Trial Outcomes & Findings for Chronic Kidney Disease (CKD) Guideline Adherence - A Quality Improvement Study (NCT NCT00921687)

NCT ID: NCT00921687

Last Updated: 2013-05-27

Results Overview

Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 781 participants
• Primary outcome timeframe: One year
• Results posted on: 2013-05-27

Participant Flow

Participant milestones

Measure	Control Providers in the control group received education only (CKD lecture and a CKD reference card).	Intervention The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
Overall Study STARTED	418	363
Overall Study COMPLETED	418	363
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chronic Kidney Disease (CKD) Guideline Adherence - A Quality Improvement Study

Baseline characteristics by cohort

Measure	Control Clinic n=418 Participants Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card).	Intervention Clinic n=363 Participants The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.	Total n=781 Participants Total of all reporting groups
Age Continuous	71 years STANDARD_DEVIATION 10.3 • n=5 Participants	71 years STANDARD_DEVIATION 10.7 • n=7 Participants	71 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	401 Participants n=5 Participants	343 Participants n=7 Participants	744 Participants n=5 Participants
Diabetes Yes	210 participants n=5 Participants	163 participants n=7 Participants	373 participants n=5 Participants
Diabetes No	208 participants n=5 Participants	200 participants n=7 Participants	408 participants n=5 Participants
Hypertension Yes	389 participants n=5 Participants	352 participants n=7 Participants	741 participants n=5 Participants
Hypertension No	29 participants n=5 Participants	11 participants n=7 Participants	40 participants n=5 Participants
Stage of chronic kidney disease Stage III	383 participants n=5 Participants	325 participants n=7 Participants	708 participants n=5 Participants
Stage of chronic kidney disease Stage IV	32 participants n=5 Participants	36 participants n=7 Participants	68 participants n=5 Participants
Stage of chronic kidney disease Stage V	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Probability for having a PTH measured during the study period comparing intervention vs control clinic during the study period as estimated by Generalized Estimating Equation (determines probability, not proportion). Participants assigned 1 if PTH was measured and 0 if PTH was not measured during the study period.

Outcome measures

Measure	Control Clinic n=418 Participants	Intervention Clinic n=363 Participants
PTH (Parathyroid Hormone) Adherence	0.23 probability of having a PTH measured	0.28 probability of having a PTH measured

SECONDARY outcome

Timeframe: One year

Probability of last Clinic BP <130/80 mmHg Comparing Intervention vs Control Clinic During the Study Period as estimated using Generalized Estimating Equation.

Outcome measures

Measure	Control Clinic n=418 Participants	Intervention Clinic n=363 Participants
Last Clinic BP <130/80 mmHg	0.41 probability of controlled clinic BP Interval 0.36 to 0.46	0.44 probability of controlled clinic BP Interval 0.39 to 0.49

Adverse Events

Control Clinic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention Clinic

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, MHS, MS

Louis Stokes Cleveland VA Medical Center

Phone: 6126255423

Email: draw0003@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place