Trial Outcomes & Findings for A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD) (NCT NCT01290614)

Results Overview

Average SBP for those with a baseline BP \> 130/80

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

2199 participants

Primary outcome timeframe

one year

Results posted on

2015-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Pharmacist Intervention Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.	Control - Usual Care Patients assigned to control will continue to receive care from their VA provider. Usual Care: Patients in the control arm will continue to receive "usual care" from their VA providers.
Overall Study STARTED	1070	1129
Overall Study COMPLETED	518	1129
Overall Study NOT COMPLETED	552	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Chronic Care Model Based Quality Improvement (QI) Program to Improve the Care of Patients With Chronic Kidney Disease (CKD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pharmacist Intervention n=1070 Participants Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.	Control - Usual Care n=1129 Participants Patients assigned to control will continue to receive care from their VA provider. Usual Care: Patients in the control arm will continue to receive "usual care" from their VA providers.	Total n=2199 Participants Total of all reporting groups
Age, Continuous	75.6 years STANDARD_DEVIATION 8.2 • n=5 Participants	75.7 years STANDARD_DEVIATION 8.2 • n=7 Participants	75.6 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	1054 Participants n=5 Participants	1106 Participants n=7 Participants	2160 Participants n=5 Participants
Race/Ethnicity, Customized Black	62 participants n=5 Participants	56 participants n=7 Participants	118 participants n=5 Participants
Race/Ethnicity, Customized Not Black	1008 participants n=5 Participants	1073 participants n=7 Participants	2081 participants n=5 Participants
Region of Enrollment United States	1070 participants n=5 Participants	1129 participants n=7 Participants	2199 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Population: Baseline blood pressure \>130/80 mmHg

Average SBP for those with a baseline BP \> 130/80

Outcome measures

Outcome measures
Measure	Pharmacist Intervention n=474 Participants Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.	Control - Usual Care n=473 Participants Patients assigned to control will continue to receive care from their VA provider. Usual Care: Patients in the control arm will continue to receive "usual care" from their VA providers.
Systolic Blood Pressure (SBP)	135.1 mmHg Standard Deviation 17.4	134.4 mmHg Standard Deviation 17.6

SECONDARY outcome

Timeframe: one year

The primary process outcome was measurement of PTH during the study period.

Outcome measures

Outcome measures
Measure	Pharmacist Intervention n=1070 Participants Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR \<30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.	Control - Usual Care n=1129 Participants Patients assigned to control will continue to receive care from their VA provider. Usual Care: Patients in the control arm will continue to receive "usual care" from their VA providers.
Number of Participants With PTH Measurement During the Study Period	502 participants	182 participants

Adverse Events

Pharmacist Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Drawz, MD

University of Minnesota

Phone: 6126255423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place