Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Implementation Science
Published in: Implementation Science 1/2021

Open Access 01-12-2021 | Care | Study protocol

A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol

Authors: Lisa Zubkoff, Kathleen Doyle Lyons, J. Nicholas Dionne-Odom, Gregory Hagley, Maria Pisu, Andres Azuero, Marie Flannery, Richard Taylor, Elizabeth Carpenter-Song, Supriya Mohile, Marie Anne Bakitas

Published in: Implementation Science | Issue 1/2021

Login to get access

Abstract

Background

Virtual Learning Collaboratives (VLC), learning communities focused on a common purpose, are used frequently in healthcare settings to implement best practices. Yet, there is limited research testing the effectiveness of this approach compared to other implementation strategies. This study evaluates the effectiveness of a VLC compared to Technical Assistance (TA) among community oncology practices implementing ENABLE (Educate, Nurture, Advise, Before Life Ends), an evidence-based, early palliative care telehealth, psycho-educational intervention for patients with newly diagnosed advanced cancer and their caregivers.

Methods

Using Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) and Proctor’s Implementation Outcomes Frameworks, this two-arm hybrid type-III cluster-randomized controlled trial (RCT) will compare two implementation strategies, VLC versus TA, among the 48 National Cancer Institute Community Oncology Research Program (NCORP) practice clusters that have not historically provided palliative care to all patients with advanced cancer. Three cohorts of practice clusters will be randomized to the study arms. Each practice cluster will recruit 15–27 patients and a family caregiver to participate in ENABLE. The primary study outcome is ENABLE uptake (patient level), i.e., the proportion of eligible patients who complete the ENABLE program (receive a palliative care assessment and complete the six ENABLE sessions over 12 weeks). The secondary outcome is overall program implementation (practice cluster level), as measured by the General Organizational Index at baseline, 6, and 12 months. Exploratory aims assess patient and caregiver mood and quality of life outcomes at baseline, 12, and 24 weeks. Practice cluster randomization will seek to keep the proportion of rural practices, practice sizes, and minority patients seen within each practice balanced across the two study arms.

Discussion

This study will advance the field of implementation science by evaluating VLC effectiveness, a commonly used but understudied, implementation strategy. The study will advance the field of palliative care by building the capacity and infrastructure to implement an early palliative care program in community oncology practices.
Literature
1.
Kavalieratos D, Corbelli J, Zhang D, Dionne-Odom JN, Ernecoff NC, Hanmer J, et al. Association between palliative care and patient and caregiver outcomes: a systematic review and meta-analysis. JAMA. 2016;316(20):2104–14.PubMedPubMedCentralCrossRef
2.
Meneses K, Landier W, Dionne-Odom JN. Vulnerable population challenges in the transformation of cancer care. Semin Oncol Nurs. 2016;32(2):144–53.PubMedCrossRef
3.
Hoerger M, Wayser GR, Schwing G, Suzuki A, Perry LM. Impact of interdisciplinary outpatient specialty palliative care on survial and quality of life in adults with advanced cancer: a meta-analysis of randomized controlled trials. Ann Behav Med. 2018;53(7):674–85.PubMedCentralCrossRef
4.
Smith TJ, Temin S, Alesi ER, Abernethy AP, Balboni TA, Basch EM, et al. American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care. J Clin Oncol. 2012;30(8):880–7.PubMedCrossRef
5.
Carlos RC, Sicks JD, Chang GJ, Lyss AP, Stewart TL, Sung L, et al. Capacity for cancer care delivery research in National Cancer Institute Community Oncology Research Program Community Practices: availability of radiology and primary care research partners. J Am Coll Radiol. 2017;14(12):1530–7.PubMedPubMedCentralCrossRef
6.
Kent EE, Mitchell SA, Castro KM, DeWalt DA, Kaluzny AD, Hautala JA, et al. Cancer care delivery research: building the evidence base to support practice change in community oncology. J Clin Oncol. 2015;33(24):2705–11.PubMedPubMedCentralCrossRef
7.
Kamal AH, Wolf SP, Troy J, Leff V, Dahlin C, Rotella JD, et al. Policy changes key to promoting sustainability and growth of the specialty palliative care workforce. Health Aff (Millwood). 2019;38(6):910–8.PubMedCrossRef
8.
Lupu D, Quigley L, Mehfoud N, Salsberg ES. The growing demand for hospice and palliative medicine physicians: will the supply keep up? J Pain Symptom Manage. 2018;55(4):1216–23.PubMedCrossRef
9.
10.
Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009;302(7):741–9.PubMedPubMedCentralCrossRef
11.
Bakitas MA, Tosteson TD, Li Z, Lyons KD, Hull JG, Li Z, et al. Early versus delayed initiation of concurrent palliative oncology care: patient outcomes in the ENABLE III randomized controlled trial. J Clin Oncol. 2015;33(13):1438–45.PubMedPubMedCentralCrossRef
12.
Dionne-Odom JN, Azuero A, Lyons KD, Hull JG, Tosteson T, Li Z, et al. Benefits of early versus delayed palliative care to informal family caregivers of patients with advanced cancer: outcomes from the ENABLE III randomized controlled trial. J Clin Oncol. 2015;33(13):1446–52.PubMedPubMedCentralCrossRef
13.
The breakthrough series: IHI’s collaborative model for achieving breakthrough improvement. Boston, MA; 2003.
14.
Nadeem E, Olin SS, Hill LC, Hoagwood KE, Horwitz SM. Understanding the components of quality improvement collaboratives: a systematic literature review. Milbank Q. 2013;91(2):354–94.PubMedPubMedCentralCrossRef
15.
Schouten LM, Hulscher ME, van Everdingen JJ, Huijsman R, Grol RP. Evidence for the impact of quality improvement collaboratives: systematic review. BMJ. 2008;336(7659):1491–4.PubMedPubMedCentralCrossRef
16.
Fu LY, Zook K, Gingold JA, Gillespie CW, Briccetti C, Cora-Bramble D, et al. Strategies for improving vaccine delivery: a cluster-randomized trial. Pediatrics. 2016;137(6).
17.
Speroff T, Ely EW, Greevy R, Weinger MB, Talbot TR, Wall RJ, et al. Quality improvement projects targeting health care-associated infections: comparing virtual collaborative and toolkit approaches. J Hosp Med. 2011;6(5):271–8.PubMedCrossRef
18.
Leeman J, Calancie L, Hartman MA, Escoffery CT, Herrmann AK, Tague LE, et al. What strategies are used to build practitioners' capacity to implement community-based interventions and are they effective?: a systematic review. Implement Sci. 2015;10:80.PubMedPubMedCentralCrossRef
19.
Chilenski SM, Perkins DF, Olson J, Hoffman L, Feinberg ME, Greenberg M, et al. The power of a collaborative relationship between technical assistance providers and community prevention teams: a correlational and longitudinal study. Eval Program Plann. 2016;54:19–29.PubMedCrossRef
20.
21.
Hulscher ME, Schouten LM, Grol RP, Buchan H. Determinants of success of quality improvement collaboratives: what does the literature show? BMJ Qual Saf. 2013;22(1):19–31.PubMedCrossRef
22.
Nadeem E, Olin S, Hill L, Hoagwood K, Horwitz S. A literature review of learning collaboratives in mental health care: used but untested. Psychiatr Serv. 2014;65(9):1088–99.PubMedPubMedCentralCrossRef
23.
24.
Glasgow RE, McKay HG, Piette JD, Reynolds KD. The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? Patient Educ Couns. 2001;44(2):119–27.PubMedCrossRef
25.
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76.PubMedCrossRef
26.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26.PubMedPubMedCentralCrossRef
27.
Damschroder LJ, Moin T, Datta SK, Reardon CM, Steinle N, Weinreb J, et al. Implementation and evaluation of the VA DPP clinical demonstration: protocol for a multi-site non-randomized hybrid effectiveness-implementation type III trial. Implement Sci. 2015;10:68.PubMedPubMedCentralCrossRef
28.
Smelson DA, Chinman M, McCarthy S, Hannah G, Sawh L, Glickman M. A cluster randomized Hybrid Type III trial testing an implementation support strategy to facilitate the use of an evidence-based practice in VA homeless programs. Implement Sci. 2015;10:79.PubMedPubMedCentralCrossRef
29.
Dearing JW, Kreuter MW. Designing for diffusion: how can we increase uptake of cancer communication innovations? Patient Educ Couns. 2010;81(Suppl):S100–10.PubMedPubMedCentralCrossRef
30.
Rogers EM. Diffusion of innovations. Fifth Edition ed. New York: Free Press; 2003.
31.
32.
Manca DP, Aubrey-Bassler K, Kandola K, Aguilar C, Campbell-Scherer D, Sopcak N, et al. Implementing and evaluating a program to facilitate chronic disease prevention and screening in primary care: a mixed methods program evaluation. Implement Sci. 2014;9:135.PubMedPubMedCentralCrossRef
33.
Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001;20(6):64–78.PubMedCrossRef
34.
Wasson JH, Splaine ME, Bazos D, Fisher ES. Overview: working inside, outside, and side by side to improve the quality of health care. Jt Comm J Qual Improv. 1998;24(10):513–7.PubMed
35.
McCorkle R, Ercolano E, Lazenby M, Schulman-Green D, Schilling LS, Lorig K, et al. Self-management: enabling and empowering patients living with cancer as a chronic illness. CA Cancer J Clin. 2011;61(1):50–62.PubMedPubMedCentralCrossRef
36.
Dionne-Odom JN, Kono A, Frost J, Jackson L, Ellis D, Ahmed A, et al. Translating and testing the ENABLE: CHF-PC concurrent palliative care model for older adults with heart failure and their family caregivers. J Palliat Med. 2014;17(9):995–1004.PubMedPubMedCentralCrossRef
37.
Bakitas M, Lyons KD, Hegel MT, Balan S, Barnett KN, Brokaw FC, et al. The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions. Palliat Support Care. 2009;7(1):75–86.PubMedPubMedCentralCrossRef
38.
Zubkoff L, Dionne-Odom JN, Pisu M, Babu D, Akyar I, Smith T, et al. Developing a “toolkit” to measure implementation of concurrent palliative care in rural community cancer centers. Palliat Support Care. 2017:1–13.
39.
Heiervang KS, Egeland KM, Landers M, Ruud T, Joa I, Drake RE, et al. Psychometric properties of the general organizational index (GOI): a measure of individualization and quality improvement to complement program fidelity. Adm Policy Ment Health. 2020.
40.
Freund T, Wensing M, Mahler C, Gensichen J, Erler A, Beyer M, et al. Development of a primary care-based complex care management intervention for chronically ill patients at high risk for hospitalization: a study protocol. Implementation Science. 2010;5(1):70.PubMedCrossRefPubMedCentral
41.
Babu D, Dionne-Odom JN, Smith T, Zubkoff L, Bakitas M. Oncology providers’ perceptions of early/concurrent palliative care. In: Annual Assembly of the Americal Academy of Hospice and Palliative Medicine and the Hospice and Palliative Nurses Association. Chicago: IL; 2016.
42.
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res. 2002;52(2):69–77.PubMedCrossRef
43.
44.
Herrmann C. International experiences with the hospital anxiety and depression scale--a review of validation data and clinical results. J Psychosom Res. 1997;42(1):17–41.PubMedCrossRef
45.
McMillan SC, Small BJ, Weitzner M, Schonwetter R, Tittle M, Moody L, et al. Impact of coping skills intervention with family caregivers of hospice patients with cancer: a randomized clinical trial. Cancer. 2006;106(1):214–22.PubMedCrossRef
46.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.PubMedCrossRef
47.
Brady MJ, Cella D. Assessing quality of life in palliative care. Cancer Treat Res. 1999;100:203–16.PubMedCrossRef
48.
Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, et al. Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument. J Clin Oncol. 1997;15(3):974–86.PubMedCrossRef
49.
Lyons KD, Bakitas M, Hegel MT, Hanscom B, Hull J, Ahles TA. Reliability and validity of the functional assessment of chronic illness therapy-palliative care (FACIT-Pal) scale. J Pain Symptom Manage. 2009;37(1):23–32.PubMedCrossRef
50.
51.
Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010;63(11):1179–94.PubMedPubMedCentralCrossRef
52.
Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009;18(7):873–80.PubMedPubMedCentralCrossRef
53.
54.
55.
56.
Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, et al. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000;89(7):1634–46.PubMedCrossRef
57.
58.
Montgomery R, Borgatta E, Borgatta M. Societal and family change in the burden of care. In: Liu W, Kendig H, editors. Who Should Care for the Elderly? Singapore: Singapore University Press; 2000. p. 27–54.CrossRef
59.
O'Hara RE, Hull JG, Lyons KD, Bakitas M, Hegel MT, Li Z, et al. Impact on caregiver burden of a patient-focused palliative care intervention for patients with advanced cancer. Palliat Support Care. 2010;8(4):395–404.PubMedPubMedCentralCrossRef
60.
Tarlow BJ, Wisniewski SR, Belle SH, Rupert M, Ory MG, Gallagher-Thompson D. Positive aspects of caregiving: contributions of the REACH project to the development of new measures for alzheimer's caregiving. Research on Aging. 2004;26(4):429–53.CrossRef
61.
Archbold PG, Stewart BJ, Greenlick MR, Harvath T. Mutuality and preparedness as predictors of caregiver role strain. Res Nurs Health. 1990;13(6):375–84.PubMedCrossRef
62.
Carter JH, Stewart BJ, Archbold PG, Inoue I, Jaglin J, Lannon M, et al. Living with a person who has Parkinson’s disease: the spouse’s perspective by stage of disease. Parkinson’s Study Group. Mov Disord. 1998;13(1):20–8.
63.
Zwicker D. Preparedness for Caregiving Scale. New York: New York University, College of Nursing; 2010.
64.
McHugo GJ, Drake RE, Whitley R, Bond GR, Campbell K, Rapp CA, et al. Fidelity outcomes in the National Implementing Evidence-Based Practices Project. Psyciatr Serv. 2007;58(10):1279–84.CrossRef
65.
Brooks J, McCluskey S, Turley E, King N. The utility of template analysis in qualitative psychology research. Qual Res Psychol. 2015;12(2):202–22.PubMedCrossRef
66.
Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. 2013;48(6 Pt 2):2134–56.PubMedPubMedCentralCrossRef
67.
Guetterman TC, Fetters MD, Creswell JW. Integrating quantitative and qualitative results in health science mixed methods research through joint displays. Ann Fam Med. 2015;13(6):554–61.PubMedPubMedCentralCrossRef
68.
Wisdom J, Creswell JW. Mixed methods: integrating quantitative and qualitative data collection and analysis while studying patient-centered medical home models. Rockville, MD; 2013 February 2013. Report No.: 13-0028-EF.
69.
Glickman ME, Rao SR, Schultz MR. False discovery rate control is a recommended alternative to Bonferroni-type adjustments in health studies. J Clin Epidemiol. 2014;67(8):850–7.PubMedCrossRef
70.
Ferrell BR, Temel JS, Temin S, Alesi ER, Balboni TA, Basch EM, et al. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017;35(1):96–112.PubMedCrossRef
71.
Boushon B, Provost L, Gagnon J, Carver P. Using a virtual breakthrough series collaborative to improve access in primary care. Jt Comm J Qual Patient Saf. 2006;32(10):573–84.PubMed
72.
Butler A, Canamucio A, Macpherson D, Skoko J, True G. Primary care staff perspectives on a virtual learning collaborative to support medical home implementation. J Gen Intern Med. 2014;29(Suppl 2):S579–88.PubMedCrossRef
73.
Cranley LA, Norton PG, Cummings GG, Barnard D, Estabrooks CA. SCOPE: safer care for older persons (in residential) environments: a study protocol. Implement Sci. 2011;6:71.PubMedPubMedCentralCrossRef
74.
Gance-Cleveland B, Aldrich H, Dandreaux D, Oetzel KB, Schmiege S. A virtual childhood obesity collaborative: satisfaction with online continuing education. J Pediatr Health Care. 2015;29(5):413–23.PubMedCrossRef
75.
Gance-Cleveland B, Aldrich H, Schmiege S, Tyler K. Virtual obesity collaborative with and without decision-support technology. Int J Qual Health Care. 2016;28(3):316–23.PubMedCrossRef
76.
Gingold JA, Briccetti C, Zook K, Gillespie CW, Gubernick RS, Moon RY, et al. Context matters: practitioner perspectives on immunization delivery quality improvement efforts. Clin Pediatr (Phila). 2016;55(9):825–37.PubMedCrossRef
77.
John T, Morton M, Weissman M, O'Brien E, Hamburger E, Hancock Y, et al. Feasibility of a virtual learning collaborative to implement an obesity QI project in 29 pediatric practices. Int J Qual Health Care. 2014;26(2):205–13.PubMedCrossRef
78.
McHugh MC, Margolis LH, Rosenberg A, Humphreys E. Advancing MCH interdisciplinary/interprofessional leadership training and practice through a learning collaborative. Matern Child Health J. 2016;20(11):2247–53.PubMedCrossRef
79.
Zubkoff L, Neily J, Mills PD, Borzecki A, Shin M, Lynn MM, Gunnar W, Rosen A. Using a virtual breakthrough series collaborative to reduce postoperative respiratory failure in 16 Veterans Health Administration hospitals. Jt Comm J Qual Patient Saf. 2014;40(1):11–20.
80.
Zubkoff L, Neily J, King B, Dellefield ME, Krein S, Young-Xu Y, Boar S, Mills PD. Virtual breakthrough series, part 1: preventing catheter-associated urinary tract infection and hospital-acquired pressure ulcers in the veterans health administration. Jt Comm J Qual Patient Saf. 2016;42(11):485–98.
81.
Zubkoff L, Neily J, Quigley P, Soncrant C, Young-Xu Y, Boar S, Mills PD. Virtual breakthrough series, part 2: improving fall prevention practices in the veterans health administration. Jt Comm J Qual Patient Saf. 2016;42(11):497–517.
82.
Zubkoff L, Neily J, King B, Morgan S, Young-Xu Y, Boar S, Mills PD. Preventing pressure ulcers in the VHA using a virtual breakthrough series. J Nurs Care Qual. 2016;32(4):301–8.
83.
Aschbrenner K.A., Pratt S.I., Bond GR., Zubkoff L, Naslund J.A., Jue K, et al. A virtual learning collaborative to implement health promotion in routine mental health settings: protocol for a cluster randomized trial. Contemp Clin Trials. 2019;84(105816).
84.
Quill TE, Abernethy AP. Generalist plus specialist palliative care--creating a more sustainable model. N Eng J Med. 2013;368(23465068):1173–5.CrossRef
85.
Lupu D. American Academy of Hospice and Palliative Medicine Workforce Task Force. Estimate of current hospice and palliative medicine physician workforce shortage. J Pain Symptom Manage. 2010;40(6):899–911.
Metadata
Title
A cluster randomized controlled trial comparing Virtual Learning Collaborative and Technical Assistance strategies to implement an early palliative care program for patients with advanced cancer and their caregivers: a study protocol
Authors
Lisa Zubkoff
Kathleen Doyle Lyons
J. Nicholas Dionne-Odom
Gregory Hagley
Maria Pisu
Andres Azuero
Marie Flannery
Richard Taylor
Elizabeth Carpenter-Song
Supriya Mohile
Marie Anne Bakitas
Publication date
01-12-2021
Publisher
BioMed Central
Keyword
Care
Published in
Implementation Science / Issue 1/2021
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-021-01086-3

Other articles of this Issue 1/2021

Implementation Science 1/2021 Go to the issue

Research

Understanding the implementation of evidence-informed policies and practices from a policy perspective: a critical interpretive synthesis

Systematic review

The effectiveness of quality improvement collaboratives in improving stroke care and the facilitators and barriers to their implementation: a systematic review

Research

Outer-context determinants in the sustainment phase of a reimbursement-driven implementation of evidence-based practices in children’s mental health services

Methodology

Validation and refinement of the Stakeholder-driven Community Diffusion Survey for childhood obesity prevention

Research

Theory-based approach to developing an implementation plan to support the adoption of a patient decision aid for Down syndrome prenatal screening

Correction

Correction to: Coincidence analysis: a new method for causal inference in implementation science