The Consent and Prescription Compliance (COPRECO) Study: Does Obtaining Consent in the Emergency Department Affect Study Results in a Telephone Follow‐up Study of Medication Compliance?

Campbell, Samuel; McCarvill, Erin M.; Magee, Kirk; Cajee, Ismail; Crawford, Megan

doi:10.1111/j.1553-2712.2008.00234.x

Cited by 14 publications

(15 citation statements)

References 24 publications

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“…We found that ED patients do not object to receiving a telephone follow-up survey for an observational study to which they had not previously consented in person. This finding accords with other emergency medicine research on the topic (33)(34)(35).…”

Section: Discussionsupporting

confidence: 95%

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Vinson

Hoehn

Graber

et al. 2012

The Journal of Emergency Medicine

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Section: Discussionsupporting

confidence: 95%

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Vinson

Hoehn

Graber

et al. 2012

The Journal of Emergency Medicine

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“…4 The other prior similar study referenced by Offerman et al reached 80% of patients (167 of 209) using delayed consent, which was similar to the 81% (180 of 221) reached following ED consent. 5 The much higher rates of contact reported by Offerman et al may in part be because of sociodemographic differences in the study population or because the study question is essentially a continuation of the patient's clinical care. Regardless of the explanation, a 99% contact rate is unusually high, and future researchers should neither expect to obtain nor be criticized for not obtaining a similar response rate.…”

mentioning

confidence: 60%

Delayed Telephone Consent in Emergency Medicine Research

Platts‐Mills¹,

Keil

2013

Acad Emerg Med

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We appreciate the work of Offerman and colleagues, 1 which describes the process of enrolling emergency department (ED) patients in a study by identifying them using the ED record and contacting them by telephone after the ED visit to request consent. We agree with the authors' conclusion that delayed telephone consent is generally ethical and efficient, but offer the following observations.The investigators report that of 506 eligible patients identified by emergency providers in the ED, 501 (99.0%) patients or their surrogates were successfully reached by phone using phone numbers in the ED medical records, and 500 (99.8%) consented to the study. These very high rates of reaching and consenting patients are not consistent with our experience or that of others performing ED-based research.A recent large study of medication adherence among ED patients obtained 1-week follow-up for 86% of patients (3,386 of 3,940). 2 In the medication adherence study contact information was obtained via in-person interview, and patients received $10 gift cards for completing follow-ups. Our own experience conducting research on older adults is similar; short-term follow-up can be achieved for 85% to 90% of older patients if one obtains comprehensive contact information in the ED and makes considerable efforts to reach the patient. 3 When we used similar methods to that of Offerman et al. (i.e., making calls to patients using information from the ED record), only approximately 50% of patients or surrogates were contacted. 4 The other prior similar study referenced by Offerman et al. reached 80% of patients (167 of 209) using delayed consent, which was similar to the 81% (180 of 221) reached following ED consent. 5 The much higher rates of contact reported by Offerman et al. may in part be because of sociodemographic differences in the study population or because the study question is essentially a continuation of the patient's clinical care. Regardless of the explanation, a 99% contact rate is unusually high, and future researchers should neither expect to obtain nor be criticized for not obtaining a similar response rate. Further, we think it unlikely that deferred consent is likely to provide consistently higher follow-up rates than ED consent.The other conclusion the authors draw from their study is that this approach is ethical. We agree that in most situations making an unsolicited phone call to request study participation following an ED visit is ethical, but the details matter. Calls to home phones for individuals who have recently visited the ED for complaints related to substance abuse or an early pregnancy may be unwelcome and unethical, even if the study does not contain an intervention.

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“…Only one prior study has evaluated a consent process similar to the current study. Patients enrolled into a medication compliance study were randomized to immediate ED consent versus no ED consent . Only one of the 149 subjects undergoing telephone follow‐up refused to participate, demonstrating the success and willingness of the subjects to be included in observational research studies without their knowledge.…”

Section: Discussionmentioning

confidence: 99%

The Use of Delayed Telephone Informed Consent for Observational Emergency Medicine Research Is Ethical and Effective

Offerman

Nishijima

Ballard

et al. 2013

Academic Emergency Medicine

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Objectives To describe the rate of successful consent using an altered (deferred telephone) consent process in emergency department (ED) patients. Methods This study evaluated the consent process employed during a prospective, multicenter, observational study of outcomes in anticoagulated patients with blunt head trauma. The study was approved by the institutional review boards at all participating centers. Patients were not informed of the study during their enrollment at their index ED visit. Patient names, clinical findings, and contact information were collected at the time of initial ED visits. The patients or their legally designated surrogates were contacted by telephone at least 14 days after ED discharge, given all the elements of informed consent, and then were consented for study participation. Study results are presented with simple descriptive statistics. Results Five hundred and six patients with a mean age of 75.8 years (SD ±12.2 years) including 274 female subjects (54.2%; 95% CI = 49.7% to 58.6%) were enrolled into the study. Patients or their surrogates were successfully contacted by telephone in 501 out of 506 cases (99.0%, 95% CI = 97.7% to 99.7%). Consent was obtained in 500 out of 501 cases at time of telephone follow-up (99.8%; 95% CI = 98.9% to 100.0%). Surrogates provided consent in 199 cases (39.7%, 95% CI = 35.4% to 44.2%). Median time from ED visit to phone contact was 21 days (IQR 17 to 27 days). The median number of phone attempts for successful contact was 1 (IQR 1 to 2 attempts). Conclusions The authors achieved a very high rate of successful telephone follow-up in this predominantly older ED population. Obtaining consent to participate in a research study using a deferred telephone contact process was effective and well-received by both subjects and surrogates. Institutional Review Boards should consider deferred telephone consent for minimal-risk studies requiring telephone follow-up, as opposed to a consent process requiring written documentation at the time of initial ED visit.

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The Consent and Prescription Compliance (COPRECO) Study: Does Obtaining Consent in the Emergency Department Affect Study Results in a Telephone Follow‐up Study of Medication Compliance?

Cited by 14 publications

References 24 publications

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Managing Emergency Department Patients with Recent-onset Atrial Fibrillation

Delayed Telephone Consent in Emergency Medicine Research

The Use of Delayed Telephone Informed Consent for Observational Emergency Medicine Research Is Ethical and Effective

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