Dataset Information

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

ABSTRACT: One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a "reasonable person." However, research is limited on what types of information patients, caregivers, and providers consider "key information." Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe to be important and necessary as part of the IC process to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients, such as the benefits to others and contributions to science that are associated with participation in clinical research. Furthermore, increasing patient engagement during the IC process may allow providers to streamline information that is aligned with patient information needs and preferences.

SUBMITTER: Raj M

PROVIDER: S-EPMC5743761 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

Raj Minakshi M Choi Sung Won SW Gurtekin Tuba Suzer TS Platt Jodyn J

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation 20170904 1

One of the significant modifications to the Common Rule is the requirement that prospective participants be given information sufficient for a "reasonable person." However, research is limited on what types of information patients, caregivers, and providers consider "key information." Although certain aspects of informed consent (IC) may be considered standard, considering the individualized needs and preferences of patients is necessary for patient-centered consent. In this study, we qualitativ ...[more]

PMID: 28882447

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Project description:BackgroundEfforts to reduce opioid overdose fatalities have resulted in tapering (i.e., reducing or discontinuing) opioid prescriptions despite a limited understanding of patients' experiences.ObjectiveTo explore patients' perspectives on opioid taper experiences to ultimately improve taper processes and outcomes.DesignQualitative study.ParticipantsPatients on long-term opioid therapy for chronic pain who had undergone a reduction of opioid daily prescribed dosage of ≥50% in the past 2 years in two distinct medical systems and regions.ApproachFrom 2019 to 2020, we conducted semi-structured interviews that were audio-recorded, transcribed, systematically coded, and analyzed to summarize the content and identify key themes regarding taper experiences overall and with particular attention to patient-provider relationships and provider communication during tapers.Key resultsParticipants (n=41) had lived with chronic pain for an average of 17.4 years (range, 3-36 years) and described generally adverse experiences with opioid tapers, the initiation of which was not always adequately justified or explained to them. Consequences of tapers ranged from minor to substantial and included withdrawal, mobility issues, emotional distress, exacerbated mental health symptoms, and feelings of social stigmatization for which adequate supports were typically unavailable. Narratives highlighted the consequential role of patient-provider relationships throughout taper experiences, with most participants describing significant interpersonal challenges including poor provider communication and limited patient engagement in decision making. A few participants identified qualities of providers, relationships, and communication that fostered more positive taper experiences and outcomes.ConclusionsFrom patients' perspectives, opioid tapers can produce significant physical, emotional, and social consequences, sometimes reducing trust and engagement in healthcare. Patient-provider relationships and communication influence patients' perceptions of the quality and outcomes of opioid tapers. To improve patients' experiences of opioid tapers, tapering plans should be based on individualized risk-benefit assessments and involve patient-centered approaches and improved provider communication.

Project description:Storytelling has long been considered an effective means of communication, allowing the teller to process their emotions in light of particular life challenges. Effects on the listener also have been demonstrated to be beneficial, especially if the listener is faced with a similar life challenge. Less is known regarding the potential effects of storytelling on listening dyads and opportunities for joint processing following exposure to relevant stories. We sought to study these phenomena in the context of hematopoietic cell transplantation (HCT), a demanding medical procedure requiring intensive informal caregiving and thus great patient-caregiver entwinement. The purpose of this qualitative descriptive study was to explore participants' perceptions of a 4-week web-based digital storytelling (DST) intervention using both quantitative ratings of acceptability and qualitative coding of interviews conducted after intervention completion. A total of 202 participants (101 HCT patient-caregiver dyads) were recruited from the Mayo Clinic Arizona and randomized into either a DST arm or an Information Control (IC) arm. Participants in the DST arm rated the acceptability of the intervention and were asked to participate in a 30-minute phone interview to discuss their experience with the DST intervention. All interviews were recorded and transcribed verbatim and imported into NVivo 12 for coding and analysis, using a combination of deductive and inductive approaches to organize the data, create categories, and develop themes and subthemes. A total of 38 participants (19 HCT patient-caregiver dyads) completed the post-intervention interviews. Patients were 63% male and 82% White, 68% received allogeneic HCT, and their mean age was 55 years. The median time from HCT was 25 days (range, 6 to 56 days). Caregivers were mostly patients' spouses (73%) and female (69%), with a mean age of 56 years. In general, the 4-week web-based DST intervention was well accepted and liked by both patients and caregivers regarding the duration, dyadic participation, and convenience of participating in the intervention at home. Patients and caregivers who completed the DST intervention indicated that they were satisfied with the intervention (mean score, 4.5 of 5), were likely to recommend it to others (mean score, 4.4), would watch more stories (mean score, 4.1), and that the experience was worth their time (mean score, 4.6). Major themes that emerged from the qualitative analysis included (1) building communal connection through engaging with the stories; (2) positive emotional growth after HCT; (3) value of gaining the other's perspective; and (4) impact of open communication on the patient-caregiver relationship. A web-based DST intervention provides an attractive format through which to deliver a nonpharmacologic psychosocial intervention to HCT patient-caregiver dyads. Watching the emotional content in digital stories may help patients and caregivers cope with psychoemotional challenges together and provide an opportunity for emotional disclosure. Further work on determining optimal paths to disclosure is warranted.

Dataset Information

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

Publications

Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives.

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