Current use and costs of electronic health records for clinical trial research: a descriptive study

Kimberly A. Mc Cord; Hannah Ewald; Aviv Ladanie; Matthias Briel; Benjamin Speich; Heiner C. Bucher; Lars G. Hemkens

doi:10.9778/cmajo.20180096

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Figure 1:
Flow chart showing trial selection. Note: EHR = electronic health record, RCT = randomized controlled trial.

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Table 1:

Characteristics of randomized controlled trials published in English between January 2000 and Sept. 13, 2017 that used electronic health records

Characteristic	No. (%) of trials^*
Characteristic	Overall n = 189	EHR-evaluating n = 172	EHR-supported n = 17
EHR for intervention	172 (91.0)	172 (100.0)	–
Computerized physician order entry system or clinical decision-support system	128 (67.7)	128 (74.4)	–
Telehealth	14 (7.4)	14 (8.1)	–
Personal health record	26 (13.8)	26 (15.1)	–
Electronic patient-reported outcomes	4 (2.1)	4 (2.3)	–
EHR for outcome measurement	158 (83.6)	143 (83.1)	15 (88)
EHR for patient recruitment	105 (55.6)	91 (52.9)	14 (82)
Country/region
North America	153 (81.0)	140 (81.4)	13 (76)
United Kingdom	9 (4.8)	7 (4.1)	2 (12)
Continental Europe	15 (7.9)	14 (8.1)	1 (6)
Other^†	12 (6.3)	11 (6.4)	1 (6)
Cluster RCT	64 (33.9)	61 (35.5)	3 (18)
Unit of randomization
Clinician	49 (25.9)	46 (26.7)	3 (18)
Patient	76 (40.2)	65 (37.8)	11 (65)
Pharmacy	1 (0.5)	1 (0.6)	0 (0)
Practice/clinic	54 (28.6)	51 (29.6)	3 (18)
Unit/floor	9 (4.8)	9 (5.2)	0 (0)
Publication year, median (IQR)	2012 (2009–2014)	2012 (2009–2014)	2013 (2010–2013)
Sample size, median (IQR)
Total	89 (24–732)	80 (22–513)	732 (73–2513)
Cluster RCTs excluded	239 (57–1187)	254 (60–1187)	900 (111–3075)
Cluster RCTs only	24 (12–47)	24 (12–52)	18 (12–24)
Blinding
Open label	27 (14.3)	23 (13.4)	4 (24)
Single-blinded	19 (10.0)	18 (10.5)	1 (6)
Double-blinded	7 (3.7)	6 (3.5)	1 (6)
Outcome assessment blinding	35 (18.5)	30 (17.4)	5 (29)
Not reported	101 (53.4)	95 (55.2)	6 (35)

Note: EHR = electronic health record, IQR = interquartile range, RCT = randomized controlled trial.
↵* Except where noted otherwise.
↵† Includes China, Japan, Taiwan, Iran, India, Pakistan, Lebanon, Australia and Kenya.

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Table 2:

Characteristics of randomized controlled trials supported by electronic health records

Investigator	Country; sample size	EHR use for recruitment; study type	EHR use for outcome assessment; extent of use of routinely collected data	Patient population/ indication	Intervention and control^*	Primary outcome; length of follow-up; amount of missing data	Setting
Bereznicki et al.,18 2008	Australia; 1551 patients	Yes; retrospective	Yes; EHR alone	Uncontrolled asthma	Intervention: contact by community pharmacist plus educational material and referral to general practitioner for asthma management	Ratio of dispensed preventer and reliever medication; 6 mo; NR	Community pharmacy network
Corson et al.,19 2011	US; 42 caregivers (randomly allocated), 365 patients	No; prospective	Yes; hybrid, primary outcome EHR alone	Musculoskeletal pain	Intervention: patient and clinician education, symptom monitoring and feedback to clinicians	Guideline-concordant care; 12 mo; NR	Primary care clinics associated with Department of Veterans Affairs medical centre and urban hospital
de Jong et al.,20 2013	Netherlands; 73 general practitioner trainees (randomly allocated)^†	Yes; retrospective	Yes; hybrid, primary outcome EHR alone	Skin and psychosocial conditions	Steering patient mix of general practitioner trainees	Trainee exposure to specific field, and knowledge and self-efficacy; 6 mo; 5%–10%	Practice network with general practitioner training program
Fu et al.,21 2014	US; 6400 patients	Yes; retrospective	Yes, hybrid; primary outcome active data collection alone	Current smokers	Proactive outreach plus choice of smoking cessation services	6-mo prolonged smoking abstinence at 1 yr; 12 mo; 48.3% (but 0% for EHR outcome)	Department of Veterans Affairs medical centre
Galbreath et al.,22 2004	US; 1069 patients	Yes; retrospective	Yes, hybrid; primary outcome active data collection alone	Symptomatic congestive heart failure	Congestive heart failure management program (plus at-home scale)	All-cause mortality and use of health care services; NR (time to event); NR	Various health care networks^‡ and Medicare/ Medicaid participants
Gerber et al.,23 2013	US; 18 practices, 170 caregivers (randomly allocated), 185 212 patients	Yes; retrospective	Yes, hybrid; primary outcome active data collection alone	Clinical practice groups with primary care pediatricians (children with acute respiratory tract infections)	Antibiotic stewardship program	Change in broad-spectrum antibiotics prescribed for bacterial infections or in antibiotic prescribed for viral infections; 12 mo; 5% of caregivers	Pediatric primary care network
Green et al.,24 2013	US; 4675 patients	Yes; retrospective	Yes; EHR alone	Prevention of colorectal cancer	Automated interventions v. assisted care v. navigated care v. usual care	Receiving any colorectal cancer test and being current for colorectal cancer testing in years 1 and 2; 24 mo; 0.2%	Primary care practice network
Hoffman et al.,25 2010	US; 404 patients	Yes; retrospective	No; active data collection alone	Prevention of colorectal cancer	Fecal immunochemical test (v. guaiac-based occult blood test)	Screening adherence; 3 mo; NR	Department of Veterans Affairs network (primary care clinics and laboratory)
Israel et al.,26 2013	US; 732 patients	Yes, retrospective	No; active data collection alone	Adult inpatients with at least 1 of several cardiovascular disease diagnoses in EHR	Minimal intervention (medication reconciliation), enhanced intervention (minimal intervention plus pharmacist) or usual care	Rate of underuse of cardiovascular drugs; 3 mo; NR	University hospital (orthopedic, internal medicine, family medicine and cardiology wards)
McCarren et al.,27 2013	US; 12 practices (randomly allocated), 220 patients	Yes; retrospective	Yes; EHR alone	Heart failure and guideline-nonconcordant β-blocker prescription	Information to pharmacy about prescription nonconcordance	Guideline-concordant prescriptions; 6 mo; 0%	Veterans Health Administration facilities and pharmacies
Phillips et al.,29 2011	US; 3895 patients	Yes; retrospective	Yes; EHR alone	Prevention of breast cancer	Telephone calls and reminder letters from patient navigators	Adherence to biennial mammography; 9 mo; NR	Hospital-based internal medicine practices
Piazza et al.,30 2013	US; 2513 patients	Yes; retrospective	Yes; EHR alone	Medical service inpatients at risk for venous thromboembolism with planned discharge within 48 h	Alert for physician	Symptomatic deep vein thrombosis or pulmonary embolism; 3 mo; < 0.1%	Inpatient medical unit
Qureshi et al.,31 2012	UK; 24 caregivers (randomly allocated), 748 patients	No; prospective	Yes; hybrid, primary outcome EHR alone	Adult primary care patients with no previously diagnosed cardiovascular risk	Family history questionnaire (in addition to Framingham risk score)	Proportion of identified participants with high cardiovascular risk scores; NA; 1.7%	Family practices in research network
Skinner et al.,32 2015	US; 1032 patients	Yes; retrospective	Yes; EHR alone	Prevention of colorectal cancer	Tablet-based Cancer Risk Intake System assessment before appointment and control group	Received risk-appropriate colorectal cancer testing and any type of colorectal cancer testing; 12 mo; 0%	Family practices affiliated with university medical centre
Stewart et al.,28 2014	US; 235 patients	Yes; retrospective	Yes; hybrid, primary outcome EHR alone	Dysthymia or major depressive disorder	Collaborative care program with psychotherapy and antidepressant drugs	Cardiovascular events; 96 mo; 0%	Academic group practice
Vestbo et al.,33 2016	UK; 2802 patients	No; prospective	Yes; hybrid, primary outcome active data collection alone	COPD and regular maintenance inhaler therapy	Fluticasone furoate + vilanterol (100 μg/ 25 μg) once a day via inhalation v. usual care	Moderate or severe COPD exacerbation; 12 mo; 24.8%	Health care network in and around Salford, hospitals, general practitioners, pharmacies
Wolf et al.,34 2005	US; 113 health care providers (randomly allocated), 1978 patients	Yes; retrospective	Yes; EHR alone	Prevention of colorectal cancer	Education session plus performance feedback	Completion of colorectal cancer screening; NA; NR	Department of Veterans Affairs primary care clinics

Note: COPD = chronic obstructive pulmonary disease, EHR = electronic health record, NA = not applicable, NR = not reported.
↵* All comparisons are “usual care” unless otherwise specified.
↵† Number of patients not reported.
↵‡ University of Texas Health Science Center at San Antonio, in partnership with Wilford Hall Medical Center, Brooke Army Medical Center, South Texas Veterans Health Care System, TRICARE Region 6 and University Health System.

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Table 3:

Costs of randomized controlled trials supported by electronic health records^*

Type of data extraction from EHR source; investigator	EHR source preexisting	Intervention integrated during routine care (no additional staff needed)	Total trial cost, US$	No. of patients^†	Cost per patient, US$
Automatic
Bereznicki et al.,18 2008	Yes	Yes	67 750^††	1551	44
Manual
Green et al.,24 2013	Yes	No	2 800 000^§	5000	560
Piazza et al.,30 2013	Unclear	No	5 026 000^¶	2513	2000
Wolf et al.,34 2005	Yes	Yes	86 753^**	1978	44
Unclear whether automatic or manual
McCarren et al.,27 2013	Yes	Yes	69 300^††	220	315

Note: EHR = electronic health record.
↵* In all trials, the EHR was used for recruitment (retrospective) and outcome assessment (all with EHR alone).
↵† As reported by authors for these costs data.
‡ Total received funding, including $42 157 for staff costs for the duration of the project, $6132 for a consultant programmer (for software development), $15 330 for pharmacy payments and $6132 for nonsalary costs such as printing, postage and travel.
↵§ Total received funding.
↵¶ Study costs were $2000 per patient and included costs of the trial start-up and close out.
↵** Total cost of the colorectal cancer screening promotional effort (intervention only).
↵†† Total received funding. “Most of the [working] time was donated.”

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Table 4:

Risk of bias assessment with the Cochrane risk of bias tool15

Investigator	Random sequence generation	Allocation concealment	Blinding of participants and personnel	Blinding of outcome assessment	Incomplete outcome data (> 10%)	Selective outcome reporting^*
Bereznicki et al.18	?	−	−	−	?	NA
Corson et al.19	?	?	+	−	?	NA
de Jong et al.20	−	?	+	?	−	NA
Fu et al.21	?	?	+	−	+^†	NA
Galbreath et al.22	?	?	+	+	?	NA
Gerber et al.23	?	−	+	?	−	NA
Green et al.24	−	−	+	−	−	NA
Hoffman et al.25	−	?	?	?	?	NA
Israel et al.26	−	?	−	−	?	NA
McCarren et al.27	−	?	+	+	−	NA
Phillips et al.29	?	?	+	?	?	NA
Piazza et al.30	−	−	+	?	−	NA
Qureshi et al.31	−	−	+	?	−	NA
Skinner et al.32	?	?	+	?	−	NA
Stewart et al.28	−	−	+	−	−	NA
Vestbo et al.33	−	−	+	?	+	NA
Wolf et al.34	?	?	+	?	?	NA

Note: EHR = electronic health record, NA = nonapplicable, − = low risk of bias, ? = unclear risk of bias, + = high risk of bias.
↵* Since only the publication identified in our literature search was assessed (there was no systematic protocol search and no searching for further manuscripts related to that study), we did not consider this item.
↵† The completeness of outcome data based on the electronic health record (secondary study outcome) was perfect (0% missing data).