search
Back to results

Advancing Symptom Alleviation With Palliative Treatment (ADAPT)

Primary Purpose

Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADAPT Intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring Quality of Life, Symptom Assessment, Palliative Care, Disease Management, Delivery of Health Care, Advance Care Planning

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans enrolled in VA Eastern Colorado Health Care System or VA Puget - Sound Health Care System
  • Diagnosis of CHF, pulmonary fibrosis, or COPD in 2 years prior to enrollment
  • High risk for hospitalization and death
  • Poor quality of life
  • Symptomatic
  • Primary care or other provider who is willing to facilitate intervention medical recommendations
  • Able to read and understand English
  • Consistent access to and able to use a standard telephone

Exclusion Criteria:

  • Previous diagnosis of dementia
  • Active substance abuse
  • Comorbid metastatic cancer
  • Nursing home resident
  • Heart or lung transplant or left ventricular assist device (LVAD)
  • Currently receiving hospice, palliative or home-based primary care
  • Currently pregnant
  • Currently a prisoner

Sites / Locations

  • Rocky Mountain Regional VA Medical Center, Aurora, CO
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ADAPT Intervention

Enhanced usual care

Arm Description

The intervention includes 3 components: nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning. collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. The team has as-needed consultation with a cardiologist or pulmonologist. The nurse and social worker visits are in-person or by phone.

Patients in the control group will continue to receive care at the discretion of their providers, which may include referrals to and ongoing care from cardiology, pulmonary, palliative care, or mental health. They will also have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency. Patients' providers will be given the results of baseline depression surveys if they screen positive for depression, and patients will be given an information sheet that outlines self-care for CHF or COPD.

Outcomes

Primary Outcome Measures

Function Assessment of Chronic Illness Therapy-General (FACT-G)
The FACT-G is a widely used, valid, reliable, and responsive self-report measure of health-related quality of life that includes domains of physical, social/family, emotional, and functional well-being. The primary outcome will be the difference in FACT-G score at 6 months.

Secondary Outcome Measures

General Symptom Distress Scale (GSDS)
The GSDS is a single item measure of overall symptom distress that is reliable and valid and asks, "In general, how distressing are all of your symptoms to you?"
Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 is a 8-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-8 was developed in medically-ill outpatients.
Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)
The KCCQ-SF is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ-SF is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The KCCQ-SF will be administered to participants with heart failure.
Clinical COPD Questionnaire (CCQ)
The CCQ is a self-administered 10-item measure of COPD symptoms, functioning, and emotional well-being. It is well-validated, reliable, and responsive and will be administered to participants with COPD.
Quality of Life at the End of Life (QUAL-E)
The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness.
Advance care planning communication and documentation
Advance care planning communication will be measured via patient self-report through the question, "At your last appointment with Dr. [Primary Care Provider] (PCP), did you discuss your treatment preferences should you become very ill?" (response items: yes, no, I don't know). Care preferences and care concurrence with preferences will be measured through two questions asking to choose a preference and then choosing the goals of current care. Advance care planning documentation (scanned advance directive (either a living will or durable power of attorney for health care); or medical orders for life-sustaining treatment) in the electronic medical record will be assessed via electronic medical record review.
Interim events
The following events will be assessed during the study period through medical record review to supplement patient report: hospitalization and mortality. Vital status will also be ascertained via the VA Vital Status File and the National Death Index.
Generalized Anxiety Disorder Scale (GAD-7)
The GAD-7 is a valid and reliable self-report measure of anxiety tested in medically ill outpatient populations.
Advance Care Planning Engagement
This survey was designed to measure behaviors related to surrogate decision makers, values and quality of life, and informed decision making.
PEG (Pain)
The PEG measures pain intensity and interference (Krebs, 2009).
Insomnia Severity Index (ISI)
The ISI measures insomnia severity (Bastien, 2000).
PROMIS Fatigue
The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity.
K-BILD
Quality of life measure for interstitial lung disease.

Full Information

First Posted
March 14, 2016
Last Updated
April 27, 2021
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT02713347
Brief Title
Advancing Symptom Alleviation With Palliative Treatment
Acronym
ADAPT
Official Title
Palliative Care to Improve Quality of Life in CHF and COPD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), and interstitial lung disease (i.e., pulmonary fibrosis) are common serious illnesses. Despite disease-specific medical care, people with these illnesses often left with poor quality of life (i.e., burdensome symptoms, impaired function). Furthermore, while these illnesses are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning, the process of considering and communicating healthcare values and goals. The investigators are conducting a randomized clinical trial to study a symptom management, psychosocial care and advance care planning intervention to improve quality of life. The study is important because it aims to improve quality of life and provision of care according to peoples' goals and preferences in common, burdensome illnesses. Furthermore, this study will generate information that supports the broader dissemination and implementation of the intervention and informs the development of future palliative care and team-based interventions in the VA.
Detailed Description
Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD) and interstitial lung disease (i.e., pulmonary fibrosis) have commonalities that make them ideal for early palliative care provided alongside disease-specific treatments. Quality of life is reduced in these illnesses because, despite disease-specific treatments, the same symptoms (e.g., shortness of breath, fatigue) often persist in these illnesses. Quality of life is also reduced because between 50-60% of people with either illness have clinically significant depressive symptoms. Finally, while CHF, COPD, and interstitial lung disease are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning. Providing palliative care concomitantly with other medical care offers an important opportunity to improve quality of life and advance care planning for people with CHF, COPD, or interstitial lung disease. For other conditions such as lung cancer, when provided early, prior to the end of life, palliative care improves quality of life, depressive symptoms, and survival while reducing health care utilization. While palliative care has been well-studied in patients with advanced cancer, it has not been adequately studied in CHF, COPD, or interstitial lung disease. The goal of this project is to determine whether the benefits of early palliative care extend to CHF, COPD or interstitial lung disease. The investigators developed and demonstrated early success with a patient-centered palliative care intervention to improve quality of life (i.e., symptoms, function) and advance care planning in CHF and COPD. The intervention consists of the following components: (1) algorithm-guided management of breathlessness, fatigue, and pain, provided by a nurse; the algorithms supplement disease-focused treatments with palliative and behavioral treatments; (2) a 6-session psychosocial care program targeting adjustment to illness and depression, provided by a social worker; and (3) engagement of patients and providers in advance care planning. The nurse and social worker are teamed with a palliative care specialist and representative primary care provider in brief weekly meetings. The team is integrated into primary care through nurse interaction with primary care providers and through electronic medical record communication. The investigators will conduct a hybrid effectiveness and implementation study. Population-based sampling methods will be used to enroll 300 Veterans with CHF, COPD, or interstitial lung disease who have poor quality of life and are at high risk for hospitalization or death. The primary aim is to test the effectiveness of the intervention in a randomized controlled trial (intervention vs. enhanced usual care) in two VA health care systems. In a secondary aim, the investigators will examine the implementation of the intervention to guide future implementation and dissemination, increase the relevance to operational partners, and maximize the effectiveness of subsequent palliative care and team-based interventions. Aim 1: Determine the effect of the intervention on (a) quality of life as a primary outcome, and (b) depression, symptom burden, advance care planning communication and documentation, disease-specific health status, emergency department visits, hospitalizations, and mortality as secondary outcomes. Aim 2: Examine the implementation of the intervention. Aim 2a: Assess the degree, barriers, and facilitators of implementation of various components. Identify which intervention components and processes are most critical from the perspectives of patients, intervention team members, and primary care providers whose patients received the intervention. Aim 2b. Evaluate the resources (e.g., personnel time and other costs) associated with the intervention, and estimate the resources needed for implementation and maintenance in other VA settings. The proposed study is significant because it addresses patient-centered needs in illnesses that are major sources of disability. The study is innovative because it tests the effectiveness of palliative care in CHF, COPD, and interstitial lung disease, leading causes of death among Veterans. In addition, the intervention is integrated into primary care, and the intervention components are structured to ease replication, implementation, and dissemination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema, Pulmonary Fibrosis, Interstitial Lung Disease
Keywords
Quality of Life, Symptom Assessment, Palliative Care, Disease Management, Delivery of Health Care, Advance Care Planning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel
Masking
InvestigatorOutcomes Assessor
Masking Description
Statistician
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADAPT Intervention
Arm Type
Experimental
Arm Description
The intervention includes 3 components: nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning. collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. The team has as-needed consultation with a cardiologist or pulmonologist. The nurse and social worker visits are in-person or by phone.
Arm Title
Enhanced usual care
Arm Type
No Intervention
Arm Description
Patients in the control group will continue to receive care at the discretion of their providers, which may include referrals to and ongoing care from cardiology, pulmonary, palliative care, or mental health. They will also have the same amount of interaction with research assistants as the intervention patients, completing questionnaires and participating in study visits at the same frequency. Patients' providers will be given the results of baseline depression surveys if they screen positive for depression, and patients will be given an information sheet that outlines self-care for CHF or COPD.
Intervention Type
Behavioral
Intervention Name(s)
ADAPT Intervention
Intervention Description
The intervention includes 3 components: nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain. social worker provides structured counseling targeting adjustment to illness and depression and advance care planning. collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. The team has as-needed consultation with a cardiologist or pulmonologist. The nurse and social worker visits are in-person or by phone.
Primary Outcome Measure Information:
Title
Function Assessment of Chronic Illness Therapy-General (FACT-G)
Description
The FACT-G is a widely used, valid, reliable, and responsive self-report measure of health-related quality of life that includes domains of physical, social/family, emotional, and functional well-being. The primary outcome will be the difference in FACT-G score at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
General Symptom Distress Scale (GSDS)
Description
The GSDS is a single item measure of overall symptom distress that is reliable and valid and asks, "In general, how distressing are all of your symptoms to you?"
Time Frame
6 months
Title
Patient Health Questionnaire-8 (PHQ-8)
Description
The PHQ-8 is a 8-item valid and reliable instrument that provides a continuous measure of depressive symptoms and is 88% sensitive and specific for a diagnosis of major depressive disorder. The PHQ-8 was developed in medically-ill outpatients.
Time Frame
6 months
Title
Kansas City Cardiomyopathy Questionnaire- Short Form (KCCQ-SF)
Description
The KCCQ-SF is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ-SF is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The KCCQ-SF will be administered to participants with heart failure.
Time Frame
6 months
Title
Clinical COPD Questionnaire (CCQ)
Description
The CCQ is a self-administered 10-item measure of COPD symptoms, functioning, and emotional well-being. It is well-validated, reliable, and responsive and will be administered to participants with COPD.
Time Frame
6 months
Title
Quality of Life at the End of Life (QUAL-E)
Description
The QUAL-E is a valid and reliable self-report measure of several domains, each scored separately, of quality of life in advanced illness.
Time Frame
6 months
Title
Advance care planning communication and documentation
Description
Advance care planning communication will be measured via patient self-report through the question, "At your last appointment with Dr. [Primary Care Provider] (PCP), did you discuss your treatment preferences should you become very ill?" (response items: yes, no, I don't know). Care preferences and care concurrence with preferences will be measured through two questions asking to choose a preference and then choosing the goals of current care. Advance care planning documentation (scanned advance directive (either a living will or durable power of attorney for health care); or medical orders for life-sustaining treatment) in the electronic medical record will be assessed via electronic medical record review.
Time Frame
6 months
Title
Interim events
Description
The following events will be assessed during the study period through medical record review to supplement patient report: hospitalization and mortality. Vital status will also be ascertained via the VA Vital Status File and the National Death Index.
Time Frame
6 months
Title
Generalized Anxiety Disorder Scale (GAD-7)
Description
The GAD-7 is a valid and reliable self-report measure of anxiety tested in medically ill outpatient populations.
Time Frame
6 months
Title
Advance Care Planning Engagement
Description
This survey was designed to measure behaviors related to surrogate decision makers, values and quality of life, and informed decision making.
Time Frame
6 months
Title
PEG (Pain)
Description
The PEG measures pain intensity and interference (Krebs, 2009).
Time Frame
6 months
Title
Insomnia Severity Index (ISI)
Description
The ISI measures insomnia severity (Bastien, 2000).
Time Frame
6 months
Title
PROMIS Fatigue
Description
The Patient Reported Outcome Measurement Information System- Fatigue (PROMIS fatigue) measures fatigue severity.
Time Frame
6 months
Title
K-BILD
Description
Quality of life measure for interstitial lung disease.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans enrolled in VA Eastern Colorado Health Care System or VA Puget - Sound Health Care System Diagnosis of CHF, pulmonary fibrosis, or COPD in 2 years prior to enrollment High risk for hospitalization and death Poor quality of life Symptomatic Primary care or other provider who is willing to facilitate intervention medical recommendations Able to read and understand English Consistent access to and able to use a standard telephone Exclusion Criteria: Previous diagnosis of dementia Active substance abuse Comorbid metastatic cancer Nursing home resident Heart or lung transplant or left ventricular assist device (LVAD) Currently receiving hospice, palliative or home-based primary care Currently pregnant Currently a prisoner
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Bekelman, MD MPH
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will consider a plan to share individual patient data in consultation with VA privacy, information security, and research and development offices.
Citations:
PubMed Identifier
28422561
Citation
Bekelman DB, Johnson-Koenke R, Ahluwalia SC, Walling AM, Peterson J, Sudore RL. Development and Feasibility of a Structured Goals of Care Communication Guide. J Palliat Med. 2017 Sep;20(9):1004-1012. doi: 10.1089/jpm.2016.0383. Epub 2017 Apr 19.
Results Reference
result
PubMed Identifier
28982506
Citation
Kavalieratos D, Gelfman LP, Tycon LE, Riegel B, Bekelman DB, Ikejiani DZ, Goldstein N, Kimmel SE, Bakitas MA, Arnold RM. Palliative Care in Heart Failure: Rationale, Evidence, and Future Priorities. J Am Coll Cardiol. 2017 Oct 10;70(15):1919-1930. doi: 10.1016/j.jacc.2017.08.036.
Results Reference
result
PubMed Identifier
29461908
Citation
Bekelman DB, Johnson-Koenke R, Bowles DW, Fischer SM. Improving Early Palliative Care with a Scalable, Stepped Peer Navigator and Social Work Intervention: A Single-Arm Clinical Trial. J Palliat Med. 2018 Jul;21(7):1011-1016. doi: 10.1089/jpm.2017.0424. Epub 2018 Feb 20.
Results Reference
result
PubMed Identifier
29482218
Citation
Bekelman DB, Allen LA, McBryde CF, Hattler B, Fairclough DL, Havranek EP, Turvey C, Meek PM. Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial. JAMA Intern Med. 2018 Apr 1;178(4):511-519. doi: 10.1001/jamainternmed.2017.8667.
Results Reference
result
PubMed Identifier
29975619
Citation
Portz JD, Cognetta S, Bekelman DB. Potential Technology Development for Palliative Care. J Palliat Med. 2018 Jul;21(7):899-900. doi: 10.1089/jpm.2018.0126. No abstract available.
Results Reference
result
PubMed Identifier
30702055
Citation
Bekelman DB, Knoepke CE, Turvey C. Identifying critical psychotherapy targets in serious cardiac conditions: The importance of addressing coping with symptoms, healthcare navigation, and social support. Palliat Support Care. 2019 Oct;17(5):531-535. doi: 10.1017/S1478951518001037.
Results Reference
result
PubMed Identifier
31196156
Citation
Graney BA, Au DH, Baron AE, Cheng A, Combs SA, Glorioso TJ, Paden G, Parsons EC, Rabin BA, Ritzwoller DP, Stonecipher JJ, Turvey C, Welsh CH, Bekelman DB. Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial to improve quality of life: a study protocol for a randomized clinical trial. Trials. 2019 Jun 13;20(1):355. doi: 10.1186/s13063-019-3417-1.
Results Reference
result
PubMed Identifier
31050771
Citation
Bekelman DB. Improving Primary and Specialist Palliative Care in Cardiovascular Disease. JAMA Netw Open. 2019 May 3;2(5):e192356. doi: 10.1001/jamanetworkopen.2019.2356. No abstract available.
Results Reference
result
PubMed Identifier
31518274
Citation
Portz JD, Fruhauf C, Bull S, Boxer RS, Bekelman DB, Casillas A, Gleason K, Bayliss EA. "Call a Teenager... That's What I Do!" - Grandchildren Help Older Adults Use New Technologies: Qualitative Study. JMIR Aging. 2019 Jun 6;2(1):e13713. doi: 10.2196/13713.
Results Reference
result
PubMed Identifier
30958272
Citation
Portz JD, Bayliss EA, Bull S, Boxer RS, Bekelman DB, Gleason K, Czaja S. Using the Technology Acceptance Model to Explore User Experience, Intent to Use, and Use Behavior of a Patient Portal Among Older Adults With Multiple Chronic Conditions: Descriptive Qualitative Study. J Med Internet Res. 2019 Apr 8;21(4):e11604. doi: 10.2196/11604.
Results Reference
result
PubMed Identifier
30632603
Citation
Buck HG, Bekelman D, Cameron J, Chung M, Hooker S, Pucciarelli G, Stromberg A, Riegel B, Vellone E. A body of work, a missed opportunity: Dyadic research in older adults. J Am Geriatr Soc. 2019 Apr;67(4):854-855. doi: 10.1111/jgs.15749. Epub 2019 Jan 11. No abstract available.
Results Reference
result
PubMed Identifier
32383388
Citation
Giannitrapani KF, Walling AM, Garcia A, Foglia M, Lowery JS, Lo N, Bekelman D, Brown-Johnson C, Haverfield M, Festa N, Shreve ST, Gale RC, Lehmann LS, Lorenz KA. Pilot of the Life-Sustaining Treatment Decisions Initiative Among Veterans With Serious Illness. Am J Hosp Palliat Care. 2021 Jan;38(1):68-76. doi: 10.1177/1049909120923595. Epub 2020 May 8.
Results Reference
result
PubMed Identifier
32781166
Citation
Brown-Johnson C, Haverfield MC, Giannitrapani KF, Lo N, Lowery JS, Foglia MB, Walling AM, Bekelman DB, Shreve ST, Lehmann LS, Lorenz KA. Implementing Goals-of-Care Conversations: Lessons From High- and Low-Performing Sites From a VA National Initiative. J Pain Symptom Manage. 2021 Feb;61(2):262-269. doi: 10.1016/j.jpainsymman.2020.07.040. Epub 2020 Aug 8.
Results Reference
result
PubMed Identifier
31916910
Citation
Hadler RA, Curtis BR, Ikejiani DZ, Bekelman DB, Harinstein M, Bakitas MA, Hess R, Arnold RM, Kavalieratos D. "I'd Have to Basically Be on My Deathbed": Heart Failure Patients' Perceptions of and Preferences for Palliative Care. J Palliat Med. 2020 Jul;23(7):915-921. doi: 10.1089/jpm.2019.0451. Epub 2020 Jan 9.
Results Reference
result
PubMed Identifier
32955969
Citation
Schenker Y, Ellington L, Bell L, Kross EK, Rosenberg AR, Kutner JS, Bickel KE, Ritchie C, Kavalieratos D, Bekelman DB, Mooney KB, Fischer SM. The National Postdoctoral Palliative Care Research Training Collaborative: History, Activities, Challenges, and Future Goals. J Palliat Med. 2021 Apr;24(4):545-553. doi: 10.1089/jpm.2020.0411. Epub 2020 Sep 21.
Results Reference
result
PubMed Identifier
32740225
Citation
Cooney TM, Proulx CM, Bekelman DB. Changes in Social Support and Relational Mutuality as Moderators in the Association Between Heart Failure Patient Functioning and Caregiver Burden. J Cardiovasc Nurs. 2021 May-Jun 01;36(3):212-220. doi: 10.1097/JCN.0000000000000726.
Results Reference
result

Learn more about this trial

Advancing Symptom Alleviation With Palliative Treatment

We'll reach out to this number within 24 hrs