APPENDIX I The Affiliate Evaluation Methodology WORKING DRAFT -- NOT FOR DISTRIBUTION The Affiliate Evaluation Methods Design Affiliate sites were selected to participate in Healthy Steps based on a minimal set of requirements. These included: a commitment to implementing the program for three years and participating in evaluation activities; establishment of a local advisory committee; identification of one or more local funders for the program; and a large patient population to complete enrollment within six to nine months. Affiliate sites did not utilize a comparison population. Six sites, comprising seven primary pediatric practices, participated in the Affiliate Evaluation. The seven participating practices represent a mix of organizational types including two group practices, a hospital-based clinic, a community based clinic, two hospital-based residency training pediatric clinics, and a group practice in partnership with the local health department. Enrollment Enrollment of children in the Affiliate Evaluation began in July 1997 when the first child enrolled at the Garden City, Kansas site. The initiation of sites was staggered over a four-month period in part to allow evaluation staff time to work with the sites to set up enrollment and other evaluation procedures. Once enrollment was initiated, all sites but one consecutively enrolled newborns entering the practice. At one site, program operations began before the implementation of the Affiliate Evaluation. Families who had been receiving Healthy Steps services prior to the implementation of the evaluation were “back-enrolled” into the evaluation. Enrollment took place in the hospital following the child’s birth or at the first pediatric office visit. In cases of multiple births, one child was randomly selected to be enrolled in the evaluation. Enrollment of families ended in September 1998 when the last child enrolled at the Houston, Texas site. To be eligible for enrollment in the Healthy Steps Affiliate Evaluation, the newborn had to be less than 4 weeks of age (from birth to 28 days of life, inclusive) and a patient at the Healthy Steps site. Children were not eligible to participate if: 1) their parents expected to move from the area or change site of care within 6 months; 2) their mothers (or custodial parent) did not speak English or Spanish fluently; 3) they were to be adopted (hospital only) or placed in foster care; or 4) they were too ill to make an office visit within the first 28 days of life. Eligibility was limited to the first 28 days of life to ensure that each intervention family could be offered a home visit within the first few weeks postpartum. Target enrollment at each site was 200 families (100 families per practice at ChicagoRavenswood, the site composed of two practices). On average, affiliate sites took seven months to enroll 200 families. Table A.1 provides enrollment information for each site. In total, 1,103 families enrolled in the Affiliate Evaluation. As Table A.1 indicates, only 51 families (4%) approached to participate in the program declined. Of the parents who declined to participate, most said they were “not interested,” “did not have the time,” or they failed to give a reason. Other less commonly cited reasons included: they lived too far from the practice, they were enrolled in a day care program, they felt they did not need the support, or the father refused to participate. At one site, a number of families declined because they chose a provider who was not participating in the Healthy Steps program. Ten percent of families (n=126) deferred enrollment but failed to return during the eligible enrollment period. 31 WORKING DRAFT -- NOT FOR DISTRIBUTION Table A.1 Enrollment of Families in the Affiliate Evaluation by Site Site Charlotte ChicagoRavenswood (Col. McNeil) ChicagoRavenswood (M/F Center) ChicagoBethany Garden City Houston* San Antonio Enrollment Start End Date Date 9/97 3/98 9/97 2/98 Total Eligible Total Enrolled Total Declined Total Deferred N 240 124 N 212 94 % 88 76 N 18 6 % 8 5 N 10 24 % 4 19 9/97 5/98 100 96 96 0 0 4 4 9/97 7/98 251 192 76 15 6 44 18 7/97 10/97 10/97 1/98 10/98 5/98 192 109 264 186 107 216 97 98 82 3 2 7 2 2 3 3 0 41 2 0 16 1,103 86 51 4 126 10 Total: *Enrollment at this site was slower than anticipated. Children enrolled through September 1998 were included in the affiliate evaluation. Informed Consent and Confidentiality of Participants All enrollment procedures and study protocols were reviewed and approved by The Johns Hopkins University Bloomberg School of Public Health’s Committee on Human Research. At the time of enrollment, families were asked to sign a letter of consent (consent form). In addition, at enrollment, each child was assigned a unique Healthy Steps identifier to be used rather than the child’s name for data collection purposes. This number appeared on all questionnaires and with all other references to the child. It identified the child, the Healthy Steps site, the child’s evaluation sites and the site of enrollment (hospital or office). This unique identifier maintained the confidentiality of the child and family, while making it possible to link information across affiliate families and data instruments. Characteristics of Families Participating in the Affiliate Evaluation Information about characteristics of the infants and parents participating in the Affiliate Evaluation was derived from enrollment forms and the Newborn Form. The Newborn Form was administered either by an interviewer to the parent (or surrogate) or self-administered by the parent(s) as part of the enrollment process. Questions on the Newborn Form covered characteristics of the infant and demographic characteristics of the mother, father and family, prenatal utilization of services, health behaviors of the mother and father, and parents’ choice of a pediatric provider for the newborn. It was available in English and Spanish. The Newborn Form was completed by 1096 (99%) of the total 1,103 families enrolled. The majority of Newborn Forms were filled out by mothers (84% by mothers alone and 14% by mothers and fathers together). On average, mothers participating in the Healthy Steps Affiliate 32 WORKING DRAFT -- NOT FOR DISTRIBUTION Evaluation tended to be young (more than one half were less than 25 years old), with limited education (45% percent had not graduated from high school). Fathers tended to be slightly older and better educated than mothers. About half of the mothers described their race as White; over half reported that they were of Hispanic ethnic origin. Somewhat fewer than half of fathers described themselves as White and one half reported that they were of Hispanic decent. Slightly more than half of mothers (54%) were married at the time of enrollment into the Affiliate Evaluation. However, more than two thirds reported that they were living with the baby’s father. Approximately 40% of families enrolled in the Affiliate Evaluation were first-time parents. For more than half of the families (54%), maternity care was paid for by Medicaid, with 25% of families utilizing private insurance to cover the maternity care expenses. More than half of families reported receiving assistance from the Women, Infants and Children (WIC) program during pregnancy. Almost one quarter of families received food stamps during pregnancy. One quarter of families did not receive any special services during pregnancy. Slightly more than half the babies enrolled in the Affiliate Evaluation were boys. Fewer than 5 percent of infants enrolled weighed less than 2500 grams at birth. Almost 60% of babies stayed in the hospital less than 48 hours after birth; nearly all (90%) of infants spent at least some time in the mother’s hospital room. At the time of enrollment, less than 30% of infants were being exclusively breastfed. Very few mothers (fewer than 8 percent) reported smoking at the time of enrollment into the Affiliate Evaluation. In contrast, more than 25% of fathers were smokers. Slightly more than one half of mothers had 10-14 prenatal visits, with about 5 percent of mothers receiving very few (0-4) visits and about 7 percent receiving 20 or more visits. Almost 60% of families had selected their pediatric practice prior to the birth of their infant. However, only 20% of families had actually visited the practice before the baby’s birth. The most frequently cited means through which families knew of the pediatric practice was they had taken other children there, or they learned about the practice from a prenatal care provider or a friend. The two most frequently endorsed reasons for choosing the practice were that the practice provides good care and that the practice had been recommended. Data Collection Both qualitative and quantitative data were collected as part of the affiliate evaluation. Data were collected from providers, families, and medical records. Data instruments included: key informant interviews; site questionnaires; provider knowledge, attitudes and practices surveys; HS Specialists’ logs of contacts with families; parent questionnaires; a parent telephone interview; and, medical record reviews. A description of each follows. Key Informant Interviews Members of the Johns Hopkins University (JHU) evaluation team conducted interviews with key informants (individuals identified as “stakeholders”) at each site at start-up and approximately 30 months into the program. The interviews were based on structured questionnaires that included openand close-ended questions. The questionnaires were mailed to informants so that they could complete the objective portions of the questionnaire and return it to JHU prior to their interviews. 33 WORKING DRAFT -- NOT FOR DISTRIBUTION At start-up informants included the head of pediatrics, the Healthy Steps lead physician(s), the site administrator(s), and the HS Specialists. At some sites, representatives from local foundations completed interviews. Interviews took place during the enrollment site visit (1997). They were conducted face-to-face, in private and lasted between 30 minutes and 1 hour. Informants were assured that all responses would be kept strictly confidential. The interviews at start-up consisted of a series of questions related to the introduction of Healthy Steps into the practice, and the decision-making process to participate in the program. Informants were asked to comment on their previous experience with similar programs, understanding of the Healthy Steps model, anticipated problems with implementation, the role of the HS Specialist, and anticipated benefits of the program. At 30 months, only the Healthy Steps lead physician(s), the site administrator(s), and the HS Specialists participated in the key informant interviews. The majority of interviews were conducted by telephone by a member of the evaluation team during the summer of 2000. One lead physician was interviewed in person. Two lead physicians completed their interviews in writing. Telephone interviews were scheduled at a convenient time for the informant and s/he was asked to find a private place where s/he would feel free to talk openly about the program. Informants were assured that all responses would be kept strictly confidential. Interviews at 30 months took on average 1 hour to complete. The 30-month key informant interviews contained objective questions related to the components of the HS program, teamwork and communication patterns. Subjective, open-ended questions addressed the practice context/environment and changes over time, factors that affected implementation, the impact of HS in the practice, the role of the HS Specialist and the future of the Healthy Steps at the site. Sample The exact number of interviews varied by site. Table A.2 gives the final sample by provider type and time period. All informants invited to participate at start-up responded; at 30 months two lead pediatricians failed to respond. Seventeen key informants completed interviews at both time periods. Table A.2 Key Informant Interviews by Provider Type and Time Period Start-up 4 8 8 11 4 Head of Pediatrics Lead Healthy Steps Pediatrician Site Administrator HS Specialist Local Foundation Representative Total 35 30 Months NA 5 6 12 NA 22 Numbers may vary from start-up to 30 months due to changes in staffing. At 30-months, interviews with the Heads of Pediatrics and local foundation representatives were not requested. Analysis Separate techniques were used to process the objective and subjective data from the key informant interviews. Similar techniques were used at start-up and 30 months. 34 WORKING DRAFT -- NOT FOR DISTRIBUTION Prior to the interview, a member of the evaluation team checked the objective portions of the interview for completeness. Missing or incomplete data were confirmed during the interview. The objective portions of the interview were double-keyed to ensure accuracy using SPSS-DE. Following verification of the data and data entry, analysis was conducted using the SAS programming package. The quantitative data were explored using simple frequencies. Comparisons between responses at start-up and 30 months were made when appropriate. Within several days of conducting the interview, the interviewer summarized the subjective information received from each informant using an interview guide. The guide combined responses to one or more individual questions into larger topic areas. The summaries by informants were subsequently organized across sites by informant category (HS Specialist, lead physician, site administrator) and within sites across informant category. The organization of responses by site and by informant type provided a framework for describing the content of the interviews. This organization enabled evaluation staff to determine the consistency of responses within each site as well as consistency and differences across sites. The qualitative data were analyzed by members of the evaluation team, working independently. Each reviewer identified topics or themes within the data. At start-up, topics and themes included: 1) becoming a Healthy Steps site (characteristics of the decision-making process to participate; buy-in by staff); 2) making Healthy Steps a reality (implementation of Healthy Steps, support for program and evaluation activities, integration of the HS Specialist into the practice, and implementation of a team approach); 3) expectations for the impact of Healthy Steps. At 30-months, topics were: 1) the background and practice context into which Healthy Steps was placed; 2) the spectrum of the implementation of Healthy Steps; 3) the Healthy Steps program and its components; and, 4) the strengths, benefits and challenges of Healthy Steps. Two overarching themes, building relationships and time, were identified. Site Questionnaires The first site questionnaire was administered at start-up (1997) to capture the practice context in 1996 before Healthy Steps. A second site questionnaire was administered at 30 months (2000) to address changes in the practice since initiating Healthy Steps. Each site questionnaire was completed by the site administrator, lead physician, or other designee. The questionnaires contained items regarding the practice context and practice environment in which pediatric services were being delivered prior to and towards the end of the Healthy Steps intervention. Sample Site questionnaires were returned by all practices comprising the six Healthy Steps affiliate sites at both start-up and 30 months. Analysis Once the site questionnaires were returned to JHU, they were edited and coded for computer entry. During this process, sites were consulted, as appropriate, to answer questions that arose during coding, and provide missing data. Data were double-keyed. Following verification of the data and data entry, analyses were conducted using the SAS programming package. Since the affiliate evaluation did not include a comparison population, data were examined using simple frequencies. Comparisons of responses between start-up and 30 months were made when appropriate using chi square or t-test. 35 WORKING DRAFT -- NOT FOR DISTRIBUTION Provider Knowledge, Attitudes & Practices Surveys All providers who worked with Healthy Steps families at each affiliate site were asked to participate in a survey at start-up and 30 months. These provider knowledge, attitudes, and practices (PKAP) surveys provided information on a variety of topics, including providers’ perceptions of the barriers to providing the best well child care to their patients, their opinions about the care they provided to their clientele, their satisfaction with their ability to meet the needs of parents, their views of the HS Specialists, and the topics they discussed with parents. The content of the provider KAP questionnaires varied depending on the clinical or administrative position of the individual at the site. Variations of the survey were administered to four groups of individuals: physicians and nurse practitioners; nurses and other clinical staff; clerical and administrative staff; and Healthy Steps Specialists. Physicians and nurse practitioners (MDs/NPs) completed the longest questionnaire. The questionnaire at start-up contained questions related to their background, including their education, number of years in pediatric care and working at the site, and any special training they had received in child development or child behavior. Many of these questions were updated at 30 months. Questions were asked about the amount of time they spent at well child visits in the first two months of life (at start-up) and for two-year olds (at 30 months) performing these specific activities: physical exam, anticipatory guidance, answering parents' questions, and other activities. The survey at start-up and 30 months also contained questions about barriers to providing well child care, topics they discuss with families, their satisfaction with the time they spend discussing behavior and development with parents, and their ability to meet the needs of parents. Similar questions were asked about their satisfaction with the ability of clinical support staff to meet the needs of parents. An instrument was included in the surveys that asked about physicians’ and nurse practitioners’ perceptions of the services that the HS Specialist provided to families. The questionnaires for nurses and other clinical staff included background educational information along with questions about topics they discussed with parents, their perceptions of the care provided at the practice, and their perceptions of the services provided by the HS Specialists. The questionnaires for clerical and administrative staff included the same items except items relating to topics discussed with parents. The HS Specialists responded to the questionnaire for nurses and clinical staff. A member of the evaluation staff, working with the HS Specialists, identified a list of eligible providers at each site to determine the sample of providers to be surveyed. To maintain the confidentiality of participants, each provider was assigned a unique identification number. This number was the only identifying information on the questionnaire. At each site, the HS Specialists hand delivered a copy of the questionnaire and an envelope to each provider. Providers were instructed to complete the questionnaire and return it sealed in the envelope to the HS Specialist. The name of the provider appeared on the envelope for tracking purposes only. Data collection was to be completed within one month but was extended at all sites in order to improve response rates. The HS Specialists returned the completed questionnaires to JHU for processing. Sample The exact number of completed questionnaires varied from site to site depending on staffing structure and response rates. Tables A.3 provides the overall response rate and the response rate by site for the PKAP Survey at start-up and 30 months. Please note that sites are presented in random order. 36 WORKING DRAFT -- NOT FOR DISTRIBUTION Although the response rates include Resident physicians, they have been excluded from the sample for analysis because only two affiliate sites had Resident physicians and their perceptions of the program may not be representative of other primary care providers at the sites. Accordingly, the sample at start-up included 24 MDs/NPs, 24 nurses and other clinical staff, 16 clerical and administrative staff, and 11 HS Specialists. The sample at 30 months comprised 22 MDs/NPs, 16 nurses and other clinical staff, 18 clerical and administrative staff, and 11 HS Specialists. One important aspect of the samples is the number of respondents who completed surveys at both start-up and 30 months. Table A.3 Response to the Affiliate Provider KAP Survey at Start-up and 30 Months Sites MDs/NPs1 %2 N Start-Up Nurses/ HS Other Specialists Clinical N % N % Clerical/ Admin Staff N % Overall N % 1 2 3 4 5 6 TOTAL 0 6 10 0 8 0 24 1 2 2 2 2 2 11 0 4 6 3 1 2 16 1 21 27 5 16 5 75 Sites 0.0 85.7 66.7 0.0 100.0 0.0 63.2 MDs/NPs1 %2 N 50.0 100.0 100.0 100.0 100.0 100.0 91.7 0 9 9 0 5 1 24 0.0 81.2 75.0 0.0 100.0 100.0 68.6 30 Months Nurses/ HS Other Specialists Clinical N % N % 1 1 50.0 2 2 9 100.0 2 3 5 50.0 1 4 1 50.0 2 5 5 100.0 2 6 1 100.0 2 TOTAL 22 75.9 11 Sites are listed in random order. 100.0 100.0 50.0 100.0 100.0 100.0 91.7 1 7 4 0 4 0 16 100.0 70.0 50.0 0.0 66.7 0.0 64.0 0.0 57.1 85.7 42.9 100.0 66.7 59.3 14.3 77.8 75.0 31.3 100.0 62.5 66.9 Clerical/ Admin Staff N % Overall N % 3 10 2 1 1 1 18 7 28 12 4 12 4 67 100.0 90.9 40.0 100.0 100.0 100.0 81.8 87.5 87.5 48.0 80.0 85.7 100.0 76.1 1 At two sites, surveys were completed by resident physicians. They have been excluded from the analyses as their disproportionate representation at only 2 sites would skew the results and due to the timing of the 30-month survey, the response rate was comparatively low (30.2%). 2 Percentage based on number of eligible clinicians/staff. Analysis Upon receipt at JHU, the questionnaires were removed from the envelopes and the envelopes were discarded to ensure the confidentiality of the respondent. The questionnaires were edited and coded for computer entry. Quality assurance procedures were utilized. During this process, sites were consulted, as appropriate, to answer coding questions and provide missing data. Coded questionnaires were entered into the computer using SPSS-DE. Simple frequencies and binary analyses were performed using the SAS-PC software package. 37 WORKING DRAFT -- NOT FOR DISTRIBUTION Much of the information contained in the surveys included items that could be used to construct scales that measured a broader concept. Examples of such scales include the satisfaction of clinicians with their ability to meet the developmental needs of families with young children, or an index of barriers to providing quality well child care related to managed care restrictions and policies. For many of these scales, the process of identifying items to be combined together was straightforward. For those for which the process was not straightforward, a factor analysis was performed on baseline data to evaluate whether there might be some underlying linear structure in the data. This was the case, for example, for the long instrument assessing perceptions of the care provided at the site. Factor analysis was only moderately helpful in these instances, so the items were grouped primarily based on conceptually similar content. Internal consistency was assessed for all scales using a Cronbach Alpha. Only scales with an alpha value of at least 0.6, the generally accepted lower limit below which the scale is assumed to not be internally consistent, are reported here. Negative items were recoded so that the responses to all items in the subscales were in a positive direction. Therefore, higher scores generally indicated better outcomes. We created mean scores for the subscales to facilitate interpretation of the results. For questions with response categories based on a 5-point Likert scale, a mean score of 4.5 or higher indicated that the respondent strongly agreed or was very satisfied. For questions with response categories based on a 4-point Likert scale, a mean score of 3.5 was equivalent to strongly agreed or very satisfied. Because the Affiliate Evaluation did not include a comparison population, chi square analyses were used to compare differences between groups of respondents at start-up and 30 months. Due to the small sample sizes, analyses did not adjust for potential differences among sites. Although HS Specialists completed the survey for nurses and other clinical staff, analyses were conducted separately for HS Specialists due to their intimate involvement in the program. Healthy Steps Specialists’ Log of Contacts At the beginning of the HS evaluation, each HS Specialist was provided with data abstraction forms and instructions for documenting contacts with the families receiving HS services. Each form was labeled with the child’s name and HS identification number, and sent to the HS Specialist for completion. HS Specialists were asked to document every contact they had with the family including home visits, office visits, telephone calls from or to families, parent groups, mailings or other contacts. Information requested about each contact included: the date of contact, whether the contact was completed or not, the person(s) contacted, and actual subjects discussed with the person(s) during the contact (see Figure A.1 for example of completed log). Up to 15 individual topics could be recorded by the HS Specialist for any one encounter with a family. Forms were returned to JHU on a quarterly basis. Trained coders at JHU edited and coded the logs. During this process, Healthy Steps Specialists were consulted, as appropriate, to answer coding questions and provide missing data. A comprehensive list of topics discussed with families was developed; these topics were grouped into six larger categories by members of the team at Boston University School of Medicine by whom the intervention was designed. The six categories included: promoting development, nutrition, promoting health, providing family support, injury prevention, and maternal health. Abstracted data were entered by Sosio Incorporated; 100% were double keyed. Sample Fifteen HS Specialists recorded contacts with affiliate families from birth to 32 months. Logs of contacts were created by HS Specialists for 1,072 families, who comprised 97% of the 1,103 families enrolled in the Affiliate Evaluation. The sample for analysis excludes 11 families who actively withdrew from the evaluation, left the practice, or whose child died within 2 months of birth. An 38 WORKING DRAFT -- NOT FOR DISTRIBUTION additional 49 families were excluded because they had not made a visit to the practice by 2 months (the families who were back enrolled at the Garden City site were not excluded for this reason). The final sample included 1,012 families (92% of the total enrolled). The distribution of families varied across sites, reflecting the number of families enrolled. Figure A.1 Sample Contact Log Analysis For purposes of the analysis, we truncated the sample of logs at 32 months. We split the data into two time periods. The first period, birth to 14 months, reflected contacts made with families during the child’s first year of life. We extended this period to 14 months in an attempt to capture the child’s 12month well child visit within the first time period. The second time period consisted of contacts with the family between 15 and 32 months. As Figure A.2 demonstrates, 100% of families in the selected sample had a contact with the HS Specialist within the first 2 months of the program. By 15 months (60 weeks), approximately 77% of families were still actively participating in the program. For this reason for some analyses, we limited the sample at 15-32 months to those 783 who had a contact on or after 15 months. Finally, as the figure shows, only 29% of the original 1,012 families were still participating in the program at 32 months. Two units of analysis were considered. We conducted some analyses by contact in order to give a snapshot of the information collected on the contact logs. Most analyses were conducted by family in order to determine what services were provided to affiliate families. Simple frequencies and bivariate analyses were performed using the SAS-PC software package. 39 WORKING DRAFT -- NOT FOR DISTRIBUTION Figure A.2 Distribution of Affiliate Families who had a Recorded Contact with a HS Specialist over Time 80 60 40 20 96 10 4 11 2 12 0 12 8 88 80 72 64 56 48 40 32 24 16 8 0 0 Percent before given week 100 Weeks Parent Questionnaires As part of the Affiliate Evaluation, parents were asked to complete a brief, standardized form every 6 months beginning when they enrolled their child into the program and ending when the child reached 24 months of age (i.e., newborn, 6, 12, 18, and 24 months). These forms were designed to be selfadministered; however, the HS Specialist may have assisted parents who had difficulty completing the form. Parents were eligible to complete the form during a window that depended on the child’s birth date. For example, parents were eligible to complete the 12 month form when their child was 10 months to 16 months old. At some affiliate sites, forms were mailed to families or telephone interviews were conducted with parents whose child did not make a visit during the window of opportunity or who did not complete the form at the visit. At a few sites, parents could complete the form at home before the office visit or during a home visit. The standardized forms included questions about the parents’ perception of support they received for child rearing activities from both formal and informal sources, and receipt of practice-based and other services such as early intervention services and home visits. A series of questions focused on their engagement in activities that promote their children’s health and learning, and on their use of safety devices. Parental health behavior items included whether the mother or father smoked. Finally, there were several questions focusing on the frequency of injuries sustained by the child, emergency department visits, and hospitalizations in the last 6 months, the age(s) at which the event(s) occurred, and the reason for the emergency department visit(s) or hospitalization(s). HS Specialists collected and returned the parent questionnaires to JHU. Once at JHU, the front identification sheet was removed and processed separately from the questionnaire to maintain the respondent’s confidentiality. Trained coders at JHU edited and coded the questionnaires, checking for missing or incomplete data. Sosio Incorporated entered the data. Data analysis was conducted using SAS. Sample Table A.4 gives the total number of affiliate families who completed each parent questionnaire. There are a number of reasons why questionnaires may not have been returned by parents: 1) families may have left the practice or withdrawn form the evaluation; 2) site staff may have missed opportunities to administer the questionnaire; 3) the parent may have declined to complete the 40 WORKING DRAFT -- NOT FOR DISTRIBUTION questionnaire; or 4) the parent may not have brought the child in for an office visit during the appropriate age window. Table A.4 Response Rate to Parent Questionnaires % Newborn 6 Months 12 Months 18 Months 24 Months N 1096 768 607 479 341 Total Enrolled (n=1103) 99.4 68.7 46.0 43.4 30.9 Analysis Data at each time period were explored using simple frequencies. However, in order to maximize the sample size of the parent questionnaires, we conducted trend analyses. These analyses took into consideration differences across sites and the correlation of individual responses. A unique feature of the 24-month parent questionnaire was that The MacArthur Communicative Development Inventories/Word & Sentences (CDI-WS) was incorporated into the questionnaire with permission from the author1. The questionnaire was administered in the same manner as the other parent questionnaires. Completed forms were returned to the evaluation team, where they were datestamped, edited, and coded. Approximately 27% of the dates were missing from the completed 24month questionnaires. Because the CDI-WS is age sensitive, missing dates were assigned as the date of the nearest office visit within the window of opportunity for the questionnaire (23 – 26 months) as documented on the HS contact logs. Comparison of children with imputed dates and reported dates showed no significant differences in terms of the child’s age and sex. Age-specific and sex-specific comparisons of outcomes were also performed. Only one statistically significant difference was detected; a smaller percentages of boys with imputed dates than those with actual dates combined words at 24 months. These results gave us confidence in the accuracy of the imputed dates. Sample Only those children who were determined to be clients at the practice during the window of opportunity for the CDI-WS were included in the sample. To be eligible, a child must have visited the practice or received a home visit from the HS Specialist between 23 and 26 months of age. Of the 1,103 children originally enrolled in the evaluation at affiliate sites, 547 were determined to be clients of the practice between 23 and 26 months of age. Response rates varied somewhat by site (Table A.5). Overall, the parents of 341 (62.3%) of these children completed the CDI-WS. Of these 246 (72.1%) completed the English language version and 95 (27.9%) completed the Spanish Language version. 1 Fenson L et al. The MacArthur Communicative Development Inventories: User’s guide and technical manual. San Diego, CA: Singular Publishing Group. 1994. 41 WORKING DRAFT -- NOT FOR DISTRIBUTION Table A.5 Percentage of Eligible Children with Completed MacArthur CDI-WS by Site Site 1 2 3 4 5 6 Total N % 75 115 36 20 44 51 73.5 72.8 45.0 43.5 74.6 50.0 341 62.3 Sites are listed in random order We compared the demographic characteristics of respondents to non-respondents (Table A.6). Respondents differed significantly from non-respondents in ways that may affect results. Among respondents, mothers had significantly more years of education than did non-respondents, were generally older, and were less likely to have relied on Medicaid during pregnancy while fathers were more likely to be employed. However, there were no significant differences in race, Hispanic ethnicity, birth order, low birthweight, or mother’s employment. These differences suggest that children in families that completed the MacArthur at affiliate sites may be at less risk for poor developmental outcomes than families that did not complete it. 42 WORKING DRAFT -- NOT FOR DISTRIBUTION Table A.6 Comparison of Affiliate Families who Responded to the MacArthur CDI-WS to Families that Did Not Respond Respondents N = 341 % Non-Respondents N = 206 % Mother’s Age* 19 or less 20 – 29 30 or more 20.2 42.8 37.0 26.2 48.5 25.2 Mother’s Education* Some High School or Less High School Graduate Some College, Vocational College Graduate 40.2 17.0 15.3 27.6 43.6 24.8 15.4 16.3 Mother’s Race White Black/African American Asian/Native American Other 61.5 10.3 0.6 27.7 51.2 18.5 1.0 29.3 Mother’s Ethnicity—Hispanic 54.0 57.8 Mother Married at Child’s Birth** 67.5 51.0 First-time Parent 46.9 46.6 Used Medicaid to Cover Pregnancy/Delivery*** 37.7 63.5 Mother Employed Outside Home 32.4 24.4 Father Employed* 85.0 77.7 5.0 3.6 Child Low Birthweight (<2500 grams) *p<.05; ** p<.01; *** p<.001 Employment status was not reported for 4.6% of fathers Parent Telephone Interview Half way through the Healthy Steps program, when their children were approximately 18 months old, affiliate families were asked to participate in a telephone interview. The telephone interview updated demographic information on the family. It also contained questions about parenting practices related to the child’s nutrition, development, safety, and health care utilization. In addition, parents were 43 WORKING DRAFT -- NOT FOR DISTRIBUTION asked to comment on the Healthy Steps services they had received from their practice and their satisfaction with these services. The interview also contained a limited number of questions regarding the parents’ own health and health behaviors. The telephone interviews were conducted by Battelle/Centers for Public Health Research and Evaluation using a computer assisted telephone interview (CATI). CATI not only facilitated the interviewing process but it reduced data errors by automatically skipping questions based on the respondent’s answers, refusing inconsistent or “impossible” responses, and entering responses directly into the computer. Sample Of the 1,103 affiliate families originally enrolled in the Healthy Steps program, 30% were not eligible to participate in this telephone survey, the majority because they had moved out of the area. Of the 784 families eligible to participate, 636 families (81%) completed an interview. Eighteen percent of eligible families (141) could not be located. Only 7 eligible families refused to be interviewed. Nearly all (99%) of interviews were completed by the study child’s biological mother; 73% of interviews were conducted in English and 27% in Spanish. Interviews took on average 28 minutes to complete. Most children were 17-18 months old at the time of the interview (92%) and 93% of study children still were receiving care at the Healthy Steps site. Of the mothers interviewed, 12% were less 20 years old; 33% were over 30 years old. At the time of the interview, 12% of mothers interviewed were in school and nearly half (46%) were employed. Sixty-two percent were married. Slightly over half (54%) of the mothers interviewed owned their own homes. When considering results from these interviews, it is important to keep in mind that a number of families did not complete this interview; 81% of eligible families completed an interview but that represents only 58% of the total families enrolled in the Affiliate Evaluation. We know that families who were not eligible to participate in the interview or who did not complete the interview differed from the eligible families who completed an interview. As Table A.7 indicates, a statistically significant greater percentage of mothers who completed the interview at 18 months were older, better educated and married than mothers who were not eligible to be interviewed or did not complete an interview. A greater percentage of White mothers completed an interview, while fewer AfricanAmerican mothers did. Mothers did not differ in terms of their ethnicity. Families who completed an interview tended to be wealthier than families who did not, as measured by the percentage of fathers employed outside the home and the method of payment for pregnancy and delivery expenses. These differences may bias the results. 44 WORKING DRAFT -- NOT FOR DISTRIBUTION Table A.7 Comparison of Affiliate Families who were Not Eligible to be Interviewed or Did Not Complete a Telephone Interview to Families who Completed a Telephone Interview at 18 Months Families Not Eligible/ Did Not Complete Interview (n=467) N % Families Completed Interview (n=636) N % Mother’s Age at Child’s Birth*** Less than 20 20-29 30 or older 117 256 87 25.4 55.7 18.9 140 298 196 22.1 47.0 30.9 Mother’s Education at Child’s Birth*** Less than HS HS Graduate Some college, vocational school College graduate or higher 243 111 70 32 53.3 24.3 15.4 7.0 254 130 107 137 40.4 20.7 17.0 21.8 Mother’s Race*** White African-American Asian/Native American Other 186 143 6 123 40.6 31.2 1.3 26.9 356 102 8 166 56.3 16.1 1.3 26.3 Mother’s Ethnicity – Hispanic 239 51.7 340 53.6 Mother Married at Child’s Birth*** 202 44.1 380 60.5 Father Employed Outside the Home*** 324 73.3 530 87.2 First-time Parent 180 39.0 278 43.8 Used Medicaid to Cover Pregnancy/Delivery*** 306 67.3 294 47.6 Child Low Birthweight (< 2500 gms) *** p<.001 22 4.9 31 5.0 Analysis Simple frequencies and bivariate analyses were performed using SAS-PC software package. Medical Record Reviews Medical record reviews were conducted for all children enrolled in the Affiliate Evaluation and for a retrospective sample of children. For each site, the retrospective sample consisted of 100 children who received care at the practice approximately 1 year prior to the Healthy Steps program. Sites generated a list of all children who had attended the practice during the year prior to Healthy Steps. From this list, the first 100 children were selected for the retrospective sample based on the same criteria as the Healthy Steps sample; that is, they had to have made a visit to the pediatric practice within the first 28 days of life. 45 WORKING DRAFT -- NOT FOR DISTRIBUTION The same procedures were followed for abstracting data from a child’s medical record for the Healthy Steps and retrospective samples. Data were abstracted using detailed protocols designed by the JHU evaluation team. In order to ensure the consistency of data collection across sites, a member of the JHU evaluation team provided on-site training in medical review. For each visit, the reviewer recorded the following information: the date of visit, type of visit and whether the visit was kept; the child’s height and weight; whether the child received any immunizations or developmental assessments at the visit and if so, what kind(s); and whether the child was referred for any services and if so, what kind and for what reason. All visits in the child’s medical record were abstracted from birth until 14 months. We extended the abstraction through 14 months in an attempt to capture the child’s one-year well child visit. Sample In general, the sample used for the analyses of the medical record data consisted of all children who made two or more visits to the practice, with one of the visits occurring after 6 months. We defined the sample in this manner in an attempt to identify children who were still receiving care at the practice at 14 months. The final sample used for the medical record analyses included 1,354 children (890 children who participated in Healthy Steps and 464 children who had received care at the practice one year prior to Healthy Steps. This represents 78% of eligible children. Analysis Simple frequencies and bivariate analyses were performed using SAS-PC software package. Age-Appropriate Well Child Visits: We looked at the percentage of children who received a well child visit at 1, 2, 4, 6, 9, and 12 months of age. The time periods were based on the American Academy of Pediatrics’ recommended schedule of well child visits for the first year of life. For a well child visit to be considered age-appropriate, the visit had to occur within a window around each age. For example, the six-month well child visit had to occur between 5 to 7 months. For each time period, we had to determine which children were actively seeking health care from the provider or in other words, who were “at risk” for a well child visit. We defined the eligible sample as children who had made a visit to the practice, as recorded in their medical record, during or after the previous ageappropriate well child visit window. For example, for a child to be eligible for the six-month ageappropriate well child visit, s/he had to have made a well child visit after 3 months. Up-to-Date Immunizations: We created a variable to reflect whether a child had received all his/her recommended immunizations by 12 months. By definition, a child was up-to-date if by 12 months they had received 3 DTP vaccinations, 2 Polio vaccinations, 3 Hib vaccinations and 2 Hep-B vaccinations. We did not include the MMR in the definition of up-to-date. The MMR should not be given prior to 12 months. Because we stopped abstracting the medical record at 14 months, this did not leave a very wide window for receipt of a MMR. If a child was missing data for any vaccinations, they were categorized as missing the up-to-date immunization. At one site, a sizeable number of children were missing the up-to-date report of their HIB vaccinations. We defined the sample as all children who made 2 or more visits to the practice, with 1 visit occurring after 6 months. 46
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