Stakeholder-engaged process for refining the design of a clinical trial in home hospice

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Abstract

Background

Clinical trials in home hospice settings are important to build the evidence base for practice, but balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is challenging. A stakeholder-engaged process can help inform and refine key aspects of home hospice clinical trials. The aim of this study was to describe a stakeholder-engaged process to refine, design, and implement aspects of an educational intervention trial in home hospice, including recommendations for refining intervention content and delivery, recruitment and enrollment strategies, and content and frequency of outcome measurement.

Methods

A panel of interprofessional (1 hospice administrator, 3 nurses, 2 physicians, 2 pharmacists) and 2 former family caregiver stakeholders was systematically selected and invited to participate based on expertise, representing 2 geographically distinct hospices who were participating in the clinical trial. Teleconferences followed a predetermined procedural sequence: 1. pre-meeting materials distribution and review; 2. pre-meeting email solicitation of concerns in response to materials; 3. teleconference with structured and guided discussion; and 4. documentation and distribution of minutes for accuracy review and future meeting guidance. Discussion topics were distinct for each panel meeting. Written reflections on the stakeholder engagement process were collected from panel members to further refine our process.

Results

Five initial biweekly teleconferences resulted in recommendations for recruitment strategy, enrollment process, measurement frequency, patient inclusion, and primary care physician notification of the patient’s trial involvement. The panel continues to participate in quarterly teleconferences to review progress and unexpected questions and concerns. Panelist reflections reveal personal and professional benefit from participation.

Conclusions

An interprofessional stakeholder process is feasible and invaluable for developing home hospice intervention studies, contributing to better science, successful trial implementation, and relevant, valid outcomes.

Trial registration

Clinicaltrials.gov, NCT03972163, Registered June 3, 2019.

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Most cited references 26

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The dark side of coproduction: do the costs outweigh the benefits for health research?

Kathryn Oliver, Anita Kothari, Nicholas Mays (2019)

Background Coproduction, a collaborative model of research that includes stakeholders in the research process, has been widely advocated as a means of facilitating research use and impact. We summarise the arguments in favour of coproduction, the different approaches to establishing coproductive work and their costs, and offer some advice as to when and how to consider coproduction. Debate Despite the multiplicity of reasons and incentives to coproduce, there is little consensus about what coproduction is, why we do it, what effects we are trying to achieve, or the best coproduction techniques to achieve policy, practice or population health change. Furthermore, coproduction is not free risk or cost. Tensions can arise throughout coproduced research processes between the different interests involved. We identify five types of costs associated with coproduced research affecting the research itself, the research process, professional risks for researchers and stakeholders, personal risks for researchers and stakeholders, and risks to the wider cause of scholarship. Yet, these costs are rarely referred to in the literature, which generally calls for greater inclusion of stakeholders in research processes, focusing exclusively on potential positives. There are few tools to help researchers avoid or alleviate risks to themselves and their stakeholders. Conclusions First, we recommend identifying specific motivations for coproduction and clarifying exactly which outcomes are required for whom for any particular piece of research. Second, we suggest selecting strategies specifically designed to enable these outcomes to be achieved, and properly evaluated. Finally, in the absence of strong evidence about the impact and process of coproduction, we advise a cautious approach to coproduction. This would involve conscious and reflective research practice, evaluation of how coproduced research practices change outcomes, and exploration of the costs and benefits of coproduction. We propose some preliminary advice to help decide when coproduction is likely to be more or less useful.

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The impact of patient-centered care on outcomes.

I R McWhinney, P. J. Oates, W Weston … (2000)

We designed this observational cohort study to assess the association between patient-centered communication in primary care visits and subsequent health and medical care utilization. We selected 39 family physicians at random, and 315 of their patients participated. Office visits were audiotaped and scored for patient-centered communication. In addition, patients were asked for their perceptions of the patient-centeredness of the visit. The outcomes were: (1) patients' health, assessed by a visual analogue scale on symptom discomfort and concern; (2) self-report of health, using the Medical Outcomes Study Short Form-36; and (3) medical care utilization variables of diagnostic tests, referrals, and visits to the family physician, assessed by chart review. The 2 measures of patient-centeredness were correlated with the outcomes of visits, adjusting for the clustering of patients by physician and controlling for confounding variables. Patient-centered communication was correlated with the patients' perceptions of finding common ground. In addition, positive perceptions (both the total score and the subscore on finding common ground) were associated with better recovery from their discomfort and concern, better emotional health 2 months later, and fewer diagnostic tests and referrals. Patient-centered communication influences patients' health through perceptions that their visit was patient centered, and especially through perceptions that common ground was achieved with the physician. Patient-centered practice improved health status and increased the efficiency of care by reducing diagnostic tests and referrals.

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Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss.

Holly G. Prigerson, Paul K. Maciejewski, Charles Reynolds … (1995)

Certain symptoms of grief have been shown (a) to be distinct from bereavement-related depression and anxiety, and (b) to predict long-term functional impairments. We termed these symptoms of "complicated grief" and developed the Inventory of Complicated Grief (ICG) to assess them. Data were derived from 97 conjugally bereaved elders who completed the ICG, along with other self-report scales measuring grief, depression, and background characteristics. Exploratory factor analyses indicated that the ICG measured a single underlying construct of complicated grief. High internal consistency and test-retest reliabilities were evidence of the ICG's reliability. The ICG total score's association with severity of depressive symptoms and a general measure of grief suggested a valid, yet distinct, assessment of emotional distress. Respondents with ICG scores > 25 were significantly more impaired in social, general, mental, and physical health functioning and in bodily pain than those with ICG scores < or = 25. Thus, the ICG, a scale with demonstrated internal consistency, and convergent and criterion validity, provides an easily administered assessment for symptoms of complicated grief.

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Author and article information

Contributors

Jennifer Tjia:

ORCID: http://orcid.org/0000-0003-4541-0460

jennifer.tjia@umassmed.edu

Journal

Journal ID (nlm-ta): BMC Med Res Methodol

Journal ID (iso-abbrev): BMC Med Res Methodol

Title: BMC Medical Research Methodology

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2288

Publication date (Electronic): 30 April 2021

Publication date PMC-release: 30 April 2021

Publication date Collection: 2021

Volume: 21

Electronic Location Identifier: 92

Affiliations

[1 ]University of Massachusetts Medical School, 368 Plantation Street, AS6-2065, Worcester, MA 01605 USA

[2 ]University of Utah College of Nursing, Salt Lake City, UT USA

[3 ]University of Rhode Island School of Nursing, Kingston, RI USA

Author information

Jennifer Tjia http://orcid.org/0000-0003-4541-0460

Article

Publisher ID: 1275

DOI: 10.1186/s12874-021-01275-0

PMC ID: 8091786

PubMed ID: 33941089

SO-VID: 1c7f9528-00a8-4f63-8f91-68efb79e1855

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 14 August 2020

Date accepted : 12 April 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100000049, National Institute on Aging;

Award ID: NIA R21AG60017

Award Recipient : Jennifer Tjia

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: stakeholder,home hospice,clinical trial,outcome measurement,deprescribing

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ScienceOpen disciplines: Medicine

Keywords: stakeholder, home hospice, clinical trial, outcome measurement, deprescribing

Stakeholder-engaged process for refining the design of a clinical trial in home hospice

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Abstract

Background

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Trial registration

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Drug Repurposing

Most cited references 26

The dark side of coproduction: do the costs outweigh the benefits for health research?

The impact of patient-centered care on outcomes.

Inventory of Complicated Grief: a scale to measure maladaptive symptoms of loss.

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