Use of a modified informed consent process among vulnerable patients: a descriptive study

Sudore, RL; Landefeld, C. Seth; Ba, Williams; Barnes, DE; Lindquist, K; Schillinger, Dean

doi:10.1007/bf02743161

Cited by 88 publications

(108 citation statements)

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“…We used an interactive consent process, as previously described. (21) This study was approved by the UCSF-SFGH institutional review boards.…”

Section: Methodsmentioning

confidence: 99%

“…We hypothesized that participants would rate the redesigned advance directive easier to use and understand, more useful for personal treatment decisions, and more valuable for care planning. Because the hospital in which the redesigned advance directive was to be implemented has a large proportion of Spanish-speaking patients and patients with limited literacy, (20,21) and because engagement in advance care planning has been shown to be lower in minorities and subjects with lower education, (9,(22)(23)(24) we also explored whether the effects of the redesigned form were greater among participants with limited literacy and among Spanish-speakers.…”

Section: Introductionmentioning

confidence: 99%

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An advance directive redesigned to meet the literacy level of most adults: A randomized trial

Sudore

Landefeld

Barnes

et al. 2007

Patient Education and Counseling

123

183

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Objective-To determine whether an advance directive redesigned to meet most adults' literacy needs (5 th grade reading level with graphics) was more useful for advance care planning than a standard form (>12 th grade level).Methods-We enrolled 205 English and Spanish-speaking patients, aged ≥ 50 years from an urban, general medicine clinic. We randomized participants to review either form. Main outcomes included acceptability and usefulness in advance care planning. Participants then reviewed the alternate form; we assessed form preference and six-month completion rates.Results-40% of enrolled participants had limited literacy. Compared to the standard form, the redesigned form was rated higher for acceptability and usefulness in care planning, P≤0.03, particularly for limited literacy participants (P for interaction ≤ 0.07). The redesigned form was preferred by 73% of participants. More participants randomized to the redesigned form completed an advance directive at six months (19% vs. 8%, P=0.03); of these, 95% completed the redesigned form.Conclusions-The redesigned advance directive was rated more acceptable and useful for advance care planning and was preferred over a standard form. It also resulted in higher six month completion rates.Practice Implications-An advance directive redesigned to meet most adults' literacy needs may better enable patients to engage in advance care planning.

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“…We used an interactive consent process, as previously described. (21) This study was approved by the UCSF-SFGH institutional review boards.…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

An advance directive redesigned to meet the literacy level of most adults: A randomized trial

Sudore

Landefeld

Barnes

et al. 2007

Patient Education and Counseling

123

183

View full text Add to dashboard Cite

show abstract

“…We excluded patients who could not confirm understanding of the consent process. 22 For this study, we excluded those who died before discharge, were completely dependent in all ADLs at baseline, did not have information on at least four ADLs at each interview, or did not have 30-day follow-up. Participants who completed the baseline interview received a $10 pharmacy or grocery store gift certificate.…”

Section: Design Overviewmentioning

confidence: 99%

Hospitalization-Associated Disability in Adults Admitted to a Safety-Net Hospital

et al. 2015

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BACKGROUND:Little is known about hospitalizationassociated disability (HAD) in older adults who receive care in safety-net hospitals. OBJECTIVES: To describe HAD and to examine its association with age in adults aged 55 and older hospitalized in a safety-net hospital. DESIGN: Secondary post hoc analysis of a prospective cohort from a discharge intervention trial, the Support from Hospital to Home for Elders. SETTING: Medicine, cardiology, and neurology inpatient services of San Francisco General Hospital, a safety-net hospital. PARTICIPANTS: A total of 583 participants 55 and older who spoke English, Spanish, or Chinese. We determined the incidence of HAD 30 days post-hospitalization and ORs for HAD by age group. MEASUREMENTS: The outcome measure was death or HAD at 30 days after hospital discharge. HAD is defined as a new or additional disability in one or more activities of daily living (ADL) that is present at hospital discharge compared to baseline. Participants' functional status at baseline (2 weeks prior to admission) and 30 days postdischarge was ascertained by self-report of ADL function. RESULTS: Many participants (75.3 %) were functionally independent at baseline. By age group, HAD occurred as follows: 27.4 % in ages 55-59, 22.2 % in ages 60-64, 17.4 % in ages 65-69, 30.3 % in ages 70-79, and 61.7 % in ages 80 or older. Compared to the youngest group, only the adjusted OR for HAD in adults over 80 was significant, at 2.45 (95 % CI 1.17, 5.15). CONCLUSIONS: In adults at a safety-net hospital, HAD occurred in similar proportions among adults aged 55-59 and those aged 70-79, and was highest in the oldest adults, aged ≥ 80. In safety-net hospitals, interventions to reduce HAD among patients 70 years and older should consider expanding age criteria to adults as young as 55.

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“…While most authors have found benefits from designing consent forms that are shorter and easier to read (Coyne et al, 2003;Flory and Emanuel, 2004;Kang et al, 2009;Paris et al, 2010) simply decreasing the reading level will not ensure that all potential participants give consent and authorization that have been substantively informed. For example, easy-to-read consent forms might not be enough for potential research participants who lack familiarity with providing informed consent or the activities of participating in research (Sudore et al, 2006).…”

mentioning

confidence: 99%

How to Achieve Informed Consent for Research from Spanish-Speaking Individuals with Low Literacy: A Qualitative Report

Cortés

Drainoni

Henault

2010

Journal of Health Communication

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Use of a modified informed consent process among vulnerable patients: a descriptive study

Cited by 88 publications

References 0 publications

An advance directive redesigned to meet the literacy level of most adults: A randomized trial

An advance directive redesigned to meet the literacy level of most adults: A randomized trial

Hospitalization-Associated Disability in Adults Admitted to a Safety-Net Hospital

How to Achieve Informed Consent for Research from Spanish-Speaking Individuals with Low Literacy: A Qualitative Report

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