Titrated Disease Management for Patients With Hypertension

NCT01390272 | Completed Results

• 1 other identifier: IIR 10-383
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial examines whether programs aimed at matching resources to patient hypertension (i.e. high blood pressure) control lead to greater reduction in systolic blood pressure (top number of blood pressure reading) than simply having maintenance phone calls in addition to usual care. Answering this question will provide important evidence concerning the overall goal of sustained long-term implementation of the disease management programs as part of patient aligned care teams in the Veterans Affairs and other healthcare systems.

Conditions

Hypertension

Keywords

Hypertension; Telephone; Disease Management; Veterans; Pharmacists; Nurses

Outcome Measures

Primary Outcomes (4)

• Systolic Blood Pressure

  Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.

  Baseline

• Systolic Blood Pressure

  Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.

  6 months

• Systolic Blood Pressure

  Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.

  12 months

• Systolic Blood Pressure

  Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.

  18 months

Secondary Outcomes (9)

• Number of Participants With Hypertension Control

  Baseline

• Number of Participants With Hypertension Control

  6 months

• Number of Participants With Hypertension Control

  12 months

• Number of Participants With Hypertension Control

  18 months

• Cost Effectiveness

  Over 18 months of study intervention

Study Arms (2)

Titration Intervention

EXPERIMENTAL

The intervention arm includes three levels of resource intensity targeted to improve patients' systolic blood pressure (SBP) \[top number of blood pressure measurement\]. Medium/level 1 resource intensity: a registered nurse (RN) will provide monthly tailored behavioral support telephone calls + home BP monitoring. High/level 2 resource intensity: a pharmacist will provide monthly tailored behavioral support telephone calls + home BP monitoring + pharmacist-directed medication management. Booster (low) resource intensity: a licensed practical nurse (LPN) will provide non-tailored behavioral support telephone calls every two months to patients whose SBP comes under control.

Behavioral: Booster/ low resource; Behavioral: Medium/Level 1 resource intensity; Behavioral: High/Level 2 resource intensity

LPN Control

ACTIVE COMPARATOR

A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months (identical to booster (low) resource intensity component of the titrated intervention). The control arm will utilize the same procedures as the booster level for intervention patients for whom SBP comes under control.

Behavioral: Booster/ low resource

Interventions

Booster/ low resource BEHAVIORAL

A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.

Also known as: Control Arm - Low resource

LPN Control

Medium/Level 1 resource intensity BEHAVIORAL

Monthly tailored RN delivered calls + home BP monitoring.

Also known as: Intervention Arm - Level 1

Titration Intervention

High/Level 2 resource intensity BEHAVIORAL

Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).

Also known as: Intervention Arm - Level 2

Titration Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years.
• Assigned primary care provider in one of the clinics of the Durham VA Medical Center (VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic and Greenville (CBOC)).
• Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last year.
• Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or 401.9 for \>= 2 outpatient encounters during the prior year and Received a prescription for at least 1 of the following classes of hypertensive medication in the previous year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination; and/or 8) antihypertensives, other.
• Out of control systolic blood pressure: Durham VAMC (including CBOCs or other affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP measurements \>= 150 mmHg for non-diabetic or \>= 140 mmHg for diabetic patients over the last year and last systolic BP measurement \>= 140 mmHg for non-diabetic or \>= 130 mmHg for diabetic patients. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of \>= 140 mmHg or diabetic patients with mean outpatient systolic BP of \>= 130 mmHg over the past year may be approached.
• Patients must indicate that they both:
• Have a VA or affiliated clinic provider that they consider to be their main PCP.
• Receive the majority of healthcare at the Durham VA Medical Center (or affiliated clinic - such as Hillandale or Greenville).

You may not qualify if:

• Active diagnosis of psychosis.
• Diagnosis of metastatic cancer.
• Type 1 diabetes
• Class IV congestive heart failure (CHF).
• Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR) levels are \<= 15.
• Chronic obstructive pulmonary disease (COPD) requiring oxygen.
• Resident in nursing home or receiving home healthcare.
• Patient is pregnant or reports planning to become pregnant in the next two years
• At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease clinical trial.
• Planning to leave the area prior to the anticipated end of participation.
• Inability or unwillingness to come to the Durham VAMC or affiliated clinic such as Hillandale or Greenville for baseline-, 6-, 12-, and 18-month study visits.
• Does not have reasonable access to a telephone.
• Does not speak English.
• Severely impaired hearing or speech (Patients must be able to respond to phone calls.).
• Severely impaired vision (Patients must be able to read mailed material).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (2)

• Jackson GL, Weinberger M, Kirshner MA, Stechuchak KM, Melnyk SD, Bosworth HB, Coffman CJ, Neelon B, Van Houtven C, Gentry PW, Morris IJ, Rose CM, Taylor JP, May CL, Han B, Wainwright C, Alkon A, Powell L, Edelman D. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics. Contemp Clin Trials. 2016 Sep;50:5-15. doi: 10.1016/j.cct.2016.07.009. Epub 2016 Jul 12.

  PMID: 27417982 RESULT

• Jackson GL, Stechuchak KM, Weinberger M, Bosworth HB, Coffman CJ, Kirshner MA, Edelman D. How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity. Mil Med. 2018 Sep 1;183(9-10):e583-e588. doi: 10.1093/milmed/usx111.

  PMID: 29672720 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Immunization, Secondary; Culture Media

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Results Point of Contact

• Title: Dr. George Lee Jackson, PhD MHA
• Organization: Durham VA Medical Center, Durham, NC

George.Jackson3@va.gov

919-286-0411

Study Officials

• George L Jackson, PhD MHA

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 11, 2011
• Study Start: July 27, 2012
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)