911 Participants
n=5 Participants
|
4041 Participants
n=7 Participants
|
7952 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
468 Participants
n=5 Participants
|
507 Participants
n=7 Participants
|
975 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4003 Participants
n=5 Participants
|
4058 Participants
n=7 Participants
|
8061 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1159 Participants
n=5 Participants
|
1088 Participants
n=7 Participants
|
2247 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
101 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
36 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
209 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Blood Pressure
Systolic Blood Pressure
|
133.1 mmHg
STANDARD_DEVIATION 18.7 • n=5 Participants
|
132.5 mmHg
STANDARD_DEVIATION 17.9 • n=7 Participants
|
132.8 mmHg
STANDARD_DEVIATION 18.4 • n=5 Participants
|
|
Blood Pressure
Diastolic Blood Pressure
|
73.7 mmHg
STANDARD_DEVIATION 11.2 • n=5 Participants
|
73.4 mmHg
STANDARD_DEVIATION 10.8 • n=7 Participants
|
73.5 mmHg
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Hemoglobin A1c
|
7.6 percent of HbA1c
STANDARD_DEVIATION 2.1 • n=5 Participants
|
7.5 percent of HbA1c
STANDARD_DEVIATION 2.1 • n=7 Participants
|
7.6 percent of HbA1c
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Estimated GFR
|
48.1 ml/min/1.73 m^2
STANDARD_DEVIATION 16.8 • n=5 Participants
|
49.4 ml/min/1.73 m^2
STANDARD_DEVIATION 15.6 • n=7 Participants
|
48.7 ml/min/1.73 m^2
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Proteinuria
< 30 mg/mmol
|
930 participants
n=5 Participants
|
840 participants
n=7 Participants
|
1770 participants
n=5 Participants
|
|
Proteinuria
>=30 mg/mmol and < 300 mg/mmol
|
1100 participants
n=5 Participants
|
1195 participants
n=7 Participants
|
2295 participants
n=5 Participants
|
|
Proteinuria
>=300 mg/mmol
|
597 participants
n=5 Participants
|
437 participants
n=7 Participants
|
1034 participants
n=5 Participants
|
|
Proteinuria
Not reported
|
2881 participants
n=5 Participants
|
3020 participants
n=7 Participants
|
5901 participants
n=5 Participants
|
|
Body Mass Index
|
33.4 kg/m^2
STANDARD_DEVIATION 7.6 • n=5 Participants
|
33 kg/m^2
STANDARD_DEVIATION 7.4 • n=7 Participants
|
33.2 kg/m^2
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Age-Adjusted Charlson Comorbidity Score
|
3.7 units on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsHospitalization rates at 12 months for all study participants, capturing all cause unplanned hospitalizations including both regular hospitalizations as currently defined by CMS and observation status overnight. Hospitalizations will be ascertained from Electronic Health Record of each participating healthcare system with assistance from Pieces.
Outcome measures
| Measure |
Intervention
n=5508 Participants
Group to receive Collaborative model of primary care and subspecialty care enhanced by Pieces and Practice Facilitator
Collaborative Model of Primary care and Subspecialty care: Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
|
Usual Care
n=5492 Participants
Group to receive usual care
|
|---|---|---|
|
All Cause Hospitalizations for Patients With a Triad of Chronic Kidney Disease, Diabetes and Hypertension
|
20.7 percentage of participants hospitalized
Interval 19.6509 to 21.7912
|
21.12 percentage of participants hospitalized
Interval 20.0657 to 22.2251
|
SECONDARY outcome
Timeframe: 12 months30-day all-cause readmissions (for those patients who have an index hospitalization), emergency room visits, cardiovascular events and deaths, and disease-specific hospitalizations for cardiovascular complications, congestive heart failure, volume overload, hypertension complications, acute coronary syndrome, myocardial infarction, coronary/peripheral revascularization, stroke, amputation/limb ischemia, uncontrolled diabetes, hypoglycemia, diabetes complications, acute kidney injury, hyperkalemia, electrolyte disturbances, medication errors, drug toxicity, and infections.
Outcome measures
| Measure |
Intervention
n=1139 Participants
Group to receive Collaborative model of primary care and subspecialty care enhanced by Pieces and Practice Facilitator
Collaborative Model of Primary care and Subspecialty care: Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
|
Usual Care
n=1160 Participants
Group to receive usual care
|
|---|---|---|
|
30-day All Cause Readmissions (for Those Patients Who Have an Index Hospitalization)
|
429 participants
|
433 participants
|
Adverse Events
Intervention
Serious events: 1193 serious events
Other events: 1426 other events
Deaths: 129 deaths
Usual Care
Serious events: 1223 serious events
Other events: 1475 other events
Deaths: 148 deaths
Serious adverse events
| Measure |
Intervention
n=5508 participants at risk
Group to receive Collaborative model of primary care and subspecialty care enhanced by Pieces and Practice Facilitator
Collaborative Model of Primary care and Subspecialty care: Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
|
Usual Care
n=5492 participants at risk
Group to receive regular care
|
|---|---|---|
|
General disorders
Hospitalizations
|
20.7%
1139/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
21.1%
1160/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
General disorders
Death
|
2.3%
129/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
2.7%
148/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Renal and urinary disorders
Dialysis
|
0.67%
37/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
0.58%
32/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
Other adverse events
| Measure |
Intervention
n=5508 participants at risk
Group to receive Collaborative model of primary care and subspecialty care enhanced by Pieces and Practice Facilitator
Collaborative Model of Primary care and Subspecialty care: Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
|
Usual Care
n=5492 participants at risk
Group to receive regular care
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
12.7%
701/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
11.3%
619/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.9%
215/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
3.4%
185/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Product Issues
Drug toxicity
|
0.13%
7/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
0.11%
6/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Renal and urinary disorders
Fluid overload
|
0.91%
50/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
0.67%
37/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
2.9%
160/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
2.7%
149/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Endocrine disorders
Hypoglycemia
|
0.20%
11/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
0.18%
10/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Blood and lymphatic system disorders
Hyponatremia
|
3.1%
171/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
2.9%
162/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Cardiac disorders
Hypotension
|
2.6%
142/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
2.6%
142/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.22%
12/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
0.22%
12/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Infections and infestations
Septic shock
|
4.1%
226/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
4.0%
219/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Nervous system disorders
Stroke
|
3.4%
187/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
2.8%
155/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Cardiac disorders
Syncope
|
1.6%
86/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
1.4%
79/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.07%
4/5508 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
0.04%
2/5492 • 1 YEAR
ICD-10-CM and ICD-10-PCS coding events occurred within 1 year during inpatient hospitalizations post study enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place