The pilot study was designed as an external pilot which is a small-scale version of the main study which is not intended to be a part of the main study [24]. The pilot intervention period was 3 months. The study design was based on published guidance for developing and testing complex interventions [23–25].
Setting
In Norway, most NHs are owned and run by the municipalities and financed by taxes and patient payment. A majority of the patients are above 67 years, have complex health problems, significant deficiencies in functioning related to activities of daily living (ADL), and about 80 % suffer from cognitive impairment [26]. There are no legal requirements for staff-to-patient ratios or specifications of qualifications required for workers [27]. However, NHs have RNs on duty 24 h a day. In addition, NH staff may comprise some authorized social educators (ASE) who have a bachelor’s degree in care related to people with intellectual disability, including dementia. ASEs have a defined health-care and pharmacological competence. According to Statistics Norway, the staff comprises on average 31 % RNs, 45 % licensed practical nurses (care education on a high school level most often leaving before the age 18), and 24 % health-care aides (no vocational health education). Statistics Norway has overall responsibility for official statistics in Norway.
Participants
The sample was recruited from the same urban municipality in Norway as intended for the C-RCT. The municipality has a total of 27 NHs. All NHs are under the administration of the director for health and social affairs in the municipality. NHs are typically managed by registered nurses (RNs) and have an agreement with a general practitioner (GP) who visits the NH once a week. Under the manager, a NH may have one or several care managers. The care managers are most often not involved in the everyday care of patients. We recruited three NHs for the pilot, representing each arm in the planned C-RCT. These NHs have 24-h long-term residency, were recruited based on the same eligibility criteria as for the planned C-RCT and allocated as a cluster to single intervention (SI), a multifaceted intervention (MI), or control (C). NHs with similar staff-to-patient ratios on the day shift and GP coverage were eligible for selection. NHs designated with a specialty or with enhanced staff-to-patient ratio were excluded. RNs/ASEs working half time or more were eligible for participation in the workshop (see below) and to be recruited as an opinion leader (see below) in the intervention group. RNs/ASEs working less than half time or only night shifts were excluded. For the pilot, only RNs were involved in the study, and for the rest of the text we will use the term RN only. All care staff members in the NH were invited to the educational outreach meetings (see below) throughout the intervention period. All long-term care patients (who had stayed one month or more) were eligible for inclusion.
Intervention
The educational programs were developed according to recommendations from implementation research, pedagogic theory, and experience from members in the project group [17–22, 28–32]. To ensure a realistic intervention, one of the researchers had two meetings with experienced NH nurses to collect their comments on content and intensity of the educational programs and on the FI guideline.
The FI guideline
The project group developed a FI guideline for nurse-led assessment and treatment of FI based on international best practice recommendations [1, 33–35]. The FI guideline facilitates a systematic assessment and includes questions related to bowel symptom history and bowel patterns. As FI among NH patients is considered to have a complex etiology, the guideline facilitates the RNs to consider a range of possible causes. Examples are loose stools, immobility, cognitive impairment, impaction, and use of laxatives. Based on this assessment, the RN defines a nursing diagnosis, for example: FI related to loose stools, possibly due to incorrect doses of Laxoberal® (sodium picosulfate), urgency, and reduced mobility. This leads to FI episodes with loose stool and red perineal skin. The guideline then offers a range of possible interventions. An important intention is to empower the RNs’ clinical reasoning [36] and critical thinking [37, 38]. Individualization of the nurses’ diagnoses and the interventions for each patient is important. Both NHs receiving the SI and MI were introduced to the FI guideline during the workshop.
The SI comprised: one educational meeting (7 h), defined by the Cochrane Effective Practice and Organization of Care (EPOC) as “participation of health-care providers in conference, lectures, workshops, or traineeships” [19]. The educational meeting was organized as an interactive workshop that targeted knowledge, attitudes, and skills. The workshop was conducted in a meeting room in the NH. The workshop started with the RNs completing a knowledge test and was a part of the data collection and one of the outcome measures. However, by organizing it as a part of the workshop, the pedagogical intention was to make it a trigger for learning as answers were given in the following educational session. Part two of the workshop was case-based discussions concerning the FI guideline. How to integrate the use of the guideline to the electronic documentation system was an important issue. This was addressed by having access to a “learning module” in their local electronic patient record (EPR). Real patient cases were discussed, and the result was input into the EPR during the workshop. This gave the RNs and the care leaders the opportunity to experience how it could best be done. The topics of the workshop, including the guideline, were made available for the RNs as printed educational material.
In addition, MI comprised of two more elements: 1) recruitment of a local opinion leader, defined by EPOC as “use of providers nominated by their colleges as educationally influential” [19], and 2) educational outreach visits defined by EPOC as “use of a trained person who meets with providers in their practice setting to give information with the intent of changing the providers’ practice” [19]. The local opinion leader was recruited after the educational meeting based on the informant method [39]. This was done by discussing with the care manager which of the RNs was considered to be able to influence and motivate the staff in general. The care manager had the responsibility for facilitating adherence to the program and the guidelines in cooperation with the opinion leader. The local opinion leader and care manager received a 1.5-h additional educational meeting on how to fulfill their roles in the study. The opinion leader and the care manager received contact information for the researcher for support during the intervention period.
The educational outreach visits were carried out in the NHs, facilitated by the project coordinator, and consisted of six sessions, lasting 1.5 h each. The opinion leader prepared cases for discussion together with the project coordinator. The project coordinator is the first author of this article and is a RN with additional educational theory and delivery competence. All of the care staff were the target group for the educational outreach and were invited to participate in the educational meetings throughout the intervention period. Facilitating and empowering care staffs’ clinical reasoning and critical thinking were the main pedagogical approach.
Control group
The control group did not receive any educational program and continued with ordinary practice. The main reason for including a control group in the pilot study was to investigate their motivation to fill in questionnaires without getting the educational intervention in return.
Measures
The overall aim for the C-RCT is to study the effect of offering NH care staff an educational program on diagnosing and treating FI on reduction in FI for NH patients. The C-RCT primary outcome is frequency of FI among patients, and secondary outcomes are: remission of FI among patients identified with FI at baseline; incidence of FI among patients identified as continent at baseline; change in related concerns among patients; change in knowledge among RNs; and change in behavior among care staff. We also want to investigate correlates of FI among patients.
The following measures and data collection procedures were piloted for the main study:
The main unit of analysis for the planned C-RCT will be nursing home patients, and the same unit was used in the pilot study. The primary outcome measure was frequency of FI, measured by the Norwegian interRAI Long-Term Care Facilities Assessment System (interRAI LTCF) [40], section H3: Bowel continence. Bowel continence has the categories 0–5 where 0 = continent, 1 = continent with a stoma, 2 = seldom incontinent (not incontinent during the last three days, but has episodes of incontinence), 3 = occasionally incontinent (more seldom than daily), 4 = often incontinent (daily, but has some control), 5 = incontinent (no control), and 8 = did not occur (no bowel movement). The interRAI is a standardized, validated and comprehensive tool to assess patients’ health status. It measures patients’ functional, medical, cognitive, and psychosocial status [40]. In order to get some additional information on type of FI (gas, loose, or solid stool), urgency, and impact on daily life, a Norwegian version of the St. Marks anal incontinence score [41] was used. It gives a total score from 0 (complete continence) to 24 (complete incontinence).
Secondary outcome measures:
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1.
Both remission and incidence of FI measured by interRAI LTCF, section H3: Bowel continence.
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2.
Change in related factors measured by interRAI LTCF, section E: Mood and behavior, section F: Psychosocial well-being, section H1: Urinary continence, section J: State of health—Constipation and diarrhea, section L: Skin condition, and section M: Participation in activities.
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3.
Change in knowledge among RNs measured by a multiple choice test developed by the researchers according to established guidelines [42].
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4.
Change in care as reported in the EPR by care staff as measured by N-Catch. N-Catch is a validated audit instrument for care staff reports in the EPR [43–46]. N-Catch measures the quality of the content in the EPR on a scale from 0 to 32 where 0 is low quality and 32 is high quality. The instrument includes criteria for both quantity and quality of content. In order to get a score on quantity, the different parts only need to be present in the EPR (health status and a nursing care plan including nursing diagnoses, outcome, interventions, and evaluations). To get a high quality score, the content is assessed according to criteria reflecting clinical reasoning and critical thinking: does the assessment of health status seem sufficient, do the nurses’ diagnoses have a logical focus and etiology, and are the outcomes and interventions individualized, relevant, and realistic [34–38, 43–46]. Change in care will also be measured by the Fecal Incontinence in Nursing Home questionnaire [8] where RNs are offered a list of interventions relevant for FI and asked to identify what is done for each individual patient.
In addition, correlates of FI were measured by interRAI LTCF, section C: Cognitive functioning, section D: Communication and vision, section G: Functionality and mobility, section I: Medical diagnosis, section J: Health condition, section K: Mouth and nutrition status, section N: Medications, and section O: Treatment, examinations/procedures.
In the pilot study, the project coordinator gave information and training on completion of the interRAI [40], the St. Mark’s anal incontinence questionnaire [41], and the Fecal Incontinence in Nursing Home Patients questionnaire [8]. In addition, the project coordinator gave information and training on the procedure of printing data from the EPR in accordance with the audit instrument N-Catch. RNs with good knowledge of the patients completed questionnaires regarding patients’ health.
Criteria for feasibility, adherence and acceptability
Feasibility, adherence, and acceptability of the educational programs were evaluated according to the following criteria:
Feasibility criteria:
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Acceptable recruitment process.
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>80% completed questionnaires returned
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<10% missing data in each completed questionnaire
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>0.5 mean change on the frequency scale on the primary outcome measure
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Acceptable time use for RN’s involved in the data collection
Adherence criteria:
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>95 % of the recruited RNs participated in the workshop
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>70 % of the health personnel participated in the educational outreach on each actual day
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8.
>90 of the patients assessed by the FI-guideline
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9.
>80% of the assessment specified by the FI-guideline reported in the EPR
Acceptability criteria:
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Acceptable performance of the knowledge test according to sensitivity to change in knowledge
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11.
Satisfaction from RNs regarding the educational intervention
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12.
Satisfaction and acceptability from RNs regarding the FI guideline
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13.
Acceptable level of barriers versus facilitators for change in the NHs
Quantitative data was collected at baseline (t0) and after 3 months (t1 = end of intervention). In order to obtain data concerning criteria 11–13, qualitative data was collected by one focus group interview [47, 48] performed 1 month after the end of the intervention. To receive additional information, four focused individual interviews [49] were performed 4 months after the end of the intervention. Informants were recruited from the two intervention NHs. The focus group interview was moderated by one of the researchers not involved in the intervention. The project coordinator was present and could ask questions to explore a theme. The individual interviews were performed by the project coordinator. All NHs were offered economic compensation linked to the data collection in order to pay for the process of hiring extra staff to make it possible for the RNs to be absent from daily care to undertake data collection.
Analyses
Descriptive statistical analyses were performed using IBM SPSS version 21. Data from the interviews was digitally recorded, transcribed, and then analyzed by qualitative content analysis in accordance with Graneheim and Lundman [50].
All interviews were audiotaped and transcribed verbatim. First, the researcher reviewed the text several times to receive a general impression of the content. Second, the parts of the text addressing criteria 11, 12, and 13 were defined as content areas. Third, words, sentences, or paragraphs related to the content areas were identified and defined as meaning units. The meaning units were then condensed and labeled with a code. Fourth, the codes with similar meanings were grouped into categories. Related categories were then abstracted to themes with the intention to reveal the underlying meaning on an interpretive level [50]. The process from meaning units to themes went back and forth as members of the project group gave their feedback in the process of analysis.
Ethical aspects
The study was conducted with the approval of the Regional Committee for Medical and Health Research Ethics (REK) (2013/755 REK Nord) and by The Norwegian Social Science Data Services (35020). NH managers were informed and gave permission to perform the study in the individual NH. Informed consent was obtained from RNs for the knowledge test. After evaluating the overall project, the REK authorized RNs recruited to be involved in the data collection procedure with dispensations from the duty of confidentiality to gather relevant patient health information (proxy data) in order to measure effect of the educational intervention. The patients were given written information about the study and had the opportunity to withdraw themselves from data being gathered. In cases where RNs assessed a patient as not cognitively competent to read and understand the information, the letter was sent to the patients’ representative. All patient information was de-identified by care staff before transfer to the researcher. The study was performed in concordance with the Helsinki Declaration. The project is registered in the clinical trial registry (NCT01939821).