Patient-Reported Outcome Measurement in Heart Failure Clinic (PRO-HF)

Stanford University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Kansas City Cardiomyopathy Questionnaire-12

Study type: Interventional

Funder types: Other

Identifiers

NCT04164004

53713

Details and patient eligibility

About

This is a randomized study evaluating the effect of routinely collecting a standardized questionnaire of heart failure health status during heart failure clinic visits. Participants will be randomized to early or delayed implementation of a validated health-related quality of life survey (the Kansas City Cardiomyopathy Questionnaire). Participants randomized to early implementation will be given this 12-question survey at each heart failure clinic visit at the beginning of the study; their heart failure clinician will have access to survey results but will continue to manage participants based on standard treatment practice. Patients randomized to delayed implementation will start receiving the survey at each clinic visit one year later. By comparing the health status and treatment rates between early and delayed implementation, this study will determine the impact of standardized health status assessment on patient outcomes and clinician decision-making.

Enrollment: 1,249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stanford Heart Failure clinic visit during enrollment period

Exclusion criteria

• Seen in amyloid clinic

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,249 participants in 2 patient groups

Routine Collection of Patient-Reported Health Status (KCCQ-12 Arm)

Experimental group

Description:

Patients in the KCCQ-12 arm will undergo KCCQ-12 assessment of patient-reported heart failure health status in the electronic health record at each heart failure clinic visit beginning at the start of the trial. Assessment results will be available to clinicians in the electronic health record when making treatment decisions during each clinic visit.

Treatment:

Other: Kansas City Cardiomyopathy Questionnaire-12

Usual Care

Active Comparator group

Description:

Patients in the usual care arm will not complete KCCQ-12 assessments in the electronic health record with clinic visits. They will complete a KCCQ-12 assessment at baseline that will not be available to the treating clinician.

Treatment:

Other: Kansas City Cardiomyopathy Questionnaire-12