Patient-Reported Outcome Measurement in Heart Failure Clinic

NCT04164004 | Completed Results

• 1 other identifier: 53713
• Study Type: interventional
• Target: 1,249
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Quality of life; Patient-reported outcomes; Quality of care; Implementation research

Outcome Measures

Primary Outcomes (2)

• Kansas City Cardiomyopathy Questionnaire-12 Score

  The first KCCQ-12 score collected one year after randomization will be compared between the KCCQ-12 and usual care arms. KCCQ-12 scores will be collected in the usual care arm starting one year after randomization. Scores will be adjusted for baseline KCCQ-12 in both arms. This will be the primary effectiveness outcome. KCCQ-12 has 4 domains (Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score) and one Summary Score. Domain scores are scaled 0-100, and the overall score is the average of the domain scores. For the domain and overall scores, 0 denotes the lowest reportable health status and 100 the highest. Higher values represent a better outcome.

  Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization

• Kansas City Cardiomyopathy Questionnaire-12 Response Rate

  Frequency of KCCQ-12 response at each clinic visit among patients in the KCCQ-12 arm. This will be the primary implementation outcome. The rate will be calculated as the number of responses divided by the total number of requests to complete the survey.

  1 year

Secondary Outcomes (32)

• Percentage of Patients on Beta-blocker Therapy Among Patients With Reduced Ejection Fraction

  Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization

• Median Dose of Beta-Blocker Therapy Among Patients With Reduced Ejection Fraction

  Evaluated at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization

• Percentage of Patients on Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction

  Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization

• Median Dose of Renin-Angiotensin-Aldosterone System Inhibitors Among Patients With Reduced Ejection Fraction

  Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization

• Percentage of Patients on Mineralocorticoid Receptor Antagonist Among Patients With Reduced Ejection Fraction

  Collected at the first heart failure clinic visit at least one year post-randomization or via telephone interview 15 months post-randomization

Study Arms (2)

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

EXPERIMENTAL

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.

Other: Kansas City Cardiomyopathy Questionnaire-12

Usual Care

ACTIVE COMPARATOR

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.

Other: Kansas City Cardiomyopathy Questionnaire-12

Interventions

Kansas City Cardiomyopathy Questionnaire-12 OTHER

Health status assessment will be completed using the well-validated Kansas City Cardiomyopathy Questionnaire-12 prior to or at the time of heart failure clinic visits.

Also known as: KCCQ-12

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

Eligibility Criteria

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

You may qualify if:

• Stanford Heart Failure clinic visit during enrollment period

You may not qualify if:

• Seen in amyloid clinic

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital & Clinics

Stanford, California, 94305, United States

Location

Related Publications (3)

• Sandhu AT, Calma J, Skye M, Kalwani N, Zheng J, Schirmer J, Din N, Brown Johnson C, Gupta A, Lan R, Yu B, Spertus JA, Heidenreich PA. Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial. Circulation. 2024 May 28;149(22):1717-1728. doi: 10.1161/CIRCULATIONAHA.124.069624. Epub 2024 Apr 7.

  PMID: 38583147 DERIVED

• Brown-Johnson C, Calma J, Amano A, Winget M, Harris SR, Vilendrer S, Asch SM, Heidenreich P, Sandhu AT, Kalwani NM. Evaluating the Implementation of Patient-Reported Outcomes in Heart Failure Clinic: A Qualitative Assessment. Circ Cardiovasc Qual Outcomes. 2023 May;16(5):e009677. doi: 10.1161/CIRCOUTCOMES.122.009677. Epub 2023 Apr 28.

  PMID: 37114990 DERIVED

• Sandhu AT, Zheng J, Kalwani NM, Gupta A, Calma J, Skye M, Lan R, Yu B, Spertus JA, Heidenreich PA. Impact of Patient-Reported Outcome Measurement in Heart Failure Clinic on Clinician Health Status Assessment and Patient Experience: A Substudy of the PRO-HF Trial. Circ Heart Fail. 2023 Feb;16(2):e010280. doi: 10.1161/CIRCHEARTFAILURE.122.010280. Epub 2022 Nov 5.

  PMID: 36334312 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Alexander Sandhu
• Organization: Stanford University

ats114@stanford.edu

9097671214

Study Officials

• Alexander T Sandhu, MD, MS

  Instructor of Medicine

  PRINCIPAL INVESTIGATOR

• Paul A Heidenreich, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Heart Failure Fellow, Principal Investigator

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: August 30, 2021
• Primary Completion: October 10, 2023
• Study Completion: November 3, 2023
• Last Updated: April 8, 2026
• Results First Posted: April 4, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)