Table 1 Components of fidelity addressed by each study

UMMC

Quasi-experimental design with 3 intervention hospitals and 2 usual care hospitals decreased chances of cross-over.

Packaged both nurse training and patient intervention into a toolkit.

Pre- post-intervention nurse surveys in intervention and control sites.

30 day-post-intervention patient surveys.

30-day post-intervention patient surveys.

Increased chances of sustainability as all nurses in intervention sites were trained.

Research nurse trained trainers until they demonstrated fidelity of training.

Nurse interviews in intervention sites only.

EMR download medications and counseling.

Patient intervention manualized.

Also see Fig. 1.

EMR download from nurse documentation.

UCSD

Randomization was completed using iPads and tablets so recruiters had timely access to randomized condition, minimizing data entry errors and cross-contamination of intervention.

An operations manual guided research staff on the various components of the study.

Reports were generated from the comprehensive UCSD database (that combined both research-specific data with intervention data) to ensure protocol adherence (e.g., proper number of attempts for counseling clients, nicotine patches distributed to clients, materials mailed, etc.).

Treatment receipt was assessed by monitoring of quitline counseling database, hospital documentation of patch delivery, and self-report at follow-up regarding receipt and use of nicotine patches and/or quitline services or other tobacco treatment.

Counseling adherence data was collected from the quitline documenting the number of calls participants completed.

Standardized training that included role-play, was provided to recruitment staff (i.e., respiratory therapists and dedicated research recruiters) and to quitline staff responsible for providing the counseling intervention.

Also see Table 2.

Two- and six-month evaluation Calls contained self-reported use of quitting aids (including those from the study) and use of behavioral treatment (including quitline).

The project manager went into the field quarterly, or when new employees were hired, observed, and provided feedback to staff to ensure adherence to project protocols.

The counseling used a structured protocol.

Bi-weekly meetings allowed quitline counselors to discuss specific counseling cases and review skills, increasing fidelity.

Timing, length, and frequency of counseling calls was recorded.

KU

Quitline Alere Well Being (AWB) provided reports on how the patient had been referred to the quitline—fax or warm handoff.

A master’s degree level certified tobacco treatment specialist trained hospital tobacco use counselors.

Trainers observed counselors’ delivery of counseling and counselor’s documentation of the intervention.

Treatment receipt was assessed by hospital treatment counselor documentation and self-report at follow-up as to whether participants received quit line services or other tobacco treatment.

Counseling adherence data was collected from the quitline documenting the number of calls participants completed.

Differentiation was assessed by comparing records of group assignment to the group file in which AWB reported data back to the research team.

Hospital counseling training included didactics, role-playing, and supervised delivery of the intervention.

Fidelity monitors observed a 10 % convenience sample of the tobacco use treatment sessions delivered in the hospital.

During the training process, the fidelity monitor observed new trainee counselors at least once per week.

A checklist was used to assess provision of each component of treatment by intervention arm for the study.

Hospital tobacco treatment counselors used a counseling checklist to document assessment, smoking cessation medication usage and recommendations, and referrals to the quitline.

Also see Table 3.

Fidelity monitors assessed how well counselors documented in the medical record the treatment that was provided.

NYU

The processes of transferring participant data to the Quitline (control) and providing multi-session telephone counseling (intervention) were accomplished by different study team members, limiting chance of cross-over.

Standardized operating procedure (SOP) manuals were developed for all study procedures.

Intervention counselors completed standardized documentation of their counseling sessions using a study database with close-ended and open-ended fields to document the number and duration of counseling calls, correctness of contact information, overall success in reaching participants, NRT orders, and topics covered.

Treatment receipt (i.e., patient understanding of the intervention and confidence) was not systematically assessed.

Enactment was assessed by counselor documentation and 2-month patient follow-up surveys.

Differentiation was assessed by comparing participant group assignments with Quitline and intervention counselor documentation.

Intervention counselors underwent 20–30 h of initial training on the counseling protocol.

Also see Table 4.

2-month follow-up surveys assessed patient satisfaction with treatment.

Also see Table 4.

Training included didactic lectures, role-plays and practice with standardized patients (actors trained to portray real patients).

Each month a random sample of intervention counseling sessions were audiotaped and reviewed by the study’s clinical supervisor using a standardized form assessing adherence to the protocol and counseling approach.

Intervention counselors participated in weekly supervision with the study’s clinical supervisor providing an opportunity for training updates (e.g., review of the protocol and counseling approaches).

The study supervisor met with counselors individually to review the form and provide feedback.

UAB

Treatment differentiation occurred by limiting access of the web-site to those randomized to the intervention through registration to the website by an intervention staff member.

Hospital staff attended at least one two-hour training session.

Once registered, participants received automated emails.

The website tracked messages sent to and from the Tobacco Treatment Counselor.

The website tracked participants’ web-site log-ins, number of days website accessed, and number of web pages visited.

The website tracked registrations, log-ins and automated email messages and subset of participants were surveyed.

Also see Table 5.

Also see Table 5.

KPCHR

Counselor documented assisted referral acceptance, completion of referrals to outpatient counseling, and documented discharge medication orders.

Study staff were trained and certified in Good Clinical Practice.

Counselor completed a tobacco consult checklist for each smoker seen, and a study enrollment checklist for consented and randomized patients.

Counselor documented consult topics discussed with the patient, assisted referral acceptance and referrals, and discharge medication orders.

Utilization of quit resources was documented at 6-month follow-up and electronic medical records where available.

Counselor documented receipt of printed quit information for patients in the control group.

Counselors attended the same training sessions on tobacco-dependence treatment delivery for hospitalized patients.

Counselors were monitored during initial piloting, and participated in ongoing case management discussions among the counselor group.

IVR call attempts, call completions, and responses, were monitored electronically.

Documentation, including IVR completion data, was tracked and reviewed monthly by study staff.

Other staff received appropriate training in use of the study’s electronic data management system at each site and in coding rules to complete the forms properly.

Also see Table 6.

A participant screening and tracking protocol was used to identify patients with subsequent hospital admissions to prevent reenrollment.

MGH

Medication was provided exclusively to intervention participants at the time of hospital discharge (verified by study ID).

For smoking cessation medication, study staff were trained by the overall coordinator and site coordinators to obtain medication from the inpatient pharmacy and deliver it to intervention participants’ bedside at the time of hospital discharge.

Medication – Study staff delivered 1 month of smoking cessation medication to the patient’s bedside.

Study staff electronically tracked medication dispensation via a standard database.

Similarly, only intervention participants were entered into the IVR database to receive calls after hospital discharge (determined by study ID).

Staff were also trained to enter intervention participants’ information into the IVR database so that they could be called according to the TelASK (participating IVR company) protocol).

IVR calls were initiated by TelASK with automated telephone calls to smokers.

The study did not formally track treatment receipt.

IVR calls were monitored by TelASK and study staff via secure access to a web-portal. Telephonic behavioral counseling enrollment and calls were monitored by AWI via standard database.

All call activity was recorded electronically via call flow sheets, and a subset of calls was randomly selected by TelASK for internal quality review.

Also see Table 7.