- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07356843
Palliative Care for People With HF
March 23, 2026 updated by: Lyndsay DeGroot, Indiana University
Implementing Community Palliative Care for People With Heart Failure
Imagine having heart failure, a condition where the heart struggles to pump blood, making daily life hard.
People with heart failure often don't feel well and end up going to the hospital a lot.
Many of these people could feel better with extra help, but there aren't many programs that offer support beyond usual heart failure treatments.
That's where the ADAPT program comes in, which stands for "Advancing Symptom Alleviation with Palliative Treatment."
In this program, nurses and social workers call people weekly, helping them manage their toughest symptoms, offering tools to cope with heart failure, and keeping the patients' current doctors involved.
We tested this program in a research study with heart failure patients and found that it improved their quality of life and lowered depression, anxiety, and heart failure symptoms.
The question now is if the ADAPT program will work in the community, outside of a research setting, so that more people could benefit from it.
Specifically, can the ADAPT program work well in new places?
Will patients and their families find it helpful?
Most importantly, can it help improve the lives of people with heart failure in these new settings?
To answer these questions, the study team will work with healthcare providers to 1) ask how to adjust the ADAPT program to work well in various settings (e.g.
primary care, heart failure clinic) and 2) use this information to create simple materials and trainings to help them easily provide ADAPT.
This will prepare for the next phase of this project to test out the new ADAPT program.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lyndsay DeGroot, PhD, RN
- Phone Number: 317-278-7743
- Email: lydegroo@iu.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 47408
- Recruiting
- IUHealth
-
Contact:
- Lyndsay DeGroot, PhD, RN
- Phone Number: 317-278-7743
- Email: lydegroo@iu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Outpatient clinician or staff member with at least 6 months of experience caring for patients with HF
Description
Inclusion Criteria:
- Outpatient clinician or staff member (e.g. physician, physician assistant, nurse practitioner, registered nurse, social worker, psychologist, medical assistant) or healthcare leadership personnel (e.g. Chief Nursing Officer, Clinic Medical Director etc.)
- at least 6 months of experience caring for patients with HF
- 18 years or older
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Themes
Time Frame: Baseline
|
Qualitative themes from interviews and clinic observations and descriptive summary statistics (e.g.
means, percentages) of barriers and facilitators from pCAT and PCSI surveys.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lyndsay DeGroot, PhD, RN, Indiana University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061.
- Bekelman DB, Rabin BA, Nowels CT, Sahay A, Heidenreich PA, Fischer SM, Main DS. Barriers and Facilitators to Scaling Up Outpatient Palliative Care. J Palliat Med. 2016 Apr;19(4):456-9. doi: 10.1089/jpm.2015.0280. Epub 2016 Mar 14.
- Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.
- Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.
- 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.
- May P, Normand C, Cassel JB, Del Fabbro E, Fine RL, Menz R, Morrison CA, Penrod JD, Robinson C, Morrison RS. Economics of Palliative Care for Hospitalized Adults With Serious Illness: A Meta-analysis. JAMA Intern Med. 2018 Jun 1;178(6):820-829. doi: 10.1001/jamainternmed.2018.0750.
- Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.
- Fernandez ME, Ten Hoor GA, van Lieshout S, Rodriguez SA, Beidas RS, Parcel G, Ruiter RAC, Markham CM, Kok G. Implementation Mapping: Using Intervention Mapping to Develop Implementation Strategies. Front Public Health. 2019 Jun 18;7:158. doi: 10.3389/fpubh.2019.00158. eCollection 2019.
- Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, Damschroder LJ. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR). Implement Sci. 2021 Jul 2;16(1):67. doi: 10.1186/s13012-021-01111-5.
- Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. No abstract available.
- Vindrola-Padros C, Johnson GA. Rapid Techniques in Qualitative Research: A Critical Review of the Literature. Qual Health Res. 2020 Aug;30(10):1596-1604. doi: 10.1177/1049732320921835.
- Gertner AK, Franklin J, Roth I, Cruden GH, Haley AD, Finley EP, Hamilton AB, Palinkas LA, Powell BJ. A scoping review of the use of ethnographic approaches in implementation research and recommendations for reporting. Implement Res Pract. 2021 Jan-Dec;2:2633489521992743. doi: 10.1177/2633489521992743. Epub 2021 Mar 16.
- Kowalski CP, Nevedal AL, Finley EP, Young JP, Lewinski AA, Midboe AM, Hamilton AB. Planning for and Assessing Rigor in Rapid Qualitative Analysis (PARRQA): a consensus-based framework for designing, conducting, and reporting. Implement Sci. 2024 Oct 11;19(1):71. doi: 10.1186/s13012-024-01397-1.
- Keniston A, McBeth L, Astik G, Auerbach A, Busch J, Kangelaris KN, Kulkarni SA, Linker AS, Sakumoto M, Leykum L, Burden M. Practical Applications of Rapid Qualitative Analysis for Operations, Quality Improvement, and Research in Dynamically Changing Hospital Environments. Jt Comm J Qual Patient Saf. 2023 Feb;49(2):98-104. doi: 10.1016/j.jcjq.2022.11.003. Epub 2022 Nov 7.
- Bekelman DB, Feser W, Morgan B, Welsh CH, Parsons EC, Paden G, Baron A, Hattler B, McBryde C, Cheng A, Lange AV, Au DH. Nurse and Social Worker Palliative Telecare Team and Quality of Life in Patients With COPD, Heart Failure, or Interstitial Lung Disease: The ADAPT Randomized Clinical Trial. JAMA. 2024 Jan 16;331(3):212-223. doi: 10.1001/jama.2023.24035.
- Chyr LC, DeGroot L, Waldfogel JM, Hannum SM, Sloan DH, Cotter VT, Zhang A, Heughan JA, Wilson RF, Robinson KA, Dy SM. Implementation and Effectiveness of Integrating Palliative Care Into Ambulatory Care of Noncancer Serious Chronic Illness: Mixed Methods Review and Meta-Analysis. Ann Fam Med. 2022 Jan-Feb;20(1):77-83. doi: 10.1370/afm.2754.
- Gelfman LP, Blum M, Ogunniyi MO, McIlvennan CK, Kavalieratos D, Allen LA. Palliative Care Across the Spectrum of Heart Failure. JACC Heart Fail. 2024 Jun;12(6):973-989. doi: 10.1016/j.jchf.2024.01.010. Epub 2024 Mar 6.
- DeGroot L, Koirala B, Pavlovic N, Nelson K, Allen J, Davidson P, Abshire M. Outpatient Palliative Care in Heart Failure: An Integrative Review. J Palliat Med. 2020 Sep;23(9):1257-1269. doi: 10.1089/jpm.2020.0031. Epub 2020 Jun 9.
- Diop MS, Rudolph JL, Zimmerman KM, Richter MA, Skarf LM. Palliative Care Interventions for Patients with Heart Failure: A Systematic Review and Meta-Analysis. J Palliat Med. 2017 Jan;20(1):84-92. doi: 10.1089/jpm.2016.0330. Epub 2016 Dec 2.
- DeGroot L, Pavlovic N, Perrin N, Gilotra NA, Dy SM, Davidson PM, Szanton SL, Saylor MA. Palliative Care Needs of Physically Frail Community-Dwelling Older Adults With Heart Failure. J Pain Symptom Manage. 2023 Jun;65(6):500-509. doi: 10.1016/j.jpainsymman.2023.01.016. Epub 2023 Feb 1.
- DeGroot L, Pavlovic N, Perrin N, Gilotra NA, Miller H, Denfeld QE, McIlvennan CK, Dy SM, Davidson PM, Szanton SL, Abshire Saylor M. The Association of Unmet Palliative Care Needs and Physical Frailty With Clinical Outcomes: A Prospective Study of Adults With Heart Failure. J Cardiovasc Nurs. 2025 Jul-Aug 01;40(4):296-303. doi: 10.1097/JCN.0000000000001087. Epub 2024 Apr 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
January 13, 2026
First Submitted That Met QC Criteria
January 13, 2026
First Posted (Actual)
January 21, 2026
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 23, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28648
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Qualitative interview data is often identifiable
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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