DÄ internationalArchive44/2016Medication and Treatment Adherence Following Hospital Discharge

Original article

Medication and Treatment Adherence Following Hospital Discharge

A Study of an Intervention Aimed at Reducing Risk Associated With Medication Change

Dtsch Arztebl Int 2016; 113: 749-56. DOI: 10.3238/arztebl.2016.0749

Greißing, C; Buchal, P; Kabitz, H; Schuchmann, M; Zantl, N; Schiek, S; Bertsche, T

Background: Patients’ drug regimens often need to be changed when they pass from one care sector to another, but these changes sometimes pose a safety risk. To avoid such risks, a new inter-sector transition concept was developed incorporating discharge medication plans and counseling modules for the patients themselves and the doctors receiving them into their care.

Methods: A prospective interventional trial was carried out in two internal medicine wards of a general hospital. After data acquisition from the control group, the transition concept was developed and evaluated in an independent intervention group. The discharge medication plan and the first post-discharge prescription were compared to identify patients who had at least one medication change that increased the post-discharge risk of either failure to achieve the therapeutic goal (category A, first endpoint) or of patient’s lack of treatment adherence (category B). Gaps in care after discharge were also analyzed.

Results: 200 consecutive patients were enrolled in the trial. In the intention-to-treat analysis, the percentage of patients with potentially jeopardizing medication changes in category A declined from 54% (54/100) in the control group to 15% (15/100) in the intervention group. (p<0.001). For medication changes in category B, there was a corresponding decline from 53% (53/100) to 7% (7/100) (p < 0.001). Gaps in care were seen in 28% (28/100) of control patients and 18% (18/100) of patients in the intervention group (p = 0.031).

Conclusion: The likelihood of a potentially jeopardizing medication change upon hospital discharge can be markedly reduced with the aid of a modular transition concept. Gaps in care can be closed in this way as well.

LNSLNS

Almost all patients have their medications changed during a hospital stay (1). After discharge, further medication changes may result from necessary adjustments to treatment or new diagnoses. However, there is also a risk that patients are affected by unintended medication changes occurring after discharge, potentially leading to adverse drug events and hospital readmission (24). Sending out discharge summaries with complete information about the discharge medications at an early point and advising patients on their discharge medications are among the key preventive strategies to optimize the safety of drug therapy at the interface between hospital and outpatient care (59). However, such measures have not been widely adopted as yet in Germany.

The aim of this study was to develop and evaluate a modular transition concept (“Konstanz model“) with discharge medication plans for the physicians providing ongoing care as well as the patients plus structured discharge counseling in a model region of a tertiary care hospital.

Methods

Definitions

In eBox 1, definitions of the terms “potentially jeopardizing medication changes”, “first post-discharge prescription“, “care gap“, and “high-risk medications“ are provided. In eBox 2, examples of potentially jeopardizing medication changes are given.

Definitions of (potentially jeopardizing) medication changes, care gaps and high-risk medications
Definitions of (potentially jeopardizing) medication changes, care gaps and high-risk medications
eBox 1
Definitions of (potentially jeopardizing) medication changes, care gaps and high-risk medications
Examples of and notes to medication changes in the categories A and B between discharge medications and the first post-discharge prescription (gray)*
Examples of and notes to medication changes in the categories A and B between discharge medications and the first post-discharge prescription (gray)*
eBox 2
Examples of and notes to medication changes in the categories A and B between discharge medications and the first post-discharge prescription (gray)*

Study design

We conducted a prospective intervention study. Starting from November 2013, consecutive patients were included in the control group on working days over a period of 12 weeks. Based on the insights from the control group, the modules of the transition concept were then developed over a period of 15 months and implemented on the pilot wards. Subsequently, consecutive patients were included in the intervention group over a further 12-week period, using the same procedure as with the control group. Patients already included in the control group were not re-recruited for the intervention group. Researchers who conducted the study had no influence on the inclusion of patients at a specific point in time (control or intervention phase). Control group patients received the standard medical and nursing care on hospital admission and discharge. The standard care included a physician-obtained medication history on admission and a physician-led discharge discussion as well as handing out the preliminary discharge summary and enough medications until the next working day to the patient, as it is legally required or specified in relevant checklists (10, 11). For intervention group patients, a transition concept with four modules was used:

  • Module 1: a discharge medication plan for the referring physician providing ongoing care (eFigure)
  • Module 2: a patient discharge medication plan
  • Module 3: discharge counseling
  • Module 4: specific medication information cards on defined high-risk medications.
Example of a discharge medication plan
Example of a discharge medication plan
eFigure 1
Example of a discharge medication plan
CONSORT flow chart
CONSORT flow chart
eFigure 2
CONSORT flow chart

The modules and the criteria for their use were defined in advance by an interdisciplinary expert panel composed of physicians and clinical pharmacists (Figure 1). Prior to the start of the study, an information event was held to educate the primary care physicians in the region about module 1 (discharge medication plans for referring physicians). The sole purpose of this event was to provide information to the community-based practitioners, covering the structure and the mailing of the medication plan; it was not intended to be a training event or an intervention.

Process and modules of the transition concept as well as criteria for their use (gray); several modules (1–4) can be used in a single patient
Process and modules of the transition concept as well as criteria for their use (gray); several modules (1–4) can be used in a single patient
Figure 1
Process and modules of the transition concept as well as criteria for their use (gray); several modules (1–4) can be used in a single patient

Study setting and study population

Following the positive opinions of the ethics committees of the University of Leipzig and the State Medical Chamber of Baden–Württemberg (Stuttgart) (209/13 ff and 213/107 ff), the study was conducted in 2 medical departments (46 inpatient beds) in a tertiary care hospital. The inclusion criteria were met by all patients >18 years and fit to give their informed consent who were discharged home and had at least one medication on their discharge medication plan. Patients discharged to a nursing home, to another department or another hospital, and patients where family members or nursing services were solely responsible for the provision of medications after discharge were excluded from this study. All patients gave their written informed consent prior to participating in this study.

Primary and secondary outcomes

The primary outcome was the proportion of patients with at least one potentially jeopardizing category A medication change (potential threat to the therapeutic goal). The secondary outcomes were the proportion of patients with at least one potentially jeopardizing category B medication change (potential threat to treatment adherence by the patient) and the proportion of patients with a gap in care after hospital discharge.

Data collection methods

Medication changes were identified by means of a structured comparison of the discharge medications with the first post-discharge prescription. To determine the first post-discharge prescription, participating patients received written instructions at the time of discharge that they should—over a period of 4 weeks—keep copies of all filled prescriptions, medication lists or medication packages prescribed during this period. During a structured patient interview at week 4 after hospital discharge, the clinical pharmacist recorded the first post-discharge prescription based on the collected documents and medication packages.

To identify any gap in care, the discharge date documented in the hospital information system was compared with the date of the filling of the first post-discharge prescription at a pharmacy. This was determined using prescriptions copies and information provided by the patient during the interview. The exact time spent on discharge counseling in the intervention group was documented by the clinical pharmacist providing this service. Sociodemographic data as well as pre-hospital and inpatient medications were extracted from the hospital’s patient health records. Diagnoses and information about the course of the treatment were obtained from the discharge summary, while information about the patient’s educational level and employment status was collected during the interview.

Sample size calculation and statistical analysis

Based on the results of a pilot study, we assumed that in 50% of patients at least one potentially jeopardizing category A medication change (primary outcome) can be expected. For the intervention concept, an absolute risk reduction of at least 20% was regarded as a clinically relevant outcome. Assuming this risk constellation, we arrived at a sample size of at least 93 patients per group, given an independent control group and intervention group, using a two-sided chi square test with a significance level of α = 0.05 and a power of 1 – β = 0.80 for the primary outcome.

The results are reported as medians with first and third quartile (Q25/Q75) or as percentages. If not stated otherwise, the results of the intention-to-treat (ITT) analysis are presented. Missing values were filled in based on the assumption of a worst-case scenario. Here, it was assumed for all patients with missing values in the control group that no medication changes and care gaps occurred. For intervention group patients with missing values, it was assumed that they were affected by medication changes and care gaps. Risk reductions are reported as absolute risk reductions (ARR). Differences between the groups were analyzed using the Mann–Whitney U test for non-normally distributed data and the chi-square test for proportional values (nominal, dichotomous data). A significance level of α = 0.05 was assumed. Backed by multiple statistical tests used for endpoint evaluation, the interpretation of the result was based on a Bonferroni-adjusted significance level of α‘ = 0.0038. Statistical calculations were performed using SPSS (Statistical Package for the Social Science, Version 20, IBM, USA) and Microsoft Excel (Microsoft Corporation, Version 2010, USA).

Results

Patient population and medical care structure

Of the altogether 779 patients treated in the participating departments during the recruitment period of this study, 269 met the inclusion criteria. Of these, 200 patients consented to participating in the study (ITT population). During the intervention phase, for 99 patients a discharge medication plan was sent to the referring physician providing ongoing care (Module 1 in Figure 1); in one patient, the physician providing ongoing care was not known. The modules 2 and 3 were used in 92 patients, while module 4 was used in 30 patients. The first post-discharge prescription was documented in 96 patients of the control group and 98 patients of the intervention group during the interview, based on copies of prescriptions (control: 37; intervention: 32), medication lists (control: 71; intervention: 72) and medication packages (control: 47, intervention: 42). The date of filling the first post-discharge prescription could be obtained and documented in 60 patients of the control group and 67 of the intervention group (per-protocol population; p = 0.390) (eFigure). No significant differences in patient characteristics were found between the control group and the intervention group (Table 1, eTable).

Patient characteristics of the intention-to-treat (ITT) population (continued in the eTable)
Patient characteristics of the intention-to-treat (ITT) population (continued in the eTable)
Table 1
Patient characteristics of the intention-to-treat (ITT) population (continued in the eTable)
Patient characteristics – continued (intention-to-treat population)
Patient characteristics – continued (intention-to-treat population)
eTable
Patient characteristics – continued (intention-to-treat population)

Fifty family physicians were responsible for the control group and 60 for the intervention group, while 31 were responsible for both the control group and the intervention group. The same two chief physicians, the same 5 senior physicians as well as 14 registrars (changing due to rotations required by the residency program) were responsible for the recruited patients. The median time spent on structured discharge counseling (module 3) was 7 minutes per patient in the intervention group (quantile [Q]25/Q75: 5/7 minutes).

Potentially jeopardizing medication change after hospital discharge

At least one medication change occurred in 84 of 100 patients of the control group and 43 of 100 patients of the intervention group (p<0.001). The proportion of patients with at least one potentially jeopardizing category A medication change (primary outcome) was 39 percentage points (Please note: This does not mean a reduction of 39 percent, but a reduction by 39 percentage points. See also the following percentages) lower than in the control group (control: 54/100 [54%] versus intervention: 15/100 [15%]; p<0.001). In 9 patients of the control group (9%), a high-risk medication was affected by a category A medication change (antibiotic [N = 4], cardiac glycoside [N = 2], opioid analgesic [N = 2], oral anticoagulant [N = 1]), but in no patient of the intervention group (p = 0.001). The proportion of patients with at least one potentially jeopardizing category B medication change (secondary outcome) was reduced by 46 percentage points (control: 53/100 [53%] versus intervention: 7/100 [7%]; p<0.001) (Figure 2). In 4 patients of the control group (4%), a high-risk medication was affected by a category B medication change (antibiotic [N = 2], opioid analgesic [N = 1], oral anticoagulant [N = 1]), but in no patient of the intervention group (p = 0.058).

Proportion of patients
Proportion of patients
Figure 2
Proportion of patients

Gap in care after hospital discharge

Altogether in 79 of 100 patients of the control group and 72 of 100 patients of the intervention group, at least one new medication or medication with changed active ingredient was recommended compared with the pre-hospital medications (p = 0.250). The proportion of patients with a gap in care was by 10 percentage points lower in the intervention group compared with the control group (control: 28/100 [28%] versus intervention: 18/100 [18%], p = 0.031). The discharge medications of 36 of the 100 patients of the control group and of 29 of the 100 (29%) patients of the intervention group included new high-risk medications or high-risk medications with a changed active ingredient compared with the pre-hospital medications (p = 0.512). Among these patients, the proportion of individuals with a gap in care was reduced by 21 percentage points (control: 17/36 [47%] versus intervention: 8/29 [26%], p = 0.054) (Table 2).

Proportion of patients with a gap in care after discharge from hospital and median duration of the care gap (intention-to-treat population)
Proportion of patients with a gap in care after discharge from hospital and median duration of the care gap (intention-to-treat population)
Table 2
Proportion of patients with a gap in care after discharge from hospital and median duration of the care gap (intention-to-treat population)

Discussion

In our study, at least every second patient receiving standard care had a change in medication which could have jeopardized the therapeutic goal of drug therapy after discharge (category A). In addition, almost one third of the patients in need of a new prescription after discharge experienced a gap in care. The modular transition concept proofed to be an effective preventive strategy, as it reduced the proportion of patients with potentially jeopardizing medication changes by 39 percentage points and that of patients with care gaps by 10 percentage points.

The success of the modular transition concept may be explained by the following factors: First, when the model project was developed, priority was given to strengthening the cross-sectoral communication between the hospital and the community-based referring physicians. Thus, a long-standing request of the primary-care physician community to receive a discharge medication plan at an early point in time, which has already been described in numerous studies, was addressed with this model (8, 12). Second, our study builds on the insights derived from earlier projects which revealed that medication lists and patient information sessions helped to prevent adverse drug events (57). By integrating these two strategies in our modular transition concept, we achieved that especially category A medication changes, which have the potential to jeopardize the therapeutic goal, occurred less frequently. Furthermore, as the result of the intervention, no more medication changes involving high-risk medications associated with a significant threat to patient safety were observed (13, 14). In addition, components of medication reconciliation, which has already been successfully implemented in other countries, were included in our model (1517). For example, full data on both pre-hospital and the discharge medications were entered in a structured way into the hospital information system, using dedicated hospital admission and discharge software tools. The discharge medications were selected based on the pre-hospital medications. By taking this approach, it was ensured that in the case of medicines with a therapeutically equivalent effect, e.g. statins, the medications prescribed prior to the hospital stay were included in the discharge medication plan, instead of the drugs listed in the hospital. This process optimization helped to achieve that medication changes potentially leading to reduced treatment adherence (category B) only affected 7% of the patients in the intervention group. Even though these medication changes could primarily be considered acceptable from a therapeutic perspective, they may lead to medication-related problems after discharge, especially when there is a lack of patient information or little health-related knowledge (18, 19).

In addition, the implemented transition concept reduced the proportions of patients with a gap in care after discharge by 10 percentage points. In case high-risk medications were among the discharge medications, a reduction by 21 percentage points was observed. Despite improvements achieved with our concept, 18% of patients in the intervention group still experienced a gap in care, even though the need to immediately see their primary care physicians had clearly been pointed out to them during discharge counseling. This shows that many patients after having been discharged from hospital do not visit their referring physician in a timely manner. Other approaches are required to ensure the continuity of care with regard to drug therapy after hospital discharge. Here, the German E-Health Act and the introduction of a discharge prescription represent important steps towards a nation-wide implementation (20, 21).

We developed our transition concept with the sole aim to prevent potentially jeopardizing medication changes. As evidenced by previous studies, such medication changes can serve as important indicators for the quality of care at interfaces, as they are directly related to both adverse drug events and hospital readmissions (14, 22). It was not within the scope of this study to evaluate any necessary and planned medication changes after discharge.

This modular transition concept is notable in that each of the modules can be tailored to the needs of individual patients, using criteria defined by an expert panel. Thus, these modules are of particular clinical relevance to patient safety (14, 23). Consequently, the “Konstanz model“ does not only significantly reduce the risk of potentially jeopardizing medication changes and care gaps, but represents an efficient solution which can be applied to other hospitals and regions as well.

Furthermore, future studies should include close multi-professional management of patients after discharge to ensure that a long-term effect is achieved. For example, a recent study showed that patients with coronary heart disease who after discharge from hospital underwent an intensive multi-professional rehabilitation program had a lower mortality rate compared with patients who did not participate in such a program (24). Lastly, new insights into drug therapy safety should increasingly be taken into consideration when medications are prescribed at care interfaces and solutions should be devolved based on cross-sectoral approaches (25).

Limitations

This study was not a randomized controlled trial. Moreover, there was a 15-month interval between the control phase and the intervention phase during which the intervention strategies were developed and implemented. Despite similar patient and medical care structures and the fact that, in the opinion of the study-supporting expert panel, organizational changes during the two phases of the study could largely be excluded, it cannot be ruled out that during this interval other changes had an impact on the outcome. This monocentric study was performed in two internal medicine departments of a tertiary care hospital. Thus, it needs to be established whether the study results can be applied to other departments. The first post-discharge prescription was determined based on patient-collected copies of prescriptions, medication lists and medication packages, as well as information obtained during the interview at week 4 after discharge from hospital. Consequently, there is a potential for recall bias which needs to be taken into account in the interpretation of the results. However, with no change in methodology, its potential impact on the control group and the intervention group can be expected to be similar.

Finally, the definitions of medication changes and care gaps used in this study vary to some extent from those used in other studies (14, 26, 27), potentially limiting comparability. The categorization of medication changes is based on an expert decision. Necessary, planned medication changes, adverse drug events and factors potentially influencing treatment outcome were not investigated in this study.

Acknowledgements
We would like to thank all participating patients, physicians, nursing staff, and clinical pharmacists for their support. We extend our thanks to Mr. Martin Kiewitz and Dr. Reinhold Funk for their IT support and the Pharmacists’ Association of Baden–Württemberg for their professional and financial support.

Contact for the Konstanz Model: Claudia Greißing, pharmacist.
Pharmacy Department, Konstanz Hospital, Luisenstraße 7, 78464 Konstanz, Germany. Phone: +49-7531/8011060, claudia.greissing@klinikum-konstanz.de

Conflict of interest statement

Claudia Greißing and Prof. Bertsche declare that they received third-party funding from the Pharmacists’ Association of Baden-Württemberg to support the conduct of this study.

The remaining authors declare that no conflict of interest exists.

Manuscript received on 14 April 2016; revised version accepted on 12 July 2016.

Translated from the original German by Ralf Thoene, MD.

Corresponding author
Prof. Dr. rer. nat. Thilo Bertsche
Zentrum für Arzneimittelsicherheit
Universität und Universitätsklinikum
Eilenburger Str. 15a
04317 Leipzig, Germany
thilo.bertsche@medizin.uni-leipzig.de

@Supplementary material
For eReferences please refer to:
www.aerzteblatt-international.de/ref4416

eSupplement:
www.aerzteblatt-international.de/16m0749

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Pharmacy Department, Konstanz Hospital: Peter Buchal, Claudia Greißing
Drug Safety Center, Leipzig University and University Hospital of Leipzig, Department of Clinical Pharmacy, Institute of Pharmacy, Leipzig University: Claudia Greißing, Susanne Schiek, Prof. Dr. rer. nat. Bertsche
Konstanz Hospital, Medical Clinic II: Prof. Dr. med. Kabitz
Konstanz Hospital, Medical Clinic I: Prof. Dr. med. Schuchmann
Singen Hospital, Department of Urology and Pediatric Urology: PD Dr. med. Zantl
Process and modules of the transition concept as well as criteria for their use (gray); several modules (1–4) can be used in a single patient
Process and modules of the transition concept as well as criteria for their use (gray); several modules (1–4) can be used in a single patient
Figure 1
Process and modules of the transition concept as well as criteria for their use (gray); several modules (1–4) can be used in a single patient
Proportion of patients
Proportion of patients
Figure 2
Proportion of patients
Key messages
Patient characteristics of the intention-to-treat (ITT) population (continued in the eTable)
Patient characteristics of the intention-to-treat (ITT) population (continued in the eTable)
Table 1
Patient characteristics of the intention-to-treat (ITT) population (continued in the eTable)
Proportion of patients with a gap in care after discharge from hospital and median duration of the care gap (intention-to-treat population)
Proportion of patients with a gap in care after discharge from hospital and median duration of the care gap (intention-to-treat population)
Table 2
Proportion of patients with a gap in care after discharge from hospital and median duration of the care gap (intention-to-treat population)
Definitions of (potentially jeopardizing) medication changes, care gaps and high-risk medications
Definitions of (potentially jeopardizing) medication changes, care gaps and high-risk medications
eBox 1
Definitions of (potentially jeopardizing) medication changes, care gaps and high-risk medications
Examples of and notes to medication changes in the categories A and B between discharge medications and the first post-discharge prescription (gray)*
Examples of and notes to medication changes in the categories A and B between discharge medications and the first post-discharge prescription (gray)*
eBox 2
Examples of and notes to medication changes in the categories A and B between discharge medications and the first post-discharge prescription (gray)*
Example of a discharge medication plan
Example of a discharge medication plan
eFigure 1
Example of a discharge medication plan
CONSORT flow chart
CONSORT flow chart
eFigure 2
CONSORT flow chart
Patient characteristics – continued (intention-to-treat population)
Patient characteristics – continued (intention-to-treat population)
eTable
Patient characteristics – continued (intention-to-treat population)
1.Grimmsmann T, Schwabe U, Himmel W: The influence of hospitalisation on drug prescription in primary care—a large-scale follow-up study. Eur J Clin Pharmacol 2007; 63: 783–90 CrossRef MEDLINE
2.Tam VC, Knowles SR, Cornish PL, Fine N, Marchesano R, Etchells EE: Frequency, type and clinical importance of medication history errors at admission to hospital: a systematic review. CMAJ 2005; 173: 510–5 CrossRef MEDLINE PubMed Central
3.Bell CM, Brener SS, Gunraj N, et al.: Association of ICU or hospital admission with unintentional discontinuation of medications for chronic diseases. JAMA 2011; 306: 840–7 CrossRef MEDLINE
4.Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW: Adverse drug events occurring following hospital discharge. J Gen Intern Med 2005; 20: 317–23 CrossRef MEDLINE PubMed Central
5.Kaboli PJ, Hoth AB, McClimon BJ, Schnipper JL: Clinical pharmacists and inpatient medical care: a systematic review. Arch Intern Med 2006; 166: 955–64 CrossRef MEDLINE
6.Hohmann C, Neumann-Haefelin T, Klotz JM, Freidank A, Radziwill R: Adherence to hospital discharge medication in patients with
ischemic stroke: a prospective, interventional 2-phase study.
Stroke 2013; 44: 522–4 CrossRef MEDLINE
7.Send AFJ, Schwab M, Gauss A, Rudofsky G, Haefeli WE, Seidling HM: Pilot study to assess the influence of an enhanced medication plan on patient knowledge at hospital discharge. Eur J Clin
Pharmacol 2014; 70: 1243–50 CrossRef MEDLINE
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