Systematic Review of Establishing Treatment Fidelity: Building the Foundation of Comparative Effectiveness Research

Alice Bernet, PMHNP-BC, PhD Student | Vanderbilt University School of Nursing

AIM

Present findings of a systematic review, related to the reporting of treatment fidelity in the implementation of shared medical appointments (SMAs) in the treatment of diabetes mellitus (DM).

BACKGROUND

·DM is a common chronic illness in the US.

·Estimated US annual cost of treating DM will rise with the aging and obesity of the US population.

·SMA, a patient-centered intervention for enhancing the a) system care processes and b) patient experience, is increasingly suggested as an intervention for the management of DM.

·Without demonstration of treatment fidelity, it is not possible to assess adequately the comparative effectiveness of SMA intervention studies.

TREATMENT FIDELITY

Methods used to monitor and enhance the reliability and validity of behavioral interventions

Categories

Treatment Design: reports factors to evaluate and replicate trials

Training Providers: measure and sustain skill acquisition

Delivery of Treatment: content & dose are delivered as intended

Receipt of Treatment: assess pts cognitive and behavioral skills

Enactment of Treatment: ability of pts to use skills in daily life

Examples of Strategies

Design: measure duration, frequency, and length of SMA & “usual care” sessions

Training: standardize provider training; provide booster sessions

Delivery: measure adherence to protocol via recording of SMA sessions

Receipt: administer pre-post test of diabetes knowledge

Enactment: assess self-reports of exercise and dietary habits

METHODS

Design: Systematic review of SMA research published between 1980 and 2011.

Search Strategy: MEDLINE, CINAHL using terms: shared/group medical appointments, cluster visits, chronic illness, and diabetes. Reference sections of systematic and integrative reviews mined.

Article Selection: Evaluations of SMA intervention effectiveness were included; descriptive studies without evaluative components were excluded.

Data Collection Procedure: Standardized instrument using a 25-item checklist based on the NIH Behavior Change Consortium recommendations for Treatment Fidelity (Bellg, et al., 2004; Borrelli, et al., 2005).

RESULTS

Study Design Profile: 13 intervention studies from retrieved articles

• 12 met inclusion criteria

–8 RCT, 2 quasi-experimental studies, 1 retrospective chart review, 1 descriptive study

–1 excluded as it did not aim to evaluate the effectiveness of SMAs on DM-related outcomes (Rijswijk, et al., 2010).

Study Settings

•Ten sites were in the US: 4 VAMC, 3 community-based health centers, 2 HMOs, 1 academic medical center

•Two academic medical centers outside US: Turin, Italy; Bergen, Norway

Treatment Fidelity Strategies

•Range of documented TF strategies: 4-11

•Median # of TF strategies: 7

•# of studies below the median: 4

DISCUSSION

•Assessment of treatment fidelity was limited by what was reported by investigators.

•Although several studies fully described the intervention condition, they lacked adequate description of the comparison conditions.

•The greatest deficits in treatment fidelity measures were in provider training and treatment delivery.

•Few studies incorporated measures that could be used to assess receipt of treatment or enactment of skills.

IMPLICATIONS FOR RESEARCH AND PRACTICE

•Without reported treatment fidelity strategies, we cannot assume that the investigator accounted for variation in the implementation of the SMA.

•Adherence to the NIH recommended strategies is essential for the SMA to enhance the efficiency and quality of DM management.

The SMA requires more research, with demonstration of treatment fidelity, before recommending general adoption of this intervention

Session